Single‐incision sling operations for urinary incontinence in women

Abstract

Background

Stress urinary incontinence imposes a significant health and economic burden on individuals and society. Single‐incision slings are a minimally‐invasive treatment option for stress urinary incontinence. They involve passing a short synthetic device through the anterior vaginal wall to support the mid‐urethra. The use of polypropylene mesh in urogynaecology, including mid‐urethral slings, is restricted in many countries. This is a review update (previous search date 2012).

Objectives

To assess the effects of single‐incision sling operations for treating urinary incontinence in women, and to summarise the principal findings of relevant economic evaluations.

Search methods

We searched the Cochrane Incontinence Specialised Register, which contains trials identified from: CENTRAL, MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, and two trials registers. We handsearched journals, conference proceedings, and reference lists of relevant articles to 20 September 2022.

Selection criteria

We included randomised or quasi‐randomised controlled trials in women with stress (or stress‐predominant mixed) urinary incontinence in which at least one, but not all, trial arms included a single‐incision sling.

Data collection and analysis

We used standard Cochrane methodological procedures. The primary outcome was subjective cure or improvement of urinary incontinence.

Main results

We included 62 studies with a total of 8051 women in this review. We did not identify any studies comparing single‐incision slings to no treatment, conservative treatment, colposuspension, or laparoscopic procedures. We assessed most studies as being at low or unclear risk of bias, with five studies at high risk of bias for outcome assessment.

Sixteen trials used TVT‐Secur, a single‐incision sling withdrawn from the market in 2013. The primary analysis in this review excludes trials using TVT‐Secur. We report separate analyses for these trials, which did not substantially alter the effect estimates.

We identified two cost‐effectiveness analyses and one cost‐minimisation analysis.

Single‐incision sling versus autologous fascial sling

One study (70 women) compared single‐incision slings to autologous fascial slings. It is uncertain if single‐incision slings have any effect on risk of dyspareunia (painful sex) or mesh exposure, extrusion or erosion compared with autologous fascial slings. Subjective cure or improvement of urinary incontinence at 12 months, patient‐reported pain at 24 months or longer, number of women with urinary retention, quality of life at 12 months and the number of women requiring repeat continence surgery or sling revision were not reported for this comparison.

Single‐incision sling versus retropubic sling

Ten studies compared single‐incision slings to retropubic slings. There may be little to no difference between single‐incision slings and retropubic slings in subjective cure or improvement of incontinence at 12 months (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.91 to 1.07; 2 trials, 297 women; low‐certainty evidence). It is uncertain whether single‐incision slings increase the risk of mesh exposure, extrusion or erosion compared with retropubic minimally‐invasive slings; the wide confidence interval is consistent with both benefit and harm (RR 1.55, 95% CI 0.24 to 9.82; 3 trials, 267 women; low‐certainty evidence). It is uncertain whether single‐incision slings lead to fewer women having postoperative urinary retention compared with retropubic slings; the wide confidence interval is consistent with possible benefit and harm (RR 0.47, 95% CI 0.12 to 1.84; 2 trials, 209 women; low‐certainty evidence). The effect of single‐incision slings on the risk of repeat continence surgery or mesh revision compared with retropubic slings is uncertain (RR 4.19, 95% CI 0.31 to 57.28; 2 trials, 182 women; very low‐certainty evidence). One study reported quality of life, but not in a suitable format for analysis. Patient‐reported pain at more than 24 months and the number of women with dyspareunia were not reported for this comparison. We downgraded the evidence due to concerns about risks of bias, imprecision and inconsistency.

Single‐incision sling versus transobturator sling

Fifty‐one studies compared single‐incision slings to transobturator slings. The evidence ranged from high to low certainty. There is no evidence of a difference in subjective cure or improvement of incontinence at 12 months when comparing single‐incision slings with transobturator slings (RR 1.00, 95% CI 0.97 to 1.03; 17 trials, 2359 women; high‐certainty evidence). Single‐incision slings probably have a reduced risk of patient‐reported pain at 24 months post‐surgery compared with transobturator slings (RR 0.12, 95% CI 0.02 to 0.68; 2 trials, 250 women; moderate‐certainty evidence). The effect of single‐incision slings on the risk of dyspareunia is uncertain compared with transobturator slings, as the wide confidence interval is consistent with possible benefit and possible harm (RR 0.78, 95% CI 0.41 to 1.48; 8 trials, 810 women; moderate‐certainty evidence). There are a similar number of mesh exposures, extrusions or erosions with single‐incision slings compared with transobturator slings (RR 0.61, 95% CI 0.39 to 0.96; 16 trials, 2378 women; high‐certainty evidence). Single‐incision slings probably result in similar or reduced cases of postoperative urinary retention compared with transobturator slings (RR 0.68, 95% CI 0.47 to 0.97; 23 trials, 2891 women; moderate‐certainty evidence). Women with single‐incision slings may have lower quality of life at 12 months compared to transobturator slings (standardised mean difference (SMD) 0.24, 95% CI 0.09 to 0.39; 8 trials, 698 women; low‐certainty evidence). It is unclear whether single‐incision slings lead to slightly more women requiring repeat continence surgery or mesh revision compared with transobturator slings (95% CI consistent with possible benefit and harm; RR 1.42, 95% CI 0.94 to 2.16; 13 trials, 1460 women; low‐certainty evidence). We downgraded the evidence due to indirectness, imprecision and risks of bias.

Authors' conclusions

Single‐incision sling operations have been extensively researched in randomised controlled trials. They may be as effective as retropubic slings and are as effective as transobturator slings for subjective cure or improvement of stress urinary incontinence at 12 months. It is uncertain if single‐incision slings lead to better or worse rates of subjective cure or improvement compared with autologous fascial slings. There are still uncertainties regarding adverse events and longer‐term outcomes. Therefore, longer‐term data are needed to clarify the safety and long‐term effectiveness of single‐incision slings compared to other mid‐urethral slings.

Plain language summary

How effective and safe are single‐incision slings for women with urinary incontinence compared with other operations?

Key messages

‐ Single‐incision slings are as likely as mid‐urethral slings to cure incontinence and may be associated with less pain. 
‐ We are less certain about the differences between single‐incision slings and other surgeries. 
‐ Current evidence is largely limited to 2 years of follow‐up. We need more long‐term results to establish how effective and safe single‐incision slings are compared to other surgical treatments.

What is urinary incontinence?

Urinary incontinence is when a person leaks urine by accident. It affects up to half of women over their lifetime. Stress urinary incontinence is urinary leakage that occurs during coughing, sneezing, or exercising. It is caused by weakness in the pelvic floor muscles that support the urethra (urine drainage tube from the bladder).

How is urinary incontinence treated?

It is treated first with exercises to strengthen the pelvic floor muscles. Around 1 in 10 women may need surgery.

All surgeries for urinary incontinence aim to support the bladder neck and the urethra. Surgery options vary in terms of how invasive they are, potential complications and recovery times. The most common surgeries today use a ‘sling’ which helps keep the urethra closed when there is sudden bladder pressure. Slings can be grouped into three categories:

‐ autologousslings: made from the patient’s own body tissue (fascia);
‐ standard mid‐urethral slings: made from relatively long strips of polypropylene (plastic) mesh tape that are anchored in the surrounding tissues. Two common types are ‘retropubic slings’ and ‘transobturatorslings’. A key difference is in how the surgeon positions the tape. 
‐ ‘single‐incision slings’: made from relatively short strips of mesh tape, placed through a single cut inside the vagina.

For all polypropylene mesh slings, once the sling is in position, connective tissue grows through the holes in the mesh to anchor the sling in position.

In recent years, mesh slings have come under widespread public scrutiny and some have been withdrawn from the market.

What did we want to find out?

We wanted to learn how single‐incision slings compare to other surgeries for urinary incontinence. We were interested in their effects on:

‐ curing or improving urinary incontinence;
‐ risk of pain and painful sex;
‐ risk of mesh erosions (exposure of or protrusion of tape into the vagina);
‐ urinary retention;
‐ risk of injuries and infections;
‐ need for further surgery;
‐ quality of life.

What did we do?

We searched for studies that compared single‐incision slings to:

‐ other types of slings;
‐ other types of surgeries;
‐ conservative treatment (e.g. pelvic floor exercises) or no treatment.

We compared and summarised the studies’ results and rated our confidence in the evidence, based on factors such as study methods and sizes.

What did we find?

We found 62 studies with 8051 women that compared single‐incision slings to other sling surgeries. The women varied in age, weight and number of children born.

Ten studies received funding from industry or device manufacturers. Of these, 4 made a clear statement that industry sponsors were not involved in study design, conduct or writing. The remaining 6 studies provided few or unclear details.

Main results

One study compared single‐incision to autologous slings and found that there is little difference between the 2 operations for the complications of painful sex and mesh exposure/erosions. The study did not report on other outcomes.

Single‐incision versus retropubic slings: 10 studies

‐ There is little to no difference between these procedures for patient‐reported cure or improvement of urinary incontinence. 
‐ Single‐incision slings may cause more mesh erosions compared to retropubic slings, but the evidence is uncertain. 
‐ We do not know whether single‐incision slings have any effect on the risk of urinary retention, the need for further surgery or quality of life compared with retropubic slings. 
‐ There was no information on long‐term pain or painful sex.

Single‐incision versus transobturator slings: 51 studies

‐ Women who have single‐incision slings are just as likely to have their incontinence cured or improved at 12 months as those with transobturator slings. 
‐ Women with single‐incision slings may have: (a) a similar number of mesh erosions and (b) the same risk of urinary retention, but (c) report less pain. 
‐ We are uncertain whether single‐incision slings affect the risk of painful sex. 
‐ Women may have a slightly poorer quality of life at 12 months compared to women with transobturator slings. 
‐ It is unclear whether the slings differ in the risk of needing further surgery later.

What are the limitations of the evidence?

Overall, we could not be certain of the results comparing single‐incision slings to either autologous slings or retropubic slings because the studies were small and varied in important ways. We have more confidence in the substantial amount of evidence comparing single‐incision to transobturator slings; this evidence is less likely to change with the publication of more trials.

How up to date is this evidence?

This review updates our previous version. The evidence is current to September 2022.

Summary of findings

Summary of findings 1. Single‐incision slings compared to autologous fascial slings for urinary incontinence in women.

Single‐incision slings (excluding TVT‐S) compared to autologous fascial slings for urinary incontinence in women
Patient or population: women with urinary incontinence Settings: secondary care Intervention: single‐incision slings (excluding TVT‐S) Comparison: autologous fascial slings
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Autologous fascial sling	Single‐incision slings (excluding TVT‐S)
Subjective cure or improvement of urinary incontinence: at 12 months	‐	‐	‐	‐	‐	Not reported
Patient‐reported pain: at more than 24 months	‐	‐	‐	‐	‐	Not reported
Number of women with dyspareunia	Study population		RR 1.33 (95% CI 0.32 to 5.53)	70 (1 study)	⊕⊕⊝⊝ Lowa	‐
	86 per 1000	114 per 1000 (27 to 474)
Number of women with mesh exposure, extrusion or erosion in any area	Study population		RR 2.00 (95% CI 0.19 to 21.06)	70 (1 study)	⊕⊕⊝⊝ Lowa	‐
	29 per 1000	57 per 1000 (5 to 602)
Number of women with urinary retention	‐	‐	‐	‐	‐	Not reported
Quality of life: at 12 months	‐	‐	‐	‐	‐	Not reported
Number of women requiring repeat continence surgery	‐	‐	‐	‐	‐	Not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio; TVT‐S: tension‐free vaginal tape‐Secur
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

^aDowngraded twice for serious imprecision: very wide CIs including both benefit and harm, and one small study with small sample size.

Summary of findings 2. Single‐incision slings compared to retropubic minimally‐invasive slings for urinary incontinence in women.

Single‐incision slings (excluding TVT‐S) compared to retropubic minimally‐invasive slings for urinary incontinence in women
Patient or population: women with urinary incontinence Setting: secondary care Intervention: single‐incision slings (excluding TVT‐S) Comparison: retropubic minimally‐invasive slings
Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Risk with retropubic minimally‐invasive slings	Risk with single‐incision slings (excluding TVT‐S)
Subjective cure or improvement of urinary incontinence: at 12 months	Study population		RR 0.99 (0.91 to 1.07)	297 (2 studies)	⊕⊕⊝⊝ Lowa,b	‐
	886 per 1000	877 per 1000 (806 to 948)
Patient‐reported pain: at more than 24 months	‐	‐	‐	‐	‐	Not reported
Number of women with dyspareunia	‐		‐	‐	‐	Not reported
Number of women with mesh exposure, extrusion or erosion in any area	Study population		RR 1.55 (0.24 to 9.82)	267 (3 studies)	⊕⊕⊝⊝ Lowc	‐
	7 per 1000	12 per 1000 (2 to 73)
Number of women with urinary retention	Study population		RR 0.47 (0.12 to 1.84)	209 (2 studies)	⊕⊕⊝⊝ Lowc	‐
	59 per 1000	28 per 1000 (7 to 108)
Quality of life: at 12 months	See comment		‐	‐	‐	One study reported quality‐of‐life data, but not in a suitable form for analysis.
Number of women requiring repeat continence surgery or mesh revision	Study population		RR 4.19 (0.31 to 57.28)	182 (2 studies)	⊕⊝⊝⊝ Very lowc,d	‐
	44 per 1000	184 per 1000 (14 to 1000)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio; TVT‐S: tension‐free vaginal tape‐Secur
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

^aDowngraded one level due to risk of bias (unclear risk across several domains, lack of blinding).
^bDowngraded one level for imprecision: few participants.
^cDowngraded two levels for imprecision (few participants and wide 95% CI consistent with possible benefits and possible harms).
^dDowngraded one level for inconsistency: statistical heterogeneity probably due to variation in follow‐up periods in included studies.

Summary of findings 3. Single‐incision slings compared to transobturator minimally‐invasive slings for urinary incontinence in women.

Single‐incision slings (excluding TVT‐S) compared to transobturator minimally‐invasive slings for urinary incontinence in women
Patient or population: women with urinary incontinence Setting: secondary care Intervention: single‐incision slings (excluding TVT‐S) Comparison: transobturator minimally‐invasive slings
Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Risk with transobturator minimally‐invasive slings	Risk with single‐incision slings (excluding TVT‐S)
Subjective cure or improvement of urinary incontinence: 12 months	Study population		RR 1.00 (0.97 to 1.03)	2359 (17 studies)	⊕⊕⊕⊕ High	‐
	875 per 1000	875 per 1000 (849 to 901)
Patient‐reported pain: at more than 24 months	Study population		RR 0.12 (0.02 to 0.68)	250 (2 studies)	⊕⊕⊝⊝ Moderatea	‐
	104 per 1000	12 per 1000 (2 to 71)
Number of women with dyspareunia	Study population		RR 0.78 (0.41 to 1.48)	810 (8 studies)	⊕⊕⊕⊝ Moderateb	‐
	45 per 1000	35 per 1000 (19 to 67)
Number of women with mesh exposure, extrusion or erosion in any area	Study population		RR 0.61 (0.39 to 0.96)	2378 (16 studies)	⊕⊕⊕⊕ High	‐
	38 per 1000	23 per 1000 (15 to 37)
Number of women with urinary retention	Study population		RR 0.68 (0.47 to 0.97)	2891 (23 studies)	⊕⊕⊕⊝ Moderatec	‐
	44 per 1000	30 per 1000 (21 to 42)
Quality of life: at 12 months	‐	‐	SMD 0.24 (0.09 to 0.39)	689 (8 studies)	⊕⊕⊝⊝ Lowa,d	‐
Number of women requiring repeat continence surgery or mesh revision	Study population		RR 1.42 (0.94 to 2.16)	1460 (13 studies)	⊕⊕⊝⊝ Lowb,d	‐
	44 per 1000	63 per 1000 (42 to 96)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio; SIS: single‐incision sling; SMD: standardised mean difference; TVT‐S: tension‐free vaginal tape‐Secur
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

^aDowngraded one level for imprecision (small sample size).
^bDowngraded one level due to imprecision (95% CI consistent with possible benefits and possible harms).
^cDowngraded one level due to risk of bias (unclear randomisation and allocation concealment).
^dDowngraded one level due to risk of bias (unclear performance and detection bias).

Background

For a glossary of medical terms, please see Appendix 1.

Description of the condition

Urinary incontinence is common, with a lifetime incidence of up to 50% and a prevalence of 10% to 40% (Milsom 2009). It is associated with pregnancy and childbirth, although there is a genetic component (Tähtinen 2016). It affects quality of life, reducing the ability to work and to engage in social and physical activities. There is increased psychological burden and sexual dysfunction in affected women.

Stress urinary incontinence (SUI) is the involuntary loss of urine when coughing, sneezing or exercising. It is most significantly associated with pregnancy, childbirth, age and the menopause. It affects 20% to 50% of all women; up to 80% of incontinent women have symptomatic SUI. This represents a large unmet health need, imposing significant health and economic burdens on society and the women affected (Papanicolaou 2005). Physiologically, SUI is caused by an anatomical or mechanical weakness in the urethra, urethral sphincter or pelvic floor fascia. It is commonly treated by pelvic floor physiotherapy then surgery. When physiotherapy is not successful, surgery may be offered; up to 10% of women in high‐income countries will undergo surgery for stress incontinence in their lifetime (Agarwal 2014).

Urge incontinence is the involuntary loss of urine in association with a feeling of 'urgency', a sudden compelling desire to pass urine which is difficult to defer. It is caused by involuntary detrusor contractions, which may be neurogenic or idiopathic. Treatment is by medication (most commonly anti‐muscarinic drugs), intra‐vesical botulinum toxin injections or, in extreme cases, surgery.

Mixed incontinence is a combination of stress and urge incontinence.

Incontinent women spend on average USD (US dollars) 5.42 and up to USD 100 per week on products, depending on the severity of their symptoms, with an average of two products per day but a maximum of 32 products per day (Chisholm 2022). In 1995 USD, the annual direct cost of urinary incontinence in women was USD 12.4 billion (124 million) (Wilson 2001). A systematic review of SUI studies demonstrates the heterogeneity of cost estimates in this area (Zwolsman 2019). About 70% of this cost is borne by the individual and their families, mainly through routine care (purchasing pads and disposable underwear, laundry and dry cleaning). Of the remaining 30%, 14% is spent on nursing home admissions, 9% on treatment, 6% on addressing complications and 1% on diagnosis (Chong 2011). Indirect economic costs, such as the social and psychological burden of SUI, are difficult to quantify (Chong 2011).

The costs of diagnosis, treatment and follow‐up for SUI differ between countries. A 2004 study conducted in three European countries found that the total cost of SUI per patient per year was EUR (euros) 395, EUR 515 and EUR 655 in the UK, Germany and Spain, respectively (Papanicolaou 2005). With respect to the costs that fall directly on women and their families, Subak 2014 estimated that women (mean age 53) had weekly out‐of‐pocket costs of USD 18.65 (with a standard deviation of USD 30.30); the median cost was USD 10.55. This equates to nearly USD 1000 per year to purchase consumables and services not available through their healthcare provider.

Costs both at a societal and an individual level are increasing over time due to increased prevalence secondary to ageing populations, an increased desire for improved quality of life, improved recognition of the condition, and greater surgical and non‐surgical management options (Villoro 2016).

Description of the intervention

Historically, surgical treatment for SUI has involved invasive procedures, including open colposuspension and autologous fascial slings. Open colposuspension involves placing stitches in the vagina on either side of the urethra. These stitches are then tied to supportive ligaments to elevate the vagina and support the urethra. Autologous fascial slings (also known as ‘traditional slings’) involve taking a strip of tissue from the patient’s lower abdomen and using it as a sling around the bladder neck and urethra (Lapitan 2017; Saraswat 2020).

Over time, and particularly since about 2005, less invasive procedures using slings made from polypropylene mesh tape have largely replaced colposuspension and autologous fascial slings. There are two main types of polypropylene sling: retropubic and transobturator. Retropubic slings (also known as tension‐free vaginal tape (TVT)) involve passing the sling through a small incision inside the vagina. The tape is then positioned under the bladder neck/urethra, and the ends of the tape are passed through a belly incision or an inner thigh incision before the surgeon adjusts the tightness (tension) of the tape. Transobturator slings involve placing the sling under the mid‐portion of the urethra through a small incision in the vagina. The tape is then passed into a tunnel created around each side of the urethra and out through the thigh fold through two small skin incisions.

Both retropubic and transobturator slings are placed using trocars: devices for making small incisions in outer tissue layers, which allow surgeons to insert cannulas to allow placement of the slings. Once these slings are in position, supporting connective tissue grows through the holes in the mesh weave to anchor it in position, usually over three to four weeks. Both types also rely on fixation to nearby tissues with a long trajectory arm. However, they differ in the way the surgeon positions and anchors the sling. Retropubic slings are anchored to the abdominal wall. They are associated with bladder injury (up to 4%), vascular injury and voiding dysfunction. Transobturator slings are passed through the groin and obturator foramen (large openings in the hipbone) via either an 'outside in' or 'inside out' approach, and are anchored to the obturator muscle. They are associated with a 12% incidence of groin and hip pain postoperatively and a 1% reoperation rate (Latthe 2007). For both types, many of these complications are associated in some way with the blind passage of the trocar through tissues (Caldwell 2021).

Collectively, transobturator and retropubic are often referred to as ‘standard’ mid‐urethral slings (SMUS). As noted above, these devices have largely replaced colposuspension and autologous fascial sling procedures for treating SUI. Using UK Hospital Episode Statistics (HES) data as an example, in 2000, the numbers of standard mid‐urethral slings and colposuspension procedures being performed were similar: 3000 to 4000 of each per year. By 2010, the number of standard mid‐urethral sling procedures had increased to approximately 11,000 per year and far fewer colposuspension and autologous fascial sling surgeries were performed. This was mostly due to the shorter operating times and lower intraoperative complication rates seen with standard mid‐urethral slings.

Surgical treatments for stress urinary incontinence have continued to evolve. The subsequent development of single‐incision slings (SIS, also commonly referred to as single‐incision mini‐slings (SIMS)) has aimed to reduce the adverse event profile associated with both transobturator and retropubic standard mid‐urethral slings. Single‐incision slings involve a significantly shorter length of polypropylene mesh tape (8 cm to 14 cm), and as the name implies, a single incision is made within the vagina with no tape exit wounds in the groin or lower abdomen. In these procedures, the slings are anchored to the obturator membrane (transobturator approach) or retropubic space (retropubic approach), stopping short of the pelvic floor.

As for all mid‐urethral sling procedures, it is possible to perform single‐incision slings under local anaesthetic, if patients and surgeons prefer. Single‐incision slings may be as effective as standard mid‐urethral slings in terms of cure of incontinence, with a similar adverse event profile (Abdel‐Fattah 2022). TVT‐Secur is one type of single‐incision sling which has been withdrawn from the market due to reduced clinical efficacy compared to other single‐incision slings.

A review of the main groups of surgical approaches for SUI is outlined in Table 4.

1. Surgery for stress urinary incontinence (SUI).

Surgery for SUI	Description	Efficacy
Anterior vaginal repair with Kelly sutures	Anterior repair with urethral buttressing sutures	Primary prolapse surgery, up to 50% effective to treat SUI but may worsen symptoms of occult SUI (Glazener 2017)
Needle suspension surgery	Transvaginal needle bladder neck suspension	Less effective than open colposuspension (Glazener 2017)
Burch colposuspension	Open abdominal retropubic colposuspension	85% to 95% cure at 1 year and 70% cure at 5 years. Open colposuspension has a greater risk of pelvic organ prolapse compared to mid‐urethral slings and anterior repair (Lapitan 2017).
Laparoscopic colposuspension	Laparoscopic retropubic colposuspension	Probably little difference in terms of cure of incontinence between laparoscopic colposuspension and open colposuspension and laparoscopic colposuspension and mid‐urethral sling procedures (Freites 2019)
Traditional mid‐urethral sling	Harvests autologous fascia (rectus sheath and tensor fascia lata) and inserts as a mid‐urethral sling	May be more effective than open colposuspension at 1 to 5 years, and women may be less likely to require further surgery. May be as effective as mid‐urethral slings (Saraswat 2020)
Transobturator sling	Insertion of a polypropylene sling between the urethra and the obturator muscles	Short‐term cure: 62% to 98%; long‐term cure: 43% to 92%. More groin pain than with retropubic slings (Ford 2017)
Retropubic mid‐urethral sling	Insertion of a polypropylene sling between the urethra and the abdomen	Short‐term cure: 71% to 97%; long‐term cure: 51% to 88% (Ford 2017).
Single‐incision mid‐urethral sling	Insertion of a shorter polypropylene sling to support the urethra	SIS was noninferior to SMUS in a large multicentre RCT in the UK, with success rate of 72% at 3 years (versus 67% for SMUS) (Abdel‐Fattah 2022).
Urethral bulking injections	Injection of an inert polymer to support the urethra under general anaesthetic	Not as effective as open colposuspension; lack of long‐term data (Kirchin 2017)

RCT: randomised controlled trial; SIS: single‐incision sling; SMUS: standard mid‐urethral sling; SUI: stress urinary incontinence

Summary of the use of polypropylene mesh in urogynaecology

Synthetic polypropylene devices have been under scrutiny in recent years due to increased reporting of longer‐term complications of pain and exposure and erosion of mesh by patients and clinicians. These developments have led to government enquiries (see, for example, Scottish Government 2017). There are more than 2000 published reports from trials of synthetic mid‐urethral slings for stress urinary incontinence. Although some of these publications have included long‐term data (e.g. Nilsson 2013, 17 years), the vast majority did not publish outcome data after 12 months post surgery. Due to the size of trials, it is difficult to power individual studies to report on the incidence and severity of longer‐term outcomes. The meta‐analyses of this topic are limited both by the outcomes trial authors have chosen to report and the follow‐up period of the trials. Therefore, interpretation of results should be approached with caution, as serious but rare complications, such as mesh exposure, extrusion or erosion, can be under‐reported.

Since July 2018, all transvaginal mesh procedures for incontinence and prolapse have been suspended in the UK, including mid‐urethral and single‐incision slings. Other procedures for incontinence and prolapse have been placed under 'high vigilance restriction', including all native tissue continence surgery, all abdominal mesh surgery for prolapse and some native tissue surgery for prolapse (RCOG 2018). Alongside the Royal College of Obstetricians and Gynaecologists (RCOG) mesh safety alert, the report by the Mesh Oversight Group highlights recommendations. These include:

• the performance of continence surgery by a smaller number of high‐volume practitioners;

• discussion of complex cases in multidisciplinary teams and onward referral to tertiary centres for mesh insertion or laparoscopic removal;

• reporting on national databases (e.g. British Society of Urogynaecology audit database) (BSUG 2021); and

• recommendations on improving the consent process (NHS England 2017).

In England, mesh complication centres have been commissioned by National Health Service (NHS) Improvement to offer specialist centres for women with complications from urogynaecological mesh, to support multidisciplinary team‐working in this complex area. Similar services have been set up by NHS Scotland (the national Complex Mesh Surgical Service hosted by NHS Greater Glasgow and Clyde), NHS Wales and Health and Social Care (HSC) Northern Ireland in 2021. Patients benefit from the involvement of pain services; mesh complications can be managed by urogynaecologists with support from colorectal surgeons, interventional radiologists, urologists, physiotherapy, pain services and mesh psychology. On the whole, European and other countries have not suspended all mesh operations, although many have made recommendations for improved reporting and follow‐up of cases (SCENIHR 2015).

Consequently, there has been a shift towards fully informed consent and shared decision‐making between patients and their surgeons in order to effectively counsel women about the safety profile of surgery for stress incontinence. Women consistently prefer surgical treatments that are not associated with chronic pain, are associated with a shorter hospital stay and have a smaller risk for urinary symptoms to recur after surgery (Brazzelli 2019). The UK's National Institute for Health and Care Excellence (NICE) has developed a decision aid to help women navigate what is becoming an increasingly complex choice (NICE 2019).

How the intervention might work

Single‐incision slings have been developed based on the same mechanistic principles as standard mid‐urethral slings (i.e. the retropubic and transobturator slings). They aim to restore urethral support during a sudden rise in intra‐abdominal pressure – for example, during a cough or sneeze – thus preventing involuntary loss of urine. They aim to minimise the risk of major complications associated with transobturator slings and retropubic slings, such as bladder, vaginal, urethral or vascular perforations, mesh exposure, extrusion or erosion and long‐term pain, by reducing tissue dissection and placement away from critical structures. These slings have shorter tape lengths and do not penetrate the obturator fossa (hence potentially minimising the risk of groin pain) or the retropubic space (minimising the risk of major vessel or visceral injury).

Nine minimally‐invasive single‐incision sling devices have been used in clinical practice: TVT‐Secur, MiniArc, Ajust, Needleless, Tissue Fixation System (TFS), Altis, Ophira, CureMesh and Solyx.

We have classified TVT‐Abbrevo as a short transobturator sling rather than a single‐incision sling for the purposes of this review. We have included trials which use TVT‐Abbrevo in the obturator comparison group. We therefore excluded trials comparing TVT‐Abbrevo and another transobturator sling.

• TVT‐Secur is inserted with a metal introducer that anchors the device in the obturator membrane and is placed snugly against the urethra.

• MiniArc has a curved introducer that clips into two plastic anchoring hooks on the ends of the sling; this is used to insert the sling and secure it into the obturator membrane.

• Ajust also has a curved introducer with plastic anchoring hooks, but it differs from the other devices in that it has a pulley‐like system that allows adjustment following insertion.

• Needleless is 60% longer than the other mini‐slings. It has a pocket‐like fold on each end and an artery forceps is placed onto the end of the sling in this pouch. The sling is pushed laterally and through the obturator membrane at insertion.

• Ophira is a type 1 polypropylene monofilament mesh with two fixation arms that penetrate the obturator internus muscle on either side with the help of a retractile insertion guide.

• TFS consists of non‐stretch multi‐filament polypropylene tape with two polypropylene soft tissue anchors at either end. The tape is passed in the same direction as standard tension‐free vaginal tape (TVT) but the anchors are embedded into the pubo‐urethral ligament inferior to the pubic symphysis.

• Altis is characterised by low mesh elasticity, bidirectional intraoperative adjustability and an anchoring mechanism that fully perforates the obturator membrane.

• CureMesh is a 14‐cm polypropylene mesh similar to the MiniArc sling but manufactured domestically in South Korea.

• Solyx is a 9‐cm mesh which uses a curved introducer to anchor to the obturator membrane.

Why it is important to do this review

This large systematic review update adds 10 years of published data from 62 studies to the previous version of the review (search date in 2012). The management of stress urinary incontinence has completely changed in this time and there is a need to re‐analyse the evidence base for polypropylene mesh devices. Most significantly, the TVT‐Secur device has been withdrawn from the market. Longer‐term follow‐up data from several trials have been published. The use of polypropylene mesh in urogynaecology has completely changed due to the reporting of adverse events, such as the recording of cases in national databases. Women are being counselled to consider their options before undergoing surgery, and these discussions are reviewed in multidisciplinary teams prior to theatre listing in many centres. Despite the safety concerns raised, single‐incision and mid‐urethral slings continue to be used worldwide as a safe, minimally‐invasive and effective treatment for stress urinary incontinence; a common and burdensome condition for many women. This systematic review will help clinicians and women to navigate a complex balance of the risks and benefits of SUI surgery, and help guide future research and clinical practice.

As a secondary objective, the review also summarises published evidence for the impact of single‐incision slings on both resource use (costs) and its comparative efficiency (cost‐effectiveness).

Objectives

To assess the effects of single‐incision sling operations for treating urinary incontinence in women, and to summarise the principal findings of relevant economic evaluations.

Methods

Criteria for considering studies for this review

Types of studies

We included randomised controlled trials (RCTs) or quasi‐randomised controlled trials in which at least one trial arm involved a single‐incision sling. We included cluster‐RCTs, but excluded cross‐over studies since this study design would not be appropriate for investigating the effectiveness of single‐incision sling operations for urinary incontinence.

Types of participants

We included studies of adult women with stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency, diagnosed either via urodynamics or clinically. We included trials involving women with mixed urinary incontinence if these women were shown to have stress‐predominant symptoms.

Types of interventions

We included trials where at least one arm involved a single‐incision sling to treat stress or mixed urinary incontinence. Eligible comparison interventions included other surgical techniques and non‐surgical interventions. For the purpose of this review, we have defined a single‐incision sling as one which does not involve either a retropubic or transobturator passage of the tape or trocar and involves a single vaginal incision.

We sought evidence for the following comparisons:

• single‐incision slings versus no treatment;

• single‐incision slings versus conservative treatment;

• single‐incision slings versus colposuspension;

• single‐incision slings versus laparoscopic procedures;

• single‐incision slings versus autologous fascial slings;

• single‐incision slings versus retropubic minimally‐invasive slings;

• single‐incision slings versus transobturator minimally‐invasive slings;

• single‐incision slings versus retropubic and transobturator minimally‐invasive slings

We assessed single‐incision slings versus autologous fascial slings, retropubic minimally‐invasive slings and transobturator minimally‐invasive slings within the summary of findings tables.

Since TVT‐Secur single‐incision slings have been withdrawn, we report trials investigating this type of single‐incision sling separately in stratified analyses.

Types of outcome measures

We assessed the following outcome measures.

Primary outcomes

• Subjective cure or improvement of urinary incontinence

Secondary outcomes

• Objective cure or improvement of urinary incontinence

• Patient‐reported pain

• Number of women with dyspareunia

• Number of women with mesh exposure, extrusion or erosion in any area. For the purpose of this systematic review, we have included any of these outcomes described by study authors in one group.

• Number of women with urinary retention

• Number of bladder or urethral injuries

• Number of other injuries (e.g. neurovascular or vaginal)

• Number of infections (e.g. urinary tract infection (UTI), mesh infection)

• Number of women with de novo urgency

• Quality of life

• Number of women requiring repeat continence surgery or mesh revision

Timing of outcome assessment

Subjective and objective cure or improvement were measured at 12 months, more than 12 but less than 24 months, 24 months to less than 36 months, and 36 months or longer.

Patient‐reported pain was measured from 30 days to less than 12 months, 12 months to less than 24 months, and longer than 24 months.

We assume that injuries occur at the time of surgery. We therefore included any outcomes reported within 30 days of surgery as an injury; for example, bladder, urethral and neurovascular injury within 30 days of surgery. After this period, we included such events with mesh exposure, extrusion and erosion, unless stated as a primary injury by the study authors (e.g. vaginal mesh extrusion reported > 30 days after surgery).

We measured quality of life at 12 months.

Main outcomes for summary of findings tables

• Subjective cure or improvement of urinary incontinence at 12 months

• Patient‐reported pain at more than two years

• Number of women with dyspareunia

• Number of women with mesh exposure, extrusion or erosions in any area

• Number of women with urinary retention

• Quality of life at 12 months

• Number of women requiring repeat continence surgery or mesh revision

Search methods for identification of studies

We imposed no language or any other limits on the searches.

Electronic searches

Search for clinical effectiveness studies

We identified relevant trials from the Cochrane Incontinence Specialised Register. The most recent search of the Register for this review update was 20 September 2022. The Register contained trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library; MEDLINE (on Ovid); MEDLINE In‐Process, In‐Data‐Review and Other Non‐Indexed Citations (on Ovid); MEDLINE Epub Ahead of Print (on Ovid); MEDLINE Daily (on Ovid); ClinicalTrials.gov; WHO ICTRP; and handsearching of journals and conference proceedings. Many of the trials in the Cochrane Incontinence Specialised Register are also contained in CENTRAL. The Cochrane Incontinence Group closed in April 2023; its specialised register is no longer being maintained.

Please see Appendix 2 for the terms used to search the Cochrane Incontinence Specialised Register.

Search for economic evaluations

We performed additional searches for the brief economic commentary (BEC). We searched the NHS Economic Evaluation Database (NHS EED) on the Centre for Reviews and Dissemination (CRD) website (from the earliest record in NHS EED in 1968, up to and including 31 December 2014, when their coverage ended) (searched 14 June 2019). As NHS EED is no longer actively updated, on 11 July 2022, we performed additional searches of the following databases to identify eligible studies added to these databases from 1 January 2015 onwards:

• MEDLINE on OvidSP (covering 1 January 1946 to June Week 5 2022); and

• Embase (on OvidSP) (covering 1 January 1974 to 2022 Week 27).

The searches described above are also being used to develop a Cochrane Incontinence Specialised Register of Economic Evaluations which was searched, on 1 December 2022, for this BEC.

Details of the searches that we performed can be found in Appendix 3.

Searching other resources

We searched the reference lists of all relevant reviews and trial reports to identify further studies.

Data collection and analysis

We conducted all data abstraction, synthesis and analysis for this version of the review in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2019).

Selection of studies

Two review authors (out of EC, EEJ, MS, AB and ASA) independently screened the titles and abstracts identified by the searches. We retrieved full reports of potentially eligible trials and two review authors (out of EC, EEJ, MS, AB and ASA) independently assessed them. We resolved disagreements by discussion, with arbitration by a third review author if required.

Data extraction and management

Two review authors (out of EC, EEJ, MS, AB and ASA) extracted data independently using a standard, pre‐piloted form containing our pre‐specified outcomes. We processed included trial data as described in the Cochrane Handbook (Higgins 2019), resolving any differences by discussion and, when necessary, referring to a third review author for arbitration. When data may have been collected but not reported, we sought clarification from the trialists.

Assessment of risk of bias in included studies

We used Cochrane's risk of bias tool to examine the following domains: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessors, incomplete outcome data, selective reporting, and other potential bias (Higgins 2011). Two review authors (out of EC, EEJ, MS, AB and ASA) independently assessed the risks of bias for included studies, resolving any disagreements by discussion or, where necessary, through arbitration by a third review author.

Measures of treatment effect

We used Review Manager 5 to conduct meta‐analyses when we identified two or more eligible trials (Review Manager 2020). We calculated a combined estimate of treatment effect across trials for each specified outcome. For categorical outcomes, we calculated a risk ratio (RR) and corresponding 95% confidence interval (CI). For continuous variables, we used means and standard deviations (SDs) to derive a mean difference (MD) and corresponding 95% CI. When feasible, we used intention‐to‐treat (ITT) data.

If similar outcomes were reported on different scales, we calculated the standardised mean difference (SMD) and corresponding 95% CI. We reversed the direction of effect, if necessary, to ensure consistency across trials. We interpreted the SMD as follows:

• SMD 0.8: large effect;

• SMD 0.5: moderate effect;

• SMD 0.2: small effect.

Unit of analysis issues

We handled multi‐arm studies following the guidance in the Cochrane Handbook (Higgins 2019). We made every effort to avoid double‐counting of data in studies with three treatment arms by dividing the number of events and participants by half in the group included twice in the meta‐analysis.

Had we identified any cluster‐RCTs, we would have analysed them at the level of the cluster, not at the level of the individual, provided the study authors had reported effect estimates and their standard errors, taking the cluster design into account. In future review updates, if we include any cluster‐RCTs, if study authors have not accounted for the cluster design in their analysis, we will calculate the effective sample size using an estimate of the intra‐cluster correlation coefficient (ICC), using the methods described in the Cochrane Handbook (Higgins 2019)

Dealing with missing data

We tried to obtain missing data from studies by contacting study authors for further information. Where these data were not available, we reported the data as given in the trials. We did not impute missing data. Where multiple publications from the same trial reported different values, we used the most recent, or in some cases, the most robust (e.g. we privileged the full‐text published paper, reporting longer‐term follow‐up numbers over conference abstracts).

Assessment of heterogeneity

We investigated differences between trials when apparent from visual inspection of the results, or when statistically significant heterogeneity was demonstrated by using the Chi² test at the 10% probability level or assessment of the I² statistic (Higgins 2019). We interpreted statistical heterogeneity through interpretation of the I² statistic as follows:

• 0% to 40%: might not be important;

• 30% to 60%: may represent moderate heterogeneity;

• 50% to 90%: may represent substantial heterogeneity;

• 75% to 100%: considerable heterogeneity.

When we found no obvious reason for heterogeneity to exist (after consideration of populations, interventions, outcomes and settings of the individual trials), or when heterogeneity persisted despite removal of trials, we used a random‐effects model for analysis.

Assessment of reporting biases

Where 10 or more studies contributed to a meta‐analysis, we assessed the likelihood of potential publication bias by generating funnel plots. We generated these funnel plots to investigate potential small‐study effects using Review Manager 5, and assessed them for symmetry.

Data synthesis

We used a fixed‐effect approach for the meta‐analysis unless significant statistical heterogeneity was demonstrated in the analysis, in which case we used a random‐effects model.

We stratified the data from trials, analysing the effects of TVT‐Secur separately in the meta‐analyses as the device has been withdrawn from the market due to demonstrable inferiority to other single‐incision sling devices. We have retained these data in the review to guide clinical practice for women who have had these implants.

Subgroup analysis and investigation of heterogeneity

Where possible, we conducted stratified analyses, to separate results from studies using TVT‐Secur as an intervention from other single‐incision slings.

Sensitivity analysis

Stress incontinence concomitant with anterior compartment prolapse is common. Anterior repair alone may improve continence in over half of women but may also generate new cases by making occult SUI symptomatic (see Table 4). The effect of the anterior compartment prolapse repair on SUI in women who undergo a concomitant SUI and prolapse surgery has not been demonstrated. We therefore performed sensitivity analyses for the trials including concomitant prolapse and SUI surgery. We also performed sensitivity analyses by removing any studies that were explicit that concomitant pelvic organ prolapse (POP) surgery was performed as well as those that did not clearly report whether concomitant POP surgery was performed in the study.

We also performed sensitivity analyses to further explore the robustness of data. These included sensitivity analyses removing studies with a significant loss of follow‐up data (more than 30%), heterogeneity in analyses (I² ≥ 75%) and any trials with two or more domains at high risk of bias. We performed these sensitivity analyses for all primary and secondary outcomes.

We reported sensitivity analyses that had a demonstrable effect on the results of meta‐analyses in the Effects of interventions. Full details of the sensitivity analyses are described in Table 5 and Table 6.

2. Sensitivity analysis: single‐incision slings versus retropubic slings.

Outcome	Number of studies	Effect estimate	Studies removed	Effect estimate after removal
Sensitivity analysis for studies with concomitant prolapse surgery
Mesh erosions in any area (non–TVT‐S strata)	3	RR 1.55 (95% CI 0.24 to 9.82)	Ow 2019	RR 4.47 (95% CI 0.22 to 89.94)
Mesh erosions in any area (TVT‐S strata)	3	RR 1.25 (95% CI 0.34 to 4.55)	Barber 2012	RR 1.84 (95% CI 0.40 to 8.48)
Urinary retention (TVT‐S strata)	4	RR 0.64 (95% CI 0.28 to 1.73)	Barber 2012	RR 0.72 (95% CI 0.25 to 2.08)
Bladder or urethral injuries: < 30 days after treatment (TVT‐S strata)	5	RR 0.61 (95% CI 0.25 to 1.51)	Barber 2012	RR 0.59 (95% CI 0.16 to 2.24)
Other injuries (e.g. neurovascular or vaginal): < 30 days after treatment (TVT‐S strata)	3	RR 0.93 (95% CI 0.21 to 4.09)	Barber 2012	RR 1.56 (95% CI 0.21 to 11.82)
Infections (e.g. UTI, mesh infection) (TVT‐S strata)	3	RR 0.93 (95% CI 0.61 to 1.42)	Barber 2012	RR 0.97 (95% CI 0.57 to 1.65)
Sensitivity analysis for studies performing concomitant prolapse surgery or that did not report whether concomitant surgery was performed
Patient‐reported pain: 12 months to 24 months (TVT‐S strata)	3	RR 0.76 (95% CI 0.17 to 3.32)	Wang 2011	RR 0.76 (95% CI 0.17 to 3.32)
Number of women with mesh exposure, extrusion and erosions in any area (TVT‐S strata)	3	RR 1.25 (95% CI 0.34 to 4.55)	Barber 2012	RR 1.84 (95% CI 0.40 to 8.48)
Urinary retention (TVT‐S strata)	3	RR 0.69 (95% CI 0.28 to 1.73)	Abdelwahab 2010, Barber 2012, Wang 2011	RR 1.02 (95% CI 0.15 to 6.99)
Bladder or urethral injuries: < 30 days after treatment (TVT‐S strata)	5	RR 0.61 (95% CI 0.25 to 1.51)	Abdelwahab 2010, Barber 2012, Wang 2011	RR 0.89 (95% CI 0.13 to 6.08)
Other injuries (e.g. neurovascular or vaginal): < 30 days after treatment (TVT‐S strata)	3	RR 0.93 (95% CI 0.21 to 4.09)	Barber 2012	RR 1.56 (95% CI 0.21 to 11.82)
Infections (e.g. UTI, mesh infection) (TVT‐S strata)	3	RR 0.93 (95% CI 0.61 to 1.42)	Abdelwahab 2010, Barber 2012	RR 1.39 (95% CI 0.69 to 2.77)
De novo urgency (TVT‐S strata)	3	RR 1.32 (95% CI 0.74 to 2.35)	Abdelwahab 2010, Wang 2011	RR 0.71 (95% CI 0.29 to 1.75)
Sensitivity analysis for large loss to follow‐up (> 30%)
NA	NA	NA	NA	NA
Sensitivity analysis for meta‐analyses with I² > 75%
NA	NA	NA	NA	NA
Sensitivity analysis for studies with ≥ 2 domains at high risk of bias
NA	NA	NA	NA	NA

CI: confidence interval; NA: not applicable; RR: risk ratio; TVT‐S: tension‐free vaginal tape Secur; UTI: urinary tract infection

3. Sensitivity analysis: single‐incision slings versus transobturator slings.

Outcome	Number of studies	Effect estimate	Studies removed	Effect estimate after removal
Sensitivity analysis for studies with concomitant prolapse surgery
Subjective cure or improvement of urinary incontinence: at 12 months (non–TVT‐S strata)	17	RR 1.00 (95% CI 0.97 to 1.03)	Lee 2012, Melendez‐Munoz 2018	RR 1.00 (95% CI 0.93 to 1.03)
Subjective cure or improvement of urinary incontinence: 24 to 36 months (non–TVT‐S strata)	3	RR 0.98 (95% CI 0.84 to 1.03)	Fernandez‐Gonzalez 2017, Lee 2012	RR 1.08 (95% CI 0.92 to 1.14)
Subjective cure or improvement of urinary incontinence: 36+ months (non–TVT‐S strata)	4	RR 0.96, 95% CI 0.89 to 1.03	Amat 2011, Lee 2012, Melendez‐Munoz 2018	RR 1.14 (95% CI 0.93 to 1.41)
Objective cure or improvement of urinary incontinence: at 12 months (non–TVT‐S strata)	19	RR 1.01 (95% CI 0.98 to 1.03)	Amat 2011, Lee 2012, Melendez‐Munoz 2018	RR 1.01 (95% CI 0.99 to 1.04)
Objective cure or improvement of urinary incontinence: at 12 months (TVT‐S strata)	7	RR 0.84 (95% CI 0.74 to 0.97)	Hota 2012	RR 0.87 (95% CI 0.76 to 0.99)
Objective cure or improvement of urinary incontinence: 24 months to 36 months (non–TVT‐S strata)	3	RR 0.99, 95% CI 0.93 to 1.04	Lee 2012, Fernandez‐Gonzalez 2017	RR 1.05 (95% CI 0.94 to 1.18)
Objective cure or improvement of urinary incontinence: ≥ 36 months (non–TVT‐S strata)	4	RR 0.98, 95% CI 0.92 to 1.03	Amat 2011, Lee 2012, Melendez‐Munoz 2018	RR 1.11 (95% CI 0.88 to 1.41)
Patient‐reported pain: 30 days to 12 months (non–TVT‐S strata)	5	RR 0.23, 95% CI 0.11 to 0.52	Amat 2011, Lee 2012	RR 0.20 (95% CI 0.06 to 0.65)
Patient‐reported pain: 12 months to 24 months (TVT‐S strata)	6	RR 0.31 (95% CI 0.15 to 0.65)	Friedman 2009	RR 0.15 (95% CI 0.03 to 0.66)
Dyspareunia (non–TVT‐S strata)	8	RR 0.78 (95% CI 0.41 to 1.48)	Smith 2017	RR 0.72 (95% CI 0.37 to 1.41)
Number of women with mesh exposure, extrusion or erosion in any area (non–TVT‐S strata)	16	RR 0.61 (95% CI 0.39 to 0.96)	Amat 2011, Fernandez‐Gonzalez 2017, Melendez‐Munoz 2018, Smith 2017	RR 0.59 (95% CI 0.33 to 1.04)
Number of women with mesh exposure, extrusion or erosion in any area (TVT‐S strata)	7	RR 2.34 (95% CI 1.24 to 4.40)	Hota 2012	RR 1.76 (95% CI 0.90 to 3.47)
Number of women with urinary retention (non–TVT‐S strata)	23	RR 0.68 (95% CI 0.47 to 0.97)	Amat 2011, Fernandez‐Gonzalez 2017, Lee 2012, Smith 2017	RR 0.74 (95% CI 0.50 to 1.10)
Number of women with urinary retention (TVT‐S strata)	9	RR 0.82 (95% CI 0.40 to 1.67)	Friedman 2009, Hota 2012	RR 0.55 (95% CI 0.24 to 1.24)
Number of bladder or urethral injuries: < 30 days after treatment (non–TVT‐S strata)	19	RR 0.38 (95% CI 0.14 to 1.08)	Amat 2011, Fernandez‐Gonzalez 2017, Smith 2017	RR 0.39 (95% CI 0.09 to 1.66)
Number of bladder or urethral injuries: < 30 days after treatment (TVT‐S strata)	6	RR 2.51 (95% CI 0.52 to 12.15)	Friedman 2009	RR 2.51 (95% CI 0.52 to 12.15)
Other injuries: < 30 days after treatment (non–TVT‐S strata)	11	RR 0.55 (95% CI 0.26 to 1.13)	Smith 2017	RR 0.48 (95% CI 0.22 to 1.04)
Other injuries: < 30 days after treatment (TVT‐S strata)	6	RR 0.82 (95% CI 0.30 to 2.22)	Friedman 2009	RR 0.93 (95% CI 0.32 to 2.68)
Number of infections (e.g. UTI, mesh infections) (non–TVT‐S strata)	14	RR 1.04 (95% CI 0.74 to 1.45)	Amat 2011, Fernandez‐Gonzalez 2017, Lee 2012, Sabadell 2017, Smith 2017	RR 1.11 (95% CI 0.78 to 1.58)
Number of women with de novo urgency (non–TVT‐S strata)	13	RR 1.07, 95% CI 0.77 to 1.49	Amat 2011, Fernandez‐Gonzalez 2017, Melendez‐Munoz 2018, Sabadell 2017, Smith 2017	RR 1.22 (95% CI 0.74 to 2.01)
Number of women with de novo urgency (TVT‐S strata)	7	RR 1.15 (95% CI 0.77 to 1.73)	Friedman 2009	RR 0.92 (95% CI 0.59 to 1.44)
Quality of life: at 12 months (non–TVT‐S strata)	8	SMD 0.24 (95% CI 0.09 to 0.39)	Fernandez‐Gonzalez 2017	SMD 0.17 (95% CI −0.01 to 0.35)
Number of women requiring repeat continence surgery or mesh revision (non–TVT‐S strata)	13	RR 1.42 (95% CI 0.94 to 2.16)	Lee 2012, Melendez‐Munoz 2018, Smith 2017	RR 1.67 (95% CI 0.98 to 2.84)
Number of women requiring repeat continence surgery or mesh revision (TVT‐S strata)	8	RR 2.40 (95% CI 1.37 to 4.18)	Friedman 2009, Hota 2012	RR 1.84 (95% CI 1.01 to 3.36)
Sensitivity analysis for studies that performed concomitant prolapse surgery or did not report whether prolapse surgery occurred
Subjective cure or improvement of urinary incontinence: at 12 months (non–TVT‐S strata)	17	RR 1.00 (95% CI 0.97 to 1.03)	Pascom 2018, Dogan 2018a, Elsayed Barakat 2020, Gaber 2016, Jurakova 2016, Lee 2012, Martoccia 2020, Maturana 2019, Melendez‐Munoz 2018, Pastore 2016, Schellart 2014, Schweitzer 2015, Van Rensberg 2015, Xin 2016	RR 1.02 (0.87 to 1.07)
Subjective cure or improvement of urinary incontinence: at 12 months (TVT‐S strata)	3	RR 0.89 (95% CI 0.78 to 1.00)	Bianchi‐Ferraro 2013	RR 0.88 (0.74 to 0.83)
Objective cure or improvement of urinary incontinence: at 12 months (non–TVT‐S strata)	19	RR 1.01 (95% CI 0.98 to 1.03)	Amat 2011, Chen 2020, Pascom 2018, Dogan 2018a, Elsayed Barakat 2020, Gaber 2016, Gul 2018, Jurakova 2016, Lee 2012, Melendez‐Munoz 2018, Merali 2012, Saleh 2020, Schellart 2014, Schweitzer 2015, Van Rensburg 2015, Xin 2016	RR 0.99 (95% CI 0.91 to 1.08)
Objective cure or improvement of urinary incontinence: at 12 months (TVT‐S strata)	7	RR 0.84 (95% CI 0.74 to 0.97)	Bianchi‐Ferraro 2013, Hota 2012, Shawky 2015, Tommaselli 2010	RR 0.87 (95% CI 0.77 to 0.98)
Objective cure or improvement of urinary incontinence: at 24 to 36 months (TVT‐S strata)	3	RR 0.87 (95% CI 0.74 to 1.03)	Bianchi‐Ferraro 2013	RR 0.84 (95% CI 0.65 to 1.08)
Patient‐reported pain: 30 days to 12 months (non–TVT‐S strata)	5	RR 0.23 (95% CI 0.11 to 0.52)	Amat 2011, Pascom 2018, Lee 2012	RR 0.30 (95% CI 0.07 to 1.18)
Patient‐reported pain: 30 days to 12 months (TVT‐S strata)	6	RR 0.31 (95% CI 0.15 to 0.65)	Bianchi‐Ferraro 2013, Friedman 2009, Oliveira 2011, Tommaselli 2010, Wang 2011	RR 0.13 (95% CI 0.02 to 1.03)
Dyspareunia (non–TVT‐S strata)	8	RR 0.78 (95% CI 0.41 to 1.48)	Dogan 2018a, Elsayed Barakat 2020, Maturana 2019, Radwan 2020, Saleh 2020, Schellart 2014, Smith 2017	RR 4.80 (95% CI 0.24 to 97.42)
Number of women with mesh exposure, extrusion or erosion in any area (non–TVT‐S strata)	16	RR 0.61 (95% CI 0.39 to 0.96)	Amat 2011, Pascom 2018, Dogan 2018a, Fernandez‐Gonzalez 2017, Gaber 2016, Maturana 2019, Melendez‐Munoz 2018, Pastore 2016, Radwan 2020, Schellart 2014, Schweitzer 2015, Sivaslioglu 2012, Smith 2017, Xin 2016	RR 0.50 (95% CI 0.05 to 5.39)
Number of women with mesh exposure, extrusion or erosion in any area (TVT‐S strata)	7	RR 2.34 (95% CI 1.24 to 4.40)	Bianchi‐Ferraro 2013, Hota 2012, Tomaselli 2010	RR 1.96 (95% CI 0.82 to 4.67)
Urinary retention (non–TVT‐S strata)	23	RR 0.68 (95% CI 0.47 to 0.97)	Amat 2011, Chen 2020, Pascom 2018, Dogan 2018a, Elsayed Barakat 2020, Fernandez‐Gonzalez 2017, Gaber 2016, Lee 2012, Maturana 2019, Oliveira 2011, Pastore 2016, Saleh 2020, Schellart 2014, Schweitzer 2015, Sivaslioglu 2012, Smith 2017, Xin 2018	RR 0.60 (95% CI 0.29 to 1.22)
Urinary retention (TVT‐S strata)	9	RR 0.82 (95% CI 0.40 to 1.67)	Bianchi‐Ferraro 2013, Friedman 2009, Hota 2012, Oliveira 2011, Tommaselli 2010, Wang 2011	RR 0.61 (95% CI 0.20 to 1.84)
Bladder or urethral injuries: < 30 days after treatment (non–TVT‐S strata)	19	RR 0.38 (95% CI 0.14 to 1.08)	Amat 2011, Pascom 2018, Dogan 2018a, Fernandez‐Gonzelez 2017, Gaber 2016, Gul 2018, Maturana 2019, Oliveira 2011, Radwan 2020, Schweitzer 2015, Sivaslioglu 2012, Smith 2017, Sottner 2012, Xin 2016	RR not estimable: no events in the remaining studies
Bladder or urethral injuries: < 30 days after treatment (TVT‐S strata)	6	RR 2.51 (95% CI 0.52 to 12.15)	Friedman 2009, Oliveira 2011, Wang 2011	RR 2.32 (95% CI 0.37 to 14.37)
Other injuries: < 30 days after treatment (non–TVT‐S strata)	11	RR 0.55 (95% CI 0.26 to 1.13)	Pascom 2018, Dogan 2018a, Oliveira 2011, Radwan 2020, Schellart 2014, Schweitzer 2015, Smith 2017	RR 0.20 (95% CI 0.01 to 4.04)
Other injuries: < 30 days after treatment (TVT‐S strata)	6	RR 0.82 (95% CI 0.30 to 2.22)	Bianchi‐Ferraro 2013, Friedman 2009, Oliveira 2011, Tommaselli 2010	RR 2.75 (95% CI 0.31 to 24.72)
Infections (non–TVT‐S strata)	14	RR 1.04 (95% CI 0.74 to 1.45)	Amat 2011, Chen 2020, Pascom 2018, Fernandez‐Gonzelez 2017, Gaber 2016, Lee 2012, Maturana 2019, Oliveira 2011, Sabadell 2017, Saleh 2020, Schellart 2014, Schweitzer 2015, Smith 2017	RR 1.40 (95% CI 0.48 to 4.12)
Infections (TVT‐S strata)	5	RR 1.00 (95% CI 0.52 to 1.94)	Bianchi‐Ferraro 2013, Oliveira 2011	RR 1.16 (95% CI 0.53 to 2.51)
De novo urgency (non–TVT‐S strata)	13	RR 1.07 95% CI 0.77 to 1.49)	Amat 2011, Pascom 2018, Fernandez‐Gonzalez 2017, Gaber 2016, Maturana 2019, Melendez‐Munoz 2016, Oliveira 2011, Pastore 2016, Sabadell 2017, Schweitzer 2015, Smith 2017	RR 1.28 (95% CI 0.54 to 3.07)
De novo urgency (TVT‐S strata)	7	RR 1.15 (95% CI 0.77 to 1.73)	Bianchi‐Ferraro 2013, Friedman 2009, Oliveira 2011, Tommaselli 2010, Wang 2011	RR 0.58 (95% CI 0.30 to 1.13)
Quality of life: at 12 months (non–TVT‐S strata)	8	SMD 0.24 (95% CI 0.09 to 0.39)	Chen 2020, Pascom 2018, Fernandez‐Gonzalez 2017, Jurakova 2016, Martoccia 2020, Maturana 2019, Pastore 2016	SMD 0.53 (95% CI 0.13 to 0.92)
Quality of life: at 12 months (TVT‐S strata)	4	SMD 0.05 (95% CI −0.14 to 0.24)	Bianchi‐Ferraro 2013, Tommaselli 2010	SMD 0.17 (95% CI −0.09 to 0.43)
Requiring repeat continence surgery or mesh revision (non–TVT‐S strata)	13	RR 1.42 (95% CI 0.94 to 2.16)	Pascom 2018, Dogan 2018a, Faber 2021, Lee 2012, Melendez‐Munoz 2018, Oliveira 2011, Schellart 2014, Schweitzer 2015, Sivaslioglu 2012, Smith 2017	RR 1.52 (95% CI 0.52 to 4.49)
Requiring repeat continence surgery or mesh revision (TVT‐S strata)	8	RR 2.40 (95% CI 1.37 to 4.18)	Bianchi‐Ferraro 2013, Friedman 2009, Hota 2012, Oliveira 2011, Tommaselli 2010	RR 2.15 (95% CI 1.10 to 4.18)
Sensitivity analysis for large loss to follow‐up (> 30%)
Subjective cure or improvement of urinary incontinence: at 12 months (non–TVT‐S strata)	17	RR 1.00 (95% CI 0.97 to 1.03)	Pascom 2018, Melendez‐Munoz 2018	RR 1.01 (95% CI 0.98 to 1.04)
Subjective cure or improvement of urinary incontinence: ≥ 36 months (non–TVT‐S strata)	4	RR 0.96 (95% CI 0.89 to 1.03)	Amat 2011, Melendez‐Munoz 2018	RR 1.01 (95% CI 0.88 to 1.16)
Objective cure or improvement of urinary incontinence: at 12 months (non–TVT‐S strata)	19	RR 1.01 (95% CI 0.98 to 1.03)	Amat 2011, Pascom 2018, Melendez‐Munoz 2018	RR 1.01 (95% CI 0.99 to 1.04)
Objective cure or improvement of urinary incontinence: at ≥ 36 months (non–TVT‐S strata)	4	RR 0.98 (95% CI 0.92 to 1.03)	Amat 2011, Melendez‐Munoz 2018	RR 1.04 (95% CI 0.92 to 1.18)
Patient‐reported pain: 30 days to 12 months (non–TVT‐S strata)	5	RR 0.23 (95% CI 0.11 to 0.52)	Amat 2011, Pascom 2018	RR 0.36 (95% CI 0.14 to 0.93)
Number of women with mesh exposure, extrusion or erosion in any area (non–TVT‐S strata)	16	RR 0.61 (95% CI 0.39 to 0.96)	Amat 2011, Pascom 2018, Melendez‐Munoz 2018	RR 0.50 (95% CI 0.28 to 0.88)
Urinary retention (non–TVT‐S strata)	23	RR 0.68 (95% CI 0.47 to 0.97)	Amat 2011	RR 0.70 (95% CI 0.48 to 1.03)
Bladder or urethral injuries: < 30 days after treatment (non–TVT‐S strata)	19	RR 0.38 (95% CI 0.14 to 1.08)	Amat 2011, Pascom 2018	RR 0.37 (95% CI 0.11 to 1.24)
Other injuries: < 30 days after treatment (non–TVT‐S strata)	11	RR 0.55 (95% CI 0.26 to 1.13)	Pascom 2018	RR 0.55 (95% CI 0.26 to 1.13)
Infections (non–TVT‐S strata)	14	RR 1.04 (95% CI 0.74 to 1.45)	Amat 2011, Pascom 2018	RR 0.96 (95% CI 0.65 to 1.43)
De novo urgency (non–TVT‐S strata)	13	RR 1.07 95% CI 0.77 to 1.49)	Amat 2011, Pascom 2018	RR 1.25 (95% CI 0.84 to 1.84)
Quality of life: at 12 months (non–TVT‐S strata)	8	SMD 0.24 (95% CI 0.09 to 0.39)	Pascom 2018	SMD 0.21 (95% CI 0.06 to 0.37)
Requiring repeat continence surgery or mesh revision (non–TVT‐S strata)	13	RR 1.42 (95% CI 0.94 to 2.16)	Pascom 2018, Melendez‐Munoz 2018	RR 1.39 (95% CI 0.88 to 2.21)
Sensitivity analysis for meta‐analyses with I2 > 75%
Objective cure or improvement of urinary incontinence: 12 months to 24 months	7	RR 0.84 (95% CI 0.74 to 0.97)	Shawky 2015	RR 0.90 (95% CI 0.81 to 0.99)
Sensitivity analysis for studies with 2+ domains at high risk of bias
Subjective cure or improvement of urinary incontinence: at 12 months (non–TVT‐S strata)	17	RR 1.00 (95% CI 0.97 to 1.03)	Lee 2012, Schellart 2014	RR 1.01 (95% CI 0.88 to 1.04)
Subjective cure or improvement of urinary incontinence: 24 months to 36 months (non–TVT‐S strata)	3	RR 0.98 (95% CI 0.94 to 1.03)	Lee 2012	RR 0.98 (95% CI 0.90 to 1.06)
Subjective cure or improvement of urinary incontinence: ≥ 36 months (non–TVT‐S strata)	4	RR 0.96 (95% CI 0.89 to 1.03)	Amat 2011, Lee 2012	RR 0.95 (95% CI 0.80 to 1.11)
Objective cure or improvement of urinary incontinence: at 12 months (non–TVT‐S strata)	19	RR 1.01 (95% CI 0.98 to 1.03)	Amat 2011, Chen 2020, Lee 2012, Schellart 2014	RR 1.01 (95% CI 0.98 to 1.04)
Objective cure or improvement of urinary incontinence: at 12 months (TVT‐S strata)	7	RR 0.84 (95% CI 0.74 to 0.97)	Hinoul 2011	RR 0.82 (95% CI 0.68 to 0.99)
Objective cure or improvement of urinary incontinence: 24 months to 36 months (non–TVT‐S strata)	3	RR 0.99 (95% CI 0.93 to 1.04)	Lee 2012	RR 0.98 (95% CI 0.86 to 1.13)
Objective cure or improvement of urinary incontinence: ≥ 36 months (non–TVT‐S strata)	4	RR 0.98 (95% CI 0.92 to 1.03)	Amat 2011, Lee 2012	RR 0.98 (95% CI 0.91 to 1.07)
Patient‐reported pain: 30 days to 12 months (non–TVT‐S strata)	5	RR 0.23 (95% CI 0.11 to 0.52)	Amat 2011, Lee 2012	RR 0.20 (95% CI 0.06 to 0.65)
Dyspareunia (non–TVT‐S strata)	8	RR 0.78 (95% CI 0.41 to 1.48)	Schellart 2014	RR 0.72 (95% CI 0.37 to 1.41)
Number of women with mesh exposure, extrusion or erosion in any area (non–TVT‐S strata)	16	RR 0.61 (95% CI 0.39 to 0.96)	Amat 2011, Schellart 2014	RR 0.60 (95% CI 0.37 to 0.97)
Number of women with mesh exposure, extrusion or erosion in any area (TVT‐S strata)	7	RR 2.34 (95% CI 1.24 to 4.40)	Hinoul 2011	RR 1.98 (95% CI 1.01 to 3.90)
Urinary retention (non–TVT‐S strata)	23	RR 0.68 (95% CI 0.47 to 0.97)	Amat 2011, Chen 2020, Lee 2012, Schellart 2014	RR 0.74 (95% CI 0.49 to 1.12)
Urinary retention (TVT‐S strata)	9	RR 0.82 (95% CI 0.40 to 1.67)	Hinoul 2011	RR 0.85 (95% CI 0.38 to 1.92)
Bladder or urethral injuries: < 30 days after treatment (non–TVT‐S strata)	19	RR 0.38 (95% CI 0.14 to 1.08)	Amat 2011	RR 0.34 (95% CI 0.11 to 1.06)
Bladder or urethral injuries: < 30 days after treatment (TVT‐S strata)	6	RR 2.51 (95% CI 0.52 to 12.15)	Hinoul 2011	RR 2.40 (95% CI 0.39 to 14.74)
Other injuries: < 30 days after treatment (non–TVT‐S strata)	11	RR 0.55 (95% CI 0.26 to 1.13)	Schellart 2014	RR 0.60 (95% CI 0.27 to 1.36)
Other injuries: < 30 days after treatment (TVT‐S strata)	6	RR 0.82 (95% CI 0.30 to 2.22)	Hinoul 2011	RR 0.69 (95% CI 0.24 to 2.03)
Infections (non–TVT‐S strata)	14	RR 1.04 (95% CI 0.74 to 1.45)	Amat 2011, Chen 2020, Lee 2012, Schellart 2014	RR 1.23 (95% CI 0.84 to 1.79)
Infections (TVT‐S strata)	5	RR 1.00 (95% CI 0.52 to 1.94)	Hinoul 2011	RR 0.66 (95% CI 0.30 to 1.44)
De novo urgency (non–TVT‐S strata)	13	RR 1.07 (95% CI 0.77 to 1.49)	Amat 2011	RR 1.21 (95% CI 0.83 to 1.76)
Quality of life: at 12 months (non–TVT‐S strata)	8	SMD 0.24 (95% CI 0.09 to 0.39)	Chen 2020	SMD 0.26 (95% CI 0.10 to 0.43)
Quality of life: at 12 months (TVT‐S strata)	4	SMD 0.05 (95% CI −0.14 to 0.24)	Hinoul 2011	SMD −0.12 (95% CI −0.36 to 0.12)
Requiring repeat continence surgery or mesh revision (non–TVT‐S strata)	13	RR 1.42 (95% CI 0.94 to 2.16)	Faber 2021, Lee 2012, Schellart 2014	RR 1.31 (95% CI 0.77 to 2.20)
Requiring repeat continence surgery or mesh revision (TVT‐S strata)	8	RR 2.40 (95% CI 1.37 to 4.18)	Hinoul 2011	RR 1.94 (95% CI 1.02 to 3.67)

CI: confidence interval; RR: risk ratio; SMD: standardised mean difference; TVT‐S: tension‐free vaginal tape Secur; UTI: urinary tract infection

Incorporating economic evidence

Following the searches outlined in the Search methods for identification of studies, we developed a brief economic commentary to summarise the availability and principal findings of the full economic evaluations that compare single‐incision slings with other treatments for urinary incontinence in women (Aluko 2022). This encompassed full economic evaluations (i.e. cost‐effectiveness analyses, cost‐utility analyses and cost‐benefit analyses), conducted as part of a single empirical study such as an RCT, a model based on a single such study or a model based on several such studies.

Summary of findings and assessment of the certainty of the evidence

We prepared summary of findings tables using the GRADEpro software for the main comparisons pre‐specified in Types of interventions (GRADEpro GDT). The summary of findings tables present our primary analysis; TVT‐Secur data are not included.

We used the GRADE approach to assess the certainty of evidence related to the primary and secondary outcomes, as listed in the Types of outcome measures (Schünemann 2021). We used the five GRADE considerations – study limitations, consistency of effect, imprecision, indirectness and publication bias – to assess the certainty of the body of evidence for the pre‐specified outcomes. We justified all decisions to downgrade the certainty of studies, setting these reasons out in the table footnotes.

Results

Description of studies

Results of the search

Search for clinical effectiveness studies

We retrieved a total of 513 records through a search of the Cochrane Incontinence Specialised Register, and screened the titles and abstracts. We obtained the full texts of 233, and identified 183 reports of 62 studies that met the inclusion criteria.

We excluded 38 reports of 24 studies for the reasons given in Characteristics of excluded studies. We found nine reports of nine ongoing trials (Matthews 2018; Matthews 2020; NCT01799122; NCT02263534; NCT03515109; NCT03916471; NCT05225168; PACTR201607001696163; Shen 2015; see Characteristics of ongoing studies). There are three reports of two studies in Characteristics of studies awaiting classification for the following reasons: one paper is in Russian, and we were unable to have it translated in time to assess for inclusion (Pushkar 2011); the other study has an unclear description (Huser 2020), and we are unsure if it is part of an already included study (namely, Jurakova 2016). We have contacted the Huser 2020 authors for further clarification. The PRISMA diagram showing the literature assessment process is given in Figure 1.

1.

PRISMA study flow diagram ‐ search for clinical effectiveness studies

Search for economic evaluations

Searches for economic evaluations to inform the development of the brief economic commentary produced a total of 556 titles and abstracts to be screened after de‐duplication, of which three met the inclusion criteria (Boyers 2013; Brazzelli 2019; Castañeda 2014). The flow of literature through the assessment process is shown in Figure 2.

2.

PRISMA study flow diagram: search for economic evaluations for the brief economic commentary (BEC)

Included studies

Overall, 62 studies (8051 women) met the inclusion criteria. We have added 31 new studies in this updated version of the review and any newly‐published long‐term outcome data from previously‐included studies. The previous version of this review included 31 studies and had a search date of 2012. The characteristics of the included trials varied considerably and are described in detail in the Characteristics of included studies table. A brief descriptive summary follows.

Design

Fifty‐six studies were described as RCTs (Abdel‐Fattah 2022; Abdelwahab 2010; Andrada Hamer 2011; Barber 2012; Basu 2010; Bianchi‐Ferraro 2013; Dogan 2018a; Elbadry 2017; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Faber 2021; Fernandez‐Gonzalez 2017; Foote 2015; Friedman 2009; Fu 2017; Gaber 2016; Gul 2018; Hinoul 2011; Hota 2012; Jurakova 2016; Kim 2010; Lee 2012; Lee 2015; Leitch 2017; Martoccia 2020; Masata 2012; Masata 2016; Maslow 2014; Maturana 2019; Melendez‐Munoz 2018; Merali 2012; Mostafa 2012; Oliveira 2011; Ow 2019; Pascom 2018; Pastore 2016; Radwan 2020; Ross 2014; Rudnicki 2017; Sabadell 2017; Saleh 2020; Schellart 2014; Schweitzer 2015; Seo 2012; Sharifiaghdas 2015; Shawky 2015; Sivaslioglu 2012; Smith 2017; Sottner 2012; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Wang 2011; Xin 2016; Yoon 2011), while four were quasi‐RCTs (Amat 2011; Chen 2020; Elsayed Barakat 2020; Grigoriadis 2013). One study was a pilot RCT (Mackintosh 2010). One study was described as "randomised" with no further details on type of randomisation (Dati 2012).

Most studies were two‐arm parallel studies, while five were three‐arm studies (Gaber 2016; Masata 2012; Oliveira 2011; Sottner 2012; Wang 2011). One study was four‐arm, splitting the groups between women with differing pelvic organ prolapse (POP) severity (Dati 2012).

Sample sizes

The average sample size of the studies was 130. The studies ranged in size from 29 in a pilot RCT (Mackintosh 2010) to 600 (Abdel‐Fattah 2022). One study did not provide a sample size as it was an ongoing study terminated early due to the intervention being withdrawn from the market (Leitch 2017).

Setting

Thirty‐one studies were single centre (Abdelwahab 2010; Amat 2011; Basu 2010; Bianchi‐Ferraro 2013; Chen 2020; Dogan 2018a; Elbadry 2017; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2010; Fernandez‐Gonzalez 2017; Friedman 2009; Gaber 2016; Grigoriadis 2013; Hota 2012; Jurakova 2016; Leitch 2017; Mackintosh 2010; Masata 2012; Masata 2016; Merali 2012; Oliveira 2011; Pascom 2018; Pastore 2016; Radwan 2020; Saleh 2020; Shawky 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Xin 2016), while 20 were multicentre (Abdel‐Fattah 2022; Andrada Hamer 2011; Barber 2012; Dati 2012; Faber 2021; Hinoul 2011; Lee 2012; Maslow 2014; Maturana 2019; Melendez‐Munoz 2018; Mostafa 2012; Ow 2019; Ross 2014; Rudnicki 2017; Sabadell 2017; Schellart 2014; Schweitzer 2015; Sottner 2012; Van Rensburg 2015; Wang 2011). Tommaselli 2010 was described as single centre in one paper and multicentre in other papers. Ten studies did not describe the centres in which they took place (Enzelsberger 2011; Foote 2015; Fu 2017; Gul 2018; Kim 2010; Lee 2015; Martoccia 2020; Seo 2012; Sharifiaghdas 2015; Yoon 2011).

The studies took place in: Australia (Foote 2015; Lee 2012; Leitch 2017; Melendez‐Munoz 2018; Ow 2019); Austria (Enzelsberger 2010; Enzelsberger 2011); Belgium, France and the Netherlands (Schellart 2014); Belgium and the Netherlands (Hinoul 2011); Brazil (Bianchi‐Ferraro 2013; Faber 2021; Maturana 2019; Pascom 2018); Canada (Maslow 2014; Merali 2012; Ross 2014); China (Chen 2020; Fu 2017; Tang 2014; Wang 2011; Xin 2016; Yoon 2011); Czech Republic (Jurakova 2016; Masata 2012; Masata 2016; Sottner 2012); Denmark, Norway and Sweden (Rudnicki 2017); Egypt (Abdelwahab 2010; Elbadry 2017; Elsayed Barakat 2020; Gaber 2016; Radwan 2020; Saleh 2020; Shawky 2015); Greece (Grigoriadis 2013); Iran (Emami 2019; Sharifiaghdas 2015); Israel (Friedman 2009); Italy (Dati 2012; Martoccia 2020; Pastore 2016; Tommaselli 2010); Korea (Kim 2010; Lee 2015; Seo 2012); the Netherlands (Schweitzer 2015); Portugal (Oliveira 2011); South Africa (Van Rensburg 2015); Spain (Amat 2011; Fernandez‐Gonzalez 2017; Sabadell 2017); Sweden (Andrada Hamer 2011); Turkey (Dogan 2018a; Gul 2018; Sivaslioglu 2012); the UK (Abdel‐Fattah 2022; Basu 2010; Mackintosh 2010; Mostafa 2012); and the USA (Hota 2012; Smith 2017).

Participants

It was not possible to determine participant characteristics in one included study as its publication was a trial registration and the study terminated early (Leitch 2017).

The average age for included participants varied amongst the included studies. The average age of women ranged from 40 to 50 in 12 studies (Andrada Hamer 2011; Basu 2010; Elbadry 2017; Elsayed Barakat 2020; Foote 2015; Gaber 2016; Gul 2018; Maslow 2014; Radwan 2020; Rudnicki 2017; Saleh 2020; Seo 2012), 50 to 60 in 25 studies (Abdel‐Fattah 2022; Amat 2011; Barber 2012; Bianchi‐Ferraro 2013; Chen 2020; Emami 2019; Enzelsberger 2010; Fernandez‐Gonzalez 2017; Fu 2017; Hinoul 2011; Hota 2012; Lee 2012; Masata 2012; Masata 2016; Maturana 2019; Melendez‐Munoz 2018; Oliveira 2011; Pascom 2018; Schellart 2014; Sharifiaghdas 2015; Sivaslioglu 2012; Van Rensburg 2015; Wang 2011; Xin 2016; Yoon 2011), and between 60 and 70 in three studies (Grigoriadis 2013; Jurakova 2016; Ow 2019). Average ages spanned across these ranges in 12 studies (Abdelwahab 2010; Dogan 2018a; Kim 2010; Mackintosh 2010; Mostafa 2012; Pastore 2016; Ross 2014; Sabadell 2017; Schweitzer 2015; Smith 2017; Tang 2014; Tommaselli 2010). In Sottner 2012, average age across the three arms ranged from 68.3 to 76.3. Age was not reported in eight studies (Dati 2012; Enzelsberger 2011; Faber 2021; Friedman 2009; Lee 2015; Martoccia 2020; Merali 2012; Shawky 2015).

Forty‐two studies reported an average body mass index (BMI) between 20 and 30 (Abdel‐Fattah 2022; Abdelwahab 2010; Amat 2011; Andrada Hamer 2011; Barber 2012; Chen 2020; Dogan 2018a; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2010; Fernandez‐Gonzalez 2017; Fu 2017; Gaber 2016; Grigoriadis 2013; Hinoul 2011; Hota 2012; Jurakova 2016; Lee 2012; Mackintosh 2010; Masata 2012; Masata 2016; Maslow 2014; Maturana 2019; Melendez‐Munoz 2018; Mostafa 2012; Oliveira 2011; Ow 2019; Pascom 2018; Pastore 2016; Ross 2014; Rudnicki 2017; Sabadell 2017; Saleh 2020; Schellart 2014; Seo 2012; Sivaslioglu 2012; Smith 2017; Sottner 2012; Tang 2014; Tommaselli 2010; Wang 2011; Xin 2016), and 30 to 40 in two studies (Gul 2018; Van Rensburg 2015). In Basu 2010, BMI averaged 30.1 in the single‐incision sling arm and 28.2 in the retropubic sling arm, while in Bianchi‐Ferraro 2013 the average was 29.8 in the single‐incision sling arm and 30.0 in the retropubic sling arm. Women in the single‐incision sling group of Radwan 2020 had an average BMI slightly over 30, with those in the comparator group slightly under 30. Sharifiaghdas 2015 did not report BMI but reported on weight in kilograms for both groups. BMI was not reported in 13 studies (Dati 2012; Elbadry 2017; Enzelsberger 2011; Faber 2021; Foote 2015; Friedman 2009; Kim 2010; Lee 2015; Martoccia 2020; Merali 2012; Schweitzer 2015; Shawky 2015; Yoon 2011).

The average parity in the participants varied between the included studies. Parity was between one and two on average in two studies (Chen 2020; Tang 2014), two and three in 26 studies (Abdel‐Fattah 2022; Abdelwahab 2010; Amat 2011; Andrada Hamer 2011; Barber 2012; Basu 2010; Enzelsberger 2010; Fernandez‐Gonzalez 2017; Foote 2015; Grigoriadis 2013; Hinoul 2011; Jurakova 2016; Lee 2012; Mackintosh 2010; Masata 2016; Maslow 2014; Melendez‐Munoz 2018; Mostafa 2012; Pastore 2016; Radwan 2020; Rudnicki 2017; Schellart 2014; Sivaslioglu 2012; Smith 2017; Tommaselli 2010; Wang 2011), between three and four in six studies (Dogan 2018a; Emami 2019; Gaber 2016; Pascom 2018; Saleh 2020; Van Rensburg 2015), and over four in one study (Maturana 2019). In Bianchi‐Ferraro 2013, average parity ranged from 3.6 in the retropubic sling arm to 4.0 in the single‐incision sling arm. Fu 2017 described "childbearing times", which averaged 1.6 in both the single‐incision sling and comparator arms. In Gul 2018, average parity was three in the single‐incision sling arm and two in the comparator arm. Hota 2012 reported on the number of women whose parity was zero, one, or two or more. In Masata 2012, average parity was 2.1 and 2.0 for the TVT‐Secur groups respectively and 1.8 for the TVT‐O (tension‐free vaginal tape obturator) group. Oliveira 2011 reported that average parity was 1.8 and 2.1 in the two single‐incision sling arms respectively, compared with 1.5 in the comparator arm. Ross 2014 only reported the number of women who were nulliparous. Only the average number of vaginal deliveries was reported in Sabadell 2017, which was two in each group. Similarly, Sharifiaghdas 2015 reported "normal vaginal deliveries", with an average of three in the single‐incision sling group and four in the comparator group. Across its three arms, Sottner 2012 reported that average parity ranged from 1.7 to 2.2. Parity was not reported in 16 studies (Dati 2012; Elbadry 2017; Elsayed Barakat 2020; Enzelsberger 2011; Faber 2021; Friedman 2009; Kim 2010; Lee 2015; Martoccia 2020; Merali 2012; Ow 2019; Schweitzer 2015; Seo 2012; Shawky 2015; Xin 2016; Yoon 2011).

Duration of SUI was between zero and five years in six studies (Chen 2020; Gul 2018; Sharifiaghdas 2015; Sivaslioglu 2012; Tommaselli 2010; Wang 2011), and five and 10 years in one study (Andrada Hamer 2011). In Amat 2011, women in the single‐incision sling group had SUI for 7.6 years on average, with those in the comparison group averaging 4.7 years. In Dogan 2018a, women in the single‐incision sling arm had SUI for an average of 4.9 years and those in the comparison arm averaged 5.9 years. Fu 2017 described the "course of disease" in months, which averaged 24.8 in the single‐incision sling group and 26.8 for the comparator group. Women in the two single‐incision sling arms of Oliveira 2011 had SUI for 8.4 and 8.0 years respectively, compared with 10.8 years in the comparator arm. Xin 2016 reported that the duration of SUI in months averaged 4.1 in the single‐incision sling arm and 4.4 in the comparator arm. The length of time women had SUI was not reported in 49 studies (Abdel‐Fattah 2022; Abdelwahab 2010; Barber 2012; Basu 2010; Bianchi‐Ferraro 2013; Dati 2012; Elbadry 2017; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Faber 2021; Fernandez‐Gonzalez 2017; Foote 2015; Friedman 2009; Gaber 2016; Grigoriadis 2013; Hinoul 2011; Hota 2012; Jurakova 2016; Kim 2010; Lee 2012; Lee 2015; Mackintosh 2010; Martoccia 2020; Masata 2012; Masata 2016; Maslow 2014; Maturana 2019; Melendez‐Munoz 2018; Merali 2012; Mostafa 2012; Ow 2019; Pascom 2018; Pastore 2016; Radwan 2020; Ross 2014; Rudnicki 2017; Sabadell 2017; Saleh 2020; Schellart 2014; Schweitzer 2015; Seo 2012; Shawky 2015; Smith 2017; Sottner 2012; Tang 2014; Van Rensburg 2015; Yoon 2011).

Reporting of menopausal status varied across the studies. Menopausal status alone was reported in eight studies (Amat 2011; Dogan 2018a; Fernandez‐Gonzalez 2017; Lee 2012; Melendez‐Munoz 2018; Pastore 2016; Sabadell 2017; Saleh 2020), eight studies reported on postmenopausal status alone (Abdelwahab 2010; Basu 2010; Grigoriadis 2013; Maslow 2014; Maturana 2019; Pascom 2018; Schellart 2014; Smith 2017), two studies reported on the number of both premenopausal and postmenopausal women (Enzelsberger 2010; Gaber 2016), and one study reported on the number of women who were either premenopausal, perimenopausal or postmenopausal (Hota 2012). Andrada Hamer 2011 reported on the number of premenopausal and postmenopausal women, as well as the number of postmenopausal women undergoing hormonal therapy. Barber 2012, Ross 2014 and Rudnicki 2017 reported on the number of premenopausal women, and the number of women with or without hormone therapy. Sivaslioglu 2012 and Tang 2014 reported on the number of postmenopausal women and number taking hormonal replacement therapy. Tommaselli 2010 and Xin 2016 reported on menopausal status and number taking hormonal replacement therapy. Menopausal status was not reported in 33 studies (Abdel‐Fattah 2022; Bianchi‐Ferraro 2013; Chen 2020; Dati 2012; Elbadry 2017; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2011; Faber 2021; Foote 2015; Friedman 2009; Fu 2017; Gul 2018; Hinoul 2011; Jurakova 2016; Kim 2010; Lee 2015; Mackintosh 2010; Martoccia 2020; Masata 2012; Masata 2016; Mostafa 2012; Oliveira 2011; Ow 2019; Radwan 2020; Schweitzer 2015; Seo 2012; Sharifiaghdas 2015; Shawky 2015; Sottner 2012; Van Rensburg 2015; Wang 2011; Yoon 2011).

The number of women with concomitant POP and SUI was clearly reported in 13 studies (Amat 2011; Barber 2012; Dati 2012; Enzelsberger 2010; Gaber 2016; Hinoul 2011; Hota 2012; Lee 2012; Maslow 2014; Melendez‐Munoz 2018; Sabadell 2017; Smith 2017; Van Rensburg 2015). Presence of concomitant POP was not clearly reported in 29 studies (Abdel‐Fattah 2022; Abdelwahab 2010; Andrada Hamer 2011; Basu 2010; Bianchi‐Ferraro 2013; Dogan 2018a; Emami 2019; Faber 2021; Fernandez‐Gonzalez 2017; Friedman 2009; Fu 2017; Grigoriadis 2013; Jurakova 2016; Masata 2012; Masata 2016; Mostafa 2012; Oliveira 2011; Ow 2019; Pascom 2018; Radwan 2020; Ross 2014; Rudnicki 2017; Saleh 2020; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Tang 2014; Tommaselli 2010; Xin 2016). However, these studies did note in their eligibility criteria whether POP, POP of a specific grade or the requirement for POP surgery were reasons to exclude the participants. Concomitant POP was not clearly reported and could not be inferred in 19 studies (Chen 2020; Elbadry 2017; Elsayed Barakat 2020; Enzelsberger 2011; Foote 2015; Gul 2018; Kim 2010; Lee 2015; Mackintosh 2010; Martoccia 2020; Maturana 2019; Merali 2012; Pastore 2016; Seo 2012; Shawky 2015; Sivaslioglu 2012; Sottner 2012; Wang 2011; Yoon 2011).

Sixteen studies did not perform concomitant surgery for POP (Abdel‐Fattah 2022; Andrada Hamer 2011; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Foote 2015; Fu 2017; Grigoriadis 2013; Hinoul 2011; Mackintosh 2010; Masata 2012; Masata 2016; Maslow 2014; Mostafa 2012; Ross 2014; Tang 2014), while at least one type of concomitant surgery for POP was performed in eight studies (Amat 2011; Barber 2012; Dati 2012; Fernandez‐Gonzalez 2017; Lee 2012; Melendez‐Munoz 2018; Sabadell 2017; Smith 2017). Both the Friedman 2009 and Ow 2019 studies were unclear about how many women had undergone concomitant POP surgery, but they briefly noted that procedures for concomitant POP were permissible. Hota 2012 reported on the number of women receiving either concomitant POP surgery or concomitant faecal incontinence surgery but did not disaggregate this data. Thirty‐five studies did not report whether women had undergone concomitant POP surgery (Abdelwahab 2010; Basu 2010; Bianchi‐Ferraro 2013; Chen 2020; Dogan 2018a; Elbadry 2017; Elsayed Barakat 2020; Faber 2021; Gaber 2016; Gul 2018; Jurakova 2016; Kim 2010; Lee 2015; Martoccia 2020; Maturana 2019; Merali 2012; Oliveira 2011; Pascom 2018; Pastore 2016; Radwan 2020; Rudnicki 2017; Saleh 2020; Schellart 2014; Schweitzer 2015; Seo 2012; Sharifiaghdas 2015; Shawky 2015; Sivaslioglu 2012; Sottner 2012; Tommaselli 2010; Van Rensburg 2015; Wang 2011; Xin 2016; Yoon 2011).

Interventions

Details of the single‐incision sling used in each included trial, along with the mechanism of actions, can be found in Table 7.

4. Characteristics of single‐incision slings in included studies.

Name	Manufacturer	Description	Included studies
TVT‐Secur	Gynecare, Ethicon Inc., Somerville, MA, USA	Does not include a fixation system or hook	Abdelwahab 2010; Andrada Hamer 2011; Barber 2012; Bianchi‐Ferraro 2013; Friedman 2009; Hinoul 2011; Hota 2012; Kim 2010; Masata 2012; Maslow 2014; Oliveira 2011; Ross 2014; Seo 2012; Shawky 2015; Tang 2014; Wang 2011
MiniArc	American Medical Systems, Minnetonka, MN, USA	Uses a fixation system or hook	Basu 2010; Enzelsberger 2010; Foote 2015; Lee 2012; Lee 2015; Melendez‐Munoz 2018; Merali 2012; Oliveira 2011; Schellart 2014; Smith 2017; Sottner 2012
Ajust	C. R. Bard Inc., Murray Hill, NJ, USA	Uses a fixation system or hook	Abdel‐Fattah 2022; Dati 2012; Grigoriadis 2013; Mackintosh 2010; Masata 2016; Mostafa 2012; Rudnicki 2017; Sabadell 2017; Schweitzer 2015; Sottner 2012; Tommaselli 2010; Xin 2016
Altis	Coloplast, Minneapolis, MN, USA	Uses an anchor system placed in the tissues	Abdel‐Fattah 2022; Leitch 2017
Contasure Needleless	Neomedic Int., Barcelona, Spain	Uses a fixation system or hook; uses fascial pockets at both ends, in which normal artery forceps are placed to guide the ends of the sling to the obturator tunnel	Amat 2011; Chen 2020; Dogan 2018a; Elsayed Barakat 2020; Fernandez‐Gonzalez 2017; Fu 2017; Gaber 2016; Radwan 2020; Saleh 2020; Van Rensburg 2015; Yoon 2011
Tissue Fixation System	TFS Surgical, Adelaide, Australia	Uses a fixation system or hook; anchors into the pubo‐urethral ligament‐muscle complex	Sivaslioglu 2012
Ophira	Promedon, Cordoba, Argentina	Does not include a fixation system or hook	Pascom 2018; Enzelsberger 2011; Gul 2018; Jurakova 2016; Maturana 2019; Sharifiaghdas 2015
Solyx	Boston Scientific, USA	Uses a curved introducer to anchor to the obturator membrane	Faber 2021

The included studies used a range of single‐incision slings:

• TVT‐Secur (Abdelwahab 2010; Andrada Hamer 2011; Barber 2012; Bianchi‐Ferraro 2013; Friedman 2009; Hinoul 2011; Hota 2012; Kim 2010; Masata 2012; Maslow 2014; Oliveira 2011; Ross 2014; Seo 2012; Shawky 2015; Tang 2014; Wang 2011);

• Ajust (Dati 2012; Grigoriadis 2013; Mackintosh 2010; Masata 2016; Mostafa 2012; Rudnicki 2017; Sabadell 2017; Schweitzer 2015; Sottner 2012; Tommaselli 2010; Xin 2016);

• Altis (Leitch 2017);

• MiniArc (Basu 2010; Enzelsberger 2010; Foote 2015; Lee 2012; Lee 2015; Melendez‐Munoz 2018; Merali 2012; Oliveira 2011; Schellart 2014; Smith 2017; Sottner 2012);

• Needleless (Amat 2011; Chen 2020; Dogan 2018a; Elsayed Barakat 2020; Fernandez‐Gonzalez 2017; Fu 2017; Gaber 2016; Radwan 2020; Saleh 2020; Van Rensburg 2015; Yoon 2011);

• Ophira (Enzelsberger 2011; Gul 2018; Jurakova 2016; Maturana 2019; Pascom 2018; Sharifiaghdas 2015);

• Tissue Fixation System (TFS) (Sivaslioglu 2012);

• Solyx (Faber 2021).

Abdel‐Fattah 2022 used both Ajust and Altis in a single intervention arm. Five studies were not clear on which make of sling they used as the intervention (Elbadry 2017; Emami 2019; Martoccia 2020; Ow 2019; Pastore 2016). CureMesh was not used in any of the included studies.

Comparisons

The following comparisons were made in the included studies.

• One study compared the single‐incision sling to the autologous rectus fascial sling (Sharifiaghdas 2015).

• Ten studies compared the single‐incision sling to retropubic tape (Abdelwahab 2010; Andrada Hamer 2011; Barber 2012; Basu 2010; Gaber 2016; Lee 2015; Leitch 2017; Ow 2019; Ross 2014; Wang 2011).

• Fifty‐one studies compared the single‐incision sling to the transobturator sling (Amat 2011; Bianchi‐Ferraro 2013; Chen 2020; Dati 2012; Dogan 2018a; Elbadry 2017; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Faber 2021; Fernandez‐Gonzalez 2017; Foote 2015; Friedman 2009; Fu 2017; Gaber 2016; Grigoriadis 2013; Gul 2018; Hinoul 2011; Hota 2012; Jurakova 2016; Kim 2010; Lee 2012; Mackintosh 2010; Martoccia 2020; Masata 2012; Masata 2016; Maslow 2014; Maturana 2019; Melendez‐Munoz 2018; Merali 2012; Mostafa 2012; Oliveira 2011; Pascom 2018; Pastore 2016; Radwan 2020; Sabadell 2017; Saleh 2020; Schellart 2014; Schweitzer 2015; Seo 2012; Shawky 2015; Sivaslioglu 2012; Smith 2017; Sottner 2012; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Wang 2011; Xin 2016; Yoon 2011).

• Two studies compared the single‐incision sling to a combined group of both retropubic and transobturator slings, which are also known as standard mid‐urethral slings (SMUS) (Abdel‐Fattah 2022; Rudnicki 2017).

Outcomes

The outcomes of the included studies varied and were measured using a range of tools. The studies reporting outcome measures of interest to this review and usable data are detailed below.

• Subjective cure or improvement of SUI (Abdel‐Fattah 2022; Amat 2011; Andrada Hamer 2011; Basu 2010; Bianchi‐Ferraro 2013; Dogan 2018a; Elsayed Barakat 2020; Fernandez‐Gonzalez 2017; Fu 2017; Gaber 2016; Grigoriadis 2013; Hinoul 2011; Jurakova 2016; Lee 2012; Lee 2015; Martoccia 2020; Masata 2012; Masata 2016; Maslow 2014; Maturana 2019; Melendez‐Munoz 2018; Mostafa 2012; Pascom 2018; Pastore 2016; Ross 2014; Rudnicki 2017; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Smith 2017; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Xin 2016)

• Objective cure or improvement of SUI (Abdel‐Fattah 2022; Amat 2011; Andrada Hamer 2011; Bianchi‐Ferraro 2013; Chen 2020; Dogan 2018a; Elsayed Barakat 2020; Fernandez‐Gonzalez 2017; Fu 2017; Gaber 2016; Grigoriadis 2013; Gul 2018; Hinoul 2011; Hota 2012; Jurakova 2016; Lee 2012; Lee 2015; Masata 2012; Masata 2016; Maslow 2014; Maturana 2019; Melendez‐Munoz 2018; Merali 2012; Mostafa 2012; Pascom 2018; Ross 2014; Rudnicki 2017; Saleh 2020; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Shawky 2015; Smith 2017; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Xin 2016)

• Patient‐reported pain (Abdel‐Fattah 2022; Andrada Hamer 2011; Bianchi‐Ferraro 2013; Chen 2020; Dogan 2018a; Elsayed Barakat 2020; Emami 2019; Friedman 2009; Hinoul 2011; Mackintosh 2010; Oliveira 2011; Ow 2019; Radwan 2020; Ross 2014; Rudnicki 2017; Saleh 2020; Sabadell 2017; Sivaslioglu 2012; Tang 2014)

• Dyspareunia (Abdel‐Fattah 2022; Andrada Hamer 2011; Elsayed Barakat 2020; Lee 2012; Masata 2016; Maslow 2014; Maturana 2019; Radwan 2020; Rudnicki 2017; Saleh 2020; Schellart 2014; Sharifiaghdas 2015; Smith 2017; Tang 2014)

• Mesh exposure, extrusion or erosions (Abdel‐Fattah 2022; Amat 2011; Andrada Hamer 2011; Barber 2012; Bianchi‐Ferraro 2013; Dogan 2018a; Fernandez‐Gonzalez 2017; Gaber 2016; Jurakova 2016; Masata 2012; Masata 2016; Mackintosh 2010; Maturana 2019; Melendez‐Munoz 2018; Mostafa 2012; Ow 2019; Pascom 2018; Pastore 2016; Radwan 2020; Ross 2014; Rudnicki 2017; Sabadell 2017; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010; Xin 2016)

• Urinary retention (Abdel‐Fattah 2022; Abdelwahab 2010; Amat 2011; Andrada Hamer 2011; Bianchi‐Ferraro 2013; Chen 2020; Dogan 2018a; Elsayed Barakat 2020; Fernandez‐Gonzalez 2017; Foote 2015; Friedman 2009; Fu 2017; Gaber 2016; Grigoriadis 2013; Hinoul 2011; Lee 2012; Masata 2012; Masata 2016; Maturana 2019; Mostafa 2012; Oliveira 2011; Pascom 2018; Pastore 2016; Rudnicki 2017; Saleh 2020; Schellart 2014; Schweitzer 2015; Sivaslioglu 2012; Tang 2014; Tommaselli 2010; Xin 2016; Wang 2011)

• Bladder or urethral injuries (Abdel‐Fattah 2022; Amat 2011; Andrada Hamer 2011; Barber 2012; Fernandez‐Gonzalez 2017; Friedman 2009; Gaber 2016; Grigoriadis 2013; Gul 2018; Hinoul 2011; Mackintosh 2010; Masata 2012; Masata 2016; Maslow 2014; Maturana 2019; Mostafa 2012; Oliveira 2011; Radwan 2020; Ross 2014; Rudnicki 2017; Sharifiaghdas 2015; Sivaslioglu 2012; Smith 2017; Sottner 2012; Xin 2016; Wang 2011)

• Other injuries; for example, neurovascular or vaginal (Amat 2011; Andrada Hamer 2011; Barber 2012; Bianchi‐Ferraro 2013; Emami 2019; Fernandez‐Gonzalez 2017; Friedman 2009; Grigoriadis 2013; Hinoul 2011; Masata 2012; Masata 2016; Oliveira 2011; Radwan 2020; Ross 2014; Rudnicki 2017; Schellart 2014; Smith 2017; Tommaselli 2010)

• Infections (Abdelwahab 2010; Amat 2011; Andrada Hamer 2011; Barber 2012; Bianchi‐Ferraro 2013; Chen 2020; Dogan 2018a; Fernandez‐Gonzalez 2017; Gaber 2016; Hinoul 2011; Masata 2012; Masata 2016; Maturana 2019; Oliveira 2011; Pascom 2018; Rudnicki 2017; Sabadell 2017; Saleh 2020; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Smith 2017; Tang 2014)

• De novo urgency (Abdel‐Fattah 2022; Abdelwahab 2010; Amat 2011; Andrada Hamer 2011; Bianchi‐Ferraro 2013; Dogan 2018a; Fernandez‐Gonzalez 2017; Gaber 2016; Jurakova 2016; Masata 2016; Maturana 2019; Melendez‐Munoz 2018; Mostafa 2012; Oliveira 2011; Pascom 2018; Pastore 2016; Rudnicki 2017; Sabadell 2017; Schweitzer 2015; Smith 2017; Tang 2014; Tommaselli 2010)

• Quality of life (Abdel‐Fattah 2022; Amat 2011; Bianchi‐Ferraro 2013; Chen 2020; Dogan 2018a; Fernandez‐Gonzalez 2017; Fu 2017; Gaber 2016; Hinoul 2011; Hota 2012; Jurakova 2016; Lee 2012; Martoccia 2020; Maslow 2014; Maturana 2019; Mostafa 2012; Pascom 2018; Pastore 2016; Ross 2014; Rudnicki 2017; Sabadell 2017; Sharifiaghdas 2015; Tang 2014; Van Rensburg 2015; Xin 2016)

• Repeat continence surgery or mesh revision (Abdel‐Fattah 2022; Andrada Hamer 2011; Barber 2012; Basu 2010; Bianchi‐Ferraro 2013; Dogan 2018a; Faber 2021; Friedman 2009; Hinoul 2011; Hota 2012; Lee 2012; Mackintosh 2010; Masata 2012; Masata 2016; Melendez‐Munoz 2018; Mostafa 2012; Ow 2019; Pascom 2018; Rudnicki 2017; Schellart 2014; Schweitzer 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010)

Further details on outcome measures in the included studies can be found in the Characteristics of included studies. Please see Appendix 4 for details of the studies that provided data for the outcomes of interest to this review.

Funding sources

Nine studies were funded through industry and manufacturers (Andrada Hamer 2011; Basu 2010; Hinoul 2011; Hota 2012; Lee 2012; Leitch 2017; Sabadell 2017; Schellart 2014; Schweitzer 2015), four through government funding (Abdel‐Fattah 2022; Jurakova 2016; Masata 2016; Sottner 2012), three through a charity (Barber 2012; Mostafa 2012; Rudnicki 2017), two through a university (Bianchi‐Ferraro 2013; Maslow 2014), one was funded by a hospital and government (Masata 2012), and one was funded by both industry and a hospital (Ross 2014). Two studies stated that they did not receive funding through industry but did not disclose whether they were funded by another source (Maturana 2019; Pascom 2018). One study disclosed a funding number, but the organisation that gave the grant was unclear (Fu 2017).

Twenty‐one studies declared that they did not receive specific funding (Amat 2011; Dogan 2018a; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Friedman 2009; Grigoriadis 2013; Kim 2010; Lee 2015; Mackintosh 2010; Oliveira 2011; Pastore 2016; Radwan 2020; Saleh 2020; Seo 2012; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010; Yoon 2011).

Eighteen studies did not report their funding sources (Abdelwahab 2010; Chen 2020; Dati 2012; Elbadry 2017; Faber 2021; Fernandez‐Gonzalez 2017; Foote 2015; Gaber 2016; Gul 2018; Martoccia 2020; Melendez‐Munoz 2018; Merali 2012; Ow 2019; Sharifiaghdas 2015; Shawky 2015; Van Rensburg 2015; Wang 2011; Xin 2016).

Excluded studies

We excluded 24 studies from the review for the following reasons:

• ineligible study design (Ahn 2014; Castañeda 2014; Lian 2020; Martan 2008; Melon 2022; NCT01054833; NCT03052985; Palomba 2014);

• ineligible comparison or no single‐incision arm (Araco 2011; De Leval 2011; Feng 2018; Lee JS 2010; Martan 2011; NCT02867748; Palomba 2012; Pardo 2010; Tommaselli 2012a); compared surgical techniques (Dogan 2018b; Lee KS 2010; Liapis 2010);

• the experimental interventions did not conform to the definition of a single‐incision sling (Okulu 2011);

• compared pelvic organ prolapse repair plus mini‐sling to pelvic organ prolapse repair alone (NCT01384084);

• compared TVT‐O with a 12‐cm shortened transobturator sling (TVT‐Abbrevo) (Tommaselli 2012b; Zullo 2020).

The details of these studies are given under Characteristics of excluded studies.

Two other studies are awaiting assessment and nine are ongoing trials. Further details are given in the Characteristics of studies awaiting classification and the Characteristics of ongoing studies.

Risk of bias in included studies

The findings of the risk of bias assessments for all included studies are summarised in Figure 3 and Figure 4. Further details on individual risk of bias assessments can be found in the Characteristics of included studies.

3.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

4.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Allocation

Random sequence generation

We rated four studies at high risk for this domain, due to inadequate randomisation methods (Amat 2011; Chen 2020; Elsayed Barakat 2020; Grigoriadis 2013). Thirty‐two studies were at low risk of random sequence generation bias (Abdel‐Fattah 2022; Barber 2012; Basu 2010; Dogan 2018a; Fernandez‐Gonzalez 2017; Fu 2017; Gaber 2016; Hinoul 2011; Jurakova 2016; Lee 2012; Leitch 2017; Mackintosh 2010; Masata 2012; Masata 2016; Maslow 2014; Melendez‐Munoz 2018; Mostafa 2012; Maturana 2019; Pastore 2016; Radwan 2020; Ross 2014; Rudnicki 2017; Sabadell 2017; Schellart 2014; Schweitzer 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Wang 2011; Xin 2016). The remaining 26 studies were at unclear risk of bias (Abdelwahab 2010; Andrada Hamer 2011; Bianchi‐Ferraro 2013; Dati 2012; Elbadry 2017; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Faber 2021; Foote 2015; Friedman 2009; Gul 2018; Hota 2012; Kim 2010; Lee 2015; Martoccia 2020; Merali 2012; Oliveira 2011; Ow 2019; Pascom 2018; Saleh 2020; Seo 2012; Sharifiaghdas 2015; Shawky 2015; Sottner 2012; Yoon 2011).

Allocation concealment

We judged one study to be at high risk for this domain (Chen 2020), and 38 to be at unclear risk of bias (Abdel‐Fattah 2022; Abdelwahab 2010; Amat 2011; Bianchi‐Ferraro 2013; Dati 2012; Elbadry 2017; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Faber 2021; Fernandez‐Gonzalez 2017; Foote 2015; Friedman 2009; Grigoriadis 2013; Gul 2018; Hinoul 2011; Jurakova 2016; Kim 2010; Lee 2012; Lee 2015; Martoccia 2020; Merali 2012; Oliveira 2011; Ow 2019; Pascom 2018; Pastore 2016; Ross 2014; Saleh 2020; Schellart 2014; Seo 2012; Shawky 2015; Sivaslioglu 2012; Sottner 2012; Tang 2014; Van Rensburg 2015; Xin 2016; Yoon 2011). We assessed 23 studies as being at low risk of allocation concealment bias (Andrada Hamer 2011; Barber 2012; Basu 2010; Dogan 2018a; Fu 2017; Gaber 2016; Hota 2012; Leitch 2017; Mackintosh 2010; Masata 2012; Masata 2016; Maslow 2014; Melendez‐Munoz 2018; Mostafa 2012; Maturana 2019; Radwan 2020; Rudnicki 2017; Sabadell 2017; Schweitzer 2015; Sharifiaghdas 2015; Smith 2017; Tommaselli 2010; Wang 2011).

Blinding

We judged studies to be at low, unclear or high risk of bias for these domains based on whether a lack of blinding would feasibly affect the outcomes. We judged that objective outcomes were unlikely to be affected by a lack of blinding. For subjective outcomes, we made a judgement on the extent to which they might be affected by a lack of blinding. For instance, at one year, we judged subjective outcomes measured by an independent assessor using a validated questionnaire to be at low risk of bias.

Blinding of participants or personnel (performance bias)

We judged seven studies to be at high risk of performance bias (Abdel‐Fattah 2022; Amat 2011; Faber 2021; Hinoul 2011; Lee 2012; Masata 2012; Schellart 2014), with 48 at unclear risk (Abdelwahab 2010; Andrada Hamer 2011; Basu 2010; Bianchi‐Ferraro 2013; Chen 2020; Dati 2012; Elbadry 2017; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Fernandez‐Gonzalez 2017; Foote 2015; Friedman 2009; Fu 2017; Gaber 2016; Grigoriadis 2013; Gul 2018; Hota 2012; Jurakova 2016; Kim 2010; Lee 2015; Mackintosh 2010; Martoccia 2020; Masata 2016; Maturana 2019; Melendez‐Munoz 2018; Merali 2012; Mostafa 2012; Oliveira 2011; Ow 2019; Pascom 2018; Pastore 2016; Radwan 2020; Rudnicki 2017; Sabadell 2017; Saleh 2020; Seo 2012; Sharifiaghdas 2015; Shawky 2015; Sivaslioglu 2012; Smith 2017; Sottner 2012; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Wang 2011; Xin 2016; Yoon 2011). Seven studies were at low risk of bias for this domain (Barber 2012; Dogan 2018a; Gaber 2016; Leitch 2017; Maslow 2014; Ross 2014; Schweitzer 2015).

Blinding of outcome assessors (detection bias)

We judged five studies to be at high risk of detection bias (Amat 2011; Foote 2015; Lee 2012; Schellart 2014; Smith 2017), with 48 at unclear risk (Abdel‐Fattah 2022; Abdelwahab 2010; Basu 2010; Bianchi‐Ferraro 2013; Chen 2020; Dati 2012; Elbadry 2017; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Faber 2021; Fernandez‐Gonzalez 2017; Friedman 2009; Fu 2017; Grigoriadis 2013; Gul 2018; Hinoul 2011; Hota 2012; Kim 2010; Lee 2015; Mackintosh 2010; Martoccia 2020; Masata 2012; Masata 2016; Maturana 2019; Melendez‐Munoz 2018; Merali 2012; Mostafa 2012; Oliveira 2011; Ow 2019; Pascom 2018; Pastore 2016; Radwan 2020; Ross 2014; Rudnicki 2017; Sabadell 2017; Saleh 2020; Schweitzer 2015; Seo 2012; Sharifiaghdas 2015; Shawky 2015; Sottner 2012; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Wang 2011; Yoon 2011). Nine studies were at low risk of bias for this domain (Andrada Hamer 2011; Barber 2012; Dogan 2018a; Gaber 2016; Jurakova 2016; Leitch 2017; Maslow 2014; Sivaslioglu 2012; Xin 2016).

Incomplete outcome data

We assessed three studies as being at high risk of attrition bias (Amat 2011; Hinoul 2011; Martoccia 2020). Amat 2011 and Martoccia 2020 had a high loss to follow‐up, with reasons for dropouts unclear, while Hinoul 2011 had a significant loss to follow‐up in the TVT‐Secur group. Forty‐five studies were at low risk of attrition bias (Abdel‐Fattah 2022; Abdelwahab 2010; Andrada Hamer 2011; Barber 2012; Basu 2010; Bianchi‐Ferraro 2013; Chen 2020; Dogan 2018a; Elbadry 2017; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2010; Fernandez‐Gonzalez 2017; Foote 2015; Friedman 2009; Fu 2017; Gaber 2016; Grigoriadis 2013; Gul 2018; Hota 2012; Jurakova 2016; Lee 2012; Mackintosh 2010; Masata 2012; Masata 2016; Maslow 2014; Maturana 2019; Melendez‐Munoz 2018; Mostafa 2012; Oliveira 2011; Pascom 2018; Pastore 2016; Radwan 2020; Ross 2014; Sabadell 2017; Saleh 2020; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Van Rensburg 2015; Wang 2011; Xin 2016). We judged the remaining 14 studies to be at an unclear risk for this domain (Dati 2012; Enzelsberger 2011; Faber 2021; Kim 2010; Lee 2015; Leitch 2017; Merali 2012; Ow 2019; Rudnicki 2017; Seo 2012; Shawky 2015; Sottner 2012; Tommaselli 2010; Yoon 2011).

Selective reporting

We judged one study to be at high risk of selective reporting bias (Faber 2021), while 18 were unclear risk (Chen 2020; Dati 2012; Elbadry 2017; Elsayed Barakat 2020; Enzelsberger 2011; Friedman 2009; Lee 2015; Leitch 2017; Martoccia 2020; Merali 2012; Oliveira 2011; Ow 2019; Radwan 2020; Saleh 2020; Seo 2012; Shawky 2015; Sottner 2012; Yoon 2011). We found no concerns for this domain in the remaining 43 studies, which we judged as having a low risk of bias (Abdel‐Fattah 2022; Abdelwahab 2010; Amat 2011; Andrada Hamer 2011; Barber 2012; Basu 2010; Bianchi‐Ferraro 2013; Dogan 2018a; Emami 2019; Enzelsberger 2010; Fernandez‐Gonzalez 2017; Foote 2015; Fu 2017; Gaber 2016; Grigoriadis 2013; Gul 2018; Hinoul 2011; Hota 2012; Jurakova 2016; Kim 2010; Lee 2012; Mackintosh 2010; Masata 2012; Masata 2016; Maslow 2014; Melendez‐Munoz 2018; Mostafa 2012; Maturana 2019; Pascom 2018; Pastore 2016; Ross 2014; Rudnicki 2017; Sabadell 2017; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Wang 2011; Xin 2016).

Other potential sources of bias

We judged four studies to be at high risk of other bias (Amat 2011; Barber 2012; Leitch 2017; Ross 2014). Both Amat 2011 and Barber 2012 had a high proportion of participants who underwent concomitant surgery, which could have obscured the true effect of the interventions. Leitch 2017 was withdrawn as the intervention was withdrawn from the market. Similarly, Ross 2014 finished early due to concerns about the safety of TVT‐Secur, meaning the sample size was significantly smaller than the a priori sample size estimated from the power calculation. We did not identify any other sources of bias in 47 studies, which we judged to be at low risk for this domain (Abdelwahab 2010; Andrada Hamer 2011; Basu 2010; Bianchi‐Ferraro 2013; Chen 2020; Dogan 2018a; Elsayed Barakat 2020; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Fernandez‐Gonzalez 2017; Foote 2015; Friedman 2009; Fu 2017; Gaber 2016; Grigoriadis 2013; Gul 2018; Hinoul 2011; Hota 2012; Jurakova 2016; Kim 2010; Lee 2012; Lee 2015; Mackintosh 2010; Masata 2012; Masata 2016; Maslow 2014; Maturana 2019; Melendez‐Munoz 2018; Mostafa 2012; Oliveira 2011; Pascom 2018; Pastore 2016; Radwan 2020; Rudnicki 2017; Sabadell 2017; Saleh 2020; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Wang 2011; Xin 2016). We judged the remaining 11 studies to be at unclear risk of other bias (Abdel‐Fattah 2022; Dati 2012; Elbadry 2017; Faber 2021; Martoccia 2020; Merali 2012; Ow 2019; Seo 2012; Shawky 2015; Sottner 2012; Yoon 2011).

Effects of interventions

See: Table 1; Table 2; Table 3

In all comparisons, we present stratified analyses, whereby the primary analysis does not include trials using TVT‐Secur. We report these studies separately within each outcome for each comparison.

1. Single‐incision slings versus no treatment

We did not identify any eligible studies for this comparison.

2. Single‐incision slings versus conservative treatment

We did not identify any eligible studies for this comparison.

3. Single‐incision slings versus colposuspension

We did not identify any eligible studies for this comparison.

4. Single‐incision slings versus laparoscopic procedures

We did not identify any eligible studies for this comparison.

5. Single‐incision slings versus autologous fascial slings

We identified one study investigating single‐incision slings versus autologous fascial slings (Sharifiaghdas 2015).

Primary outcomes

Subjective cure or improvement of urinary incontinence

Not reported.

Secondary outcomes

Objective cure or improvement of urinary incontinence

Between 12 and 24 months after surgery, there may be little to no difference between single‐incision slings and autologous fascial slings for objective cure or improvement of urinary incontinence (RR 1.00, 95% CI 0.85 to 1.18; 1 study, 70 participants; Analysis 1.1).

1.1. Analysis.

Comparison 1: Single‐incision slings versus autologous fascial slings, Outcome 1: Objective cure or improvement of urinary incontinence: between 12 and 24 months

Patient‐reported pain

Not reported.

Number of women with dyspareunia

Single‐incision slings may increase the risk of dyspareunia compared with autologous fascial slings, although the wide 95% CI is consistent with both possible benefit and possible harm (RR 1.33, 95% CI 0.32 to 5.53; 1 study, 70 participants; low‐certainty evidence; Analysis 1.2; Table 1).

1.2. Analysis.

Comparison 1: Single‐incision slings versus autologous fascial slings, Outcome 2: Dyspareunia

Number of women with mesh exposure, extrusion or erosions in any area

We are uncertain whether more women experience mesh exposure, extrusion or erosions with single‐incision slings compared with autologous fascial slings (RR 2.00, 95% CI 0.19 to 21.06; 1 study, 70 participants; low‐certainty evidence; Analysis 1.3; Table 1).

1.3. Analysis.

Comparison 1: Single‐incision slings versus autologous fascial slings, Outcome 3: Number of women affected by mesh exposure, extrusion or erosion in any area

Number of women with urinary retention

Not reported.

Number of bladder or urethral injuries

Based on one trial (Sharifiaghdas 2015), it is uncertain whether single‐incision slings have any effect on the risk of bladder or urethral injuries compared with autologous fascial slings (RR 0.33, 95% CI 0.01 to 7.91; 70 participants; Analysis 1.4).

1.4. Analysis.

Comparison 1: Single‐incision slings versus autologous fascial slings, Outcome 4: Bladder or urethral injuries: less than 30 days after surgery

Number of other injuries (e.g. neurovascular or vaginal)

Not reported.

Number of infections (e.g. urinary tract infection (UTI), mesh infection)

Based on one trial (Sharifiaghdas 2015), it is uncertain whether single‐incision slings have any effect on the risk of infection compared with autologous fascial slings (RR 0.13, 95% CI 0.02 to 0.95; 70 participants; Analysis 1.5).

1.5. Analysis.

Comparison 1: Single‐incision slings versus autologous fascial slings, Outcome 5: Infections (e.g. UTI, mesh infection)

Number of women with de novo urgency

Based on one trial (Sharifiaghdas 2015), it is not clear if single‐incision slings have any effect on the risk of de novo urgency compared with autologous fascial slings (RR 0.20, 95% CI 0.02 to 1.63; 70 participants).

Quality of life

Not reported.

Number of women requiring repeat continence surgery or mesh revision

Not reported.

6. Single‐incision slings versus retropubic minimally‐invasive slings

We identified 10 studies investigating single‐incision slings versus retropubic slings (Abdelwahab 2010; Andrada Hamer 2011; Barber 2012; Basu 2010; Gaber 2016; Lee 2015; Leitch 2017; Ow 2019; Ross 2014; Wang 2011). One study was terminated early and was not reported beyond the trial registration stage, so did not contribute data (Leitch 2017).

We performed Sensitivity analysis for this comparison. Full details are reported in Table 5.

Primary outcomes

Subjective cure or improvement of urinary incontinence

Studies excluding TVT‐Secur

There may be little to no difference in subjective cure of incontinence at 12 months with single‐incision slings compared to retropubic slings (RR 0.99, 95% CI 0.91 to 1.07; 2 studies, 297 women; low‐certainty evidence; Analysis 2.1.1; Table 2).

2.1. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 1: Subjective cure or improvement of urinary incontinence: at 12 months

Single‐incision slings may be less effective in curing or improving incontinence at 36 or more months; however the 95% confidence interval contains possible benefit and harm (RR 0.73, 95% CI 0.37 to 1.45; 2 studies, 196 participants; Analysis 2.2.1). Subjective cure between 12 and 24 months and between 24 and 36 months were not reported.

2.2. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 2: Subjective cure or improvement of urinary incontinence: 36 + months

TVT‐Secur

TVT‐Secur may provide a similar or slightly lower subjective cure of incontinence at 12 months compared with retropubic slings (RR 0.92, 95% CI 0.82 to 1.02; 3 studies, 445 participants; Analysis 2.1.2). No studies reported on this outcome for any of our other pre‐specified time points.

Secondary outcomes

Objective cure or improvement of urinary incontinence

Studies excluding TVT‐Secur

There may be little to no difference between single‐incision slings and retropubic slings for objective cure or improvement of incontinence at 12 months (RR 0.99, 95% CI 0.92 to 1.06; 2 studies, 297 participants; Analysis 2.3.1).

2.3. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 3: Objective cure or improvement of urinary incontinence: at 12 months

Single‐incision slings may be similar to or more effective than retropubic slings at achieving objective cure or improvement of incontinence at 36 months or longer (RR 1.10, 95% CI 1.00 to 1.20; 1 study, 115 participants; Analysis 2.4.1). Objective cure or improvement of incontinence between 12 and 24 months and between 24 and 36 months were not reported.

2.4. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 4: Objective cure or improvement of urinary incontinence: 36+ months

TVT‐Secur

Women with TVT‐Secur may have similar or lower objective cure or improvement of incontinence at 12 months compared to retropubic slings (RR 0.81, 95% CI 0.63 to 1.03; 2 studies, 179 participants; Analysis 2.3.2). No studies reported on this outcome for any of our other pre‐specified time points.

Patient‐reported pain

Studies excluding TVT‐Secur

It is possible that, between 30 days and 12 months, more women with single‐incision slings may experience pain than those with retropubic slings, although the confidence interval is very wide and includes differences that could favour either treatment (RR 3.30, 95% CI 0.14 to 77.95; 1 study, 61 participants; Analysis 2.5.1). No study reported on patient‐reported pain at 24 months or more (Table 2).

2.5. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 5: Patient‐reported pain: 30 days to 12 months

TVT‐Secur

More women with TVT‐Secur may experience pain between 30 days and 12 months than those with retropubic slings; the very wide 95% confidence interval is consistent with both benefit and harm (RR 2.80, 95% CI 0.12 to 68.18; 1 study, 263 participants; Analysis 2.5.2). Women with TVT‐Secur may be less likely to report pain between 12 and 24 months compared to a retropubic sling but the wide 95% confidence interval is consistent with both benefit and harm (RR 0.76, 95% CI 0.17 to 3.32; 3 studies, 242 participants; Analysis 2.6.2). No study including TVT‐Secur reported on patient‐reported pain at 24 months or more.

2.6. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 6: Patient‐reported pain: 12 to 24 months

Number of women with dyspareunia

Studies excluding TVT‐Secur

No studies reported this outcome (Table 2).

TVT‐Secur

TVT‐Secur may result in more women experiencing dyspareunia than retropubic slings; the wide 95% CI is consistent with both possible benefit and possible harm (RR 2.10, 95% CI 0.54 to 8.19; 2 studies, 175 participants; Analysis 2.7.2).

2.7. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 7: Dyspareunia

Number of women with mesh exposure, extrusion or erosions in any area

Studies excluding TVT‐Secur

It is uncertain if single‐incision slings have any effect on the risk of mesh exposure, extrusion or erosions compared with retropubic slings; the wide 95% CI is consistent with both possible benefit and possible harm (RR 1.55, 95% CI 0.24 to 9.82; 3 studies, 267 participants; low‐certainty evidence; Analysis 2.8.1; Table 2).

2.8. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 8: Number of women affected by mesh exposure, extrusion or erosion in any area

TVT‐Secur

It is uncertain if TVT‐Secur has any effect on the risk of mesh exposure, extrusion or erosions compared with retropubic slings; the wide 95% CI is consistent with both possible benefit and possible harm (RR 1.25, 95% CI 0.34 to 4.55; 3 studies, 452 participants; Analysis 2.8.2).

Number of women with urinary retention

Studies excluding TVT‐Secur

It is uncertain whether single‐incision slings lead to fewer women with postoperative urinary retention compared with retropubic slings; the wide 95% CI is consistent with both possible benefit and possible harm (RR 0.47, 95% CI 0.12 to 1.84; 2 studies, 209 participants; low‐certainty evidence; Analysis 2.9.1; Table 2).

2.9. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 9: Urinary retention

TVT‐Secur

It is uncertain whether TVT‐Secur leads to fewer women with postoperative urinary retention compared with retropubic slings; the wide 95% CI is consistent with both possible benefit and possible harm (RR 0.69, 95% CI 0.28 to 1.73; 4 studies, 510 participants; Analysis 2.9.2).

Number of bladder or urethral injuries

Studies excluding TVT‐Secur

It is uncertain whether single‐incision slings lead to similar or slightly fewer women experiencing bladder or urethral injuries within 30 days of surgery compared to retropubic slings; the 95% CI is wide and consistent with both reductions and increases in injury rates (RR 0.94, 95% CI 0.13 to 6.71; 2 studies, 209 participants; Analysis 2.10.1).

2.10. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 10: Bladder or urethral injuries: less than 30 days after surgery

TVT‐Secur

TVT‐Secur may lead to slightly fewer women experiencing bladder or urethral injuries within 30 days of surgery compared to retropubic slings, though the CI is wide and consistent with both possible increases or reductions in these types of injuries (RR 0.61, 95% CI 0.25 to 1.51; 5 studies, 578 participants; Analysis 2.10.2).

Number of other injuries (e.g. neurovascular or vaginal)

Studies excluding TVT‐Secur

No studies reported on this outcome.

TVT‐Secur

It is uncertain whether TVT‐Secur reduces the number of neurovascular or other injuries caused compared to retropubic slings (RR 0.93, 95% CI 0.21 to 4.09; 3 studies, 449 participants; Analysis 2.11.2).

2.11. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 11: Other injuries: less than 30 days after surgery

Number of infections (e.g. UTI, mesh infection)

Studies excluding TVT‐Secur

Gaber 2016 reported that women may be less likely to experience infections with single‐incision slings compared to retropubic slings; the wide CI includes possible reductions and increases in numbers experiencing infections (RR 0.42, 95% CI 0.11 to 1.57; 1 study, 139 participants; Analysis 2.12.1).

2.12. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 12: Infections (e.g. UTI, mesh infection)

TVT‐Secur

It is uncertain whether surgery with TVT‐Secur reduces the number of infections experienced with single‐incision slings compared to retropubic slings (RR 0.93, 95% CI 0.61 to 1.42; 3 studies, 434 participants; Analysis 2.12.2).

Number of women with de novo urgency

Studies excluding TVT‐Secur

Single‐incision slings may lead to fewer women experiencing de novo urgency compared to retropubic slings; the wide CI is consistent with both increases and reductions in de novo urgency (RR 0.62, 95% CI 0.21 to 1.79; 1 study, 139 participants; Analysis 2.13.1).

2.13. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 13: De novo urgency

TVT‐Secur

TVT‐S may lead to more women experiencing de novo urgency compared to retropubic slings; the wide CI is consistent with both increased and reduced de novo urgency (RR 1.32, 95% CI 0.74 to 2.35; 3 studies, 246 participants; Analysis 2.13.2).

Quality of life

Studies excluding TVT‐Secur

Gaber 2016 reported quality‐of‐life data, but not in a suitable form for analysis (see Table 8; Table 2).

5. Quality of life at 12 months: single‐incision sling versus retropubic sling.

Study ID	QoL tool	Reported results
Barber 2012	Pelvic Distress Inventory‐20, Pelvic Floor Impact Questionnaire‐7	"Overall, there was a significant improvement in the urinary scales of the Pelvic Floor Distress Inventory‐20 (Urinary Distress Inventory‐6: mean change in score −33 ± 24; P < .001) and the Pelvic Floor Impact Questionnaire‐7 (Urinary Impact Questionnaire‐7: mean change in score −23 ± 22; P <.001), with no significant differences between groups."
Gaber 2016	Reduction in ICIQ	SIS: 9 (8 to 10) EFA: 9 (8 to 10)
Ross 2014	IIQ (median and IQR)	SIS: 12 months: 0 (14); change from baseline: 25 Comparison: 0 (14); change from baseline: 25
	UDI (median and IQR)	SIS: 11 (17), change from baseline: 28 Comparison: 0 (11); change from baseline: 27

EFA: endopelvic free anchorage; ICIQ: International Consultation on Incontinence Questionnaire; IIQ: Incontinence Impact Questionnaire; IQR: interquartile range; QoL: quality of life; SIS: single‐incision sling; UDI: Urinary Distress Inventory

TVT‐Secur

Similarly, two studies including TVT‐Secur reported on quality of life, but not in a suitable form for meta‐analysis (Barber 2012; Ross 2014; see Table 8).

Number of women requiring repeat continence surgery or mesh revision

Studies excluding TVT‐Secur

We are uncertain if single‐incision slings have any effect on the risk of repeat surgery or mesh revision compared with retropubic slings (RR 4.19, 95% CI 0.31 to 57.28; 2 studies, 182 participants; very low‐certainty evidence; Analysis 2.14.1; Table 2).

2.14. Analysis.

Comparison 2: Single‐incision slings versus retropubic minimally‐invasive slings, Outcome 14: Requiring repeat continence surgery or mesh revision

TVT‐Secur

TVT‐Secur may lead to slightly more women requiring repeat continence surgery or mesh revision compared to retropubic slings; the CI is wide enough to include both possible reductions and increases in the number of repeat surgeries (RR 1.13, 95% CI 0.14 to 9.26; 2 studies, 388 participants; Analysis 2.14.2).

7. Single‐incision slings versus transobturator minimally‐invasive slings

Forty studies were eligible for this comparison (Amat 2011; Bianchi‐Ferraro 2013; Dogan 2018a; Emami 2019; Enzelsberger 2010; Enzelsberger 2011; Fernandez‐Gonzalez 2017; Foote 2015; Friedman 2009; Fu 2017; Grigoriadis 2013; Gul 2018; Hinoul 2011; Hota 2012; Jurakova 2016; Kim 2010; Lee 2012; Mackintosh 2010; Masata 2012; Masata 2016; Maslow 2014; Maturana 2019; Merali 2012; Mostafa 2012; Oliveira 2011; Pastore 2016; Sabadell 2017; Schellart 2014; Schweitzer 2015; Seo 2012; Shawky 2015; Sivaslioglu 2012; Smith 2017; Sottner 2012; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Wang 2011; Xin 2016; Yoon 2011).

Where 10 or more studies contributed to a meta‐analysis, we assessed the likelihood of potential publication bias by generating funnel plots (see Figure 5; Figure 6; Figure 7; Figure 8; Figure 9; Figure 10; Figure 11; Figure 12; Figure 13; Figure 14; Figure 15). There was no evidence of publication bias. We conducted a series of sensitivity analyses to explore sources of heterogeneity (see Table 6).

5.

Analysis 3.1 Subjective cure or improvement of urinary incontinence: 12 months

6.

Analysis 3.5 Objective cure or improvement of incontinence: at 12 months

7.

Analysis 3.12 Dyspareunia

8.

Analysis 3.13 Mesh erosions in any area

9.

Analysis 3.14 Urinary retention

10.

Analysis 3.15 Bladder or urethral injuries: less than 30 days after treatment

11.

Analysis 3.16 Other injuries: less than 30 days after treatment

12.

Analysis 3.17 Infections (e.g. UTI, mesh infections)

13.

Analysis 3.18 De novo urgency

14.

Analysis 3.19 Quality of life: at 12 months

15.

Analysis 3.20 Requiring repeat continence surgery or mesh revision

Primary outcomes

Subjective cure or improvement of urinary incontinence

Studies excluding TVT‐Secur

There is little to no difference in subjective cure or improvement of incontinence at 12 months post‐surgery between single‐incision slings and transobturator slings (RR 1.00, 95% CI 0.97 to 1.03; 17 studies, 2359 participants; high‐certainty evidence; Analysis 3.1.1; Table 3).

3.1. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 1: Subjective cure or improvement of urinary incontinence: 12 months

It is uncertain whether more women with single‐incision slings experience subjective cure or improvement of incontinence compared to transobturator slings between 12 and 24 months (RR 0.93, 95% CI 0.80 to 1.08; 2 studies, 254 participants; Analysis 3.2.1).

3.2. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 2: Subjective cure or improvement of urinary incontinence: 12 to 24 months

There is probably little to no difference in subjective cure or improvement of incontinence between single‐incision slings and transobturator slings at 24 to 36 months (RR 0.98, 95% CI 0.94 to 1.03; 3 studies, 534 participants; Analysis 3.3.1).

3.3. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 3: Subjective cure or improvement of urinary incontinence: 24 to 36 months

There may be a similar number of, or slightly fewer, women with subjective cure or improvement of incontinence following single‐incision slings than transobturator slings at 36 months and beyond (RR 0.96, 95% CI 0.89 to 1.03; 4 studies, 604 participants; Analysis 3.4.1).

3.4. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 4: Subjective cure or improvement of urinary incontinence: 36+ months

TVT‐Secur

A similar number of or slightly fewer women with TVT‐Secur may demonstrate subjective cure or improvement of incontinence at 12 months compared to those with transobturator slings (RR 0.89, 95% CI 0.78 to 1.00; 4 studies, 475 participants; Analysis 3.1.2). Post hoc sensitivity analyses of trials excluding concomitant POP surgery or trials that did not explicitly report prolapse surgery strengthened the result that a similar number or slightly fewer women with TVT‐Secur may demonstrate subjective cure or improvement of incontinence at 12 months (RR 0.88, 95% CI 0.74 to 0.83; 2 studies; see Table 6).

No studies reported subjective cure or improvement between 12 and 24 months.

A similar number of or fewer women with TVT‐Secur may demonstrate subjective cure or improvement of incontinence compared to those with transobturator slings between 24 and 36 months; the 95% confidence interval is consistent with both benefit and harm (RR 0.93, 95% CI 0.59 to 1.44; 2 studies, 322 participants; Analysis 3.3.2).

Fewer women with TVT‐Secur may report subjective cure or improvement of incontinence at 36 months and beyond (RR 0.81, 95% CI 0.66 to 0.99; 2 studies, 194 participants; Analysis 3.4.2).

Secondary outcomes

Objective cure or improvement of urinary incontinence

Studies excluding TVT‐Secur

There is no evidence of a clinically meaningful difference in objective cure or improvement of SUI at 12 months between single‐incision slings and transobturator slings (RR 1.01, 95% CI 0.98 to 1.03; 19 studies, 2587 participants; Analysis 3.5.1).

3.5. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 5: Objective cure or improvement of incontinence: at 12 months

A similar number of or slightly fewer women with single‐incision slings may demonstrate objective cure or improvement of SUI between 12 and 24 months than those with transobturator slings (RR 0.95, 95% CI 0.86 to 1.05; 3 studies, 304 participants; Analysis 3.6.1).

3.6. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 6: Objective cure or improvement of incontinence: 12 to 24 months

There may be little to no difference in objective cure or improvement of SUI between 24 and 36 months between single‐incision slings and transobturator slings (RR 0.99, 95% CI 0.93 to 1.04; 3 studies, 484 participants; Analysis 3.7.1).

3.7. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 7: Objective cure or improvement of incontinence: 24 to 36 months

There is probably little or no difference in objective cure or improvement of SUI between single‐incision slings and transobturator slings at 36 months and longer (RR 0.98, 95% CI 0.92 to 1.03; 4 studies, 582 participants; Analysis 3.8.1).

3.8. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 8: Objective cure or improvement of incontinence: 36+ months

TVT‐Secur

A similar number of or fewer women experience objective cure or improvement of urinary incontinence with TVT‐Secur compared to transobturator slings at 12 months (RR 0.84, 95% CI 0.74 to 0.97; 8 studies, 732 participants; Analysis 3.5.2).

No study reported objective cure or improvement between 12 and 24 months.

There may be a similar number of or fewer women who experience cure or improvement of urinary incontinence with TVT‐Secur compared to transobturator slings between 24 and 36 months (RR 0.87, 95% CI 0.74 to 1.03; 3 studies, 393 participants; Analysis 3.7.2).

Fewer women experience objective cure or improvement of urinary incontinence with TVT‐Secur compared to transobturator slings at 36 months and longer (RR 0.75, 95% CI 0.62 to 0.91; 2 studies, 194 participants; Analysis 3.8.2).

Patient‐reported pain

Studies excluding TVT‐Secur

Women with single‐incision slings report less pain between 30 days and 12 months compared to those with transobturator slings (RR 0.23, 95% CI 0.11 to 0.52; 5 studies, 566 participants; Analysis 3.9.1).

3.9. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 9: Patient‐reported pain: 30 days to 12 months

We do not know whether women with single‐incision slings experience more pain between 12 and 24 months post‐surgery compared to those with transobturator slings (RR 0.64, 95% CI 0.23 to 1.83; 2 studies, 129 participants; Analysis 3.10.1).

3.10. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 10: Patient‐reported pain: 12 to 24 months

Women with single‐incision slings probably have reduced pain at 24 months' post‐surgery compared with transobturator slings (RR 0.12, 95% CI 0.02 to 0.68; 2 studies, 250 participants; Analysis 3.11.1; Table 3).

3.11. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 11: Patient‐reported pain: 24+ months

TVT‐Secur

Women with TVT‐Secur may experience less pain between 30 days and 12 months compared to those undergoing transobturator sling surgery (RR 0.04, 95% CI 0.00 to 0.71; 2 studies, 151 participants; Analysis 3.9.2).

Women with TVT‐Secur may experience less pain compared to those undergoing transobturator sling surgery between 12 and 24 months (RR 0.31, 95% CI 0.15 to 0.65; 6 studies, 507 participants; Analysis 3.10.2).

It is unclear whether women with TVT‐Secur have more or less pain after 24 months compared to transobturator slings; the 95% CI is consistent with both benefit and harm (RR 0.16, 95% CI 0.02 to 1.23; 1 study, 64 participants; Analysis 3.11.2).

Number of women with dyspareunia

Studies excluding TVT‐Secur

It is unclear if single‐incision slings affect the risk of dyspareunia compared with transobturator slings; the wide 95% CI is consistent with both possible benefit and possible harm (RR 0.78, 95% CI 0.41 to 1.48; 8 studies, 810 participants; moderate‐certainty evidence; Analysis 3.12.1; Table 3). The funnel plot for Analysis 3.12 can be found in Figure 7.

3.12. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 12: Dyspareunia

TVT‐Secur

It is unclear if TVT‐Secur has an effect on the risk of dyspareunia compared with transobturator slings; the wide 95% confidence interval is consistent with both benefit and harm (RR 0.69, 95% CI 0.28 to 1.74; 2 studies, 262 participants; Analysis 3.12.2).

Number of women with mesh exposure, extrusion or erosion in any area

Studies excluding TVT‐Secur

Single‐incision slings cause a similar number of mesh exposures, extrusions or erosions compared to transobturator slings (RR 0.61, 95% CI 0.39 to 0.96; 16 studies, 2378 participants; high‐certainty evidence; Analysis 3.13.1; Table 3). Removing studies which did not exclude concomitant prolapse surgery widened confidence intervals (see Table 6).

3.13. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 13: Number of women affected by mesh exposure, extrusion or erosion in any area

TVT‐Secur

TVT‐Secur may increase the risk of mesh exposures, extrusions or erosions compared to transobturator slings (RR 2.34, 95% CI 1.24 to 4.40; 7 studies, 880 participants; Analysis 3.13.2). Removing studies which did not exclude concomitant prolapse surgery widened confidence intervals (RR 1.76, 95% CI 0.90 to 3.47; 6 studies; see Table 6).

Number of women with urinary retention

Studies excluding TVT‐Secur

Single‐incision slings may result in similar or reduced risk of postoperative urinary retention compared with transobturator slings (RR 0.68, 95% CI 0.47 to 0.97; 23 studies, 2891 participants; moderate‐certainty evidence; Analysis 3.14.1; Table 3).

3.14. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 14: Urinary retention

Removing studies which did not exclude concomitant prolapse surgery or did not report on concomitant surgery widened confidence intervals (RR 0.60, 95% CI 0.29 to 1.22; 6 studies; see Table 6).

TVT‐Secur

It is unclear if TVT‐Secur reduces the risk of postoperative urinary retention compared with transobturator slings as the 95% confidence interval is consistent with both benefit and harm (RR 0.82, 95% CI 0.40 to 1.67; 9 studies, 1003 participants; Analysis 3.14.2).

Number of bladder or urethral injuries

Studies excluding TVT‐Secur

There may be a similar or slightly increased risk of bladder or urethral injuries within 30 days of treatment with single‐incision slings compared to transobturator slings (RR 0.38, 95% CI 0.14 to 1.08; 19 studies, 2497 participants; Analysis 3.15.1).

3.15. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 15: Bladder or urethral injuries: less than 30 days after surgery

TVT‐Secur

It is unclear if TVT‐Secur increases the risk of bladder or urethral injuries within 30 days of treatment compared to transobturator slings; the wide 95% confidence interval is consistent with both benefit and harm (RR 2.51, 95% CI 0.52 to 12.15; 6 studies, 690 participants; Analysis 3.15.2).

Number of other injuries (e.g. neurovascular or vaginal)

Studies excluding TVT‐Secur

There may be a slightly higher risk of other injuries with single‐incision slings compared with transobturator slings (RR 0.55, 95% CI 0.26 to 1.13; 11 studies, 1228 participants; Analysis 3.16.1).

3.16. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 16: Other injuries: less than 30 days after surgery

TVT‐Secur

It is unclear if there is a difference in risk of neurovascular injury with TVT‐Secur compared to transobturator slings as the wide 95% confidence interval is consistent with both benefit and harm (RR 0.82, 95% CI 0.30 to 2.22; 6 studies, 766 participants; Analysis 3.16.2).

Number of infections (e.g. UTI, mesh infection)

Studies excluding TVT‐Secur

It is unclear what effect single‐incision slings have on the number of infections experienced by women compared to those who have transobturator slings; the 95% confidence interval is consistent with both benefit and harm (RR 1.04, 95% CI 0.74 to 1.45; 14 studies, 1773 participants; Analysis 3.17.1).

3.17. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 17: Infections (e.g. UTI, mesh infections)

TVT‐Secur

It is unclear if women with TVT‐Secur experience a similar number of infections compared to those who have transobturator slings; the 95% confidence interval is consistent with both benefit and harm (RR 1.00, 95% CI 0.52 to 1.94; 5 studies, 646 participants; Analysis 3.17.2).

Number of women with de novo urgency

Studies excluding TVT‐Secur

It is unclear if women with single‐incision slings have similar levels of de novo urgency compared to transobturator slings; the 95% CI is consistent with both benefit and harm (RR 1.07, 95% CI 0.77 to 1.49; 13 studies, 1464 participants; Analysis 3.18.1).

3.18. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 18: De novo urgency

TVT‐Secur

The effects of TVT‐Secur on the risk of de novo urgency compared to transobturator slings is unclear as the 95% CI is consistent with both benefit and harm (RR 1.15, 95% CI 0.77 to 1.73; 7 studies, 729 participants; Analysis 3.18.2).

Quality of life

Studies excluding TVT‐Secur

Women undergoing single‐incision slings may have decreased quality of life at 12 months compared with those undergoing transobturator slings (standardised mean difference (SMD) 0.24, 95% CI 0.09 to 0.39; 8 studies, 689 participants; low‐certainty evidence; Analysis 3.19; Table 3; Table 9).

3.19. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 19: Quality of life: at 12 months

6. Quality of life at 12 months: single‐incision sling versus transobturator sling.

Study ID	QoL tool	Reported results
Amat 2011	Not clear	"as previous" SIS: 6.15 preoperatively, 1.1 postoperatively Comparison: 6.54 preoperatively, 0.95 postoperatively
Bianchi‐Ferraro 2013	KHQ general health perception items (mean and SD)	SIS: 38.64 ± 24.49 preoperatively to 22.1 ± 14.64 postoperatively Comparison: 40.00 ± 22.36 preoperatively to 22.69 ± 19.59 postoperatively
Pascom 2018	UDI short form (mean and SD)	SIS: 8.5 ± 2.5 at baseline to 2.7 ± 3.2 at follow‐up Comparison: 9.3 ± 2.6 at baseline to 0.7 ± 1.3 at follow‐up
Dogan 2018a	ICIQ‐UI‐SF (0 to 21)	12 months SIS: 0/21 Comparison: 1/21 24 months SIS: 1/21 Comparison: 3/21
Fernandez‐Gonzalez 2017	ICIQ‐UI‐SF (time point not recorded)	SIS: 7.08 ± 2.56 preoperatively to 2.04 ± 3.05 postoperatively Comparison: 7.52 ± 2.46 preoperatively to 0.91 ± 2.16 postoperatively
Fu 2017	ICIQ‐UI‐SF (not clear if mean and SD score or mean and SD change in score)	SIS: 1.32 ± 1.43 Comparison: 1.24 ± 1.15
Gaber 2016	Reduction in ICIQ	SIS: 9 (8 to 10) TVT‐O: 9 (7 to 10)
Hinoul 2011	UDI (Dutch version, mean and SD)	TVT‐Secur: 21 ± 24/63 TVT‐O: 13 ± 21/90
	SF‐36 (narrative report)	"Generic QOL… did not differ significantly between baseline and 12 months. Physical function, which is known to be affected by SUI, improved significantly in both groups (P = 0.05). However, there was no significant difference between the groups"
Hota 2012	PFDI‐20 (reduction measured by median and IQR)	TVT‐Secur: 37.0 (21.5 to 73.4)/16 TVT‐O: 48.4 (28.7 to 60.4)/20
	PFIQ‐7 (reduction measured by median and IQR)	TVT‐Secur: 33.3 (7.6 to 42.9)/17 TVT‐O: 23.8 (14.3 to 42.8)/20
Jurakova 2016	ICIQ‐SF change preoperatively to postoperatively (mean ± SD (range))	SIS: 11.5 ± 3.1 (7.0 to 16.0) Comparison: 11.7 ± 3.0 (7.0 to 17.0)
Kim 2010	KHQ (narratively reported)	"Postoperative KHQ domains did not show the difference between two groups".
Lee 2012	ICIQ‐UI‐SF (median (IQR) report)	SIS: 4 (0 to 6) Comparison: 3 (0 to 6)
	ICIQ‐OAB (median (IQR) report)	SIS: 3 (1 to 4) Comparison: 3 (2 to 5)
	PISQ‐12 (median (IQR) report)	SIS: 37 (35 to 41) Comparison: 38 (33 to 41)
	IIQ‐7 (median (IQR) report)	SIS: 0 (0 to 3) Comparison: 0 (0 to 3)
	PGI‐I (median (IQR) report)	SIS: 1 (1 to 2) Comparison: 1 (1 to 2)
Maslow 2014	IIQ‐7	SIS: 50.43 ± 4.26 (n = 56) preoperatively to 9.6 ± 17.4 (n = 52) postoperatively Comparison: 42.16 ± 4.14 (n = 50) preoperatively to 2.5 ± 6.88 (n = 50) postoperatively
	UDI‐6	SIS: 52.6 ± 15.5 (n = 56) preoperatively to 17.6 ± 18.3 (n = 52) postoperatively Comparison: 47.10 ± 16.7 (n = 50) preoperatively to 8.6 ± 9.1 (n = 50) postoperatively
Mostafa 2012	KHQ average total	SIS: 33.33 (19.91 to 51.23) Comparison 36.42 (24.69 to 51.54)
Oliveira 2011	KHQ (narratively reported)	"TVT‐O and Mini‐Arc improved >80% of patients by a minimum of 15 points in six of the nine KHQ domains (incontinence impact, role limitation, physical limitation, emotion, sleep severity). TVT‐Secur improved >80% of patients by a minimum of 15 points in 3 KHQ domains (physical limitation, emotion, severity) and very close to 80% in another 3 (role limitation, sleep, and social limitation)"
Maturana 2019	UDI‐6	Unitape: 0 ± 9.3/53 TOT: 0 ± 12/41
Pastore 2016	ICIQ‐SF total score	SIS: 17.3 ± 1.9 at baseline to 2.4 ± 2.8 at follow‐up Comparison: 16/8 ± 2.5 at baseline to 2.7 ± 3.3 at follow‐up
Sabadell 2017	ICIQ‐SF mean difference	SIS: −13 (−16 to −10) Comparison: −14 (−18 to −8)
	Sandvik	SIS: −7 (−10 to −4) Comparison: −8 (−10 to −5)
Tang 2014	IIQ‐7	SIS: 16.5 preoperatively to 3.3 postoperatively Comparison: 18.4 preoperatively to 4.3 postoperatively
	PISQ‐12	SIS: 30.9 preoperatively to 33.9 postoperatively Comparison: 32.9 preoperatively to 33.9 postoperatively
Tommaselli 2010	KHQ General Health Perception (mean and SD)	TVT‐Secur: 36.2 ± 19.8/37 TVT‐O: 40.1 ± 18.8/38
Van Rensburg 2015	KHQ total score: score (n)	SIS: 36 (51) Comparison: 26
Xin 2016	ICIQ‐SF (average improvement)	SIS: 13.20 ± 5.43 Comparison: 12.35 ± 4.87

ICIQ: International Consultation on Incontinence Questionnaire; ICIQ‐OAB: International Consultation on Incontinence Questionnaire – Overactive Bladder; ICIQ‐SF: International Consultation on Incontinence Questionnaire – Short Form; ICIQ‐UI‐SF: International Consultation on Incontinence Questionnaire – Urinary Incontinence – Short Form; IIQ‐7: Incontinence Impact Questionnaire; IQR: interquartile range; KHQ: King's Health Questionnaire; PFDI‐20: Pelvic Floor Distress Inventory; PFIQ‐7: Pelvic Floor Impact Questionnaire – Short Form 7; PGI‐I: Patients Global Impression of Improvement; PISQ‐12: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; QoL: quality of life; SD: standard deviation; SF‐36: Short Form 36; SIS: single‐incision sling; TVT‐O: tension‐free vaginal tape obturator; UDI: Urinary Distress Inventory

TVT‐Secur

It is unclear if there is any difference between TVT‐Secur and transobturator slings in terms of quality of life at 12 months (SMD 0.05, 95% CI −0.14 to 0.24; 4 studies, 426 participants; Analysis 3.19.2).

Number of women requiring repeat continence surgery or mesh revision

Studies excluding TVT‐Secur

It is unclear whether single‐incision sling operations lead to slightly more women requiring repeat continence surgery or mesh revision compared with transobturator sling operations, as the 95% CI is consistent with both possible benefit and possible harm (RR 1.42, 95% CI 0.94 to 2.16; 13 studies, 1559 participants; low‐certainty evidence; Analysis 3.20.1; Table 3).

3.20. Analysis.

Comparison 3: Single‐incision slings versus transobturator minimally‐invasive slings, Outcome 20: Requiring repeat continence surgery or mesh revision

TVT‐Secur

TVT‐Secur may lead to more women requiring repeat continence surgery or mesh revision compared with transobturator slings (RR 2.40, 95% CI 1.37 to 4.18; 8 studies, 916 participants; Analysis 3.20.2).

8. Single‐incision slings versus retropubic and transobturator minimally‐invasive slings

Two studies compared single‐incision slings with a mixed group of retropubic and transobturator slings (standard mid‐urethral slings; SMUS) (Abdel‐Fattah 2022; Rudnicki 2017). Neither study utilised TVT‐Secur.

Primary outcomes

Subjective cure or improvement of urinary incontinence

There may be a similar number of or slightly fewer women with subjective cure or improvement in incontinence when undergoing single‐incision slings compared to those with SMUS at 12 months (RR 0.94, 95% CI 0.86 to 1.03; 2 studies,798 participants; Analysis 4.1.1). There may be a similar number of or slightly fewer women with subjective cure or improvement of incontinence with single‐incision slings compared to those with SMUS at 24 months (RR 0.96, 95% CI 0.86 to 1.06; 1 study, 464 participants; Analysis 4.2.1), and at 36 months and longer (RR 0.93, 95% CI 0.82 to 1.05; 1 study, 481 participants; Analysis 4.3.1).

4.1. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 1: Subjective cure or improvement of urinary incontinence: 12 months

4.2. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 2: Subjective cure or improvement of urinary incontinence: 24 months

4.3. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 3: Subjective cure or improvement of urinary incontinence: 36+ months

Secondary outcomes

Objective cure or improvement of urinary incontinence

There may be little to no difference in objective cure or improvement of incontinence between single‐incision slings and SMUS at 12 months (RR 0.97, 95% CI 0.92 to 1.03; 2 studies, 509 participants; Analysis 4.4.1), 24 months (RR 0.99, 95% CI 0.88 to 1.10; 1 study, 205 participants; Analysis 4.5.1) or at 36 months and longer (RR 0.94, 95% CI 0.82 to 1.08; 1 study, 166 participants; Analysis 4.6.1).

4.4. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 4: Objective cure or improvement of urinary incontinence: at 12 months

4.5. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 5: Objective cure or improvement of urinary incontinence: 24 months

4.6. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 6: Objective cure or improvement of urinary incontinence: 36+ months

Patient‐reported pain

It is unclear whether single‐incision slings lead to more patient‐reported pain than SMUS between 30 days and 12 months (RR 1.28, 95% CI 0.83 to 1.96; 2 studies, 820 participants; Analysis 4.7.1), 12 to 24 months (RR 1.14, 95% CI 0.72 to 1.81; 1 study, 537 participants; Analysis 4.8.1) and at 24 months and longer (RR 0.95, 95% CI 0.63 to 1.43; 1 study, 537 participants; Analysis 4.9.1). The 95% CIs are consistent with both benefit and harm.

4.7. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 7: Patient‐reported pain: 30 days to 12 months

4.8. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 8: Patient‐reported pain: 12 to 24 months

4.9. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 9: Patient‐reported pain: 24+ months

Number of women with dyspareunia

It is unclear whether the risk of dyspareunia differs between single‐incision slings compared to SMUS; the 95% CI is consistent with both benefit and harm (RR 1.33, 95% CI 0.87 to 2.03; 2 studies, 570 participants; Analysis 4.10.1).

4.10. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 10: Dyspareunia

Number of women with mesh exposure, extrusion or erosion in any area

It is unclear whether the risk of mesh exposure, extrusion or erosion differs between single‐incision slings and SMUS; the 95% CI is consistent with both benefit and harm (RR 0.72, 95% CI 0.16 to 3.21; 2 studies, 817 participants; Analysis 4.11.1).

4.11. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 11: Number of women affected by mesh exposure, extrusion or erosion in any area

Number of women with urinary retention

It is unclear if there is a difference between single‐incision slings and SMUS in the risk of women developing urinary retention; the 95% CI is consistent with both benefit and harm (RR 0.96, 95% CI 0.26 to 3.50; 2 studies, 820 participants; Analysis 4.12.1).

4.12. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 12: Urinary retention

Number of bladder or urethral injuries

Single‐incision slings reduce the risk of bladder or urethral injuries compared with SMUS (RR 0.07, 95% CI 0.01 to 0.51; 2 studies, 842 participants; Analysis 4.13.1).

4.13. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 13: Bladder or urethral injuries: less than 30 days after surgery

Number of other injuries (e.g. neurovascular or vaginal)

It is unclear whether single‐incision slings reduce the risk of other complications compared to SMUS; the 95% CI is consistent with both benefit and harm (RR 0.48, 95% CI 0.04 to 5.28; 1 study, 305 participants; Analysis 4.14).

4.14. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 14: Other injuries: less than 30 days after surgery

Number of infections (e.g. UTI, mesh infection)

It is unclear whether single‐incision slings lead to greater risk of infections compared with SMUS; the wide 95% CI is consistent with both benefit and harm (RR 1.73, 95% CI 0.70 to 4.26; 1 study, 283 participants; Analysis 4.15.1).

4.15. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 15: Infections

Number of women with de novo urgency

It is unclear if there is a difference in the risk of de novo urgency with single‐incision slings compared with SMUS; the 95% CIs are wide and consistent with both benefit and harm (RR 0.20, 95% CI 0.01 to 4.16; 1 study, 283 participants; Analysis 4.16.1).

4.16. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 16: De novo urgency

Quality of life

As the minimally important difference on the International Consultation on Incontinence Questionnaire – Lower Urinary Tract quality of life (ICIQ‐LUTSqol) instrument has been established as 5.2 (Lim 2019), one study suggested that there may be little to no difference between single‐incision slings and SMUS in terms of quality of life at 12 months (MD ‐1.00, 95% CI ‐2.96 to 0.96; 1 study, 432 participants; Analysis 4.17).

4.17. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 17: Quality of life: at 12 months

Number of women requiring repeat continence surgery or mesh revision

It is unclear if there is a difference in the risk of needing to undergo repeat continence surgery or mesh revisions with single‐incision slings over SMUS; the wide 95% CI is consistent with benefit and harm (RR 1.58, 95% CI 0.79 to 3.19; 2 studies, 817 participants; Analysis 4.18.1).

4.18. Analysis.

Comparison 4: Single‐incision slings versus retropubic and transobturator minimally‐invasive slings, Outcome 18: Requiring repeat continence surgery or mesh revision

Discussion

Summary of main results

We included 62 studies with a total of 8051 women in this review. We did not identify any studies that compared single‐incision slings to no treatment, conservative treatment, colposuspension or laparoscopic procedures.

One study compared single‐incision slings to autologous fascial slings (Table 1). We are uncertain whether there is a difference in the risk of dyspareunia or mesh exposure, extrusion or erosion between single‐incision slings and autologous slings (both low‐certainty evidence). Subjective cure and improvement of urinary incontinence at 12 months, pain at 24 months or longer, the number of women with urinary retention, impact on quality of life at 12 months and the number of women requiring repeat continence surgery or sling revision were not reported for this comparison.

Ten studies compared single‐incision slings to retropubic slings (Table 2). There may be no evidence of a difference in subjective cure or improvement of incontinence at 12 months between single‐incision slings and retropubic slings (low‐certainty evidence). It is uncertain whether single‐incision slings increase the risk of mesh exposure, extrusion or erosion or fewer women having urinary retention compared with retropubic minimally‐invasive slings (both low‐certainty evidence). The effect of single‐incision slings on the risk of repeat continence surgery or mesh revision compared with retropubic slings is uncertain (very low‐certainty evidence). One study reported quality of life, but not in a suitable format for analysis. No studies in this comparison reported on patient‐reported pain at more than 24 months or the number of women with dyspareunia.

Fifty‐one studies compared single‐incision slings with transobturator slings (Table 3). There is no evidence of a difference in subjective cure or improvement of incontinence between the two procedures at 12 months (high‐certainty evidence). Single‐incision slings probably reduce patient‐reported pain at 24 months after surgery compared with transobturator slings (moderate‐certainty evidence). The effect of single‐incision slings on the risk of dyspareunia is uncertain compared with transobturator slings as the wide confidence interval is consistent with possible benefit and possible harm (moderate‐certainty evidence). There are a similar number of postoperative mesh exposure, extrusion or erosions with single‐incision slings compared with transobturator slings (high‐certainty evidence), and probably a similar risk of postoperative urinary retention with single‐incision slings compared to transobturator slings (moderate‐certainty evidence). However, single‐incision slings may lead to a decrease in women's quality of life at 12 months compared to transobturator slings (low‐certainty evidence). It is unclear whether single‐incision slings lead to slightly more women requiring repeat continence or mesh revision surgery when compared with transobturator slings (low‐certainty evidence).

Overall completeness and applicability of evidence

Twenty‐eight out of the 62 included trials contributed data to our primary outcome of subjective cure or improvement of incontinence. Meta‐analyses demonstrate consistency across subjective/objective outcome reporting, across different short‐ and medium‐term time points studied and between the transobturator sling, retropubic sling and standard mid‐urethral slings (SMUS) comparisons. This review also demonstrates the likely inferiority of the TVT‐Secur sling for efficacy and adverse events profile compared to other single‐incision slings.

Complications

Major complications of day‐case surgical procedures are rare and therefore unlikely to be investigated robustly by smaller randomised controlled trials. We extracted data on some of these outcomes (major vessel injury, nerve injury), but they were indeterminately recorded, and more serious outcomes were not reported by trials (death, bowel injury, necrotising fasciitis). Complications are most accurately reported in large national registries and voluntary reporting databases.

It is important to differentiate between rates of perioperative injury (bladder/urethral perforation, neurovascular injury) and longer‐term mesh migration and exposure, described in this review as 'mesh exposure, extrusion or erosion'. Dyspareunia is a symptom resulting from either of these complications or de novo after the procedure. Studies have classified these complications differently. In this review, we have taken an inclusive approach and included all cases of mesh migration, exposure and extrusion in a single mesh erosion group. Use of a standardised approach, such as the International Continence Society and International Urogynecological Association (ICS‐IUGA) mesh complications classification calculator (see www.ics.org/complication) and compulsory use of database reporting (such as the IUGA or British Society of Urogynaecology (BSUG) databases (BSUG 2021)) for all mesh surgery, including long‐term outcomes, would be ideal in future trial design.

Pain is an important factor for patients when considering a surgical approach for a lifestyle‐limiting condition, particularly when this approach involves polypropylene mesh. Only 20 of the 62 included studies contributed data to the meta‐analysis for pain after 30 days of follow‐up.

Longer‐term outcomes

A major limitation of this review was the lack of long‐term follow‐up data from most studies. Only nine of the 62 included studies provided data at 36 months or more (Abdel‐Fattah 2022; Amat 2011; Basu 2010; Lee 2012; Lee 2015; Melendez‐Munoz 2018; Sivaslioglu 2012; Tang 2014; Tommaselli 2010). A further four studies provided data for 24 months to less than 36 months (Bianchi‐Ferraro 2013; Dogan 2018a; Fernandez‐Gonzalez 2017; Masata 2012). Some studies which included longer‐term data were limited by loss of participants to follow‐up. The longest follow‐up period included in this review was 10 years (Tang 2014). A cohort study has reported follow‐up to 17 years (Nilsson 2013).

It is important to consider the risk of under‐reporting longer‐term complications and serious adverse events, including pain and mesh migration, by RCTs with short follow‐up periods. We would ideally like to pool accurate follow‐up data of 10 to 15 years from each RCT to fully appraise this. Accurate reporting of these outcomes is critical for evaluating the safety of the surgery. We did not meta‐analyse cure/improvement data from a significant minority of trials which did not report follow‐up data at 12 months.

Differences in fixation systems

There are differences in the fixation systems between single‐incision slings. Five of the seven types of single‐incision slings explored in this review use a system to anchor or fix the sling to the tissues (Table 7). Two slings rely on tissue growth only to support the sling. TVT‐Secur does not have a fixation system, and this may have contributed to its poor performance. Five trials used the single‐incision sling Ophira, which also does not have an anchoring system. Unlike TVT‐Secur, Ophira does not appear inferior to other single‐incision slings on meta‐analysis (Kim 2018).

Trials including TVT‐Secur

A major consideration for this review was how to interpret the findings of the TVT‐Secur trials, which comprise an important stratified analysis. This sling has demonstrated poor results for cure and higher rates of mesh erosion. It is also important to analyse the long‐term follow‐up data from these studies for women who have had these procedures. We have therefore excluded the TVT‐Secur data from the main analysis and summary of findings tables, but have kept it in the forest plots as stratified results to guide management and to support women who have had these procedures.

Comparisons with other methods of continence surgery

Table 4 outlines single‐incision slings in the context of other surgical approaches for the management of stress incontinence. Open abdominal colposuspension was originally considered the 'gold standard' surgery for stress urinary incontinence (Lapitan 2017). Mid‐urethral slings are effective for treating stress incontinence, and became very popular due to short operating times and few short‐term complications, but a lack of longer‐term follow‐up data (including pain and mesh erosion) were noted in meta‐analysis (Ford 2017). Single‐incision slings were thought to be inferior to other mid‐urethral slings. Meta‐analysis has previously included data for TVT‐Secur slings, which have demonstrable inferiority to other single‐incision slings and caused a significant confounder in these studies (Brazzelli 2019; Nambiar 2014). Recent network meta‐analysis has demonstrated the evidence and efficacy of single‐incision slings in comparison to other continence surgery, including mid‐urethral slings, open colposuspension, laparoscopic colposuspension, autologous fascial slings and urethral bulking injections (Brazzelli 2019). In these analyses, the single‐incision sling group included TVT‐Secur, which may have negatively skewed the results for cure and improvement of incontinence.

We identified no studies that compared single‐incision slings to conservative management, laparoscopic surgery or open colposuspension. Given that retropubic and transobturator mid‐urethral slings have established efficacy as treatment for stress urinary incontinence in women, it is reasonable for single‐incision slings to be routinely compared with these slings in clinical trials.

Certainty of the evidence

We judged the certainty of evidence using the GRADE approach. We assessed most trials as being at low or unclear risk of bias (see the Assessment of risk of bias in included studies).

Data from eleven of the 62 trials included in this review were reported in abstract form only, and thus contributed limited information to our analyses and assessment of certainty (Enzelsberger 2011; Faber 2021; Friedman 2009; Gul 2018; Kim 2010; Lee 2015; Mackintosh 2010; Martoccia 2020; Seo 2012; Shawky 2015; Yoon 2011). We removed data from women who had concomitant prolapse surgery and data from studies that were unclear in reporting on concomitant surgery in sensitivity analyses, which demonstrated no differences between the groups (see Table 5 and Table 6). Seventeen of the trials included women who had TVT‐Secur slings; we analysed these separately (Table 7). None of the funnel plots demonstrated any evidence of publication bias (Figure 4).

We downgraded the certainty of evidence for several outcomes for concerns about imprecision due to low numbers of women in the trials. We also downgraded the certainty of evidence for some outcomes due to concerns about risks of bias. Other outcomes had substantial variation between the trials for follow‐up period, so we downgraded the certainty of evidence for those outcomes due to concerns about indirectness.

Potential biases in the review process

We aimed to reduce bias in the review process as far as possible. Two review authors independently extracted data and assessed risks of bias. One of the review authors of an included study is also an author of this review (SJ) (Van Rensburg 2015). However, he was not involved in any aspects of data extraction or analysis of this study.

‘Number of infections’ was reported heterogeneously by study authors, and it was not always clear whether events or participants were counted in these data, or the source of these infections. As we used patient‐focused outcomes for our review, we combined both repeat continence surgery and mesh revision surgery into a single outcome and did not distinguish between condition‐specific and general quality‐of‐life measures. There may therefore be some biases in the way these data were counted in our analyses. As per our Cochrane Review protocol, we collected data for a limited pre‐specified number of secondary outcomes, one of which was 'other injuries, neurovascular or vaginal' which is a heterogenous category. We acknowledge these limitations in our protocol and analyses.

We were unable to contact some researchers, and it is therefore possible that some studies are awaiting classification which would have otherwise been included.

We are aware that MiniArc and Ajust have been removed from worldwide markets since March 2016 and March 2019, respectively. In addition, TFS has been removed from the Australian market since November 2014. Devices are withdrawn for safety issues or financial reasons. We deemed it an inefficient use of resources to perform subgroup analysis for each of these.

There is some overlap between certain types of slings. For the comparisons we used in this study, we classified each sling as either a retropubic sling, transobturator sling or single‐incision sling. We classified TVT‐Abbrevo as a short transobturator sling, rather than a single‐incision sling. We therefore included trials which used TVT‐Abbrevo in the transobturator sling comparison group and excluded trials comparing TVT‐Abbrevo and another transobturator sling. Applying these criteria led to the exclusion of two studies (Tommaselli 2012b; Zullo 2020).

Agreements and disagreements with other studies or reviews

Older evidence available contains a TVT‐Secur‐predominant single‐incision sling comparison group which has been superseded by more recent work excluding TVT‐Secur slings (Jiao 2018; Luo 2020). Single‐incision slings are associated with less short‐ and medium‐term pain than retropubic slings and transobturator slings (Abdel‐Fattah 2011; Jeffery 2010a; Tommaselli 2015; Walsh 2011). In a large network meta‐analysis, Brazzelli and colleagues included TVT‐Secur in their single‐incision sling group and found that there was less pain compared with retropubic or transobturator slings. Women who had a single‐incision sling were slightly more likely to require repeat surgery than those who had a transobturator sling at 12 months (Brazzelli 2019).

Although older studies demonstrated that single‐incision slings were inferior to both retropubic and transobturator slings for cure rates and reoperation rates, the comparison groups in our review did not incorporate data from TVT‐Secur studies. More recent meta‐analyses have compared individual single‐incision slings with a retropubic or transobturator comparison (Jiao 2018; Luo 2020), or have compared all single‐incision slings, excluding TVT‐Secur, with standard mid‐urethral slings (Bai 2018; Kim 2018; Mostafa 2014). These reviews support the similarity of single‐incision slings (excluding TVT‐Secur) with standard mid‐urethral slings, and support both our conclusions and our method of analysis of excluding the TVT‐Secur data.

Reviews which excluded data from TVT‐Secur in their single‐incision sling comparison groups also demonstrated improved pain outcomes in the short term when compared to retropubic and transobturator slings (Bai 2018; Kim 2018; Mostafa 2014). Single‐incision slings performed equally for both subjective and objective cure rates when compared to retropubic and transobturator slings (Bai 2018; Mostafa 2014). Single‐incision slings performed comparably with a mixed sling group for subjective cure, but less well for objective cure rates in another review (Kim 2018). Single‐incision slings outperformed other mid‐urethral slings for operation times and postoperative pain (Bai 2018; Kim 2018), and demonstrated non‐inferiority for other outcomes: blood loss; length of stay in hospital; and post‐operative voiding dysfunction (Bai 2018; Kim 2018). These reviews support the conclusions of our review.

In summary, the agreement between our review, other systematic reviews, and a recent large multicentre RCT with three‐year follow‐up included in this review (Abdel‐Fattah 2022), provides confidence that these findings can be used to guide clinical practice in this complex area.

Brief economic commentary

To supplement the main systematic review of single‐incision sling interventions for urinary incontinence in women, we looked for economic evaluations which compared single‐incision slings with a variety of surgical interventions for stress urinary incontinence with a trial population consisting of women. Three studies, selected from a search carried out on 1 December 2022, comprised two cost‐effectiveness analyses (Boyers 2013; Brazzelli 2019), as well as one cost‐minimisation analysis (Castañeda 2014). These studies are summarised in more detail in Appendix 5.

Both Boyers 2013 and Castañeda 2014 compared a single‐incision sling with a transobturator mid‐urethral sling and were based on single studies. Boyers 2013 is a randomised controlled trial and Castañeda 2014 is a non‐randomised comparison of retrospective cohorts. Brazzelli 2019 compared all the main surgical interventions for SUI and conducted a network meta‐analysis and pairwise comparisons using data from a review of systematic reviews, with additional searches to update finding from those reviews.

Two studies adopted the perspective of the UK healthcare system (Boyers 2013; Brazzelli 2019); the third study adopted the perspective of the Spanish healthcare system (Castañeda 2014). The economic outcomes, measured over a one‐year time horizon by Boyers 2013, were incremental costs (expressed in 2011 pounds sterling (GBP)) to the health services, patient quality‐adjusted life years (QALYs) and incremental cost per QALY. Castañeda 2014 measured only difference in costs, expressed in 2013 euros (EUR), because they assumed there was no difference in effectiveness as there was no statistically significant difference detected in objective cure rates in their study. The outcomes in Brazzelli 2019 were expressed in QALYs, costs (2018/19 GBP) and incremental cost per QALY for one‐year, 10‐year and lifetime time horizons.

We did not subject the three identified economic evaluations to critical appraisal, and we do not attempt to draw any firm or general conclusions regarding the relative costs or efficiency of single‐incision slings in treatment of SUI. The three analyses had consistent results in the short term (one year), with single‐incision slings being considered cost‐effective. Brazzelli 2019, which considered longer‐term time horizons (10‐year and lifetime), found that single‐incision slings were not cost‐effective, as the initial lower costs were not judged worth the reductions in effectiveness.

Authors' conclusions

Implications for practice.

The clinical situation surrounding the use of synthetic polypropylene mesh is complex, and practitioners should adhere to guidance from relevant regulatory bodies. Bearing this in mind, single‐incision slings (excluding TVT‐Secur slings) are as effective as transobturator slings and retropubic slings at subjective and objective cure or improvement of stress urinary incontinence at 12 months. Single‐incision slings are probably as effective or slightly less effective at subjective and objective cure or improvement of stress urinary incontinence at 36 months or longer when compared to retropubic and transobturator slings; however, the evidence has some uncertainties. TVT‐Secur slings are less effective than retropubic and transobturator slings at subjective and objective cure or improvement of stress urinary incontinence across time periods studied.

Single‐incision slings are associated with less pain than transobturator slings in the short, medium and longer term. Single‐incision slings (excluding TVT‐Secur slings) are associated with fewer cases of mesh exposure, extrusion or erosion in any area compared to transobturator slings. However, TVT‐Secur slings are associated with a higher incidence of these mesh complications compared to transobturator slings. There is no evidence of a difference in the rate of pain, dyspareunia or mesh complications when comparing single‐incision slings to retropubic slings, transobturator slings, or both; however, data for these outcomes are more sparse.

The effects of single‐incision slings on reoperation rates or mesh revisions, patient‐reported quality of life at 12 months and other adverse events compared with other mid‐urethral sling surgeries are currently unclear. Publication of further longer‐term data may affect these findings.

Single‐incision slings remain a valid option for patients who have been appropriately counselled, bearing in mind the ongoing need for long‐term follow‐up data for all synthetic polypropylene mesh surgery and practice restrictions in many areas.

Implications for research.

This review is substantial and incorporates many randomised controlled trials. We can therefore be reasonably confident in the results demonstrated, though there are remaining uncertainties. Further long‐term data are required, especially for outcome measures for patient‐reported pain, dyspareunia, mesh exposure, extrusion or erosion, quality of life and need for repeat surgery. In particular, longer‐term outcome data for pain and mesh complications will provide relevant information to enable informed, shared decision‐making between patients and physicians.

What's new

Date	Event	Description
27 October 2023	New search has been performed	Review search updated as of September 2022. Data re‐extracted and meta‐analysis updated. Analysis reviewed. Literature review, introduction and discussion updated.
27 October 2023	New citation required and conclusions have changed	This version of the review concludes that single‐incision sling operations are likely to be as effective as obturator slings and probably as effective as retropubic slings for the subjective cure or improvement of stress urinary incontinence at 12 months. It is uncertain if single‐incision slings lead to better or worse outcomes compared with traditional suburethral slings. Single‐incision slings probably reduce the risk of mesh erosion compared with obturator slings, but may increase the risk of needing repeat surgery. The evidence is uncertain regarding other adverse events. Longer‐term data are needed to clarify the safety and long‐term effectiveness in comparison to other mid‐urethral slings.

History

Protocol first published: Issue 9, 2010
Review first published: Issue 6, 2014

Date	Event	Description
14 January 2022	New search has been performed	We have made the following changes for this update, published in 2022. 1. We updated the search to March 2020 and added 22 studies, bringing the total of included trials to 53. 2. We amended the outcomes to reflect those that are most important to women and to clinical decision‐makers. 3. We removed the comparisons between different single‐incision slings and between different surgical approaches. 4. We substantially modified the methodology of the review in accordance with current Cochrane guidance, including adding summary of findings tables and assessing the certainty of the body of evidence using the GRADE approach. 5. The authorship of the review has changed.
11 July 2017	Amended	Brief economic commentary (BEC) added. Economics‐related sections revised: the Abstract, Plain language summary, Background, Methods (outcomes, search methods), and Discussion were amended. Appendix added with details of search strategies for BEC.
11 July 2017	New citation required but conclusions have not changed	Brief economic commentary (BEC) added. Economics‐related sections revised.

Appendices

Appendix 1. Glossary of medical terms

Colposuspension	A surgical operation for the relief of stress incontinence in women, in which the paravaginal fascia is sutured to the iliopectineal ligament at the level of the bladder neck and proximal urethra
Dyspareunia	Painful sex
Mesh erosion	For the purpose of including mesh complications in this review, we have defined this as any visible vaginal mesh exposure identified on vaginal examination. Mesh exposure: a condition of displaying, revealing, exhibiting or making accessible, e.g. vaginal mesh visualised through separated vaginal epithelium Mesh extrusion: passage gradually out of a body structure or tissue, e.g. vaginal tape extrusion into the vagina. Early mesh complications result from a failure of vaginal mucosa healing, and an exposure may be seen. Later, extrusion of the tape through the vaginal wall may occur, as the mesh can migrate.
Mini‐slings	Another term for 'single‐incision sling'
Mixed urinary incontinence	Complaints of both stress and urgency urinary incontinence, i.e. involuntary loss of urine associated with urgency and also with effort or physical exertion including sporting activities or on sneezing or coughing.
Retropubic sling	Also known as tension‐free vaginal tape. A synthetic polypropylene sling (mesh tape) is passed through a cut inside the vagina. The tape is then positioned under the bladder neck (urethra), and the ends of the tape are passed through a belly incision or an inner thigh incision before the doctor adjusts the tightness (tension) of the tape.
Traditional sling	Also known as autologous fascial sling, fascia lata sling or pubovaginal sling. A strip of tissue is taken from the lower abdomen and used as a sling or hammock around the bladder neck and urethra.
Transobturator sling	A synthetic mesh is placed under the mid‐portion of the urethra through a small incision in the vagina. The mesh is then passed into a tunnel created around each side of the urethra and out through the thigh fold through 2 small skin incisions.
Single‐incision sling	A sling that does not involve either a retropubic or transobturator passage of the tape or trocar and involves only 1 vaginal incision (i.e. no exit wounds in the groin or lower abdomen)
Stress urinary incontinence	Complaint of involuntary loss of urine on effort or physical exertion, including sporting activities, or on sneezing or coughing
Urge urinary incontinence	Complaint of involuntary loss of urine associated with urgency
Urinary incontinence	Complaint of involuntary loss of urine

Appendix 2. Terms used to search the Cochrane Incontinence Specialised Register

The terms used to search the Cochrane Incontinence Specialised Register are given below:

(({DESIGN.CCT*} OR {DESIGN.RCT*}) AND {INTVENT.SURG.SLINGS.MINISLING*} AND {TOPIC.URINE.INCON*})

All searches were of the keywords field of EndNote 2018.

The Cochrane Incontinence Specialised Register search does not include a search of Embase as the Cochrane Centralised Search Service includes Embase in its search for records to be included in CENTRAL. During informal testing for a number of our Cochrane Reviews, we have found that additional searches of Embase do not locate additional relevant records for our Cochrane Reviews.

Appendix 3. Search strategies for economic evaluations for the brief economic commentary

We performed additional searches for the brief economic commentary (BEC). We searched:

• the NHS Economic Evaluation Database (NHS EED) on the Centre for Reviews and Dissemination (CRD) website (covering from the earliest record in NHS EED, dating from 1968, up to and including 31 December 2014 when their coverage ended) (searched 14 June 2019).

As NHS EED is no longer actively updated, we performed additional searches of the following databases to identify eligible studies added to these databases from 1 January 2015 onwards on 11 July 2022:

• MEDLINE on OvidSP (covering 1 January 1946 to June week 5 2022); and

• Embase (on OvidSP) (covering 1 January 1974 to 2022 week 27).

The economic evaluation search filters applied to our MEDLINE and Embase search strategies were those formerly used by the CRD to identify published reports of full economic evaluations for indexing on NHS EED. These economic evaluation search filters remain freely available on the CRD Database web-pages (CRD 2015). The other search lines in the MEDLINE and Embase search strategies were adapted from the electronic search strategies run for our Cochrane Incontinence Specialised Register along with additional terms for this population developed specifically for this review. Similarly, our NHS EED search strategy was adapted from search strategies run for our Specialised Register and based on text word and MeSH terms (capturing relevant P‐I‐C concepts) used to identify eligible studies of intervention effects. We followed the current economic methods guidance (Aluko 2022). These searches are beginning to form the basis of our Cochrane Incontinence Specialised Register of Economic Evaluations which is under development and so the searches are wider than would normally be performed for a BEC for an individual Cochrane Review. The Cochrane Incontinence Specialised Register of Economic Evaluations was also searched for this BEC.

Details of the searches that were performed can be found below.

MEDLINE on OvidSP (covering 1 January 1946 to June Week 5 2022) was searched on 11 July 2022 using the following strategy:

1. Economics/

2. exp "costs and cost analysis"/

3. Economics, Dental/

4. exp economics, hospital/

5. Economics, Medical/

6. Economics, Nursing/

7. Economics, Pharmaceutical/

8. (economic$ or cost or costs or costly or costing or price or prices or pricing or pharmacoeconomic$).ti,ab.

9. (expenditure$ not energy).ti,ab.

10. value for money.ti,ab.

11. budget$.ti,ab.

12. or/1‐11

13. ((energy or oxygen) adj cost).ti,ab.

14. (metabolic adj cost).ti,ab.

15. ((energy or oxygen) adj expenditure).ti,ab.

16. or/13‐15

17. 12 not 16

18. letter.pt.

19. editorial.pt.

20. historical article.pt.

21. or/18‐20

22. 17 not 21

23. exp animals/ not humans/

24. 22 not 23

25. (incontinen$ or continen$).tw.

26. exp urinary incontinence/

27. nycturia.tw.

28. ((bladder or detrusor or vesic$) adj5 (instability or stab$ or unstable or irritab$ or hyperreflexia or dys?ynerg$ or dyskinesi$ or irritat$)).tw.

29. (urin$ adj2 (leak$ or urge$ or frequen$)).tw.

30. dribbl$.tw.

31. bladder, neurogenic/

32. ((bladder or detrusor or vesic$) adj2 (hyper$ or overactiv$)).tw.

33. (spinal adj2 bladder$).tw.

34. (bladder$ adj2 (neuropath$ or neurogen$ or neurolog$)).tw.

35. (nervous adj1 (pollakisur$ or pollakiur$)).tw.

36. urinary bladder, overactive/

37. exp enuresis/

38. enure$.tw.

39. bedwet$.tw.

40. bed‐wet$.tw.

41. (bed adj5 wet$).tw.

42. (diurnal adj5 wet$).tw.

43. diurnal‐wet$.tw.

44. ((daytime or day‐time or nighttime or night‐time or nightime) adj5 wet$).tw.

45. (void$ adj2 dysfunct$).tw.

46. ((urin$ or bladder) adj5 sphincter$).tw.

47. (urethra$ adj2 sphincter$).tw.

48. (bladder adj2 neck).tw.

49. (vesic$ adj1 (neck$ or cervi$)).tw.

50. (detrusor adj1 sphincter$).tw.

51. or/25‐50

52. 24 and 51

Embase (on OvidSP) (covering 1 January 1974 to 2022 Week 27) was searched on 11 July 2022 using the following strategy:

1. Health Economics/

2. exp Economic Evaluation/

3. exp Health Care Cost/

4. pharmacoeconomics/

5. (econom$ or cost or costs or costly or costing or price or prices or pricing or pharmacoeconomic$).ti,ab.

6. (expenditure$ not energy).ti,ab.

7. (value adj2 money).ti,ab.

8. budget$.ti,ab.

9. or/1‐8

10. letter.pt.

11. editorial.pt.

12. note.pt.

13. or/10‐12

14. 9 not 13

15. (metabolic adj cost).ti,ab.

16. ((energy or oxygen) adj cost).ti,ab.

17. ((energy or oxygen) adj expenditure).ti,ab.

18. 15 or 16 or 17

19. 14 not 18

20. animal/

21. exp animal experiment/

22. nonhuman/

23. (rat or rats or mouse or mice or hamster or hamsters or animal or animals or dog or dogs or cat or cats or bovine or sheep).ti,ab,sh.

24. 20 or 21 or 22 or 23

25. exp human/

26. human experiment/

27. 25 or 26

28. 24 not (24 and 27)

29. 19 not 28

30. conference abstract.pt.

31. 29 not 30

32. incontinence/ or mixed incontinence/ or stress incontinence/ or urge incontinence/ or urine incontinence/

33. continence/

34. overactive bladder/

35. micturition disorder/ or lower urinary tract symptom/ or pollakisuria/

36. urinary dysfunction/ or bladder instability/ or detrusor dyssynergia/ or neurogenic bladder/ or urinary urgency/ or urine extravasation/

37. (incontinen$ or continen$).tw.

38. ((bladder or detrusor or vesic$) adj5 (instab$ or stab$ or unstab* or irritab$ or hyperreflexi$ or dys?ynerg$ or dyskinesi$ or irritat$)).tw.

39. (urin$ adj2 leak$).tw.

40. ((bladder or detrusor or vesic$) adj2 (hyper$ or overactiv$)).tw.

41. (bladder$ adj2 (neuropath$ or neurogen* or neurolog$)).tw.

42. (nervous adj pollakisur$).tw.

43. or/32‐42

44. 31 and 43

NHS EED on the CRD website was searched on 14 June 2019 (in all fields) using the following strategy:

Line	Search
1	MeSH DESCRIPTOR pelvic floor EXPLODE ALL TREES IN NHSEED
2	MeSH DESCRIPTOR pelvic floor disorders EXPLODE ALL TREES IN NHSEED
3	MeSH DESCRIPTOR Urinary Bladder, Neurogenic EXPLODE ALL TREES IN NHSEED
4	MeSH DESCRIPTOR Urinary Bladder, overactive EXPLODE ALL TREES IN NHSEED
5	((incontinen* ) OR (continen*)) IN NHSEED
6	((floor adj2 pelvi* ) OR (pelvi* adj2 floor)) IN NHSEED
7	((nycturia)) IN NHSEED
8	(((urin* or bladder) adj5 sphincter*) OR (sphincter* adj5 (urin* or bladder))) IN NHSEED
9	(((bladder OR detrusor OR vesic*) ADJ5 (instability OR stab* OR unstable OR irritab* OR hyperreflexia OR dysynerg* OR dyskinesi* OR irritat*)) OR ((instability OR stab* OR unstable OR irritab* OR hyperreflexia OR dysynerg* OR dyskinesi* OR irritat*) ADJ5 (bladder OR detrusor OR vesic*) )) IN NHSEED
10	((urethra* ADJ2 sphincter*) OR (sphincter* ADJ2 urethra* )) IN NHSEED
11	((bladder ADJ2 neck) OR (neck ADJ2 bladder )) IN NHSEED
12	((urin* ADJ2 (leak* OR urge* OR frequen*)) OR ((leak* OR urge* OR frequen*) ADJ2 urin* )) IN NHSEED
13	(dribbl*) IN NHSEED
14	((vesic* ADJ1 (neck* OR cervi*)) OR ((neck* OR cervi*) ADJ1 vesic*)) IN NHSEED
15	(((bladder OR detrusor OR vesic*) ADJ2 (hyper* OR overactiv*)) OR ((hyper* OR overactiv*) ADJ2 (bladder OR detrusor OR vesic*))) IN NHSEED
16	((detrusor ADJ1 sphincter*) OR (sphincter* ADJ1 detrusor)) IN NHSEED
17	((spinal ADJ2 bladder*) OR (bladder* ADJ2 spinal)) IN NHSEED
18	((bladder* ADJ2 (neuropath* OR neurogen* OR neurolog*)) OR ((neuropath* OR neurogen* OR neurolog*) ADJ2 bladder*)) IN NHSEED
19	((nervous ADJ1 (pollakisur* OR pollakiur*)) OR ((pollakisur* OR pollakiur*) ADJ1 nervous)) IN NHSEED
20	(MeSH DESCRIPTOR urinary incontinence EXPLODE ALL TREES) IN NHSEED
21	#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20

Cochrane Incontinence Specialised Register of Economic Evaluations was searched on 1 December 2022 using the following search terms:

(topic.urine.incon*) 
AND
(intvent.surg.slings.minisling*)

All searches were of the keywords field of EndNote (EndNote 2018).

Appendix 4. Studies contributing data to outcomes of interest

Subjective cure or improvement of UI	Amat 2011; Andrada Hamer 2011; Barber 2012; Basu 2010; Bianchi‐Ferraro 2013; Pascom 2018; Dogan 2018a; Fernandez‐Gonzalez 2017; Fu 2017; Gaber 2016; Grigoriadis 2013; Hinoul 2011; Jurakova 2016; Lee 2012; Lee 2015; Masata 2016; Maslow 2014; Melendez‐Munoz 2018; Mostafa 2012; Maturana 2019; Pastore 2016; Ross 2014; Schellart 2014; Schweitzer 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Xin 2016
Objective cure or improvement of UI	Amat 2011Andrada Hamer 2011; Barber 2012; Bianchi‐Ferraro 2013; Pascom 2018; Dogan 2018a; Enzelsberger 2011; Fernandez‐Gonzalez 2017; Gaber 2016; Grigoriadis 2013; Gul 2018; Hinoul 2011; Hota 2012; Jurakova 2016; Lee 2012; Lee 2015; Masata 2012; Masata 2016; Maslow 2014; Melendez‐Munoz 2018; Merali 2012; Mostafa 2012; Maturana 2019; Ross 2014; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Shawky 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Xin 2016
Patient‐reported pain	Amat 2011; Andrada Hamer 2011; Barber 2012; Bianchi‐Ferraro 2013; Pascom 2018; Dogan 2018a; Friedman 2009; Lee 2012; Ow 2019; Mackintosh 2010; Mostafa 2012; Oliveira 2011; Ross 2014; Sabadell 2017; Sivaslioglu 2012; Tang 2014; Tommaselli 2010; Wang 2011
Number of women with dyspareunia	Abdelwahab 2010; Andrada Hamer 2011; Dogan 2018a; Masata 2016; Maslow 2014; Maturana 2019; Schellart 2014; Sharifiaghdas 2015; Smith 2017; Tang 2014
Number of mesh exposures, extrusions and erosions in any area	Amat 2011; Andrada Hamer 2011; Barber 2012; Basu 2010; Bianchi‐Ferraro 2013; Pascom 2018; Dogan 2018a; Fernandez‐Gonzalez 2017; Gaber 2016; Hinoul 2011; Hota 2012; Ow 2019; Masata 2012; Masata 2016; Maslow 2014; Melendez‐Munoz 2018; Mostafa 2012; Maturana 2019; Pastore 2016; Ross 2014; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010; Xin 2016
Number of women with urinary retention	Amat 2011; Abdelwahab 2010; Andrada Hamer 2011; Barber 2012; Basu 2010; Bianchi‐Ferraro 2013; Pascom 2018; Dogan 2018a; Fernandez‐Gonzalez 2017; Foote 2015; Friedman 2009; Fu 2017; Gaber 2016; Grigoriadis 2013; Hinoul 2011; Hota 2012; Lee 2012; Mackintosh 2010; Masata 2012; Masata 2016; Mostafa 2012; Oliveira 2011; Maturana 2019; Pastore 2016; Schellart 2014; Schweitzer 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010; Wang 2011; Xin 2016
Number of bladder or urethral injuries	Amat 2011; Abdelwahab 2010; Andrada Hamer 2011; Barber 2012; Basu 2010; Pascom 2018; Dogan 2018a; Enzelsberger 2010; Fernandez‐Gonzalez 2017; Friedman 2009; Gaber 2016; Grigoriadis 2013; Gul 2018; Hinoul 2011; Mackintosh 2010; Masata 2012; Masata 2016; Maslow 2014; Mostafa 2012; Oliveira 2011; Maturana 2019; Ross 2014; Schweitzer 2015; Sharifiaghdas 2015; Sivaslioglu 2012; Smith 2017; Sottner 2012; Wang 2011; Xin 2016
Number of other injuries	Abdelwahab 2010; Andrada Hamer 2011; Barber 2012; Bianchi‐Ferraro 2013; Pascom 2018; Dogan 2018a; Enzelsberger 2010; Friedman 2009; Gaber 2016; Grigoriadis 2013; Hinoul 2011; Masata 2012; Masata 2016; Emami 2019; Oliveira 2011; Schellart 2014; Schweitzer 2015; Sharifiaghdas 2015; Smith 2017; Tommaselli 2010
Number of infections	Amat 2011; Andrada Hamer 2011; Barber 2012; Bianchi‐Ferraro 2013; Pascom 2018; Fernandez‐Gonzalez 2017; Gaber 2016; Hinoul 2011; Lee 2012; Masata 2012; Masata 2016; Oliveira 2011; Maturana 2019; Ross 2014; Sabadell 2017; Schellart 2014; Schweitzer 2015; Smith 2017; Tang 2014
Number of women with de novo urgency	Amat 2011; Abdelwahab 2010; Andrada Hamer 2011; Barber 2012; Bianchi‐Ferraro 2013; Pascom 2018; Fernandez‐Gonzalez 2017; Friedman 2009; Gaber 2016; Masata 2016; Melendez‐Munoz 2018; Mostafa 2012; Oliveira 2011; Maturana 2019; Pastore 2016; Sabadell 2017; Schweitzer 2015; Sharifiaghdas 2015; Smith 2017; Tang 2014; Tommaselli 2010; Wang 2011
Quality of life	Amat 2011; Barber 2012; Bianchi‐Ferraro 2013; Pascom 2018; Dogan 2018a; Fernandez‐Gonzalez 2017; Fu 2017; Gaber 2016; Hinoul 2011; Hota 2012; Jurakova 2016; Kim 2010; Lee 2012; Maslow 2014; Mostafa 2012; Oliveira 2011; Maturana 2019; Pastore 2016; Ross 2014; Sabadell 2017; Tang 2014; Tommaselli 2010; Van Rensburg 2015; Xin 2016
Number of women requiring repeat continence surgery or mesh revision	Andrada Hamer 2011; Barber 2012; Basu 2010; Bianchi‐Ferraro 2013; Pascom 2018; Dogan 2018a; Friedman 2009; Hinoul 2011; Hota 2012; Lee 2012; Ow 2019; Mackintosh 2010; Masata 2012; Masata 2016; Melendez‐Munoz 2018; Mostafa 2012; Oliveira 2011; Schellart 2014; Schweitzer 2015; Sivaslioglu 2012; Smith 2017; Tang 2014; Tommaselli 2010

UI: urinary incontinence

Appendix 5. Brief economic commentary

To supplement the main systematic review of interventions for traditional suburethral sling operations for urinary incontinence in women, we looked for economic evaluations which compared single‐incision mini‐slings (SIMSs) with a variety of surgical interventions for stress urinary incontinence (SUI) with a trial population consisting of women. Three studies were identified; two cost‐effectiveness analyses (Boyers 2013; Brazzelli 2019) and one cost‐minimisation analysis (Castañeda 2014). The cost‐effectiveness analysis by Boyers 2013 compared SIMS with transobturator tape (TOT), which adopted the perspective of the UK healthcare system. Boyers 2013 was a further report of Mostafa 2012. The economic outcomes, measured over a 12‐month horizon, were incremental costs to the health services, patient quality‐adjusted life years (QALYs) and incremental cost per QALY with costs expressed in 2011 GBP (pounds sterling). No discounting was performed, as cost and outcomes were measured for only 12 months. Costs data were collected during the trial using a microcosting approach to estimate surgery costs, while follow‐up costs were collected using questionnaires completed by participants at 12 months' follow‐up. The direct costs included resources required to conduct the surgery (operating time, staff requirements, type of anaesthesia, consumables) and the costs of subsequent care over the 12‐month study follow‐up. These costs included secondary care (hospital readmission, repeat surgery and outpatient care), primary care (general practitioner, physiotherapist and nurse contact) and any further treatment (e.g. prescription medications). The indirect costs included time taken off work owing to ill health. The EQ‐5D‐5L scores, used in estimating QALYs, were mapped from responses to the King's Health Questionnaire (KHQ) (urinary incontinence–specific quality of life (QOL) tool) with the KHQ collected at baseline, four months and 12 months. The EQ‐5D‐5L questionnaire was also administered at 12 months' follow‐up. For the economic outcomes, there was no evidence of a difference in EQ‐5D‐5L and QALYs. On average, SIMS provided slightly fewer QALYs than TOT and standard mid‐urethral slings (SMUSs) (mean difference (MD) −0.003, 95% confidence interval (Cl) −0.008 to 0.002). The mean total direct cost of the SIMS procedure was GBP 1277 (2011 GBP), while that of TOT and SMUS was GBP 1462 (2011 GBP). TOT and SMUS were, on average, GBP 185 more costly (95% Cl GBP −32 to GBP 317). There was a 94% probability of SIMS being cost‐saving compared with TOT and SMUS. The inclusion of the indirect costs falling on women and their families resulted in TOT and SMUS being 477 times more costly (95% CI GBP 130 to GBP 824) and an almost 100% probability of SIMS being cost‐saving. SIMS was cost‐effective in the base‐case analysis and all sensitivity analyses. Estimates of incremental cost per QALYs gained show whether a more effective but more costly treatment is worth any extra costs. In the base‐case analysis, SIMS was, on average, less costly and less effective than TOT and SMUS. If SIMS were adopted in preference to TOT and SMUS, it would save GBP 48,419 for each QALY lost (i.e. the incremental cost‐effectiveness ratio (ICER) for the more effective but more costly; TOT and SMUS compared with SIMS were GBP 48,419). SIMS had an 80% probability of being cost‐effective when society’s willingness to pay (WTP) for a QALY was GBP 20,000. Assuming all SIMS procedures were conducted under local anaesthesia, this would increase the savings per QALY lost to over GBP 76,000. When including the impact of earlier return to work, the savings per QALY lost increased to over GBP 162,000. For these two sensitivity analyses, SIMS had a 93% and a 100% probability of being cost‐effective, respectively. Castañeda 2014 carried out a cost‐minimisation analysis (CMA), which adopted the perspective of the Spanish healthcare system. The economic analysis utilised evidence from a retrospective observation study carried out between 2005 and 2008 for SMUS and between 2008 and 2011 for SIMS in women with SUI with a 12‐month follow‐up period. The study included 81 women (44 in the SIMS group and 37 in the SMUS group). The study only included direct healthcare costs, which were categorised based on the following phases of management: preoperative costs (consultation, diagnostic and laboratory tests and urodynamic evaluation); operative costs (health professional and surgical time, length of hospital stay); and postoperative costs up to 12 months after surgery (consultations, diagnostic and laboratory tests and management of complications). The costs were expressed in 2013 EUR (euros). There was a small difference (6.7%) in clinical effectiveness measured as objective cure at 12 months in favour of SIMS, but this was not found to be statistically significant. Given this, the authors opted to perform a CMA rather than the planned cost‐effectiveness analysis. The total annual cost per patient with SIMS was lower (EUR 2059, 95% CI EUR 1914 to EUR 2285) than with a tension‐free vaginal tape obturator (TVT‐O) (EUR 2821, 95% CI EUR 2661 to EUR 2997), a cost saving of EUR 762 (95% CI EUR 516 to EUR 987). The length of hospital stay was, on average, zero days for SIMS and 3.14 days for TVT‐O. In the base‐case analysis, SIMS had a 100% probability of being cost‐saving. The study suggested that SIMS might be more cost‐effective compared with TVT‐O. The sensitivity analysis showed that the probability of SIMS being cost‐effective when the average hospital stay for TVT‐O was two days, one day and zero days was 100%, 90% and 9%, respectively, showing that length of hospital stay is an important determinant of cost. The study concluded that SIMS is dominant over TVT‐O over a 12‐month postoperative period owing to lower cost and a comparable effectiveness. While the purpose of a BEC is not to provide critical commentary, we feel it is important to note that the authors have conflated absence of evidence of a difference in cure rates with there being no evidence in cure rates. Brazzelli 2019 compared different surgical interventions, including SIMS, for the treatment of SUI and stress‐predominant mixed urinary incontinence (MUI). The main intervention was a retropubic mid‐urethral sling (MUS) because it is known to be widely used as standard practice with other surgical interventions as comparators (open abdominal retropubic colposuspension, laparoscopic retropubic colposuspension, traditional suburethral retropubic sling procedures, transobturator MUS, SIMS and periurethral injection bulking agents). The Markov model‐based economic evaluation utilised data from a network meta‐analysis and pairwise comparisons. These meta‐analyses used data from a review of systematic reviews with additional searches to update findings. The evidence base the Brazzelli 2019 authors drew upon included results from Castañeda 2014 and Mostafa 2012 (of which Boyers 2013 is a further report). The economic model itself modelled a hypothetical cohort of women (45 years to 55 years old) undergoing surgery for treatment of SUI or stress‐predominant MUI. The economic evaluation was carried out from the UK payer’s perspective (National Health Service (NHS) and personal social services perspective), with outcomes expressed in QALYs and costs in 2018 or 2019 GBP. Both costs and QALYs were evaluated over 1‐year, 10‐year and lifetime time horizons with cost and outcomes discounted at a 3.5% discount rate. The Markov model assumed a woman could receive a maximum of three surgical interventions. However, patients were eligible for SMUS (retropubic MUS or transobturator MUS) after treatment failure of all other surgeries. The model base‐case analysis assumed that 75% of unsuccessful treatments would have a second surgical intervention, while 30% of women who failed on second surgery would go on to seek a third surgery. Owing to a lack of data, it was assumed that subsequent surgeries (retropubic MUS or transobturator MUS) were 90% as effective as a primary surgery. The analysis sought to model severe complications or adverse events that would impact patients' quality of life, cost and impact duration. The direct costs derived from the UK NHS reference costs included individual surgery costs, complementary tests, treatments and consultations before and after surgery. The baseline utility before treatment was derived from a UK‐based economic evaluation, which included women with SUI (Manca 2003). The utility value for a successful surgery was also derived from a UK‐based study that explored health outcomes in women with urinary incontinence (Kunkle 2015), while utility decrements associated with each complication included in the model were obtained from Shepherd 2010 and Kunkle 2015. The base‐case analysis results showed that the costs of SIMS at one year, 10 years and lifetime horizon was GBP 1844, GBP 5271 and GBP 10,189, respectively, with total QALYs of 0.764, 7.023 and 23.221 at one year, 10 years and lifetime horizon, respectively. At a 1‐year time horizon and a WTP threshold of GBP 20,000 and GBP 30,000, SIMS had a 100% probability of being cost‐effective and was dominant compared with other surgical interventions, excluding anterior repair and open colposuspension. Both anterior repair and open colposuspension were marginally more effective, with QALYs of 0.766 and 0.775 and costs of GBP 2955 and GBP 4847, respectively. At a 10‐year and lifetime horizon, SIMS had 0% probability of being cost‐effective at a WTP per QALY of GBP 20,000 and GBP 30,000, with retropubic MUS being dominant (i.e. less costly and more effective). For the sensitivity analysis, increased incidence rates of mesh complications and longer persistent pain complications resulted in a 0% probability of SIMS being cost‐effective at the WTP threshold of GBP 20,000 or GBP 30,000. Over a lifetime horizon, the treatment cost, incremental cost, QALY gained and incremental QALY for SIMS was GBP 10,189, GBP 1118, 23.221 and −0.793, respectively. We did not subject the three identified economic evaluations to critical appraisal (excepting our note about the assumptions made around effectiveness in Castañeda 2014), and we do not attempt to draw any firm or general conclusions regarding the relative costs or efficiency of SIMS in treatment of SUI. The three analyses had consistent results in the short term (one year), with SIMS being considered cost‐effective. However, it can be seen that over a lifetime horizon, SIMS is not considered to be cost‐effective, which may be due to the associated complications. All clinical studies utilised in the economic evaluations had a short follow‐up period. To establish a firm conclusion on the cost‐effectiveness of SIMS, there is a need for longer follow‐up studies.

Data and analyses

Comparison 1. Single‐incision slings versus autologous fascial slings.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Objective cure or improvement of urinary incontinence: between 12 and 24 months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.2 Dyspareunia	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.3 Number of women affected by mesh exposure, extrusion or erosion in any area	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.4 Bladder or urethral injuries: less than 30 days after surgery	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.5 Infections (e.g. UTI, mesh infection)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 2. Single‐incision slings versus retropubic minimally‐invasive slings.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Subjective cure or improvement of urinary incontinence: at 12 months	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.1.1 Trials including other SIS (not TVT‐S)	2	297	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.91, 1.07]
2.1.2 Trials including TVT‐S	2	189	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.83, 1.01]
2.2 Subjective cure or improvement of urinary incontinence: 36 + months	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
2.3 Objective cure or improvement of urinary incontinence: at 12 months	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
2.3.1 Trials including other SIS (not TVT‐S)	2	297	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.92, 1.06]
2.3.2 Trials including TVT‐S	2	179	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.63, 1.03]
2.4 Objective cure or improvement of urinary incontinence: 36+ months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.4.1 Trials including other SIS (not TVT‐S)	1	115	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [1.00, 1.20]
2.5 Patient‐reported pain: 30 days to 12 months	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.5.1 Trials including other SIS (not TVT‐S)	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	3.30 [0.14, 77.95]
2.5.2 Trials including TVT‐S	1	263	Risk Ratio (M‐H, Fixed, 95% CI)	2.80 [0.12, 68.18]
2.6 Patient‐reported pain: 12 to 24 months	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.6.1 Trials including TVT‐S	3	242	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.17, 3.32]
2.7 Dyspareunia	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.7.1 Trials including TVT‐S	2	175	Risk Ratio (M‐H, Fixed, 95% CI)	2.10 [0.54, 8.19]
2.8 Number of women affected by mesh exposure, extrusion or erosion in any area	6		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.8.1 Trials including other SIS (not TVT‐S)	3	267	Risk Ratio (M‐H, Fixed, 95% CI)	1.55 [0.24, 9.82]
2.8.2 Trials including TVT‐S	3	452	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.34, 4.55]
2.9 Urinary retention	6		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.9.1 Trials including other SIS (not TVT‐S)	2	209	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.12, 1.84]
2.9.2 Trials including TVT‐S	4	510	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.28, 1.73]
2.10 Bladder or urethral injuries: less than 30 days after surgery	7		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.10.1 Trials including other SIS (not TVT‐S)	2	209	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.13, 6.71]
2.10.2 Trials including TVT‐S	5	578	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.25, 1.51]
2.11 Other injuries: less than 30 days after surgery	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.11.1 Trials including TVT‐S	3	449	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.21, 4.09]
2.12 Infections (e.g. UTI, mesh infection)	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.12.1 Trials including other SIS (not TVT‐S)	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.11, 1.57]
2.12.2 Trials including TVT‐S	3	434	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.61, 1.42]
2.13 De novo urgency	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.13.1 Trials including other SIS (not TVT‐S)	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.21, 1.79]
2.13.2 Trials including TVT‐S	3	246	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.74, 2.35]
2.14 Requiring repeat continence surgery or mesh revision	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
2.14.1 Trials including other SIS (not TVT‐S)	2	182	Risk Ratio (M‐H, Random, 95% CI)	4.19 [0.31, 57.28]
2.14.2 Trials including TVT‐S	2	388	Risk Ratio (M‐H, Random, 95% CI)	1.13 [0.14, 9.26]

Comparison 3. Single‐incision slings versus transobturator minimally‐invasive slings.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Subjective cure or improvement of urinary incontinence: 12 months	20		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.1.1 Trials including other SIS (not TVT‐S)	17	2359	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.97, 1.03]
3.1.2 Trials including TVT‐S	3	379	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.80, 0.96]
3.2 Subjective cure or improvement of urinary incontinence: 12 to 24 months	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
3.2.1 Trials including other SIS (not TVT‐S)	2	255	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.80, 1.08]
3.3 Subjective cure or improvement of urinary incontinence: 24 to 36 months	5		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
3.3.1 Trials including other SIS (not TVT‐S)	3	534	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.94, 1.03]
3.3.2 Trials including TVT‐S	2	322	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.59, 1.44]
3.4 Subjective cure or improvement of urinary incontinence: 36+ months	6		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.4.1 Trials including other SIS (not TVT‐S)	4	604	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.89, 1.03]
3.4.2 Trials including TVT‐S	2	218	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.66, 0.99]
3.5 Objective cure or improvement of incontinence: at 12 months	26		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
3.5.1 Trials including other SIS (not TVT‐S)	19	2587	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.98, 1.03]
3.5.2 Trials including TVT‐S	7	636	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.74, 0.97]
3.6 Objective cure or improvement of incontinence: 12 to 24 months	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.6.1 Trials including other SIS (not TVT‐S)	2	254	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.86, 1.05]
3.7 Objective cure or improvement of incontinence: 24 to 36 months	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
3.7.1 Trials including other SIS (not TVT‐S)	3	484	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.93, 1.04]
3.7.2 Trials including TVT‐S	3	393	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.74, 1.03]
3.8 Objective cure or improvement of incontinence: 36+ months	6		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.8.1 Trials including other SIS (not TVT‐S)	4	582	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.92, 1.03]
3.8.2 Trials including TVT‐S	2	154	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.62, 0.91]
3.9 Patient‐reported pain: 30 days to 12 months	7		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.9.1 Trials including other SIS (not TVT‐S)	5	566	Risk Ratio (M‐H, Fixed, 95% CI)	0.23 [0.11, 0.52]
3.9.2 Trials including TVT‐S	2	151	Risk Ratio (M‐H, Fixed, 95% CI)	0.04 [0.00, 0.71]
3.10 Patient‐reported pain: 12 to 24 months	8		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.10.1 Trials including other SIS (not TVT‐S)	2	129	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.23, 1.83]
3.10.2 Trials including TVT‐S	6	507	Risk Ratio (M‐H, Fixed, 95% CI)	0.31 [0.15, 0.65]
3.11 Patient‐reported pain: 24+ months	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
3.11.1 Trials including other SIS (not TVT‐S)	2	250	Risk Ratio (M‐H, Random, 95% CI)	0.12 [0.02, 0.68]
3.11.2 Trials including TVT‐S	1	64	Risk Ratio (M‐H, Random, 95% CI)	0.16 [0.02, 1.23]
3.12 Dyspareunia	10		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.12.1 Trials including other SIS (not TVT‐S)	8	810	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.41, 1.48]
3.12.2 Trials including TVT‐S	2	166	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.28, 1.74]
3.13 Number of women affected by mesh exposure, extrusion or erosion in any area	23		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.13.1 Trials including other SIS (not TVT‐S)	16	2378	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.39, 0.96]
3.13.2 Trials including TVT‐S	7	880	Risk Ratio (M‐H, Fixed, 95% CI)	2.34 [1.24, 4.40]
3.14 Urinary retention	31		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.14.1 Trials including other SIS (not TVT‐S)	23	2891	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.47, 0.97]
3.14.2 Trials including TVT‐S	9	1003	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.40, 1.67]
3.15 Bladder or urethral injuries: less than 30 days after surgery	24		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.15.1 Trials including other SIS (not TVT‐S)	19	2497	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.14, 1.08]
3.15.2 Trials including TVT‐S	6	690	Risk Ratio (M‐H, Fixed, 95% CI)	2.51 [0.52, 12.15]
3.16 Other injuries: less than 30 days after surgery	16		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.16.1 Trials including other SIS (not TVT‐S)	11	1228	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.26, 1.13]
3.16.2 Trials including TVT‐S	6	766	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.30, 2.22]
3.17 Infections (e.g. UTI, mesh infections)	18		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.17.1 Trials including other SIS (not TVT‐S)	14	1773	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.74, 1.45]
3.17.2 Trials including TVT‐S	5	646	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.52, 1.94]
3.18 De novo urgency	19		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.18.1 Trials including other SIS (not TVT‐S)	13	1464	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.77, 1.49]
3.18.2 Trials including TVT‐S	7	729	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.77, 1.73]
3.19 Quality of life: at 12 months	12		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only
3.19.1 Trials including other SIS (not TVT‐S)	8	689	Std. Mean Difference (IV, Fixed, 95% CI)	0.24 [0.09, 0.39]
3.19.2 Trials including TVT‐S	4	426	Std. Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.14, 0.24]
3.20 Requiring repeat continence surgery or mesh revision	20		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.20.1 Trials including other SIS (not TVT‐S)	13	1559	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [0.94, 2.16]
3.20.2 Trials including TVT‐S	8	916	Risk Ratio (M‐H, Fixed, 95% CI)	2.40 [1.37, 4.18]

Comparison 4. Single‐incision slings versus retropubic and transobturator minimally‐invasive slings.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Subjective cure or improvement of urinary incontinence: 12 months	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.1.1 Trials including other SIS (not TVT‐S)	2	798	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.86, 1.03]
4.2 Subjective cure or improvement of urinary incontinence: 24 months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.3 Subjective cure or improvement of urinary incontinence: 36+ months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.3.1 Trials including other SIS (not TVT‐S)	1	481	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.82, 1.05]
4.4 Objective cure or improvement of urinary incontinence: at 12 months	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
4.4.1 Trials including other SIS (not TVT‐S)	2	509	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.76, 1.21]
4.5 Objective cure or improvement of urinary incontinence: 24 months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.6 Objective cure or improvement of urinary incontinence: 36+ months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.6.1 Trials including other SIS (not TVT‐S)	1	166	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.82, 1.08]
4.7 Patient‐reported pain: 30 days to 12 months	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.7.1 Trials including other SIS (not TVT‐S)	2	820	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [0.83, 1.96]
4.8 Patient‐reported pain: 12 to 24 months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.8.1 Trials including other SIS (not TVT‐S)	1	537	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.72, 1.81]
4.9 Patient‐reported pain: 24+ months	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.9.1 Trials including other SIS (not TVT‐S)	1	537	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.63, 1.43]
4.10 Dyspareunia	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.10.1 Trials including other SIS (not TVT‐S)	2	570	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.87, 2.03]
4.11 Number of women affected by mesh exposure, extrusion or erosion in any area	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.11.1 Trials including other SIS (not TVT‐S)	2	817	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.16, 3.21]
4.12 Urinary retention	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.12.1 Trials including other SIS (not TVT‐S)	2	820	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.26, 3.50]
4.13 Bladder or urethral injuries: less than 30 days after surgery	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.13.1 Trials including other SIS (not TVT‐S)	2	842	Risk Ratio (M‐H, Fixed, 95% CI)	0.07 [0.01, 0.51]
4.14 Other injuries: less than 30 days after surgery	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.14.1 Trials including other SIS (not TVT‐S)	1	305	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.04, 5.28]
4.15 Infections	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.15.1 Trials including other SIS (not TVT‐S)	1	283	Risk Ratio (M‐H, Fixed, 95% CI)	1.73 [0.70, 4.26]
4.16 De novo urgency	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.16.1 Trials including other SIS (not TVT‐S)	1	283	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.16]
4.17 Quality of life: at 12 months	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
4.18 Requiring repeat continence surgery or mesh revision	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.18.1 Trials including other SIS (not TVT‐S)	2	817	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [0.79, 3.19]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Abdel‐Fattah 2022.

Study characteristics
Methods	Study design: RCT Dates study conducted: randomised between February 2014 and July 2017
Participants	Number of participants: 600 Country: UK Setting: multicentre Type of UI: SUI Age: SIMS (n = 298): 50.4 years ± 11.0 years; SMUS (n = 298): 50.7 years ± 10.9 years BMI: SIMS (n = 297): 28.9 years ± 5.5 years; SMUS (n = 292): 28.7 years ± 5.6 years Parity: SIMS (n = 296): 2.4 ± 1.1; SMUS (n = 294): 2.4 ± 1.1 Duration of SUI: NR Menopause: NR Concomitant POP: NR (notes in exclusion criteria that women with apical and anterior vaginal wall prolapse were excluded) Number receiving concomitant POP surgery: none (notes in eligibility criteria that planned concomitant surgeries were an exclusion criterion) Inclusion criteria: women aged 18 years or older; predominant symptoms of SUI; in whom conservative treatment had failed (or been declined); planned to undergo a mid‐urethral sling procedure Exclusion criteria: anterior or apical prolapse stage ≥ 2; previous surgery for SUI; predominant symptoms of OAB; planned concomitant surgery; previous pelvic irradiation; pregnancy or planning pregnancy; inability to understand consent in English
Interventions	Group I (n = 300; 2 excluded postrandomisation): SIMS 7/276 participants underwent retropubic tape. 9/276 participants underwent obturator tape. 62/276 participants underwent Ajust mini‐sling. 195/276 participants underwent Altis mini‐sling. Group II (n = 300; 2 excluded postrandomisation): SMUS 119/261 participants underwent retropubic tape. 138/261 participants underwent obturator tape. 4/261 participants underwent Altis mini‐sling. All participants in each group were analysed together, with retropubic, obturator, Altis and Ajust not disaggregated in the analyses.
Outcomes	Primary outcomes Patient‐reported success: defined as a response of "very much improved" on the PGI‐I at 15 months; all other responses were considered to equate to treatment failure. Safety: included all expected adverse events during follow‐up, up to 36 months (pain; tape or mesh exposure, i.e. exposure of tape or mesh through the vaginal wall; operative complications such as lower urinary tract injuries, severe bleeding or bowel injuries; new onset or worsening of urinary urgency; dyspareunia; intermittent catheterisation). "All serious unexpected adverse events were reported by the collaborating hospitals and reviewed by the trial sponsor and the independent data monitoring committee according to the trial protocol." Secondary outcomes Postoperative pain to 14 days: measured using a scale of 1 to 10 where 10 was the worst pain imaginable Recovery: defined as return to normal activities within 28 days Objective success: defined as a 24‐hour pad test of < 8 g Patient symptom severity: "according to validated tools or questionnaires" QoL: "according to validated tools or questionnaires" Sexual function: "according to validated tools or questionnaires" "Health economic outcomes are being analyzed separately".
Notes	Follow‐up times: 4 weeks and 3 months postoperative; 15 months, 24 months and 36 months postrandomisation (approximately 12 months, 21 months and 33 months postoperative) Conflicts of interest: according to the summaries of disclosures within supplementary material on the journal website, no authors had a conflict of interest to disclose at the time. Study funding sources: "Supported by the NIHR (NIHR Evaluation, Health Technology Assessment Programme; funder number, 12/127/157)" Correspondence with authors: we contacted the study authors on 12 October 2022 to request disaggregated data for the SMUS arm of the study (i.e. data presented by retropubic and obturator separately). The authors responded on 12 October 2022 that the study did not compare SIS with either retropubic or obturator surgery. We followed up on 12 October 2022 to ask whether it was possible to provide data for the main outcomes disaggregated by type of surgery, although this was not the main comparison of the study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomly assigned in a 1:1 ratio to receive mini‐slings or mid‐urethral slings. Randomization was performed with the use of a remote Web‐based system and was stratified with the use of minimization according to center and previous supervised pelvic floor muscle training within 2 years" Comment: adequate method of randomisation
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Making surgeons and patients unaware of the trial‐group assignments was not possible given the different anesthesia typically used for the two different types of procedures." Comment: no blinding of participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "All follow‐up was patient‐reported through postal questionnaires." Comment: possible that the patients would know what group they were in but unclear what effect this would have on the results
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "At 15 and 36 months after randomization, the percentage of patients who returned a fully or partially completed trial questionnaire was 87.1% and 81.4%, respectively." Comment: overall attrition at follow‐up is acceptable, and there is no major differential attrition between arms.
Selective reporting (reporting bias)	Low risk	Protocol is available in supplementary material. All outcomes appear to have been reported either in the main report or in the supplementary material.
Other bias	Unclear risk	More women in the SIMS arm took anticholinergic medicine; it is unclear what effect this might have on the results.

Abdelwahab 2010.

Study characteristics
Methods	Design: RCT Dates study conducted: NR
Participants	Number of participants: 60 Country: Egypt Setting: single centre Type of UI: SUI Age: TVT‐S: 40.2 years ± 1.1 years; TVT: 39.2 years ± 9 years BMI: TVT‐S: 22.1 ± 3.3; TVT: 25.6 ± 2.1 Parity: TVT‐S: 2.3 ± 1.4; TVT: 2.1 ± 1.2 Duration of SUI: NR Postmenopausal status: TVT‐S: 3; TVT: 2 Concomitant POP: NR (notes that cystocele of III or IV is excluded but suggests that grade I or II may have been present; unclear) Number receiving concomitant POP surgery: NR Inclusion criteria: women diagnosed with SUI Exclusion criteria: DO; low bladder volume (< 200 mL); patients with grade III and IV cystocele; patients with type 0 SUI according to the Blavias and Olsson 1988 classification; recurrent cases
Interventions	Group I (n = 30): TVT‐S (U approach) Group II (n = 30): TVT (bottom to top)
Outcomes	Success rates, including cure and improvement: "cure means completely dry, while improvement means wetting but less than before surgery. Success rate includes cure and improvement". Postoperative retention Postoperative wound infection Postoperative UTI De novo urgency Dyspareunia Operative time (minutes) Intraoperative bleeding (mL) Duration of catheterisation (days) Hospital stay (days)
Notes	Follow‐up: 6 months (flowmetry was performed at 2 months, 4 months and 6 months postoperatively) Conflicts of interest: NR Study funding sources: NR
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "patients were randomly divided into two equal groups".
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	All enroled participants were included in the analysis.
Selective reporting (reporting bias)	Low risk	Protocol not available but all relevant outcomes seem to be reported
Other bias	Low risk	No other bias detected

Amat 2011.

Study characteristics
Methods	Design: quasi‐RCT Dates study conducted: September 2006 to July 2009
Participants	Number of participants: 257 Country: Spain Setting: single centre Type of UI: SUI Symptoms of urge incontinence (unclear if number or percentage): Needleless: 66; TVT‐O: 48 Age: Needleless: 58.99 years (35 years to 86); TVT‐O: 58.52 years (38 years to 85) BMI: Needleless: 28.05 (19.6 to 41.78); TVT‐O: 28.89 (19.57 to 42.19) Parity: Needleless: 2.48 (0 to 7); TVT‐O: 2.64 (0 to 9) Duration of SUI: Needless (n = 72): 7.61 years (6 months to 40 years); TVT‐O (n = 60): 4.68 years (6 months to 20 years) Menopausal status: Needleless: 108; TVT‐O: 77 Associated genital prolapse (Grade III‐IV genital prolapse on Baden grade scale): Needleless (n = 72): 53; TVT‐O (n = 60): 50 Number receiving concomitant POP surgery Vaginal hysterectomy: Needleless: 40 (28.0%); TVT‐O: 42 (36.8%) Anterior colporrhaphy: Needleless: 72 (36.8%); TVT‐O: 68 (59.6%) Posterior colporrhaphy: Needleless: 7 (4.9%); TVT‐O: 7 (6.1%) Inclusion criteria: women with SUI with positive stress test result, with or without associated genital prolapse, who are candidates for surgery Exclusion criteria: previous surgical treatment of SUI; ISD defined in urodynamic testing by VLPP < 60 cm H2O and absence of urethral hypermobility; candidates for pelvic floor rehabilitation; mixed incontinence with predominance of urge incontinence
Interventions	Group I (n = 131): C‐NDL Group II (n = 108): TVT‐O
Outcomes	Participants' subjective impression of treatment received: assessed via direct question on satisfaction of results (very satisfied, satisfied or dissatisfied) Cure rate: assessed by either the presence of a negative stress test result or a Sandvik severity score of 0 post‐surgery QoL: assessed using the question "How much does leaking urine interfere with your everyday life?" on the ICIQ‐SF Complications
Notes	Follow‐up time: 1, 2, 3 and 6 months, then annually. At follow‐up paper: Needleless: 54.27 months (36 months to 60 months); TVT‐O: 54.11 months (36 months to 60 months) Conflicts of interest: "None" Study funding sources: "Was this work supported by industry? No"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "patients were assigned to one or other group of treatment depending on the last figure of their medical history number; last even figure was allocated for technical TVT‐O and last odd figure for C‐NDL". Comment: inadequate randomisation method
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Another limitation is that this study was not blinded. It was not possible to blind the process because in the TVT‐O group, the patient presents a cutaneous scar at the obturator region. On the other hand, in our hospital the surgeon performed the follow‐up visits". Comment: surgeon was not blind and also performed follow‐up assessment. Participants also appear to not be blind.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Another limitation is that this study was not blinded. It was not possible to blind the process because in the TVT‐O group, the patient presents a cutaneous scar at the obturator region. On the other hand, in our hospital the surgeon performed the follow‐up visits". Comment: surgeon performing operations also performed the assessments, and participants were not blind.
Incomplete outcome data (attrition bias) All outcomes	High risk	15.5% dropout in TVT‐O group and 17.2% dropout in C‐NDL group. Relatively high loss to follow‐up and reasons for withdrawal NR. Attrition rate roughly balanced between groups but reasons for dropout not clear
Selective reporting (reporting bias)	Low risk	Protocol not available but all relevant outcomes seem to be reported
Other bias	High risk	High proportion of participants underwent concomitant prolapse repair

Andrada Hamer 2011.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: August 2007, March 2010
Participants	Number of participants: 133 Country: Sweden Setting: multicentre Type of UI: primary SUI or MUI with predominant SUI symptoms Age (median and range): TVT‐S: 47 years (33 years to 84 years); TVT: 48 years (33 years to 78 years) BMI (median and range): TVT‐S: 25.4 (20.3 to 42.1); TVT: 24.6 (18.8 to 36) Parity (median and range): TVT‐S: 2 (0 to 8); TVT: 2 (2 to 5) Duration of incontinence (median and range): TVT‐S: 6.5 years (1 year to 40 years); TVT: 9 years (1 year to 45 years) Menopausal status Premenopausal: TVT‐S: 42 (69%); TVT: 39 (63%) Postmenopausal: TVT‐S: 13 (21%); TVT: 16 (26%) Postmenopausal plus hormonal therapy: TVT‐S: 6 (10%); TVT: 6 (10%) Missing information: TVT‐S: 0; TVT: 3 (5%) Concomitant POP: NR (Part of the exclusion criteria was need for concomitant surgery for genital organ prolapse, but no further details were reported.) Number receiving concomitant POP surgery: none (Part of the exclusion criteria was need for concomitant surgery for genital organ prolapse.) Inclusion criteria: history of SUI; wish for surgical treatment; no wish for future pregnancy; aged 18 years or over; ≥ 3‐mL leakage on standardised pad test; cough–synchronous leakage at stress test (up to 10 coughs in standing position); the latter 2 with 300‐mL bladder volume Exclusion criteria: need for concomitant surgery for genital organ prolapse; patients undergoing regular pelvic floor training for < 3 months; planned or current pregnancy; previous surgery for UI; bladder capacity < 300 mL; known detrusor instability; cystitis < 4 times in the previous 12 months; pyelonephritis more than once during the previous 5 years; known or suspected neurological conditions; current anticoagulation therapy which could not be interrupted in due time prior to surgery; patients with known abnormal coagulation; allergy to local anaesthetics or metronidazole or both; cognitive or language problems precluding comprehension of written study information or questionnaires
Interventions	Group I (n = 64): TVT‐S Group II (n = 66): TVT
Outcomes	Pad test Stress test VAS scale KHQ
Notes	Follow‐up time: 2 months and 1 year Conflicts of interest: "This study has been performed with economical support from Gynecare Scandinavia. Gynecare has had no influence on study design, data interpretation, or content of the article". Study funding sources: "This study has been performed with economical support from Gynecare Scandinavia. Gynecare has had no influence on study design, data interpretation, or content of the article". Subjective cure rate assessed but method of interpretation not defined. Study stopped at interim analysis because of poor outcomes and high rate of serious complications with TVT‐S. Loss to follow‐up in 4 participants. 4 women were excluded because of protocol violations, and 4 declined surgery for personal reasons after they had been randomly assigned. ITT analysis not done or reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Consenting women who fulfilled all inclusion criteria were randomised in a proportion of 1:1".
Allocation concealment (selection bias)	Low risk	Quote: "an equal proportion of assignments were mixed and placed in opaque envelopes which were then sealed, mixed again and numbered and kept at a central study secretariat".
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "The evaluator blinding was achieved by placing the patient’s operative file as well as the results of the randomization in a sealed envelope immediately after surgery and by instructing the patient not to reveal the operative technique at any subsequent follow‐up". Comment: this suggests that the participants would have been aware of their assignment. Personnel blinding was NR.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "the follow up was performed by an independent evaluator, usually a urotherapist".
Incomplete outcome data (attrition bias) All outcomes	Low risk	121/125 participants available for 1‐year follow‐up
Selective reporting (reporting bias)	Low risk	Protocol was not available, but all relevant outcomes seem to be reported.
Other bias	Low risk	No other bias detected

Barber 2012.

Study characteristics
Methods	Design: RCT Dates study conducted: August 2007 to March 2010
Participants	Number of participants: 263 Country: USA Setting: multicentre Type of UI Stress only: mini‐sling 37%; TVT NR Stress and urge: mini‐sling 63%; TVT NR Age: mini‐sling: 54.6 years ± 10.5 years; TVT: 54.6 years ± 11.3 years BMI: mini‐sling: 29.6 ± 6.4; TVT: 30.0 ± 5.7 Parity: mini‐sling: 2 (0 to 6); TVT: 2 (0 to 6) Duration of SUI: NR Menopausal status Premenopausal: mini‐sling: 42.2%; TVT: 42.6% Postmenopausal with hormone therapy: mini‐sling: 18.8%; TVT: 23.8% Postmenopausal without hormone therapy: mini‐sling: 39.1%; TVT: 33.6% Concomitant POP (POP beyond the hymen): mini‐sling: 18.4%; TVT: 13.4% Number receiving concomitant POP surgery Hysterectomy (vaginal, abdominal or laparoscopic): mini‐sling (n = 133): 13 (9%); TVT (n = 127): 33 (26%) (Only vaginal hysterectomy would be considered a POP surgery, but data were not split by type of hysterectomy.) Anterior colporrhaphy: mini‐sling (n = 133): 27 (20%); TVT (n = 127): 17 (13%) Paravaginal repair: mini‐sling (n = 133): 1 (0.7%); TVT (n = 127): 1 (0.8%) Anterior mesh: mini‐sling (n = 133): 1 (0.7%); TVT (n = 127): 0 (0%) Posterior colporrhaphy: mini‐sling (n = 133): 19 (14%); TVT (n = 127): 20 (16%) Posterior mesh: mini‐sling (n = 133): 0; TVT (n = 127): 0 Vaginal vault suspension (including uterosacral vaginal vault suspensions, iliococcygeus suspensions and sacrospinous ligament fixation): mini‐sling (n = 133): 16 (12%); TVT (n = 127): 11 (9%) Sacral colpopexy (abdominal or laparoscopic): mini‐sling (n = 133): 5 (4%); TVT (n = 127): 5 (4%) Colpocleisis: mini‐sling (n = 133): 1 (0.7%); TVT (n = 127): 4 (3%) Other: mini‐sling (n = 133): 19 (14%); TVT (n = 127): 17 (14%) Inclusion criteria: at least 21 years old; demonstrated urodynamic SUI on multichannel urodynamic testing; desired surgical treatment for their incontinence; women with POP requiring concurrent surgery correction were eligible Exclusion criteria: DO on urodynamic testing; PVR volume > 100 mL; history of previous synthetic, biologic or fascial suburethral sling surgery; desires future childbearing; were currently using anticoagulation therapy or had a known bleeding diathesis; had a current urethral diverticulum or fistula of the lower urinary tract; or otherwise had a contradiction for surgery
Interventions	Group I (n = 136): TVT‐S (U‐type) Group II (n = 127): TVT
Outcomes	Primary outcome Subjective cure: defined as the absence of any UI or re‐treatment; composite outcome defined as the absence of UI as indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for SUI after the index surgery Secondary outcomes Incontinence severity: defined as 'dry', 'slight', 'moderate' and 'severe' according to the Incontinence Severity Index Postoperative stress or urge incontinence symptoms: based on responses to corresponding items in the PFDI‐20 Short‐ (< 6 weeks) and long‐term complications Postoperative pain and activity Change in symptom bother and QoL (based on the PFDI‐20; PFIQ‐7) Change in sexual function based on Prolapse/Urinary Incontinence Sexual Questionnaire‐12 Global improvement in bladder function based on the PGI‐I
Notes	Follow‐up time: 6 weeks, 6 months, 12 months, 18 months and 24 months Conflicts of interest: "Dr. Karram has been a speaker for and consultant to Ethicon Women's Health and Urology and American Medical Systems. Dr. Rardin has been a consultant to Mpathy Medical Inc. Dr. Toglia has been a preceptor for Ethicon Womens' Health and Urology. The other authors did not report any condlicts of interest". Study funding sources: "Dr. Karram has been a speaker for and consultant to Ethicon Women's Health and Urology and American Medical Systems. Dr. Rardin has been a consultant to Mpathy Medical Inc. Dr. Toglia has been a preceptor for Ethicon Womens' Health and Urology. The other authors did not report any condlicts of interest." "Funded by a grant from the Foundation for Female Health Awareness (www.femalehealthawareness.org)" 18 withdrew before randomisation; 247 completed at least 12 months with mean follow‐up of 19.6 months ± 7.7 months. Participants who received TVT were more likely to undergo concurrent hysterectomy (26% versus 9% in TVT‐S arm). Correspondence with authors: we contacted the study authors on 14 November 2022 to ask for numerical data surrounding QoL at 12 months.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random allocation with randomly permuted blocks used; stratified by site and presence or absence of prolapse beyond the hymen
Allocation concealment (selection bias)	Low risk	Consecutively numbered, sealed, opaque envelopes used
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "To maintain masking, two small, 1‐cm, sham, partial‐thickness skin incisions were made in the suprapubic region in those individuals enrolled in the mini‐sling arm to mimic the visiable [sic] incisions of TVT and covered with a steri‐strip or surgical adhesive" Comment: not described for personnel, but outcomes assessed by independent staff; unlikely that outcomes were influenced
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Research staff not involved in operation performed postoperative assessments
Incomplete outcome data (attrition bias) All outcomes	Low risk	94% of the women were followed up.
Selective reporting (reporting bias)	Low risk	Protocol was not available, but all relevant outcomes seem to be reported.
Other bias	High risk	Participants who received TVT were more likely to undergo concurrent hysterectomy (26% versus 9% in TVT‐S arm).

Basu 2010.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: enroled between January 2008 and February 2009
Participants	Number of participants: 71 Country: UK Setting: single centre Type of UI: SUI with objective evidence of USI DO: MiniArc: 19 (51.3%); TVT: 19 (57.5%) Age: MiniArc: 49.7 years ± 10.7 years; TVT: 48.2 years ± 9.4 years BMI: MiniArc: 30.1 ± 7.6; TVT: 28.2 ± 5.6 Parity (median): MiniArc: 2; TVT: 2 Duration of SUI: NR Postmenopausal: MiniArc: 12 (32.4%); TVT: 9 (27.2) Concomitant POP: NR (noted in the eligibility criteria that women with POP of POP‐Q stage ≥ 2 were excluded) Number receiving concomitant POP surgery: NR Inclusion criteria: SUI symptoms together with objective evidence of USI, which had failed to resolve with conservative measures; suitable for a continence procedure Exclusion criteria: women with a history of previous continence surgery; evidence of voiding dysfunction; known bladder pathology; POP of POP‐Q stage ≥ 2; recurrent UTIs; planning to conceive in the future
Interventions	Group I (n = 38): mini‐sling (MiniArc) Group II (n = 33): retropubic TVT (Advantage TVT)
Outcomes	Primary outcome Presence of SUI: assessed through direct questions and relevant symptom domain on the KHQ Secondary outcomes Presence of USI at 6 months Intraoperative and postoperative complications
Notes	Follow‐up time: 6 weeks and 6 months Conflicts of interest: "JD received funding from the following sources: American Medical Systems, to conduct the trial; Boston Scientific, for other research; and Ethicon, to attend meetings. Only the authors were responsible for the conduct of the trial. The authors analysed the results and wrote the manuscript without any external influence from the tape manufacturers". Study funding sources: "Trial funded by a grant from American Medical Systems. Funding has been received from Boston Scientific for other research studies. Only the authors were responsible for the conduct of the trial. The authors analysed the results and wrote the manuscript without any external influence from the tape manufacturers". In a 2012 paper, for MiniArc, 35/38 returned 3‐year questionnaires; for retropubic TVT, 26/33 returned 3‐year questionnaires. 1 person in the MiniArc group did not receive the intervention and was excluded from the analysis. No further dropouts/withdrawals
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Subjects were randomised using computer‐generated block randomisation sequence".
Allocation concealment (selection bias)	Low risk	Quote: "allocation to each group being performed via a series of opaque envelopes, by a member of the research team"
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Participants were blinded as to which of the groups they had been allocated to. Because of obvious differences between the devices, researchers could not be blinded to the group allocation". Comment: we assume this quotation refers to the blinding of personnel, but this is not clear; unsure of what impact this may have on outcome assessment
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not mentioned in methodology
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data for subjective outcome are available on all participants. 3 participants declined urodynamics at 6 months (all in TVT arm).
Selective reporting (reporting bias)	Low risk	All outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Bianchi‐Ferraro 2013.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: surgeries performed between January 2009 and November 2010
Participants	Number of participants: 122 Country: Brazil Setting: single centre Type of UI: SUI Number with associated urgency: TVT‐S: 36 (58%); TVT‐O: 31 (58.5%) Age: TVT‐S: 54.05 years ± 11.37 years ; TVT‐O: 52.13 years ± 8.79 years BMI: TVT‐S 29.84 ± 5.35; TVT: 30.02 ± 4.69 Parity: TVT‐S: 4.05 ± 2.65; TVT‐O: 3.64 ± 2.26 Duration of SUI: NR Menopause: NR Concomitant POP: NR (noted in the eligibility criteria that women with POP beyond the hymen were excluded) Number receiving concomitant POP surgery: NR Inclusion criteria: SUI; without DO; no concomitant prolapse of POP‐Q stage ≥ 2 Exclusion criteria: DO on UDS (urodynamic studies); PVR > 100 mL; maximum uroflow < 15 mL/s; presence of POP beyond the hymen; previous pelvic radiotherapy; clinical contraindications for surgical procedures
Interventions	Group I (n = 66): TVT‐S Group II (n = 56): TVT‐O
Outcomes	Primary outcomes Objective cure 1 year after surgery: defined as an absence of leakage during all assessments including pad stress test, pad test and urodynamic studies. Subjective cure: absence of reporting of leakage indicated as a KHQ symptom scale score of 0 Secondary outcomes QoL: assessed using KHQ Complications (e.g. UTI, tape exposure, de novo urgency)
Notes	Follow‐up times: 7 days, then 1 month, 3 months, 6 months and 12 months postoperative Conflicts of interest: none Study funding source: Federal University of São Paulo Dropouts: at 1 year, 5 (3 TVT‐S, 2 TVT‐O) were lost to follow‐up.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "The surgeon was only aware of the allocation group in the operating room immediately prior to the procedure". Comment: participant blinding NR; unclear who was assessing outcomes
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data available on all randomly assigned participants
Selective reporting (reporting bias)	Low risk	Protocol was not available, but all relevant outcomes seem to be reported.
Other bias	Low risk	No other bias detected

Chen 2020.

Study characteristics
Methods	Study design: quasi‐RCT Dates study conducted: February 2017 to November 2018
Participants	Number of participants: 88 Country: China Setting: single centre Type of UI: SUI Age: C‐NDL ("Needleless"): 52.58 years ± 5.96 years; mid‐urethra sling: 53.02 years ± 6.02 years BMI: Needleless: 24.51 ± 2.16; mid‐urethra sling: 24.86 ± 2.22 Parity ("Birth history (Times)"): Needleless: 1.63 ± 0.28; mid‐urethra sling: 1.68 ± 0.31 Duration of SUI ("Course of disease (yr)"): Needleless: 1.06 ± 0.26; mid‐urethra sling: 2.08 ± 0.28 Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: cough, laughter or other abdominal pressure rise leading to large amount of urine leakage; positive finger pressure test result; urine blood test confirming that bladder detrusor function is not abnormal; absence of urethral infection; provision of informed consent for the treatment with a form that was voluntarily signed Exclusion criteria: PFMT underway before admission; history of vaginal surgery or pelvic surgery; UI caused by bladder outlet obstruction; MUI or neurogenic UI; incomplete baseline data
Interventions	Group I (n = 44): Single‐incision sling Group II (n = 44): middle segment urethral suspension group (TOT) Surgical methods common to groups: no further details
Outcomes	"Highly effective": when SUI symptoms "basically disappeared" and cough‐leak urine test findings were negative "Effective": when pressure urinary symptoms were still present and cough‐leak urine test result was positive but volume of urine leakage was "reduced by less than 50% compared with before treatment" "Invalid": when UI symptoms were still present and volume of urinary leakage was "reduced by < 50%" Total effectiveness rate: calculated as "(number of cured cases + number of valid cases)/total number of cases × 100%" QoL: assessed 12 months postoperatively using ICIQ‐SF and IIQ‐7 Pain assessment: performed on postoperative day 1 using VAS on scale of 0 to 10, proportional to degree of pain Urinary retention Infection Haematomas "Other complications"
Notes	Follow‐up times: postoperative day 1, 12 months Conflicts of interest: "Dr. Wang X reports a grant from National Key Research Program of China (No. 2018YFC2002202) during the conduct of the study, and other authors have no conflicts of interest to disclose". Study funding sources: NR
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "patients were listed in the order of admission, and patients receiving an even number were included in a needleless sling group". Comment: alternate (quasi) method of randomisation
Allocation concealment (selection bias)	High risk	Quote: "patients were listed in the order of admission, and patients receiving an even number were included in a needleless sling group". Comment: alternate (quasi) method of randomisation
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR; unlikely that personnel would have been blinded to the intervention given the nature of the study; NR whether participants were blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	All 88 women who were entered into the study appear to have been accounted for in the analysis.
Selective reporting (reporting bias)	Unclear risk	No trial registration reported; unclear whether selective reporting is present
Other bias	Low risk	Nothing to suggest any other bias

Dati 2012.

Study characteristics
Methods	Design: "randomized" Dates study conducted: enrolment between 2009 and 2011
Participants	Number of participants: 115 Country: Italy Setting: multicentre Type of UI: USI Age: NR Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP POP ≥ 2: Ajust: 27; TVT‐Abbrevo: 30 POP < 2 or no POP: Ajust: 30; TVT‐Abbrevo: 28 Number receiving concomitant POP surgery: all participants in Groups I and II had concomitant POP surgery alongside Ajust (n = 27) or TVT‐Abbrevo (n = 30). Inclusion criteria: women with USI Exclusion criteria: recurrent SUI; Q‐tip test < 1; ISD; stage of POP > 3
Interventions	Group I (n = 27 with POP stage ≥ 2 < 3): Ajust, together with concomitant POP surgery Group II (n = 30 with POP stage ≥ 2 and < 3): TVT‐Abbrevo, together with concomitant POP surgery Group III (n = 30 without POP or POP stage < 2): Ajust Group IV (n = 28without POP or POP stage < 2): TVT‐Abbrevo
Outcomes	"Subjective degree of suffering": assessed by VAS in "post surgical time" Examination: at 4 weeks and 6 months CST: at 4 weeks and 6 months ICIQ questionnaire: at 4 weeks and 6 months
Notes	Follow‐up: postsurgical, 4 weeks and 6 months Conflicts of interest: NR Study funding sources: NR Abstract only Contact with study authors: we contacted the authors re: randomisation process on 13 February 2020, and they responded on 1 March 2020. The study authors noted in their email that the study was "randomised". Although the type of randomisation process was unclear, we considered this to be enough information to make the study eligible for the review. As objective and subjective response rates were combined in the abstract, we followed up with the study authors to request disaggregated data on 1 March 2020 but did not receive a response.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomized trial" Comment: unclear method of randomisation; no further details from contact with authors
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	NR
Selective reporting (reporting bias)	Unclear risk	Abstract only; unclear whether selective reporting is present
Other bias	Unclear risk	Abstract only; not enough information to judge

Dogan 2018a.

Study characteristics
Methods	Design: RCT Dates study conducted: May 2014 to May 2016
Participants	Number of participants: 179 Country: Turkey Setting: single centre Type of UI: SUI Age: mini‐sling: 49.03 years ± 9.18 years; TOT: 51.92 years ± 6.98 years BMI: mini‐sling: 27.94 ± 5.03; TOT: 26.61 ± 3.87 Parity: mini‐sling: 3 (0 to 9); TOT: 3 (1 to 6) Duration of SUI: mini‐sling: 4.85 years ± 3.67 years; TOT: 5.90 years ± 2.40 years Menopause: mini‐sling: 37 (41.57%); TOT: 42 (47.1%) Concomitant POP: NR (noted in eligibility criteria that women with concomitant POP stage ≥ 2 are excluded) Number undergoing concomitant POP surgery: NR Inclusion criteria: 18 years or older; clinically proven SUI (using CST in the supine and standing positions); failed conservative treatments; offered surgery Exclusion criteria: MUI or predominantly UUI or OAB symptoms based on initial clinical assessment and anamnesis; previous surgery for POP and UI; concomitant POP stage ≥ 2; history of surgery for POP and UI; PVR volume > 100 mL and bladder capacity < 300 mL assessed by bladder Foley catheter; known malignancy; recurrent UTI; chronic pelvic pain; known neurological or psychiatric disorder that could prevent proper assessment
Interventions	Group I (n = 90): C‐NDL Group II (n = 89): inside‐out TOT (Contasure KIM (knotless incontinence mesh))
Outcomes	Primary outcomes Objective cure: absence of leakage in supine and standing positions with a 300‐mL saline‐filled bladder Subjective cure: no stress leakage after surgery if the participant answered "never/urine does not leak" to the question "When does urine leak?" on the Turkish validated version of the ICIQ‐SF Secondary outcomes Patient‐reported satisfaction: defined as improvement in QoL using the ICIQ‐UI‐SF (range 0 to 21) Surgical outcomes: operating time (from incision to last suture); length of inpatient stay Perioperative complications: monitored by 2 different gynaecologists using a category time‐site‐pain code following the ICS/IUGA Complication Classification Code guidelines; exposure defined as vaginal mesh visualised through separated epithelium; extrusion defined as the gradual passage of mesh out of the body structure or tissue
Notes	Follow‐up time: postoperative, 6 months, 12 months and 24 months Conflicts of interest: "The authors declare that they have no conflict of interest". Study funding source: "Authors declare that no funding or any type of sponsorships was received". Dropouts: 1 lost to follow‐up in Needleless group (participant moved abroad at 12th month) Contact with study authors: we contacted the study authors on 14 November 2022 and on 1 December 2022 to clarify how many mesh erosions had occurred at different sites for each group and how many bladder perforations had occurred in each group, but we did not receive a response.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised using a computer‐generated block randomisation sequence in a 1:1 ratio design.
Allocation concealment (selection bias)	Low risk	Allocation was concealed by sealed opaque envelopes.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Patients were blinded to the allocation". Comment: blinding of personnel NR but stated that different, independent personnel undertook the postoperative outcome assessments
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcomes were reported by a second, blinded surgeon.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for in analysis
Selective reporting (reporting bias)	Low risk	Protocol is not available, but all relevant outcomes seem to be reported.
Other bias	Low risk	No other bias detected

Elbadry 2017.

Study characteristics
Methods	Design: RCT Dates study conducted: January 2016 to November 2016
Participants	Number of participants: 123 Country: Egypt Setting: single centre Type of UI: SUI Age (mean and SD): 45 years ± 10 years BMI: NR Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR Number receiving surgery for concomitant POP: NR Inclusion criteria: women with SUI Exclusion criteria: NR
Interventions	Group I (n = 62): mini‐sling Group II (n = 61): transobturator sling
Outcomes	Continence rate: method not described Improvement in incontinence: method not described Postoperative complications: including UTI and pain
Notes	Follow‐up: "post operatively"; "follow up mean 333 days"; no further details Conflicts of interest: NR Study funding sources: NR Abstract only Contact with study authors: contacted study authors 29 August 2019; information unclear about randomisation procedures
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomly categorized" Comment: unclear method of randomisation
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR; unlikely that personnel would have been blinded to the intervention given the nature of the study; NR whether participants were blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	Although not explicit, the numbers and percentages reported in the results suggest that all participants initially randomised were followed up.
Selective reporting (reporting bias)	Unclear risk	Abstract only; unclear whether selective reporting is present
Other bias	Unclear risk	Abstract only; not enough information to be able to tell

Elsayed Barakat 2020.

Study characteristics
Methods	Study design: quasi‐RCT (randomisation confirmed by communication with study authors) Dates study conducted: August 2017 to October 2020
Participants	Number of participants: 80 Country: Egypt Setting: single centre Type of UI: SUI Age: C‐NDL: 44.35 years ± 7.9 years; TVT‐O: 45.9 years ± 10.29 years BMI: C‐NDL: 27.8 years ± 4.84 years; TVT‐O: 28.1 years ± 4 years Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: women aged 18 years or older; urodynamic‐proved pure SUI; failed or declined conservative treatment Exclusion criteria: MUI; VLPP < 60 cm H2O; previous SUI surgery; neurological conditions; prior pelvic irradiation
Interventions	Group I (n = 40): C‐NDL Group II (n = 40): TVT‐O
Outcomes	CST Subjective cure rate Operative time (minutes) Pain scale Urinary retention Postoperative complications (pain and dyspareunia)
Notes	Follow‐up times: 1 month, 6 months and 12 months postoperatively Conflicts of interest: "The author has no conflicts of interests to declare". Study funding sources: "This research did not receive any specific grant from funding agencies in the public, commercial, or not‐for‐profit sectors". Correspondence with authors: we contacted the study authors on 10 October 2022 to confirm whether the study was randomised. The authors responded on 14 October 2022, stating that the study was randomised in nature and used "simple randomisation". We contacted the authors again on 17 October 2022 to enquire further about what simple randomisation consisted of in the study before following up on 1 November 2022, but we did not receive a response to this query.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "Patients were random assigned to two groups (odd patient for Contsure, even patient for TVT‐O)" Comment: alternative randomisation method (quasi‐randomisation)
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	9 of 80 participants lost to follow‐up; no differential loss to follow‐up between arms
Selective reporting (reporting bias)	Unclear risk	No trial registration reported; unclear whether selective reporting is present
Other bias	Low risk	Nothing to suggest any other bias

Emami 2019.

Study characteristics
Methods	Design: RCT Dates study conducted: enroled in 2018
Participants	Number of participants: 80 Country: Iran Setting: single centre Type of UI: SUI Age: mini‐sling: 51.98 years ± 6.33 years (36 years to 65 years); TOT: 51.15 years ± 6.4 years (37 years to 65 years) BMI: mini‐sling: 26.14 ± 2.78 (20.4 to 33.3); TOT: 26.75 ± 3.07 (22.4 to 34) Parity: mini‐sling: 3.85 ± 1.4 (2 to 8); TOT: 3.7 ± 1.5 (1 to 9) Duration of SUI: NR Menopause: NR Concomitant POP: none (notes that POP alongside SUI was an exclusion criterion for participants) Number receiving concomitant POP surgery: none (notes that POP alongside SUI was an exclusion criterion for participants) Inclusion criteria: women visiting the urology clinic in 2018 with the major complaint of SUI Exclusion criteria: grade III UI (ISD); OAB; POP accompanied by SUI or recurrent UI; patients undergoing medication or other therapies for UI; all cases with a history of neurological diseases such as cerebrovascular accident, multiple sclerosis (MS) or Parkinson's disease; simultaneous pelvic infection on examination
Interventions	Group I (n = 40): mini‐sling Group II (n = 40): TOT
Outcomes	International Consultation on Incontinence Modular Questionnaire‐6 (ICIQ‐6): filled in by the participant Female Sexual Functioning Index (FSFI): filled in by the physician Amount of bleeding: assessed by measuring blood volume in the suction bottle and gauze Pain: based on the Won‐Backer questionnaire Urodynamic study Sonography Persian‐validated version of ICIQ
Notes	Follow‐up: 8 weeks Conflict of interest: "The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article". Study funding source: "The author(s) received no financial support for the research, authorship and/or publication of this article". Dropouts: NR
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The patients were randomly assigned to the TOT and minisling groups". Comment: described as randomised but method not described
Allocation concealment (selection bias)	Unclear risk	Not described in paper
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts reported
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Enzelsberger 2010.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: NR in English abstract
Participants	Number of participants: 90 Country: Austria Setting: single centre Type of UI: SUI Age: MiniArc: 53 years (32 years to 71 years); TVT‐O: 54 years (44 years to 73 years) BMI: MiniArc: 23 (18 to 26); TVT‐O: 24 (19 to 27) Parity: MiniArc: 2 (1 to 5); TVT‐O: 2 (1 to 4) Duration of SUI: NR Menopause Premenopausal: MiniArc: 13; TVT‐O: 10 Postmenopausal: MiniArc: 32; TVT‐O: 35 Concomitant POP: 0 Number receiving concomitant POP surgery: none (assuming that no participants had genital prolapse) Inclusion criteria: positive preoperative stress test result, subjective suffering and the ability to be randomised to one of the study groups. Exclusion criteria: previous incontinence surgery, additional surgical therapy, urge incontinence, residual urine over 100 mL after spontaneous voiding, and neurological diseases such as Parkinson's disease or multiple sclerosis (MS)
Interventions	Group I (n = 45): MiniArc Group II (n = 45): Monarc (TVT‐O)
Outcomes	Not clear but continence success rate, operating time and bladder or other injuries are reported in the results
Notes	Follow‐up time: "The interval between surgery and the end of follow‐up which included clinical and urodynamic evaluation averaged 24 months". Conflicts of interest: NR Study funding sources: "the present study was not subject to any sponsorship by AMS (sling manufacturers) regarding authors and study preparations. Likewise, AMS was not involved in the data analysis or preparation of the manuscript." German language paper; details extracted here are review author translation.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "women were randomly allocated".
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding NR in English abstract
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	All outcome data reported
Selective reporting (reporting bias)	Low risk	Protocol is not available, but all relevant outcomes seem to be reported.
Other bias	Low risk	No other bias detected

Enzelsberger 2011.

Study characteristics
Methods	Design: RCT Dates study conducted: NR
Participants	Number of participants: 50 Country: Austria Setting: NR Type of UI: SUI; no further details in abstract Age: NR BMI: NR Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: 0 ("There was no combination with prolapse repair") Inclusion criteria: women with SUI Exclusion criteria: NR
Interventions	Group I(n = 25): Ophira Group II (n = 25): Monarc
Outcomes	Continence success rate: not defined in abstract
Notes	Follow‐up time: "The interval between surgery and follow‐up study with clinical and urodynamic evaluation averaged 20 months". Conflicts of interest: NR Study funding source: "Work supported by industry: No" English abstract only Contact with study authors: we contacted the study authors on 16 November 2022 to confirm whether the success rate in the paper was measured subjectively or objectively.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to assess
Allocation concealment (selection bias)	Unclear risk	Insufficient information to assess
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to assess
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient information to assess
Selective reporting (reporting bias)	Unclear risk	Insufficient information to assess
Other bias	Low risk	No other bias detected

Faber 2021.

Study characteristics
Methods	Design: RCT Dates study conducted: NR
Participants	Number of participants: 99 Country: Brazil Setting: multicentre Type of UI: SUI Age: NR (NB: notes that the participants were homogenous in terms of age) BMI: NR (NB: notes that the participants were homogenous in terms of BMI) Parity: NR (NB: notes that the participants were homogenous in terms of vaginal deliveries) Duration of SUI: NR Menopause: NR (NB: notes that the participants were homogenous in terms of menopausal status) Concomitant POP: NR (NB: notes in trial registration that women with POP stage ≥ 2 were excluded) Number receiving concomitant POP surgery: NR Inclusion criteria: women with confirmed stress‐predominant UI Exclusion criteria: NR
Interventions	Group I (n = 49): SIS ‐ Solyx Group II (n = 50): TOT ‐ Obtryx II
Outcomes	Primary outcome Improvement in the Patient Global Impression of Improvement (PGI‐I) and KHQ instruments after treatment Secondary outcomes Subjective improvement (improved or cured) Number of reoperations Estimated blood loss Operative room time Postoperative complications
Notes	Follow‐up times: 6 and 12 months Conflicts of interest: NR Study funding sources: NR Contact with study authors: we contacted the study authors on 18 November 2022 and on 1 December 2022 to clarify what outcomes were being measured by the PGI‐I and KHQ, respectively, as well as to request raw data for improvement in both the PGI‐I and KHQ. We received a response from the study authors on 30 December 2022, but this was too late to incorporate fully into the review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomized controlled study" Comment: unclear method of randomisation
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "non‐blinded" Comment: explicitly states that the study was unblinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR; 'non‐blinded' is likely to refer to participants and clinicians so unclear if outcome assessment was blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	NR
Selective reporting (reporting bias)	High risk	Trial registration notes that objective cure was a primary outcome in the study, but this does not appear to have been mentioned or measured in the abstract. Several secondary outcomes are also reported in the trial registration but not described in the abstract.
Other bias	Unclear risk	Abstract only (not enough information to judge)

Fernandez‐Gonzalez 2017.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: May 2010 to June 2014
Participants	Number of participants: 187 Country: Spain Setting: single centre Type of UI: SUI Symptoms of urge incontinence: C‐NDL: 55.1%; Monarc: 53.1% Age: C‐NDL: 57.6 years ± 11.03 years; Monarc: 57.8 years ± 57.83 years (SD as reported in full text) BMI: C‐NDL: 28.7 ± 4.97; Monarc: 28.1 ± 4.44 Parity: C‐NDL: 2 (0 to 6); Monarc: 2 (0 to 8) Duration of SUI: NR Menopausal: C‐NDL: 69.7%; Monarc: 61.2% Concomitant POP: NR (noted that concomitant POP surgery occurred at an individual level according to the degree of prolapse if symptomatic) Number receiving concomitant POP surgery Concomitant surgery: C‐NDL: 42/89 (47.2%); Monarc: 41/98 (41.8%) Vaginal hysterectomy: C‐NDL: 23/89 (25.8%); Monarc: 22/98 (22.4%) Anterior colporrhaphy: C‐NDL: 38/89 (42.7%); Monarc: 40/98 (40.8%) Posterior colporrhaphy: C‐NDL: 1/89 (1.1%); Monarc: 4/98 (4.1%) Inclusion criteria: clinical SUI and a candidate for TVT procedures Exclusion criteria: previous surgical treatment of SUI; ISD (defined in urodynamic study by VLPP < 60 cm H2O and an absence of urethral hypermobility); candidates for pelvic floor physiotherapy rehabilitation; mixed incontinence with predominance of urge symptoms (confirmed by urodynamic study)
Interventions	Group I (n = 89): C‐NDL Group II (n = 98): Monarc
Outcomes	Primary outcomes Objective cure: defined as a negative stress test result (i.e. no leakage of urine) when assessed in the lithotomy position with a comfortably full bladder after a series of forceful coughs Subjective cure: assessed with 2 questionnaires. Participants were asked if they were very satisfied, satisfied or unsatisfied according to intervention outcome. They were then asked for their postoperative Sandvik Severity Index (SSI). Cure was defined as postsurgical SSI of 0, while improvement was defined as a score lower than the pre‐surgical score. Failure was defined as when the postsurgical test score was equal to or greater than the presurgical score. Secondary outcomes QoL: assessed using the question "Estos escapes de orina que tiene, ¿cuánto afectan su vida diaria?" ("How much does leaking urine interfere with your everyday life?") on the ICIQ‐SF questionnaire, where 0 is 'no interference' and 10 is 'a lot of interference'. Complications
Notes	Follow‐up (mean and SD): Needleless: 30 months ± 12.14 months; Monarc: 27 months ± 12.68 months (notes minimum follow‐up of 12 months) Conflicts of interest: none Study funding source: NR Loss to follow‐up: Needleless: 2 lost to follow‐up (satisfaction questionnaire not registered); Monarc: 2 lost to follow‐up (negative stress test not registered, satisfaction questionnaire not registered)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised in a 1:1 ratio. A computer‐generated random allocation was used.
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "The limitation of our current study is that it was not possible to blind the post‐surgical evaluation because, in the TOT group, the patient presents a cutaneous scar at the obturator region". Comment: participants not explicitly told about their assignment and would have needed additional knowledge of the differences between the surgeries to know which procedure they had received; unclear whether other outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for
Selective reporting (reporting bias)	Low risk	All relevant outcomes appear to have been reported.
Other bias	Low risk	No other bias detected

Foote 2015.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: NR
Participants	Number of participants: 50 Country: Australia Setting: NR Type of UI: SUI Age: MiniArc: 49.6 years ± 11.8 years; Monarc: 46.2 years ± 11.3 years BMI: NR Parity: MiniArc: 2.1 ± 1.3; Monarc: 2.3 ± 1.4 Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: none (notes that to be eligible for the study, no other vaginal surgical procedures can be performed concurrently) Inclusion criteria: women with urodynamically‐proven genuine stress incontinence; no previous retropubic incontinence surgery; no allergy to polypropylene; no significant voiding difficulty; fit for surgery; no other vaginal surgical procedures being performed concurrently; able to complete the study questionnaires Exclusion criteria: NR
Interventions	Group I (n = 25): MiniArc Group II (n = 25): Monarc
Outcomes	Success: defined as a 1‐hour pad test weight ≤ 1 g History of any urinary symptoms VAS IIQ Short Questionnaire Bladder diary Short‐term outcomes (operative time, estimated blood loss, hours in hospital, 4‐hour VAS pain score with no postoperative parenteral analgesia)
Notes	Follow‐up time: 6 weeks and 6 months Conflicts of interest: "There are no conflicts of interest". Study funding source: NR
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation method NR
Allocation concealment (selection bias)	Unclear risk	Allocation concealment NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "This current series can be criticized as the follow‐up was performed by the operating surgeon". Comment: possible that this had some effect on outcome measurement
Incomplete outcome data (attrition bias) All outcomes	Low risk	Appears that all outcome data are reported
Selective reporting (reporting bias)	Low risk	Appears that all relevant outcomes are reported
Other bias	Low risk	No other bias detected

Friedman 2009.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: August 2006
Participants	Number of participants: 84 Country: Israel Setting: single centre Type of UI: SUI Age: NR BMI: NR Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR (1 abstract notes that concomitant mesh surgery for prolapse could also take place) Number receiving concomitant POP surgery: unclear (1 abstract notes that concomitant mesh surgery for prolapse could also take place) Inclusion criteria: women with SUI Exclusion criteria: NR
Interventions	Group I (n = 42): TVT‐S Group II (n = 42): TVT‐O
Outcomes	Bladder injury or abdominal bleeding Vaginal perforation Thigh, groin or vaginal pain Urinary obstruction or retention lasting > 72 h Tape removal Tape exposure Cure (not defined) De novo urgency NB: all outcomes derived from results, not methods
Notes	Follow‐up time: 12 months to 2 years Conflicts of interest: "Nothing to disclose" Study funding source: "Was this work supported by industry? No" Abstract only. Abstract notes that participants were similar at baseline in terms of age, parity, BMI and menstrual status but reports no other details. No participants were lost to follow‐up.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No description
Allocation concealment (selection bias)	Unclear risk	No description
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No description
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participant data included in analysis
Selective reporting (reporting bias)	Unclear risk	Insufficient information to assess
Other bias	Low risk	No other bias detected

Fu 2017.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: enroled patients requiring surgery between September 2014 and September 2015
Participants	Number of participants: 164 Country: China Setting: NR Type of UI: SUI Age: Needleless: 52.35 years ± 10.02 years; TOT: 52.43 years ± 10.86 years BMI: Needless: 26.04 ± 3.46; TOT: 25.85 ± 3.71 Parity (described as "Childbearing times"): Needless: 1.64 ± 0.64; TOT: 1.64 ± 0.72 Duration of SUI (described as "Course of disease/m"): Needleless: 24.82 ± 13.04; TOT: 26.81 ± 12.10 Menopause: NR Concomitant POP: none (noted that POP was an exclusion factor for the study) Number receiving concomitant POP surgery: none (noted that POP was an exclusion factor for the study) Inclusion criteria: people with simple SUI; aged from 35 years to 70 years; underwent urodynamic studies before operation Exclusion criteria: abdominal pressure < 60 cm H₂O, leak point pressure < 60 cm H₂O; patients with UUI, urethral sphincter injury (maximal urethral closure pressure < 20 cm H₂O) or POP. Women who had a history of UUI or POP operations, pelvic organ disease (e.g. uterine fibromyomata)
Interventions	Group I (n = 78): Needleless Group II (n = 86): transobturator mid‐urethral sling
Outcomes	Primary outcomes (perioperative) Operating time Intraoperative haemorrhage volume VAS pain scores 24 hours after operation Secondary outcomes Perioperative period assessment: residual urine volume; length of stay in hospital; incidence of urinary retention; recent onset of frequent urination; urinary urgency; "and so on" Postoperative cure: assessed using the PGI‐I, 1‐hour pad test and ICIQ‐SF scores Pain scores: assessed using VAS of groin and femoribus internus Symptoms of residual urine and frequent urination
Notes	Follow‐up: 24 hours, 6 months and 12 months postoperatively Conflicts of interest: none Study funding source: "This work is supported by SHDC12015911". Contact with study authors: we attempted to contact the study authors regarding whether the quality‐of‐life data presented were final scores or change scores but were unable to source a valid email address that did not result in bounce‐back emails.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random selection of opaque envelopes by laboratory assistant (nonclinical)
Allocation concealment (selection bias)	Low risk	Random selection of opaque envelopes by laboratory assistant (nonclinical)
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "In view of the specificity of surgical treatment, patients and their families were informed of surgical methods and related surgical risks before operation and signed the consent of the surgery; and the surgeon was informed of the surgical approach at the beginning of surgery". Comment: unclear whether participants were told of their assignment; surgeons blinded insofar as possible
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants appear to be accounted for.
Selective reporting (reporting bias)	Low risk	All stated outcomes reported
Other bias	Low risk	No other bias detected

Gaber 2016.

Study characteristics
Methods	Design: RCT Dates study conducted: August 2014 to July 2015
Participants	Number of participants: 209 Country: Egypt Setting: single centre Type of SUI: SUI Age: Needleless: 44.1 years ± 7.0 years; Endopelvic free anchorage (EFA): 42.7 years ± 5.4 years; TVT‐O: 44.3 years ± 8.5 years BMI: Needleless: 26.5 ± 2.5; EFA: 28.4 ± 2.7; TVT‐O: 25.7 ± 2.4 Parity: Needleless: 3 (3 to 4); EFA: 4 (3 to 4); TVT‐O: 3 (3 to 4) Duration of SUI: NR Menopause Premenopausal: C‐NDL: 47 (67.1%); EFA: 33 (47.8%); TVT‐O: 47 (67.1%) Postmenopausal: C‐NDL: 23 (32.9%); EFA: 36 (52.2%); TVT‐O: 23 (32.9%) Concomitant POP No prolapse: C‐NDL: 10 (14.3%); EFA: 11 (15.9%); TVT‐O: 11 (15.7%) Cystocoele: C‐NDL: 12 (17.1%); EFA: 14 (20.3%); TVT‐O: 19 (27.1%) Rectocoele: C‐NDL: 13 (18.6%); EFA: 11 (15.9%); TVT‐O: 11 (15.7%) Uterine prolapse: C‐NDL: 0; EFA: 0; TVT‐O: 1 (1.4%) Cystocoele: C‐NDL: 30 (42.9%); EFA: 29 (42.0%); TVT‐O: 24 (34.3%) Cystocoele plus uterine prolapse: C‐NDL: 0; EFA: 0; TVT‐O: 1 (1.4%) Cystocoele plus uterine prolapse: C‐NDL: 5 (7.1%); EFA: 4 (5.8%); TVT‐O: 3 (4.3%) Number receiving concomitant POP surgery: NR Inclusion criteria: women with proven urodynamic SUI as evidenced by involuntary leakage of urine on increased intra‐abdominal pressure without evidence of detrusor contraction Exclusion criteria: patients with MUI or OAB (were offered standard management outside the trial context); women with a history of previous failed anti‐incontinence procedures; patients with neurological diseases
Interventions	Group I (n = 70): Needleless Group II (n = 69): EFA Group III (n = 70): Monarc (TVT‐O)
Outcomes	Patient‐reported success: assessed using the PGI‐I and defined as "very much improved" or "much improved" Satisfaction: defined as an improvement of at least 8 points on the ICIQ‐UI‐SF Objective success: defined as a negative standing CST result with a comfortably full bladder Perioperative complications
Notes	Follow‐up time: 3 days, 7 days, 3 months, 6 months, 12 months Conflicts of interest: "The authors declare that they have no conflict of interest". Study funding source: NR Analysis conducted on an ITT basis In EFA group, 70 were randomised, but 1 participant did not show and was not analysed, according to the study flow diagram.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was performed with the use of a computer‐generated randomisation list and stratified by the study director.
Allocation concealment (selection bias)	Low risk	The allocation sequence was concealed from all investigations until the interventions were assigned sequentially by a trial nurse on the morning of the surgery.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The surgeons were not aware of the preoperative data of the patients. The protocol had a double blind design; that is, patients and data assessors were blinded to treatment assigned up to the 12‐month follow‐up visit". Comment: participants stated to be blind; seems that the surgeons were blinded insofar as possible
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Participants and data assessors were blinded to treatment assignment up to the 12‐month follow‐up visit.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All data appear reported
Selective reporting (reporting bias)	Low risk	All outcomes appear reported
Other bias	Low risk	No other bias detected

Grigoriadis 2013.

Study characteristics
Methods	Design: quasi‐RCT Dates study conducted: November 2008 to December 2011
Participants	Number of participants: 171 Country: Greece Setting: single centre Type of UI: SUI Age: Ajust: 67.2 years (49 years to 82 years); TVT‐O: 65.2 years (47 years to 81 years) BMI: Ajust: 28.5 ± 5.4; TVT‐O: 27.8 ± 6.3 Parity: Ajust: 2.2; TVT‐O: 2.4 Duration of SUI: NR Postmenopausal: Ajust: 81 (94.2%); TVT‐O: 80 (94.1%) Concomitant POP: NR (noted in the exclusion criteria that women with grade ≥ 1 prolapse that required surgery were excluded) Number receiving surgery for concomitant POP: none (noted in the exclusion criteria that women with grade ≥ 1 prolapse that required surgery were excluded) Inclusion criteria: women with a confirmed diagnosis of urodynamic SUI willing to participate in the study; BMI < 30 Exclusion criteria: women with preoperative MUCP of < 20 cm H₂O, urodynamic findings of DO, history of previous surgery on anterior vaginal wall, cystocele stage > I according to the ICS Classification that may require additional surgery
Interventions	Group I (n = 86): Ajust Group II (n = 85): TVT‐O
Outcomes	Objective cure: defined as an absence of SUI during the CST with the bladder filled with 400 mL of normal saline, or up to cystometric capacity Improvement in UI: defined as having fewer episodes of UI compared with before the operation, quantified using a bladder diary Failure: defined as the persistence of UI Subjective cure: no loss of urine with exercise, coughing or weightlifting, recorded according to the participant's impression Mean operative time Incidence of intraoperative and postoperative complications Duration of hospital stay
Notes	Follow‐up: 6 weeks and then every 12 months Mean follow‐up time: 22.3 months (range 12 to 36 months) Conflicts of interest: "None declared" Study funding source: "None declared"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Alternating basis with the use of a computer‐generated database
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "All operations were performed by the same experienced urogynecologist". Comment: would have been impossible for this individual to be unaware of the allocation, and it is unclear who performed the postoperative assessments; blinding of participants NR
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	All data appear reported
Selective reporting (reporting bias)	Low risk	All data appear reported
Other bias	Low risk	No other bias detected

Gul 2018.

Study characteristics
Methods	Design: RCT Dates study conducted: 2013 to 2017
Participants	Number of participants: 249 Country: Turkey Setting: NR Type of UI: SUI: Single‐incision sling: 104; TOT: 95 MUI: Single‐incision sling: 26; TOT: 24 Age: Single‐incision sling: 45.9 years ± 7.9 years; TOT: 46.2 years ± 6.1 years BMI: Single‐incision sling: 30.9 ± 3.15; TOT: 31.2 ± 4.13 Parity (median): Single‐incision sling: 3; TOT: 2 Duration of SUI: Single‐incision sling: 3.2 years ± 3.4 years; TOT: 3.5 years ± 4.7 years Menopause: NR Concomitant POP: NR Number receiving surgery for concomitant POP: NR Inclusion criteria: women with SUI Exclusion criteria: NR
Interventions	Group I (n = 130): Ophira (SIS) Group II (n = 119): TOT (Safyre)
Outcomes	Objective outcome: assessed using CST Subjective outcomes: assessed using ICIQ‐SF Pain levels (VAS) Complications Length of hospital stay Duration of surgery (minutes)
Notes	Follow‐up: 6 months and 12 months Conflicts of interest: NR Study funding source: NR Dropouts: NR Abstract only
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Mentions randomisation but not the method
Allocation concealment (selection bias)	Unclear risk	Not described in abstract
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "All surgical procedures were performed by a experienced surgeon in anti‐incontinence surgery between 2013‐2017". Comment: would have been impossible for this member of personnel not to be aware of the allocation, and unclear who is performing the postoperative outcome assessments; blinding of participants NR
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding not described in abstract
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participant data accounted for
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Hinoul 2011.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: April 2007 to January 2009
Participants	Number of participants: 195 Country: Belgium and the Netherlands Setting: multicentre Type of UI: SUI Age: TVT‐S: 52.3 years ± 11 years; TVT‐O: 53.2 years ± 12 years BMI: TVT‐S: 25.9 ± 3.7; TVT‐O: 28.1 ± 5.8 Parity (median and range): TVT‐S: 2 (0 to 5); TVT‐O: 2 (0 to 7) Duration of SUI: NR Menopause: NR Concomitant POP (using POP Quantification score) Ba: TVT‐S: −2.3 ± 0.8; TVT‐O: −2.2 ± 1.0 Bp: TVT‐S: −2.5 ± 0.7; TVT‐O: −2.3 ± 1.0 C: TVT‐S: −7.6 ± 1.5; TVT‐O: −6.7 ± 3.5 Number receiving surgery for concomitant POP: none (notes in the eligibility criteria that any concomitant surgery was an exclusion criterion) Inclusion criteria: patients with SUI during clinical or urodynamic examination or both Exclusion criteria: recurrent SUI; any concomitant surgery; stage ≥ 2 genital prolapse according to the ICS classification
Interventions	Group I (n = 97): TVT‐S Group II (n = 98): TVT‐O
Outcomes	Primary outcome Objective cure rate: at 12 months' follow‐up, measured with a standing CST with a bladder volume of 300 cm3 or > 70% maximal bladder capacity according to the participant's voiding diary (volume confirmed by bladder scan) Secondary outcomes Perioperative morbidity Pain scores: assessed using VAS (where 0 is no pain and 100 is unbearable pain), captured using a diary that was completed daily during the first week after surgery, then 2 weeks and 6 weeks after Validated assessment of activities of daily living: captured using a diary that was completed daily during the first week after surgery, then 2 weeks and 6 weeks after Subjective SUI: assessed by whether any SUI episodes had occurred in the past month Urgency or urge incontinence or both Disease‐specific QoL: measured using the Dutch version of the UDI (range 0 to 100) General QoL: assessed using SF‐36 Adverse events
Notes	Follow‐up time: 6 months and 12 months Conflicts of interest: Piet Hinoul, Jan den Boon, Alfredo L Milani: "Financial interest and/or other relationship with Ethicon"; Jan‐Paul WR Roovers: "Financial interest and/or other relationship with American Medical Systems" Study funding source: "Supported by a grant from Ethicon, Somerville, New Jersey" Dropouts: at 12 months, 47 participants withdrew: 34 TVT‐S (8 refused further participation, 1 had cardiovascular accident, 1 deceased from breast cancer, 10 could not be reached, 2 moved, 12 filled out questionnaire incorrectly), 13 TVT‐O (4 refused further participation, 1 had cardiovascular accident, 3 could not be reached, 5 did not attend clinical follow‐up)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were assigned to surgical treatment by balanced non‐restricted randomisation. Block randomisation was done at each participating centre using a computerised random‐number generator".
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Blinding of investigators and patients to group allocation was not possible since 1 procedure resulted in skin wounds while the other was exit free". Comment: explicitly states nonblinding of participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Blinding of investigators and patients to group allocation was not possible since 1 procedure resulted in skin wounds while the other was exit free". Comment: unclear if "investigators" refers to the outcome assessors or surgeons
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Significant loss to follow up of patients from the TVT Secur group"
Selective reporting (reporting bias)	Low risk	Primary outcomes are reported; some of the secondary outcomes are not.
Other bias	Low risk	No other bias detected

Hota 2012.

Study characteristics
Methods	Design: RCT Dates study conducted: May 2007 to April 2009
Participants	Number of participants: 86 Country: USA Setting: single centre Type of UI: SUI Preoperative urge present: TVT‐S: 30 (71.4%); TVT‐O: 25 (56.8%) Age (median, interquartile range): TVT‐S: 52.0 years (45.0 years to 62.0 years) TVT‐O: 50.5 years (45.5 years to 60.0 years) BMI (median, interquartile range): TVT‐S: 29.7 (25.2 to 32.4); TVT‐O: 29.3 (24.9 to 33.7) Parity 0: TVT‐S: 5 (11.9%); TVT‐O: 2 (4.6%) 1: TVT‐S: 10 (23.8%); TVT‐O: 6 (13.6%) ≥ 2: TVT‐S: 27 (64.3%); TVT‐O: 36 (81.8%) Duration of SUI: NR Menopause Premenopausal: TVT‐S: 18 (42.9%); TVT‐O: 20 (45.5%) Perimenopausal: TVT‐S: 4 (9.5%); TVT‐O: 8 (18.2%) Postmenopausal: TVT‐S: 20 (47.6%); TVT‐O: 16 (36.4%) Concomitant POP (preoperative stage) 0: TVT‐S: 3 (7.1%); TVT‐O: 4 (9.1%) 1: TVT‐S: 21 (50.0%); TVT‐O: 17 (38.6%) 2: TVT‐S: 9 (21.4%); TVT‐O: 16 (36.4%) 3: TVT‐S: 6 (14.3%); TVT‐O: 5 (11.4%) 4: TVT‐S: 1 (2.4%); TVT‐O: 0 (0.0%) Unknown: TVT‐S: 2 (4.8%); TVT‐O: 2 (4.6%) Number receiving concomitant POP surgery: TVT‐S: 20 (47.6%); TVT‐O: 22 (50.0%) (notes that the concomitant surgery performed could be for POP or faecal incontinence but did not describe procedures for each condition separately) Inclusion criteria: history of SUI with a demonstrable impact of SUI as seen on QoL questionnaires; positive CST result during urodynamic testing; women with prolapse not excluded but urodynamic testing performed using scopettes Exclusion criteria: ISD defined as a maximum urethral closure pressure of < 20 cm H2O; previous suburethral sling; predominant OAB symptoms; planning a pregnancy; elevated PVR (> 100 mL); bleeding condition or undergoing anticoagulant therapy; immunosuppression; progressive neurological disease; evidence of systemic infection
Interventions	Group I (n = 42): TVT‐S Group II (n = 44): TVT‐O
Outcomes	Primary outcome Objective failure: defined by the date of visit when the presence of SUI was noted on a CST. The CST was performed before and after surgery with 300 mL of instilled sterile saline or at maximum capacity, if it was < 300 mL Secondary outcomes PFDI‐20 PFIQ‐7 Postoperative pain PVR Mesh erosion or exposure Intraoperative estimated blood loss Length of procedure (minutes) Postoperative pain scale: assessed using a verbal analogue scale where 0 was no pain and 10 was the worst imaginable pain; rated on days 1 and 7 Need for sling revision Length of postoperative catheterisation Need for a second anti‐incontinence procedure
Notes	Follow‐up time: 12 weeks and 1 year Conflicts of interest: "The authors declare that they have nothing to disclose". Study funding source: "This work was conducted with support from Harvard Catalyst, The Harvard Clinical and Translational Science Center (National Institutes of Health Award no. UL1 RR 025758 and financial contributions from Harvard University and its affiliated academic health care centers). Financial support for this study was obtained from Ethicon Women’s Health & Urology, a division of Ethicon, Inc, a Johnson & Johnson Company, as an investigator‐initiated study". Power analysis recommended 67 participants in each arm, but study was stopped early because of "several investigators voicing concerns about an increasing number of positive post‐operative CST in women undergoing TVT‐S." The study is therefore underpowered, and this unplanned interim analysis represents a high risk of bias. Three women in each group were lost to follow‐up and did not present for either the 12‐week or 1‐year evaluation. One additional participant randomised to TVT‐S and two women randomised to TVT‐O provided some follow‐up data but did not have a CST. These participants were included in the ITT analysis.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Women were randomized in a 1:1 allocation".
Allocation concealment (selection bias)	Low risk	Sequentially numbered, opaque, sealed envelopes used; opened prior to surgery
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "The surgeon was not aware of the assigned procedure until the morning of surgery when the envelope was opened. Patients were not blinded to the procedure postoperatively as they were made aware of differences in the procedure preoperatively; specifically, the presence of skin incisions in the medial thigh with the TVT‐O and absence of them with the TVT‐S". Comment: participants not blinded postsurgery but personnel blinded insofar as possible
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	One woman in the TVT‐S group was excluded before the procedure was performed, as she did not meet the inclusion criteria. No other dropouts were reported.
Selective reporting (reporting bias)	Low risk	All stated outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Jurakova 2016.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: January 2012 to December 2013
Participants	Number of participants: 93 Country: Czech Republic Setting: single centre Type of UI: SUI Age: TOT: 64.3 years ± 10.6 years; SIS: 62.3 years ± 10.3 years BMI: TOT: 29.4 ± 6.2; SIS: 28.5 ± 6.5 Parity: TOT: 2.4 ± 1.1; SIS: 2.3 ± 1.4 Duration of SUI: NR Menopause: NR Concomitant POP: NR (notes in the eligibility criteria that women with POP‐Q stage ≥ 2 were excluded from the study) Number receiving concomitant POP surgery: NR Inclusion criteria: pure urodynamic SUI confirmed with cystometry by positive CST result with urinary bladder filling of 250 mL in the lithotomy position Exclusion criteria: urgency or predominant UUI, ISD (MUCP < 20 cm H₂O), POP (POP‐Q > 2), previous SUI or POP surgery, presence of other pathological pelvic organ conditions
Interventions	Group I (n = 48): TOT Group II (n = 45): Ophira (SIS)
Outcomes	Time of surgery Blood loss Groin pain: assessed with VAS at 3 hours and 12 hours after surgery; range from 0 (no pain) to 10 (worst possible pain) Objective cure: assessed as a negative standardised CST result Subjective cure: assessed using PGI‐I on a 7‐point satisfaction scale (1 to 7). Success was determined if the participant answered 1 ('very much better'), 2 ('much better') or 3 ('a little better'). Postoperative de novo urgency occurrence: measured using the PPIUS; range from 0 (no urgency) to 4 (urge incontinence) Major intraoperative and postoperative complications: measured using the joint ICS/IUGA classification; distinguished between tape prominence or exposure, rectum or bowel perforation, skin or musculoskeletal damage, heavy bleeding including haematoma or systemic compromise QoL: measured using ICIQ‐SF; range from 0 (no reduction in QoL) to 21
Notes	Follow‐up time: 1 year, 4 years and 5 years Conflicts of interest: "The authors declare no personal interests, financial or non‐financial, relating to this research and its publication. This is not the industry‐sponsored research, all authors have maintained ethical and transparent publication practices". Study funding source: "This scientific work was supported by the Czech Republic Ministry of Health projects FNBr 65269705 and IGA NT11124". Loss to follow‐up: TOT group 1 year: 2 did not come for scheduled visit; SIS group 1 year: 1 did not come for scheduled visit
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomised by envelope technique at the time of surgery".
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "All TOT operations were performed by one seasoned surgeon with the experience of more than 100 previous surgeries. All SIS surgeries were performed by another specialist with practice of more than 100 previous MUS [mid‐urethral sling] surgeries, including at least 30 SIS insertions. Every procedure was performed under general anesthesia". Comment: possible that by using general anaesthetic in all procedures the participants would have remained blinded. Two surgeons performed the procedures, who would have been impossible to blind, and it was unclear who was performing the postoperative assessments.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Follow‐up visits 1 year after surgery performed by an independent clinician included evaluation of objective cure confirmed by negative standardized CST". Comment: participants also likely blinded, which may mean low risk of detection bias
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for
Selective reporting (reporting bias)	Low risk	All specified outcomes reported
Other bias	Low risk	No other bias detected

Kim 2010.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: NR
Participants	Number of participants: 40 Setting: NR Country: South Korea Type of UI: SUI Age (median): TVT‐S: 49.6 years (35.0 years to 74.2 years) TOT: 50.7 years (41.4 years to 63.0 years) BMI: NR Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: women with SUI Exclusion criteria: patients with any neurologic diseases that affect the voiding pattern
Interventions	Group I (n = 20): TVT‐S Group II (n = 20): TOT
Outcomes	Voiding patterns Urodynamic findings Domains of KHQ Operative complications Subjective cure: method of assessment not defined Note: details of assessment NR in abstract
Notes	Follow‐up time: 6 months Conflicts of interest: NR Study funding source: "Specify source of funding or grant: No" Abstract only. Minimal details on randomisation and methodology to allow judgement of the reliability of outcomes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not described
Selective reporting (reporting bias)	Low risk	Protocol is not available, but all relevant outcomes seem to be reported.
Other bias	Low risk	No other bias detected

Lee 2012.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: May 2009 to December 2011
Participants	Number of participants: 235 Country: Australia Setting: multicentre Type of UI: SUI Age: MiniArc (n = 112): 52.2 years ± 10.0 years; Monarc (n = 113): 51.0 years ± 9.4 years BMI: MiniArc (n = 112): 27.4 ± 5.8; Monarc (n = 113): 27.6 ± 5.5 Parity: MiniArc (n = 112): 2 (2 to 3); Monarc (n = 113): 2 (2 to 3) Duration of SUI: NR Menopause: MiniArc (n = 112): 50 (44.6%); Monarc (n = 113): 49 (43.4%) Concomitant POP: MiniArc (n = 112): 44 (39.3%); Monarc (n = 113): 54 (47.8%) Number receiving concomitant POP surgery: Vaginal hysterectomy with or without anterior and posterior vaginal repair: MiniArc (n = 112): 23 (20.5%); Monarc (n =113): 35 (31.0%) Anterior mesh or abdominal sacrocolpopexy: MiniArc (n = 112): 5 (4.5%); Monarc (n = 113): 4 (3.5%) Posterior only with or without mesh: MiniArc (n = 112): 16 (14.3%); Monarc (n = 113): 15 (13.3%) Inclusion criteria: women referred to tertiary urogynaecological centres who had SUI or USI; women who had previous SUI surgery could be included Exclusion criteria: ISD (MUCP of ≤ 20 cm H2O with the bladder empty or a pressure rise from baseline or both required to cause urinary leakage of ≤ 60 cm H2O); previous mid‐urethral sling; untreated DO; significant voiding dysfunction (defined as maximum flow rate < 15 mL/s or < 10% Liverpool nomogram or PVR > 100 mL or both)
Interventions	Group I (n = 117): MiniArc Group II (n = 118): Monarc
Outcomes	Primary outcome Objective cure: defined as a negative CST result at follow‐up at 12 months Secondary outcomes Subjective cure: defined as an absence of patient‐reported SUI at follow‐up Urodynamic studies Perineal ultrasound scan: performed at 6 months to 12 months after surgery to evaluate tape dynamics and bladder neck descent Mesh compression: assessed by computing the mesh gap at rest (marker 4) and Valsalva (marker 1) Operative outcomes: only collected on women who underwent sling only and included operative time, estimated blood loss, and analgesia usage in first 24 hours Notes that standardised forms and tools (e.g. ICIQ‐UI‐SF, ICIQ‐OAB, PISQ‐12, IIQ‐7, PGI‐I and 24‐hour pad weigh) were used to measure outcomes
Notes	Follow‐up time: 6 weeks, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months Conflicts of interest: "This investigator‐led randomized controlled trial received an external research grant from American Medical Systems, Minnetonka, MN (J.K.‐S.L.,A.R.,P.L.D., and Y.N.L.). The other author reports no conflict of interest". Study funding source: "This investigator‐led randomized controlled trial received an external research grant from American Medical Systems, Minnetonka, MN (J.K.‐S.L., A.R., P.L.D., and Y.N.L.)." "Protocol development was independent of American Medical Systems. American Medical Systems did not have access nor did they ask for access to our data, to which we hold exclusive rights. Data analysis was done exclusively by the authors. No editorial request was made from American Medical Systems regarding this manuscript submission". Fourteen women excluded postrandomisation (three did not meet criteria, 10 withdrew from surgery, one unfit) Some women did not receive the allocated intervention as randomised; the baseline characteristics are therefore based on the number of women who received their allocated intervention (noted in brackets in 'Population'). Contact with study authors: we contacted the study authors on 14 November 2022 to confirm in which group the case of mesh exposure described in the study occurred.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Computer‐generated random allocation was concealed and stratified to centre".
Allocation concealment (selection bias)	Unclear risk	Method not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Surgeons or patients were not blinded once allocation was revealed". Comment: specifically states that blinding was not performed
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Postoperative assessments were mostly undertaken by independent assessors (usually fellows or registrars in a separate clinic), although they were not blinded to the treatment allocation". Comment: given that the personnel and participants were also not blinded, represents high risk of detection bias
Incomplete outcome data (attrition bias) All outcomes	Low risk	All randomly‐assigned participants completed follow‐up.
Selective reporting (reporting bias)	Low risk	Protocol is not available, but all relevant outcomes seem to be reported.
Other bias	Low risk	No other bias detected

Lee 2015.

Study characteristics
Methods	Design: RCT Dates study conducted: NR
Participants	Number of participants: 187 Country: South Korea Setting: NR Type of UI: SUI Age: NR BMI: NR Parity: NR Menopause: NR Duration of SUI: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: women with SUI Exclusion criteria: NR
Interventions	Group I (n = 87 at 12‐month follow‐up): MiniArc Group II (n = 71 at 12‐month follow‐up): TVT
Outcomes	Objective cure: defined as a negative CST result Subjective cure: absence of self‐reported SUI symptoms
Notes	Follow‐up: 12 months Conflicts of interest: NR Study funding source: "Funding: None" Loss to follow‐up: 158 of 187 randomised participated in 12‐month follow‐up. Reasons for dropping out were not provided. Abstract only
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Randomized" Comment: the method of randomisation was unclear.
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient information to assess
Selective reporting (reporting bias)	Unclear risk	Insufficient information to assess
Other bias	Low risk	No other bias detected

Leitch 2017.

Study characteristics
Methods	Design: RCT Dates study conducted: April 2017 to April 2019 (anticipated enrolment dates)
Participants	Number of participants randomised: target 176 Country: Australia Setting: single centre Number of participants randomised: target 176 Type of UI: SUI Age: NR BMI: NR Parity: NR Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: 18 years to 80 years old; USI; failed conservative management; placed on the surgical waiting list Exclusion criteria: SUI associated with ISD; untreated DO; significant voiding dysfunction; congenital lower urinary tract anomaly; neurogenic bladder disorders; previous radiation therapy to pelvis; past history of any form of fistula involving the vagina; allergy to polypropylene or local anaesthetic
Interventions	Group I (n = NR): Altis Group II (n = NR): TVT
Outcomes	Primary outcomes Subjective cure rate: positive answer to leaks when coughing or sneezing, when physically active or exercising, on the ICIQ‐UI Objective cure rate: defined as a negative CST results Secondary outcomes Immediate and short‐term postoperative complications: including UTI based on self‐report of participants, haematoma based on participant symptoms, clinical examination and ultrasound findings Improvement in QoL: using PGI‐I Subjective outcomes of OAB: assessed using validated symptom questionnaires (ICIQ‐UI‐SF and ICIQ‐OAB) Impact on QoL: assessed using IIQ‐7 Length of hospital stay: based on a review of medical records Postoperative pain: assessed using VAS scoring Postoperative voiding dysfunction: based on review of medical records
Notes	Follow‐up times: 6 weeks, then 6, 12 and 24 months Conflicts of interest: NR Study funding source: Coloplast Corp Trial registration. The last update of this record was 29 January 2019, where the trial was withdrawn as the intervention was removed from the market.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised with equal probability to Altis mini‐sling or TVT retropubic sling using a central computer‐generated random allocation
Allocation concealment (selection bias)	Low risk	"Prior to surgery, the surgeon will call the central number for allocation of the type of sling. A urogynaecology nurse consultant holds the randomisation codes and will notify surgeon of allocation."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Blinded (masking used). Who is/are masked/blinded? The people receiving the treatment/s. The people assessing the outcomes." Comment: participants blinded. It is unlikely that the personnel would be blinded, but outcome assessment was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	People assessing the outcomes and analysing the results/data will be blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient information to assess
Selective reporting (reporting bias)	Unclear risk	Insufficient information to assess
Other bias	High risk	The last update of this trial registration was 29 January 2019, where the trial was withdrawn, as the intervention was removed from the market.

Mackintosh 2010.

Study characteristics
Methods	Design: prospective, pilot RCT Dates study conducted: October 2009 to April 2010
Participants	Number of participants: 29 Country: United Kingdom Setting: single centre Type of UI: SUI: Ajust: 12; TVT‐O: 11 MUI: Ajust: 1; TVT‐O: 3 No urgency: Ajust: 1; TVT‐O: 2 Mild urgency: Ajust: 3; TVT‐O: 5 Moderate urgency: Ajust: 6; TVT‐O: 6 Severe urgency: Ajust: 4; TVT‐O: 2 Age: Ajust: 50.6 years ± 12.6 years; TVT‐O: 47.7 years ± 7.5 years BMI (median, IQR): Ajust: 27 (23.5 to 31.3); TVT‐O: 27.0 (24.0 to 31.0) Parity (Median, IQR): Ajust: 2.00 (1.8 to 2.0); TVT‐O: 2.0 (1.0 to 3.0) Menopause: NR Duration of SUI: NR Concomitant POP: NR Number receiving concomitant POP surgery: none (noted in the eligibility criteria that women requiring concomitant surgery at the time of the suburethral tape were excluded) Inclusion criteria: SUI or MUI with predominant SUI; women undergoing primary incontinence surgery; BMI < 35; previously failed or declined PFMT Exclusion criteria: MUI with predominant OAB or neurological condition (e.g. MS); unwilling to be randomised; inability to understand English; concomitant surgery at the time of suburethral tape procedure; patients requiring postoperative hospital stay for medical or social reasons
Interventions	Group I (n = 14): Ajust Group II (n = 15): TVT‐O
Outcomes	Operative time: defined as the time between the start of cleaning the participant to the removal of the drapes, recorded by the research assistant; anaesthetic induction time and time entering theatre were taken from the theatre database Analgesic details: prospectively requested from the attending anaesthetist or participant notes or both Pain scores for those receiving Ajust under local anaesthetic: assessed using a 10‐point Likert scale and taken at the end of dissection and insertion of applicators Blood loss: estimated at the end of the procedure and categorised as either < 50 mL, 50 mL to 100 mL or > 100 mL by the attending surgeon Operative complications Postoperative pain scores: taken at 30 minutes and 3 hours postoperatively, as well as at discharge from hospital; assessed using 10‐point Likert scale Postoperative voiding assessment: taken within 3 hours of the procedure. Participants were asked to double void (voiding twice with a 10‐minute interval between voids), then voiding volume was measured and PVR assessed by a bladder scan. "Satisfactory voiding" was defined as voided volume of ≥ 200 and a PVR of ≤ 100 mL, achieved within 24 hours of surgery without catheterisation. Time to decision at discharge: recorded when participants had achieved satisfactory voiding and provided they were not in excessive pain Postoperative hospital stay: calculated as being between procedure finish and time to decision to discharge Groin pain: assessed with 10‐point Likert scale at 4 days and 4 weeks Leg stiffness/pain: assessed using 10‐point Likert scale at 4 days and 4 weeks Satisfaction with procedure: assessed using 10‐point Likert scale at 4 days and 4 weeks. Participants were specifically instructed to not include any improvements in urinary symptoms into this rating but instead to consider their pain, anxiety during the operation and how their recovery had been up to that point regarding time spent in hospital, return to normal activities. They were also asked whether they would recommend the procedure they had to a friend or relative and why, as well as how many days it took to return to work (if applicable) and normal activities (not including strenuous exercise and lifting), as well as being given a chance to comment on any aspect of their experience to that point. ICIQ‐SF, UPS and PGI‐I: assessed at 3 months Objective cure: assessed at 3 months through a CST followed by free uroflowmetry PVR: assessed at 3 months using a bladder scan Tape erosion: performed at 3 months through a vaginal examination
Notes	Follow‐up time: 4 days and 4 weeks, 3 months Conflicts of interest: NR Study funding source: "This research is not funded by a pharmaceutical company or commercial organisation". This report was submitted as a thesis for fulfilment of a bachelor of medicine degree and was primarily a feasibility study, but it reported on efficacy and complication rates as secondary outcome measures and is therefore included.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated sequence used
Allocation concealment (selection bias)	Low risk	Allocation sequence kept electronically and concealed in opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "It was not feasible to blind patients for a number of reasons". Comment: participants not blinded. Blinding of personnel was NR, but the "surgeon was not involved in any intra, postoperative assessment of the 3 month follow‐up unless clinically indicated".
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "While blinding of assessors would have been preferable this would have required extra staff that were not available." Comment: surgeon not involved in outcome assessment and thesis describes numerous steps to reduce bias in the outcome assessment, including the use of strict scripts for assessing during interviews with participants. However, there may have been some bias present.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data available for all participants at 4‐week follow‐up; 2 participants unavailable for 3‐month follow‐up in TVT‐O arm
Selective reporting (reporting bias)	Low risk	All expected outcomes seem to be reported.
Other bias	Low risk	No other bias detected

Martoccia 2020.

Study characteristics
Methods	Design: RCT Dates study conducted: December 2015 to January 2018
Participants	Number of participants: 78 Country: Italy Setting: NR Type of UI: SUI Age: NR (notes that participants were homogenous in terms of age) BMI: NR (notes that the participants were homogenous in terms of BMI) Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: pure SUI and normotonic urethra Exclusion criteria: UUI; neurogenic bladder; previous surgery for incontinence; mental or neurological disorders
Interventions	Group I (n = NR): SIS Group II (n = NR): TVT‐O
Outcomes	Sexual function: assessed with FSFI QoL: assessed with ICIQ
Notes	Follow‐up time: 3 months to 12 months Conflicts of interest: NR Study funding sources: NR Abstract only. Note: 78 randomised but not clear how many initially randomised to each group. Notes that 36 in TVT‐O group and 36 in SIS group completed follow‐up; 6 were lost to follow‐up but not clear from which groups
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomized" Comment: unclear method of randomisation
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR; unlikely that personnel would have been blinded to the intervention given the nature of the study; NR whether participants were blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	High risk	72/78 participants completed the follow‐up; unclear whether there was differential dropout, but overall attition rate low. However, only 42/72 appear to have been analysed for FSFI.
Selective reporting (reporting bias)	Unclear risk	Abstract form only, so insufficient information to judge
Other bias	Unclear risk	Abstract only (insufficient information to judge)

Masata 2012.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: November 2007 to November 2009
Participants	Number of participants: 197 Country: Czech Republic Setting: single centre Type of UI: SUI MUI: TVT‐S H: 29 (42.6%); TVT‐S U: 27 (41.5%); TVT‐O: 29 (42.6%) Urgency: TVT‐S H: 31 (48.4%); TVT‐S U: 32 (49.2%); TVT‐O: 41 (60.3%) Age: TVT‐S H: 55.2 years ± 10.2 years; TVT‐S U: 57.7 years ± 10.1 years; TVT‐O: 56.6 years ± 9.7 years BMI: TVT‐S H: 26.2 ± 4.2; TVT‐S U: 27.6 ± 4.8; TVT‐O: 27.0 ± 4.5 Parity: TVT‐S H: 2.1 ± 0.9; TVT‐S U: 2.0 ± 0.7; TVT‐O: 1.8 ± 0.9 Duration of SUI: NR Menopause: NR Concomitant POP: NR (noted that POP stage ≥ II according to the ICS Pelvic Organ Prolapse Quantification system and those with planned concomitant surgery were excluded in eligibility criteria) Number receiving concomitant POP surgery: none (noted in the eligibility criteria that women requiring concomitant surgery were excluded) Inclusion criteria: aged over 18 years; signed informed consent; urodynamic SUI; agreement with postoperative follow‐up Exclusion criteria: predominant urge incontinence; urodynamic detrusor instability; immobile urethra; previously failed anti‐incontinence surgery; previous radiotherapy; PVR volume > 100 mL; bladder capacity < 300 mL; POP stage ≥ II according to the ICS Pelvic Organ Prolapse Quantification system; planned concomitant surgery; aged < 18 years
Interventions	Group I (n = 68): TVT‐O Group II (n = 64): TVT‐S (H‐type) Group III (n = 65): TVT‐S (U‐type)
Outcomes	Surgical evaluation: including operative time (defined as time from incision to last suture), intraoperative blood loss (estimated based on vacuum aspiration) and perioperative complications (bladder perforation and vascular injury) Early postoperative complications: including haematoma, spontaneous voiding recovery, UTI) Late postoperative complications: procedure failure, tape erosion and voiding difficulty Overall satisfaction with surgical procedure: assessed using a VAS scale of 0 to 100 and a 5‐item Likert scale ranging from 5 (cured) to 1 (significantly worsened and not satisfied) Objective cure: defined as a negative CST result when the urinary bladder was filled to 300 mL with saline solution and the test performed in both supine and standing positions Subjective cure: defined as no stress leakage of urine based on the ICIQ‐UI if the participant ticked "Never"/"Urine does not leak" for question 6 ("When does urine leak?" ). Leakage was registered if the participant ticked "Leaks when you are physically active/exercising" or "Leaks when you cough or sneeze". Urgency incontinence: defined as present if the participant ticked "Leaks before you go to the toilet" Failure of surgery: defined as when objective and subjective failure were present, or on offer of reoperation Transperineal ultrasound
Notes	Follow‐up time: 1 day, 2 weeks, 3 months, 1 year, 2 years, 3 years, 5 years Conflicts of interest: "Jaromir Masata, Kamil Svabik, Karel Zvara, Petra Drahoradova, Rachid El Haddad, and Petr Hubka have no conflicts of interest to declare. Alois Martan is a perceptor of Gynecare and Bard". Study funding source: "This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic, grant NS 10586‐3/2009"; "This work was supported by Charles University in Prague (UNCE 204024)" (ultrasound paper). Unplanned interim analysis performed at 2 years; high failure rate in TVT‐S group, which calls into question the risk of bias due to unblinding of outcome assessors. After this interim analysis at 2 years, the study was only stopped at 3 years once "the minimum number of patients needed for final statistical analysis was achieved".
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “randomization allocation in sealed envelopes which were arranged for sequential opening”
Allocation concealment (selection bias)	Low risk	Quote: “We implemented randomization by placing pieces of paper containing the randomization allocation in sealed envelopes which were arranged for sequential opening”. Comment: these were opened shortly before the procedure.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "The patients were not blinded". Comment: NR whether the personnel were blind, although blinding of personnel is unlikely
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Unplanned interim analysis, but adequate numbers recruited according to power calculation
Selective reporting (reporting bias)	Low risk	All expected outcomes seem to be reported.
Other bias	Low risk	No other bias detected

Masata 2016.

Study characteristics
Methods	Design: RCT Dates study conducted: May 2010 to May 2012
Participants	Number of participants: 100 Country: Czech Republic Setting: single centre Type of UI: SUI MUI: Ajust: 22 (44%); TVT‐O: 23 (46%) Urgency: Ajust: 27 (54%); TVT‐O: 31 (62%) Age: Ajust: 55.8 years ± 10.2 years; TVT‐O: 58.9 years ± 12.4 years BMI: Ajust: 27.3 ± 4.8; TVT‐O: 27.9 ± 4.4 Parity: Ajust: 2.0 ± 0.9; TVT‐O: 2 ± 0.6 Duration of SUI: NR Menopause: NR Concomitant POP: NR (noted that POP stage ≥ 3 according to the ICS Pelvic Organ Prolapse Quantification system were excluded) Number receiving concomitant POP surgery: none (noted in the eligibility criteria that women requiring concomitant surgery were excluded) Inclusion criteria: women aged ≥ 18 years, provision of signed informed consent, presence of urodynamic SUI Exclusion criteria: predominant urge incontinence, urodynamic DO, previous failed anti‐incontinence surgery, previous radiotherapy, PVR > 100 mL, bladder capacity < 300 mL, POP stage ≥ III (according to ICS Pelvic Organ Prolapse Quantification system), planned concomitant surgery, aged < 18 years
Interventions	Group I (n = 50): Ajust (U approach) Group II (n = 50): TVT‐O
Outcomes	Primary outcomes Objective cure: defined as the proportion of participants with a negative CST result with the urinary bladder filled to 300 mL with saline solution, and the test performed in the supine and standing positions Subjective cure: defined as no stress leakage of urine after surgery based on response to question 6 on ICIQ‐UI‐SF being "Never/Urine does not leak". Stress urinary leakage was recorded if the response to this question was "Leaks when you are physically active/exercising" or "Leaks when you cough or sneeze". Urgency incontinence was recorded if the response to this question was "Leaks before you get to the toilet". Failure of surgery was defined as both subjective and objective failure. Secondary outcomes Postoperative pain profile: assessed using a 100‐point VAS QoL: assessed using the ICIQ‐UI‐SF (scores from 0 to 21) and I‐QOL Overall satisfaction with procedure: assessing with a 100‐point VAS and the 5‐item Likert scale (5 = cured, very satisfied; 4 = improved, satisfied; 3 = no change from preoperative status; 2 = worsened, not satisfied; 1 = significantly worse, not satisfied)
Notes	Follow‐up times: 1 day, 2 days, 3 days, 4 days and 7 days postoperatively, then 2 weeks to 3 weeks and 2 years and 5 years postoperatively (Ajust group: 451.8 d ± 127.6 d; TVT‐O group: 445 d ± 157.6 d) Conflicts of interest: "Jaromir Masata: None. Kamil Svabik: consultant for Astellas. Karel Zvara: None. Petr Hubka: None. Alois Martan: perceptor of Medicare, consultant for Astellas" Study funding source: "This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic (grant NT 14162‐3/2013)". Loss to follow‐up: Ajust: 1 lost to follow‐up (missing participant died owing to undiagnosed pancreatic cancer); TVT‐O: 3 lost to follow‐up (1 refused to continue in study; 1 developed cerebral palsy 3 months after surgery and refused further follow‐up; 1 died due to chronic internal disease unrelated to surgery) ITT analysis performed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Pieces of paper showing the randomization allocation prepared by an external statistician and marked from 1 to 100 were placed in sealed envelopes which were put in a box and opened sequentially from the first one (marked 1)".
Allocation concealment (selection bias)	Low risk	Quote: "Pieces of paper showing the randomization allocation prepared by an external statistician and marked from 1 to 100 were placed in sealed envelopes which were put in a box and opened sequentially from the first one (marked 1)".
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "The envelope was opened shortly before the procedure. The patients were not blinded". Comment: participants not blinded but personnel perhaps blinded insofar as possible up to the point of procedure
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants are clearly accounted for.
Selective reporting (reporting bias)	Low risk	All stated outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Maslow 2014.

Study characteristics
Methods	Design: RCT Dates study conducted: NR
Participants	Number of participants: 106 Country: Canada Setting: multicentre Type of UI: SUI Urgency symptoms: TVT‐S (n = 55): 29 (52.7%); TVT‐O: 28 (56.0%) UUI: TVT‐S: 19 (33.9%); TVT‐O: 18 (36.0%) Age: TVT‐O: 48.7 years ± 8.3 years; TVT‐S: 48.75 years ± 9.3 years BMI: TVT‐O: 27.6 ± 4.2; TVT‐S: 29.3 ± 4.9 Parity Gravida: TVT‐S: 3.2 ± 1.54; TVT‐O: 2.9 ± 1.42 Para: TVT‐S: 2.4 ± 1.08; TVT‐O: 2.3 ± 1.15 Duration of SUI: NR Postmenopausal: TVT‐O: 16 (32.7%); TVT‐S: 21 (37.5%) Prolapse (stage ≥ I): TVT‐O (N = 49): 8 (16.3%); TVT‐S: 2 (3.6%) Number receiving concomitant POP surgery: none (noted in the eligibility criteria that women requiring prolapse surgery were excluded) Inclusion criteria: symptoms of SUI and a positive cough test result that required surgical management Exclusion criteria: women with predominant symptoms of urgency; presence of prolapse stage > 1 or prolapse requiring surgery; DO on cystometrogram at urodynamic testing; previous surgery for incontinence; ISD (MUCP < 20 cm H2O or Q‐tip < 30°); voiding dysfunction with PVR > 100 cc
Interventions	Group I (n = 56): TVT‐S ("Hammock" technique) Group II (n = 50): TVT‐O
Outcomes	Primary outcome Objective cure: assessed using the CST at 1 year postoperatively Secondary outcomes Subjective cure: defined as the absence of symptoms of SUI 1 year from surgery by asking the participant "do you leak urine with straining, cough, sneeze, laugh?" QoL scores: "from the questionnaires" Pain scores: assessed using VAS Complication rates
Notes	Follow‐up: 8 weeks and 1 year. Adverse events recorded intraoperatively and at 8 weeks and 1 year Conflicts of interest: "None" Study funding source: "Funding for the project was through the Department of Obstetrics and Gynecology at the University of Manitoba". Loss to follow‐up: TVT‐S: 2 lost to follow‐up at 1 year (1 discontinued because of intraoperative bladder injury, and 1 withdrew for personal reasons); TVT‐O: none lost to follow‐up at 1 year The study was stopped at 106 participants after an ad hoc interim analysis revealed the statistically significant inferiority of the TVT‐S for the primary outcome.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Block randomization was by a computer‐generated random number list prepared by an investigator with no clinical involvement in the trial".
Allocation concealment (selection bias)	Low risk	Quote: "The allocation sequence was concealed from the researchers enrolling and assessing participants in sequentially numbered, opaque sealed envelopes to either the TVT‐S or TVT‐O which were opened in the operating room at the time of surgery".
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Neither the patients nor the research nurse carrying out the 1‐year assessments was aware of which sling they were randomized to until after the final assessment was completed". Comment: participants were blinded, but whether personnel were blinded was not mentioned. Blinding of personnel is unlikely, but postoperative outcome assessment was blinded by research nurse.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Neither the patients nor the research nurse carrying out the 1‐year assessments was aware of which sling they were randomized to until after the final assessment was completed". Comment: outcome assessments likely to be blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	The flow of participants through the trial is adequately explained and accounted for.
Selective reporting (reporting bias)	Low risk	Study stopped as reached statistical significance for primary outcome but all outcomes reported
Other bias	Low risk	No other bias detected

Maturana 2019.

Study characteristics
Methods	Design: RCT (prospective) Dates study conducted: 2013 to 2015
Participants	Number of participants: 105 Country: Brazil Setting: multicentre Country: Brazil Type of UI: SUI Urgency symptoms: Single‐inicison sling: 26 (44.8%); TOT: 21 (44.7%) Age: Single‐inicison sling: 55.6 years ± 1.5 years; TOT: 55.7 years ± 1.8 years BMI: Single‐inicison sling: 28.4 ± 0.6; TOT: 28.9 ± 0.6 Parity: Single‐inicison sling: 4.3 ± 0.3; TOT: 4.6 ± 0.4 Duration of SUI: NR Postmenopausal: Single‐inicison sling: 37 (63.8%); TOT: 32 (68%) Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: aged > 18 years; absence of associated neurological diseases; clinical diagnosis of predominantly SUI; urodynamic study demonstrating SUI and absence of DO Exclusion criteria: absence of urodynamic changes that suggested SUI; findings suggestive of infravesical obstruction and DO; coagulopathies; pregnancy; history of foreign body sensitivity (i.e. polypropylene); acute cystitis; vulvovaginitis; previous surgery for treating SUI; history of treatment with pelvic radiotherapy
Interventions	Group I (n = 58): Single‐inicison sling – Ophira Group II (n = 47): TOT (either Unitape T Plus™ or Safyre T Plus™)
Outcomes	Subjective cure: assessed by clinical complaints Objective cure: assessed by simplified pad test Severity of urogenital symptoms: assessed with UDI‐6 (0 = no symptoms, 100 = maximum severity of urogenital symptoms) QoL: assessed using I‐QOL (0 to 100, higher scores = better QoL) Postoperative data: UTI, bladder perforation, tape exposure, retention ≤ 7 days, retention > 7 days, de novo urgency, dyspareunia (all only reported in results, not methods)
Notes	Follow‐up: immediately postoperatively, 7 days, 1 month, then 3 months, 6 months and 12 months postoperatively Conflict of interest: "The authors declare that they have no conflict of interest". Study funding source: "This study was not sponsored by the industry, and we declare that Promedon [manufacturer of single‐inicison sling] had no participation in the study design or analysis". Dropouts: Single‐inicison sling: 5 lost to follow‐up (4 participant‐led withdrawals, 1 cardiac death); TOT: 6 lost to follow‐up (all participant‐led withdrawals)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The patients were randomly divided into two groups by a simple randomization procedure using a random number generator computer program". Comment: adequate method of randomisation
Allocation concealment (selection bias)	Low risk	Quote: "Group assignment was concealed in consecutively numbered, sealed, opaque envelopes that were opened in the operating room just before the procedure". Comment: adequate method of allocation
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Group assignment was concealed in consecutively numbered, sealed, opaque envelopes that were opened in the operating room just before the procedure". Comment: personnel were probably blinded insofar as possible. Blinding of participants was NR.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described in paper
Incomplete outcome data (attrition bias) All outcomes	Low risk	11 participants did not complete. 1 died of heart failure; the other 10 withdrew because they thought they were cured. "Thus, these patients, who did not complete the study, were considered as therapeutic failure in the data analysis". Adequate explanations of losses to follow‐up
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes reported in paper
Other bias	Low risk	No evidence of other bias

Melendez‐Munoz 2018.

Study characteristics
Methods	Design: RCT Dates study conducted: women referred between February 2011 and January 2016 invited to participate
Participants	Number of participants: 246 Country: Australia Setting: multicentre Type of UI SUI: MiniArc: 89.0%; TVT‐Abbrevo: 91.8% DO: MiniArc: 5.0%; TVT‐Abbrevo: 5.5% Age: MiniArc: 50.1 years ± 10.1 years; TVT‐Abbrevo: 51.0 years ± 10.0 years BMI: MiniArc: 25.7 ± 5.0; TVT‐Abbrevo: 26.1 ± 5.0 Parity: MiniArc: 2.6 ± 1.0; TVT‐Abbrevo: 3.0 ± 0.9 Duration of SUI: NR Menopause: MiniArc: 32.3%; TVT‐Abbrevo: 27.7% Concomitant POP Concomitant POP: Miniarc: 51.9%; TVT‐Abbrevo: 53.6% POP‐Q (median, IQR) Ba: MiniArc: −1 (−2 to 0); TVT‐Abbrevo: −1 (−2 to 0) Bp: MiniArc: −1 (−2 to 0); TVT‐Abbrevo: 0 (−2 to 0) C: MiniArc: −6 (−7 to −4); TVT‐Abbrevo: −6 (−7 to −4) Number receiving concomitant POP surgery Vaginal hysterectomy ± vaginal repair: MiniArc: 40%; TVT‐Abbrevo: 41.5% Anterior mesh: MiniArc: 1.7%; TVT‐Abbrevo: 0.8% Posterior only ± mesh: MiniArc: 7.0%; TVT‐Abbrevo: 8.5% Inclusion criteria: women between 30 years and 80 years old; urinary stress incontinence; women who had objective confirmation by urodynamic assessment or pad test but had not responded to conservative treatment and were offered continence surgery Exclusion criteria: ISD (MUCP of ≤ 20 cm H2O or abdominal leak point pressure of ≤ 60 cm H2O or both); previous failed mid‐urethral tapes; untreated DO or significant voiding dysfunction (maximum flow rate < 15 mL/s or < 10% Liverpool nomogram or PVR > 100 mL or both); women with lower urinary tract anomaly (congenital); neurogenic bladder disorders; previous radiation therapy to pelvis; past history of any form of fistula involving the vagina or urethral surgery such as urethral diverticulum repair; allergy to polypropylene or local anaesthetic
Interventions	Group I (n = 121): MiniArc Group II (n = 125): TVT‐Abbrevo
Outcomes	Primary outcome Objective cure at 6 months: defined as a negative CST result with a comfortably full bladder and carried out similarly to previous studies Secondary outcomes Subjective cure: defined as no report of leakage with physical exertion on questions 3 and 5 of the ICIQ‐UI Failure rate Reoperation rate Changes in ICIQ‐UI‐SF, ICIQ‐OAB, IIQ‐7, PISQ‐12 and PGI‐I
Notes	Follow‐up: 6 weeks, 6 months and 12 months Conflicts of interest: NR Study funding source: NR Loss to follow‐up at 6 months: MiniArc: 6 lost to follow‐up, 1 withdrawn, 105 completed objective outcome, 82 completed subjective outcome; TVT‐Abbrevo: 8 lost to follow‐up, 1 withdrawn, 107 completed objective outcome, 86 completed subjective outcome Loss to follow‐up at 12 months: MiniArc: 1 lost to follow‐up, 5 withdrawals, 74 completed objective outcome, 90 completed subjective outcome; TVT‐Abbrevo: 1 lost to follow‐up, 2 withdrawals, 75 completed objective outcome, 93 completed subjective outcome
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated blocks of 4 to 8
Allocation concealment (selection bias)	Low risk	Concealed allocation
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Surgeons or patients were not blinded once allocation was revealed". Comment: unclear when the revelation of allocation was performed and how this might affect outcome assessment
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Surgeons or patients were not blinded once allocation was revealed". Comment: unclear when the revelation of allocation was performed and how this might affect outcome assessment, as blinding of outcome assessment was NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for as indicated in study flow diagram
Selective reporting (reporting bias)	Low risk	All expected outcomes reported
Other bias	Low risk	No other bias detected

Merali 2012.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: NR
Participants	Number of participants: 37 Country: Canada Setting: single centre Type of UI: SUI Age: NR BMI: NR Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: women with SUI Exclusion criteria: NR
Interventions	Group I (n = 18): MiniArc Group II (n = 19): Monarc
Outcomes	Negative or positive 1‐hour pad test result De novo urgency incontinence Note: taken from results in abstract, not methods
Notes	Follow‐up: 12 months Conflicts of interest: NR Study funding source: NR Abstract only
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	NR
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient information to assess
Selective reporting (reporting bias)	Unclear risk	Insufficient information to assess
Other bias	Unclear risk	Insufficient information to assess

Mostafa 2012.

Study characteristics
Methods	Design: prospective randomised study Dates study conducted: invited women to participate between October 2009 and October 2010
Participants	Number of participants: 137 Country: UK Setting: multicentre Type of UI SUI: Single‐incision sling Ajust: 63 (91.3%); TVT‐O: 56 (82.4%) MUI: Ajust: 6 (8.7%); TVT‐O: 12 (17.6%) No preoperative urgency: SAjust: 24 (34.8%); TVT‐O: 19 (27.9%) Mild preoperative urgency: Ajust: 12 (17.4%); TVT‐O: 21 (30.9%) Moderate preoperative urgency: Ajust: 24 (34.8%); TVT‐O: 18 (26.5%) Severe preoperative urgency: Ajust: 9 (13%); TVT‐O: 10 (14.7%) Age: Ajust: 52.6 years ± 11.2 years; TVT‐O: 49.4 years ± 8.8 years BMI (median, interquartile range): Ajust: 27 (24 to 30.3); TVT‐O: 28 (25.25 to 30) Parity: Ajust: 2.14 ± 1.004; TVT‐O: 2.25 ± 1.189 Duration of SUI: NR Menopause: NR Concomitant POP: NR (notes that women with POP‐Q stage ≥ 2 were excluded from the study in the eligibility criteria) Number receiving concomitant POP surgery: none (noted in the eligiblity criteria that women requiring concomitant surgery were excluded) Inclusion criteria: urodynamic SUI or mixed incontinence with predominant bothersome SUI; failed or declined PFMT; undergoing a primary continence procedure; ability to understand the information leaflet; BMI < 35 Exclusion criteria: women with POP (POP‐Q stage ≥ 2); previous continence surgery; concomitant surgery; previous pelvic irradiation; neurological conditions (e.g. MS); MUI with uncontrolled OAB symptoms; inability to understand English; unwilling to be randomised; patients requiring postoperative hospital stay for medical or social reasons
Interventions	Group I (n = 69): Single‐incision sling ‐ Ajust Group II (n = 68): TVT‐O
Outcomes	Primary outcome Postoperative pain profile: assessed with a 10‐point VAS at 30 minutes, 3 hours, 4 days and 4 weeks; intraoperative pain also assessed for women in the local anaesthetic group at the end of vaginal dissection and end of the second trocar insertion Secondary outcomes Perioperative morbidity Hospital stay Time to return to normal activities or work or both Patient‐reported success rate: assessed as an answer of "very much improved" or "much impoved" on the PGI‐I Objective success rate: defined as negative CST result with comfortably full bladder Impact on urinary symptoms: assessed using ICIQ‐FLUTS QoL: assessed with KHQ Sexual function: assessed with PISQ‐12 Health economic outcomes (e.g. cost per quality‐adjusted life‐year)
Notes	Follow‐up: 4 days, 4 weeks, 3 months, 4 months and 12 months (plus additional time points for pain scores) Conflicts of interest: "Dr. Abdel‐fattah is a consultant for Bard, AMS, Pfizer and Astellas. Dr. Guerrero is a preceptor for Ajust‐Bard. All authors received travel grants from different pharmaceutical companies to attend medical conferences". Study funding source: "This study (Single‐incision sling RCT) was funded by a Henry Smith Charity".
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was stratified by center using number‐allocation software ensuring an equal number of women in each group within each center".
Allocation concealment (selection bias)	Low risk	Quote: "allocation to each group was performed via central telephone randomisation".
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Blinding of women was not possible as only the Ajust procedure (study arm) was done under LA. Furthermore, performing sham groin incisions for SIMS Ajust group was deemed unacceptable, firstly as it will interfere with primary outcome (postoperative pain) assessment and secondly on ethical basis". Quote: "The follow‐up, however, was performed by an independent researcher who was blinded to the type of procedure performed. Women were reminded not to discuss their type of procedure/anaesthesia with the follow‐up clinician at any stage". Comment: participants not blinded; unclear if surgeons were blinded as NR. Outcome assessors were blinded, but participants were aware of their assignment.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "The follow‐up, however, was performed by an independent researcher who was blinded to the type of procedure performed. Women were reminded not to discuss their type of procedure/anaesthesia with the follow‐up clinician at any stage". Comment: although participants were told not to tell outcome assessors about their allocation, their knowledge may have influenced outcomes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	131/137 attended 1‐year follow‐up; flow diagram presents reasons for dropouts.
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Oliveira 2011.

Study characteristics
Methods	Design: RCT Dates study conducted: enroled between January 2008 and September 2009
Participants	Number of participants: 90 Country: Portugal Setting: single centre Type of UI: SUI Age: TVT‐O: 52.0 years ± 11.7 years; TVT‐S: 52.7 years ± 10.9 years; MiniArc: 52.6 years ± 11.8 years BMI: TVT‐O: 27.2 ± 5.3; TVT‐S: 26.3 ± 6.6; MiniArc: 29.8 ± 5.4 Parity: TVT‐O: 1.5 ± 1.1; TVT‐S: 1.8 ± 2; MiniArc: 2.1 ± 2.2 Duration of SUI (years of onset): TVT‐O: 10.8 ± 8.5; TVT‐S: 8.4 ± 5.9; MiniArc: 8.0 ± 6.1 Menopause: NR Concomitant POP: NR (does state in the eligibility criteria that women with genital prolapse of stage ≥ 2 on POP‐Q were excluded) Number receiving concomitant POP surgery: NR Inclusion criteria: clinically‐ and urodynamically‐proven SUI associated with urethral hypermobility; without previous treatment Exclusion criteria: previous surgery for SUI; genital prolapse stage ≥ 2 (by POP‐Q score); complaints of urgency, frequency, nocturia or demonstrable DO
Interventions	Group I (n = 30): TVT‐O Group II (n = 30): TVT‐S Group III (n = 30): MiniArc
Outcomes	Cure: defined as the participant not reporting any episodes of urinary leakage, ceasing to wear any incontinence protection and having a negative CST result Improvement: defined as a maintenance of SUI or positive CST result but with the number of incontinence protections used decreasing by > 50% and answering the question "Are you satisfied with the result of the surgery?" in the affirmative Failure: any other case not meeting the criteria for cure or improvement Lower urinary tract symptoms: patient‐reported urine leakage, pain and complications Patient satisfaction: assessed using KHQ FSFI: Portuguese translation, measured at 24 months
Notes	Follow‐up time: 24 hours, 1 month, 6 months, 12 months and 24 months Conflicts of interest: "I certify that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/ affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None." Study funding source: "None" No participants were lost to follow‐up.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participant outcome data assessed adequately
Selective reporting (reporting bias)	Unclear risk	Insufficient information to assess
Other bias	Low risk	No other bias detected

Ow 2019.

Study characteristics
Methods	Design: RCT Dates study conducted: enrolment: April 2016 to January 2022; date of last data collection: January 2024
Participants	Number of participants: 112 Country: Australia Setting: multicentre Type of UI: SUI associated with ISD Age: total average 66 years BMI: total average 27 Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR (Surgery for POP could be performed at the same time.) Number of women receiving concomitant POP surgery: unclear (exact numbers NR but notes "If they needed a concomitant prolapse operation, they had this done") Inclusion criteria: women aged between 18 years and 80 years; USI associated with ISD; capable of providing informed consent; able to return for follow‐up Exclusion criteria: untreated DO; significant voiding dysfunction; lower urinary tract anomaly (congenital); neurogenic bladder disorders; previous radiation therapy to the pelvis; past history of any form of fistula involving the vagina; allergy to polypropylene or local anaesthetic
Interventions	Group I (n = 54): mini‐sling Group II (n = 58): retropubic sling
Outcomes	Primary outcome Objective cure rate: assessed as a negative clinical CST result Secondary outcomes Immediate and short‐term postoperative complications Subjective outcomes: assessed using validated questionnaires QoL: assessed using questionnaire and global assessment rating scale
Notes	Follow‐up: intraoperative 6 weeks, 6 months, 2 years Conflicts of interest: "Disclosure: No" Study funding source: NR Dropouts: NR Abstract only Contact with study authors: we contacted the study authors on 9 November 2022 to request a full copy of one of the associated abstracts, including information provided in a table.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "They were randomized with equal probability to minisling or retropubic sling". Comment: states randomised but method not clear
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR; unlikely that personnel would have been blinded to the intervention given the nature of the study; NR whether participants were blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR; combination of objective and subjective outcomes
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	"112 women have been randomized and completed 6 month follow up. 54 women were randomized to SIS and 58 women to RP sling. Results were analyzed by at [sic] ITT analysis." However, follow‐up of 2 years took place for repeat surgery; dropouts and losses to follow‐up up to 24 months were NR.
Selective reporting (reporting bias)	Unclear risk	No trial registration reported; unclear whether selective reporting is present
Other bias	Unclear risk	Abstract only; not enough information to judge

Pascom 2018.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: August 2008 to December 2011
Participants	Number of participants: 130 Country: Brazil Setting: single centre Type of UI: SUI Number with associated urgency: Ophira (n = 64): 23 (35.9%); transobturator (n = 56): 20 (35.7%) Age: Ophira (n = 64): 54.2 years ± 9.6 years; transobturator (n = 56): 51.9 years ± 10 years BMI: Ophira (n = 64): 27.2 ± 4.7; transobturator (n = 56): 28.5 ± 4.7 Parity: Ophira (n = 64): 3.4 ± 2; transobturator (n = 56): 3.4 ± 1.7 Duration of SUI: NR Postmenopausal status: Ophira: 52 (75.4%); transobturator (n = 61): 37 (60.7%) Concomitant POP: NR (noted in the eligibility criteria that women with concomitant POP stage > 1 were excluded) Number undergoing concomitant POP surgery: NR Inclusion criteria: older than 18 years; SUI confirmed by a positive CST result, presence of urinary leakage > 2 g measured by a standardised pad test with 250‐mL bladder volume; USI Exclusion criteria: concomitant POP stage > 1; DO; PVR volume > 100 mL; coagulation disorders; current UTI; sequelae of previous radiation therapy of the pelvis; anticoagulant therapy; acute vulvovaginitis; anaesthesia contraindication
Interventions	Group I (n = 69): Ophira mini‐sling Group II (n = 61): unitape outside‐in TOT
Outcomes	Primary outcomes Objective cure rate: defined with a 1‐hour pad test < 2 g and a negative stress test result Subjective cure: defined using a simple question asking the women how they felt about their incontinence after the treatment, with the answer options of 'satisfied' and 'dissatisfied'. In this study, women who said they were satisfied did not want further treatment for SUI, while ones who answered dissatisfied required additional treatment Secondary outcomes QoL: assessed using I‐QOL (scale of 0 to 100, where 100 represents the best QoL) Symptom severity scores: assessed using UDI‐6 (determines degree of bother from symptom, ranging from 0, not at all, to 18, greatly) Rate of complications and reoperation De novo urgency: defined as the postoperative development of urgency symptoms not present before surgery and persisting for > 1 month
Notes	Follow‐up time: 6 months Conflicts of interest: "CM has received honoraria from advisory board meetings and speaking engagements from Promedon". Study funding source: "None"; "This is not an industry‐sponsored trial. Promedon had no role in the design or analysis of this study and only donated the devices for scientific and academic purposes".
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation method not described; unequal ratio of randomisation with no reason stated
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Group assignment was concealed in consecutively numbered, sealed, opaque envelopes that were opened in the operating room just before the procedure." Comment: assignment to groups blinded to personnel until procedure; participant blinding NR
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	All outcome data described for all participants
Selective reporting (reporting bias)	Low risk	Protocol is not available, but all relevant outcomes seem to be reported.
Other bias	Low risk	No other bias detected

Pastore 2016.

Study characteristics
Methods	Design: RCT Dates study conducted: December 2013 to January 2015
Participants	Number of participants: 48 Country: Italy Setting: single centre Type of UI: pure SUI and normotonic urethra Age (mean, range): SIS: 50.2 years (31 years to 68 years); TVT‐O: 49.8 years (33 years to 67 years) BMI (mean, SD): SIS: 28.2 ± 3.05; TVT‐O: 29.8 ± 2.30 Parity (mean, range): SIS: 2 (0 to 4); TVT‐O: 2 (1 to 4) Duration of SUI: NR Menopause: SIS: 11 (52.3%); TVT‐O: 12 (57.1%) Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: pure SUI; normotonic urethra (maximum closure pressure at rest of > 20 cm of water in the urethral profilometry using an external fluid‐filled catheter); negative urine culture results; ultrasound absence of PVR and upper urinary tract dilation; "only sexually active patients were enrolled in the study" Exclusion criteria: urge incontinence, neurogenic bladder, previous incontinence surgery, severe mental or neurological disorders, refusal to consent
Interventions	Group I (n = 24): SIS Group II (n = 24): TOT
Outcomes	Sexual function: assessed with the FSFI. The FSFI has a total of 19 questions under 6 domains, including sexual desire (score range 2 to 10), sexual arousal (range 0 to 20), lubrication (score 0 to 20), satisfaction (score 2 to 15), orgasm (score 0 to 15) and pain during intercourse (score 0 to 15). The total score was calculated by adding the sum of scores of all 6 domains. QoL: assessed using the ICIQ‐SF; maximum score for worst incontinence was 21, with a score of 0 indicating a completely continent participant.
Notes	Follow‐up: 3 months, 6 months and 12 months Conflicts of interest: "No competing financial interests exist." Study funding source: "No competing financial interests exist". 24 participants were originally randomised to each group; 3 participants in each group excluded because they were lost to follow‐up (21 participants in each group) Contact with study authors: we contacted the study authors on 14 November 2022 and on 1 December 2022 to confirm how many vaginal wall erosions over the tape occurred in each group but did not receive a response.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised computer table, controlled for baseline covariates
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "6 patients were lost to follow‐up and a total of 42 patients (21 in TVT‐O group and 21 in SIS group) completed the study protocol". Comment: losses to follow‐up balanced and explained for both groups
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Radwan 2020.

Study characteristics
Methods	Design: RCT Dates study conducted: August 2013 to March 2016
Participants	Number of participants: 40 Country: Egypt Setting: single centre Type of UI: SUI Age: Single‐incision sling: 42.7 years ± 8 years (range 28 years to 61 years); TOT: 43.2 years ± 10 years (range 28 years to 60 years) BMI: Single‐incision sling: 30.30 ± 5.805; TOT: 29.40 ± 6.311 Parity (vaginal deliveries): Single‐incision sling: 2 ± 1.6; TOT: 2 ± 1.4 Duration of SUI: NR Menopause: NR Concomitant POP: NR (notes in exclusion criteria that POP grade > 2 excluded) Number receiving concomitant POP surgery: NR Inclusion criteria: women with SUI Exclusion criteria: DO; any associated POP more than second degree; previous history of anti‐incontinence surgery; previous pelvic irradiation; previous history of pelvic tumours
Interventions	Group I (n = 20): Single‐incision sling – C‐NDL Group II (n = 20): TOT – Obtryx II
Outcomes	Postoperative pain: assessed by using a numeric rating scale (0 to 10) at first day postoperative, first week, and 1 month, 3 months, and 6 months after surgery Analgesic requirement Early return to daily activity Lower urinary tract symptoms: participants were asked about dysuria, urgency, deep pelvic pain, gynaecological problems (e.g. vaginal discharge, erosion, dyspareunia) followed by complete gynaecologic examination Success of surgery: defined as improvement of UI based on participant symptoms, cough test showing no leakage of urine and 24‐hour pad test
Notes	Follow‐up times: first day postoperative, first week, and 1 month, 3 months, and 6 months after surgery Conflicts of interest: "There are no conflicts of interest". Study funding sources: none Correspondence with authors: we contacted the study authors on 10 October 2022 to ask whether the study had been registered on a clinical trials registry, as we wanted to confirm whether the study was linked to the ongoing study PACTR201607001696163, which shares similar characteristics. A study author responded on 13 October 2022 to suggest that the trial had not been preregistered on a clinical trial platform but that another study author may have further details. We contacted the other study author to confirm on 17 October 2022 and followed up again on 1 November 2022 but did not receive a response.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomized into two equal groups with a 1: 1 ratio using sealed envelopes prepared by the department’s ethical committee" Comment: probably adequate because it was prepared by the ethical committee
Allocation concealment (selection bias)	Low risk	Quote: "randomized into two equal groups with a 1: 1 ratio using sealed envelopes prepared by the department’s ethical committee" Comment: probably adequate because it was prepared by the ethical committee
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR; unlikely that personnel would have been blinded to the intervention given the nature of the study; NR whether participants were blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	Study flow diagram states that there were no losses to follow‐up in either group.
Selective reporting (reporting bias)	Unclear risk	No reference to a protocol or trial registration
Other bias	Low risk	Nothing to suggest any other bias

Ross 2014.

Study characteristics
Methods	Design: RCT Dates study conducted: May 2008 to April 2012
Participants	Number of participants: 74 Country: Canada Setting: multicentre Type of UI: SUI UUI symptoms in past 7 days at baseline No, or yes but no problem or a small problem: TVT‐S: 32 (80%); TVT: 31 (91%) Yes, a big problem: TVT‐S: 7 (18%); TVT: 3 (9%) Unknown/yes, unknown how much problem: TVT‐S: 1 (3%); TVT: 0 (0%) Age: TVT‐S: 52.4 years ± 12.3 years; TVT: 47.2 years ± 10.8 years BMI (median, interquartile range): TVT‐S: 27.2 (7.1); TVT (n = 33): 27.8 (7.8) Parity (nulliparous): TVT‐S: 2 (5%); TVT: 2 (6%) Duration of SUI: NR Menopausal Postmenopausal: TVT‐S: 18 (45%); TVT: 11 (32%) Currently on HRT: TVT‐S: 11 (28%); TVT: 5 (15%) Concomitant POP: NR (Eligibility criteria state that women requiring concomitant POP surgery were excluded from the study.) Number receiving concomitant POP surgery: none (Eligibility criteria state that women requiring concomitant POP surgery were excluded from the study.) Inclusion criteria: women electing for SUI surgery if they leaked urine with increased abdominal pressure and were suitable for either type of surgery Exclusion criteria: previous incontinence surgery, required concurrent POP surgery, primary complaint of OAB or incontinence caused only by bladder overflow, intended to have more children, had Alzheimer's or Parkinson's disease, progressive neurological disease (e.g. MS), immunocompromised, unable to understand English, unavailable for follow‐up
Interventions	Group I (n = 40): TVT‐S Group II (n = 34): TVT
Outcomes	Primary outcome Objective cure: assessed using a standardised pad test at 12 months. The women had retrograde bladder filling with 300 mL of sterile water and wore preweighted pads while they undertook standard physical activities of the 1‐hour pad test. Cure was considered if the pad weight gain was < 1 g over the test period. Secondary outcomes Complications and adverse events: identified from hospital and routine 6‐week follow‐up charts. At 12 months, a physician carried out examination of operative wounds and digital vaginal examination to palpate for tape erosion. Women also asked to recall any problems they believed were due to surgery. Subjective cure: at 12 months, defined as either no experience of "lost or leaked urine when you coughed, laughed, sneezed, lifted, exercised, etc." or if urine loss has been "a small problem" or "no problem at all" over the past 7 days Incontinence‐related QoL: assessed using the UDI‐6 and IIQ‐7. Each ranges from 0 (no distress on UDI‐6 and no impact on IIQ‐7) to 100 (maximum distress or impact). Sexual function: at 12 months, women asked if they had returned to usual sexual activity. Sexual activity was measured using the PISQ‐12 (ranging from 0, indicating poor function, to 48, excellent function) Satisfaction with surgical outcome: women asked if outcome of surgery met expectations and if they recommend the surgery to someone else
Notes	Follow‐up time: 1 year postoperatively Conflicts of interest: "SR has accepted grant‐in‐aid funding from Johnson & Johnson Medical Companies. ST declares no competing interests. JS has accepted grant‐in‐aid funding from Johnson and Johnson Medical Companies, has completed research for Pfizer and Astellas, and has acted as a paid consultant for Gynecare, Pfizer, Triton, Astellas, and Bard. MM has in the past received payment for preceptoring for use of SIS mesh (Cook Surgical). JG has been a paid preceptor for Johnson and Johnson for teaching TVT Secur and Prolift, received honoraria for physcian CME presentations on Prolapse and stress incontinence by Johnson and Johnson and Cook, participated on Advisory Board at Canadian launch of TVT Secur by Johnson and Johnson, and been a preceptor for cadaver labs for Johnson and Johnson. SK declares no competing interests. LD declares no competing interests. MR has accepted grant‐in‐aid funding from Johnson & Johnson Medical Companies, and Cook Surgical, and acted as a consultant for Cook Surgical, has been a preceptor for Cook Surgical (SIS mesh) and Boston Scientific (Capio), is on a Scientific Advisory Committee for Cook Myosite, and receives funding from Cook Surgical for the University of Calgary Urogynecology Fellowship". Study funding source: "Grant‐in‐aid funding was provided by Johnson & Johnson Medical Companies, Markham, Canada.Johnson & Johnson did not contribute to development of the protocol, writing the manuscript or decision to submit for publication. Training in the use of TVT Secur was provided by Johnson & Johnson. Devices were purchased by individual institutions as part of usual care. Alberta Health Services (Calgary Zone and the Lois Hole Hospital) provided financial support for research nurses. Alberta Health Services played no part in the conduct of the research or in preparing the manuscript. Sue Ross receives salary support from the Women’s and Children’s Health Research Institute of the University of Alberta". Loss to follow‐up at 12 months: TVT‐S: 3 were lost to follow‐up, 4 did not do pad test, 2 did not have physician examination, and 37 responded to questionnaire. TVT: 3 were lost to follow‐up, 2 did not do pad test, 4 did not have physician examination, and 31 responded to questionnaire. TVT‐S group: 38 received procedure (2 in group underwent TOT). Study finished early because of concerns about TVT‐S and its withdrawal from the market
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The randomisation list was generated by the study analyst using permuted block randomisation with blocks of varying size (2 ‐ 6) and stratification by surgeon".
Allocation concealment (selection bias)	Unclear risk	Quote: "Neither the surgical team nor the patient knew the next treatment allocation. . . surgeons were unaware of group of allocation until day of surgery". Comment: method of allocation concealment is unclear
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Neither the surgical team nor the patient knew the next treatment allocation". Quote: "Site research nurses informed the data manager when a random allocation was needed and the patient allocation was notified a few days before surgery to ensure that the appropriate device was available in the operating room: surgeons were unaware of group of allocation until day of surgery. Neither site research nurses nor surgeons were blinded to group of allocation for operational reasons". Comment: participants appear to be blinded. Personnel were blinded insofar as possible up to the point of the procedure. However, site research nurses were not blinded, and it is implied that the same site research nurses may have undertaken the outcome assessments, although this is not explicit.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Neither site research nurses nor surgeons were blinded to group of allocation for operational reasons". Comment: site research nurses were not blinded, and it is implied that the same site research nurses may have undertaken the outcome assessments, although this is not explicit.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants can be accounted for and are adequately explained in the flow diagram.
Selective reporting (reporting bias)	Low risk	All specified outcomes appear to be reported.
Other bias	High risk	Study finished early owing to concerns about safety of TVT‐S and its withdrawal from the market, so study size significantly smaller than power calculation

Rudnicki 2017.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: May 2012 to April 2014
Participants	Number of participants: 307 (2 later declined to participate, totalling 305) Country: Denmark, Norway, Sweden Setting: multicentre Type of UI SUI: Ajust: 118 (76.1%); SMUS: 118 (78.7%) MUI: Ajust: 37 (23.9%); SMUS: 32 (21.3%) Age: Ajust: 44.9 years ± 6.9 years; SMUS: 46.1 years ± 7.2 years BMI: Ajust: 26.1 ± 4.6; SMUS: 26.6 ± 4.6 Parity (median, interquartile range): Ajust: 2.0 (3); SMUS: 2.0 (2) Duration of SUI: NR Menopause Postmenopausal: Ajust: 30 (20.4%); SMUS: 35 (24.8%) On HRT Systematic HRT: Ajust: 7 (20.6%); SMUS: 6 (16.2%) Vaginal HRT: Ajust: 10 (30.3%); SMUS: 15 (39.5%) Concomitant POP: NR (does state in the eligibility criteria that women with genital prolapse of stage ≥ 2 on POP‐Q were excluded) Number receiving concomitant POP surgery: NR Inclusion criteria: history of SUI or MUI (defined as complaint of involuntary leakage associated with urgency and stress incontinence); SUI had to be the dominant symptom (defined as more episodes of leakage due to coughing or physical exertion than to urgency); SUI confirmed by positive CST result, including 300 cm2 in the bladder; failed or declined PFMT Exclusion criteria: aged > 60 years; predominant urge incontinence; POP stage ≥ 2 on POP‐Q; previous incontinence or prolapse surgery; planned or present pregnancy; residual urine volume > 100 mL; previous pelvic irradiation; repeated UTI (≥ 4 during past year); neurological conditions (e.g. MS); current treatment with corticoids; inability to understand the protocol; history of abdominal or genital cancer or a pelvic mass
Interventions	Group I (n = 155): Ajust Group II (n = 150): SMUS (TVT = 88, TVT‐O = 13, Monarc (TOT) = 54)
Outcomes	Primary outcomes Objective cure: defined as a negative stress test result Subjective cure: defined as 0 incontinence episodes on the ICIQ‐UI‐SF Secondary outcomes QoL: assessed using PGI‐S Pain perception: assessed using VAS Complications: at 1‐year follow‐up
Notes	Follow‐up times: 0 to 6 days after surgery (pain only), 3 months and 12 months Conflicts of interest: "The authors have stated explicitly that there are no conflicts of interest in connection with this article". Study funding sources: "The Nordic Federation of Obstetrics and Gynecology Research Fund funded the study. Grant No. NF12013." Antibiotics study: a further paper published in 2020 reported on the randomisation of women to receive either antibiotics or no antibiotics; although a further report of the original study, its data were not deemed relevant to this review. Correspondence with authors: we contacted the study authors on 13 October 2022 and again on 31 October 2022 to ask whether it would be possible to obtain disaggregated data for the SMUS arm of the study (i.e. data reported by retropubic and obturator, not combined) but did not receive a response.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "All women were randomized in blocks of 25 corresponding to each center by a computer‐generated list in a ratio of 1:1 to either Ajust or the SMUS used by the specific department. Randomization was done using sealed non‐transparent envelopes. An independent statistician generated the random allocation sequence". Comment: adequate method of randomisation
Allocation concealment (selection bias)	Unclear risk	Quote: "An independent statistician generated the random allocation sequence". Comment: unclear method of allocation
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	141/155 in Ajust group and 139/150 in the SMUS group were analysed at 12 months, with no differential or large loss to follow‐up in either group.
Selective reporting (reporting bias)	Low risk	Trial registration available. All outcomes listed in the trial registration are reported in the full text, although change in PISQ‐12 is reported in the manuscript and not in the registration.
Other bias	Low risk	Nothing to suggest any other bias

Sabadell 2017.

Study characteristics
Methods	Design: RCT Dates study conducted: considered for participation between March 2013 and March 2015
Participants	Number of participants: 58 Country: Spain Setting: multicentre Type of UI: SUI Moderate: Ajust: 6 (20%); Align: 4 (14.3%) Severe: Ajust: 12 (40%); Align: 12 (42.9%) Very severe: Ajust: 12 (40%); Align: 12 (42.9%) Age (median, range): Ajust: 60.8 years (43.2 years to 73.7 years); Align: 59.1 years (45.9 years to 78.9 years) BMI (median, range): Ajust: 29.1 (22.6 to 44.0); Aign: 29.6 (18.9 to 40.9) Parity (vaginal deliveries, median, range): Ajust: 2 (1 to 6); Align: 2 (1 to 4) Duration of SUI: NR Menopause: Ajust: 25 (83.3%); Align: 20 (71.4%) Concomitant POP: Align: 7 (25.0%); Ajust: 7 (23.3%) Number receiving concomitant POP surgery Associated surgery: Ajust: 8 (26.7%); Align: 8 (28.6%) Vaginal hysterectomy + anterior repair: Ajust: 3; Align: 2 Manchester procedure: Ajust: 0; Align: 1 Anterior repair: Ajust: 1; Align: 3 Posterior repair: Ajust: 1; Align: 1 Anterior and posterior repair: Ajust: 1; Align: 1 Hysteroscopy: Ajust: 2; Align: 1 Inclusion criteria: planned surgical correction of SUI Exclusion criteria: previous continence surgery; presence of MUI with predominant urge incontinence; DO; ISD, defined as MUCP of ≤ 20 cm H2O; low mobile urethra, defined as a Q‐tip test angle of < 30°; neurogenic bladder; aged < 18 years
Interventions	Group I (n = 30): Ajust Group II (n = 28): Align
Outcomes	Patient satisfaction: assessed with the question "How satisfied are you with the result of surgery?" (Possible answers were completely satisfied, moderately satisfied, satisfied or dissatisfied.) Cure: defined as a negative CST result and being fully satisfied with the operation (no leaks, no voiding dysfunction and no use of urinary protection) Improvement: defined as a negative CST result and moderate satisfaction with the surgery because the participant still experienced urinary frequency or sporadic urgency episodes or both Failure: defined as a positive CST result or dissatisfaction with the surgery or both, including de novo urge incontinence or voiding dysfunction or both associated with frequent urinary infections and the use of the same urinary protection during daily activities as before surgery Sandvik questionnaire ICIQ‐SF De novo urgency: diagnosed by the bothersome presence of OAB symptoms not present before the procedure Elevated PVR volume: defined as a urine residual of > 100 mL
Notes	Follow‐up: 1 month, 6 months and 12 months Conflicts of interest: none Study funding source: "This work was supported by a grant from Palex Medical (Sant Cugat del Vallès, Barcelona, Spain) to cover exclusively the cost of the insurance of the study for civil liability. Palex Medical is the local distributor of Bard slings in Spain". Loss to follow‐up: no losses to follow‐up reported at 12 months Three of five centres withdrew because of difficulty recruiting. 27% of participants underwent concomitant POP surgery. Contact with study authors: we contacted the study authors on 18 November 2022 to request cure data disaggregated by subjective and objective measure.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Block randomisation by centre, centralised random‐number generator programme
Allocation concealment (selection bias)	Low risk	Sequentially‐numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "Women were assigned to a group by opening the sealed envelopes consecutively just before surgery". Quote: "Patients were not blinded to the procedure". Comment: participants not blinded but personnel appear to have been blinded insofar as possible.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants' data appear to be reported.
Selective reporting (reporting bias)	Low risk	All specified outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Saleh 2020.

Study characteristics
Methods	Design: RCT Dates study conducted: 2018 to September 2019
Participants	Number of participants: 40 Country: Egypt Setting: single centre Type of UI: SUI Age: mini‐sling: 44.35 years ± 6.9 years (range 31 years to 57 years); TOT: 45.9 years ± 9.29 years (range 28 years to 60 years) BMI: mini‐sling: 27.8 ± 4.84 (range 21 to 37); TOT: 28.1 ± 4 (range 21 to 37) Parity: mini‐sling: 3.2 ± 0.83 (median 3, range 2 to 5); TOT: 3.8 ± 0.95 (median 4, range 2 to 6) Duration of SUI: NR Menopause (answer of "yes"): mini‐sling: 5 (25%); TOT: 7 (35%) Concomitant POP: NR (notes in exclusion criteria that women with apical and anterior vaginal wall prolapse are excluded and all participants underwent vaginal examination to "exclude genitourinary fistula and any associated pelvic organ prolapse") Number receiving concomitant POP surgery: NR Inclusion criteria: women aged ≥ 18 years; SUI; failed or declined conservative treatment; USI Exclusion criteria: anterior wall or apical prolapse; previous incontinence surgery for stress incontinence; neurological conditions (e.g. multiple sclerosis, spinal cord injury; previous pelvic irradiation)
Interventions	Group I (n = 20): mini‐sling – C‐NDL Group II (n = 20): transobturator tension‐free tape – in‐out technique
Outcomes	CST: participants were asked to repeatedly cough with a bladder volume of ≥ 300 mL or a subjectively full bladder in the lithotomy position. "Small spurts" of urine lost immediately after coughing was indicative of SUI, with a large volume warranting further investigation. Urodynamics Free uroflowmetry Fluid filling cystometry with stress on VLPP Mid‐stream urine analysis and culture and sensitivity test if pyuria was present Postoperative pain, including groin and thigh pain: only reported in results, no further details Operative time: only reported in results, no further details Blood loss: only reported in results, no further details UTI or urinary retention: only reported in results, no further details Dyspareunia: only reported in results, no further detail
Notes	Follow‐up time: postoperative, 3 months, 6 months and 12 months Conflicts of interest: "The authors declare no conflict of interest". Study funding source: "The authors have no funding to report".
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Randomized by envelope technique" Comment: details about the sequence generation were lacking.
Allocation concealment (selection bias)	Unclear risk	It is not known whether the envelopes described in the random sequence generation domain were opaque and sealed.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR; unlikely that personnel would have been blinded to the intervention given the nature of the study; NR whether participants were blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "There were 2 missed cases in follow up in each arm of study". Comment: attrition was not differential, and there was a 10% dropout rate in both groups.
Selective reporting (reporting bias)	Unclear risk	No trial registration reported; unclear whether selective reporting is present
Other bias	Low risk	Nothing to suggest any other bias

Schellart 2014.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: enroled between December 2009 and December 2011
Participants	Number of participants: 193 Country: Belgium, France, Netherlands Setting: multicentre Type of UI: SUI Age: MiniArc: 53 years ± 11 years; Monarc: 53 years ± 11 years BMI: MiniArc: 26.0 ± 4.3; Monarc: 25.7 ± 3.7 Parity (median, interquartile range): MiniArc: 2 (2); Monarc: 2 (2 to 3) Duration of SUI: NR Postmenopausal: MiniArc: 26 (47%); Monarc: 20 (36%) Concomitant POP: NR (notes that women with ICS stage ≥ 2 were excluded from the study in the eligibility criteria) Number receiving concomitant POP surgery: NR Inclusion criteria: symptomatic SUI Exclusion criteria: POP stage ≥ 2 according to ICS classification; prior surgery for SUI; BMI > 35
Interventions	Group I (n = 97): MiniArc Group II (n = 96): Monarc
Outcomes	Primary outcomes Subjective cure: measured with the PGI‐I (7‐point system ranging from very much better to very much worse). Cure was defined as "very much improved" or "much improved". Postoperative pain: participants were asked to record in a diary the postoperative pain they experienced using a VAS ranging from 0 to 100 during the first 4 weeks after surgery. Pain scores were documented daily during the first week and at 2 weeks and 4 weeks after surgery. The use of pain medication was also noted; participants were advised to only use pain medication if necessary. Secondary outcomes Objective cure: defined as a negative CST result during physical examination; performed in the supine position with a bladder volume ≥ 250 mL (checked by a bladder scan) or > 70% of maximum bladder capacity according to the voiding diary Adverse events during surgery, admission and first 12 months of follow‐up Use of pain medication Reinterventions in the first year after surgery Presence and severity of stress or urge incontinence symptoms: assessed using the short version of the UDI‐6 (range 0 to 100) Severity of micturition symptoms: assessed with the PGI‐S Activities of daily living: assessed using a validated item set from the Academic Medical Center Linear Disability Score item bank, linearly transformed to scores between 0 (dead) and 100, with 1 representing the lowest and 100 representing the highest possible level of functional status
Notes	Follow‐up: 1 week, 2 weeks, 4 weeks, 12 months, 24 months and 36 months Conflicts of interest: "Rene P. Schellart certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: J.P.W.R. Roovers is a consultant and proctor for AMS. R.P. Schellart is a consultant and proctor for AMS and Astellas. D. de Ridder is a consultant and speaker for AMS. F. Van der Aa is a consultant and proctor for Medtronic, Ipsen, Bard, and AMS and a speaker for Astellas, Eli Lilly, GSK, Pfizer, and AMS. J.P. Lucot is a consultant and proctor for Olympus, Nordicpharma, Boston Scientific, and AMS. The other authors have nothing to disclose". Study funding source: "The trial was supported by an unrestricted research grant of American Medical Systems, Minneapolis, MN, USA". "The trial was supported by an unrestricted research grant from ASTORA™ Women’s Health". MiniArc group: 1 received Monarc; 1 did not undergo surgery after randomisation (95 received MiniArc). Loss to follow‐up at 36 months: MiniArc: 22 lost to follow‐up (10 participant‐led withdrawals, 12 "other reasons"); Monarc: 21 lost to follow‐up (11 participant‐led withdrawals, 1 physician‐led withdrawal, 9 "other reasons")
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was in a ratio of 1:1 stratified by centre and in blocks of either 4 or 6 carried out using a computerised random‐number generator.
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "In this study, neither patients nor assessors were blinded to the treatment". Comment: participants not blinded; NR whether personnel were blinded, although this is unlikely, and also states that the outcome assessors were unblinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "In this study, neither patients nor assessors were blinded to the treatment". Comment: neither participants nor outcome assessors were blind.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants appear accounted for.
Selective reporting (reporting bias)	Low risk	All specified outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Schweitzer 2015.

Study characteristics
Methods	Design: RCT Dates study conducted: April 2011 to August 2011
Participants	Number of participants: 156 Country: the Netherlands Setting: multicentre Type of UI: SUI Age: Ajust: 50.8 years ± 9.6 years; TVT‐O: 48.3 years ± 10.2 years BMI: NR Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR (notes that women with POP‐Q stage ≥ 2 were excluded from the study in the eligibility criteria) Number receiving concomitant POP surgery: NR Inclusion criteria: women aged between 35 years and 80 years; moderate to severe SUI, defined as a Sandvik score of ≥ 3; had not experienced relief after pelvic floor muscle physiotherapy treatment Exclusion criteria: history of anti‐incontinence surgery; PVR volume > 100 mL; genital prolapse of stage ≥ 2 according to POP‐Q; desire for future pregnancy
Interventions	Group I (n = 100): Ajust Group II (n = 56): TVT‐O
Outcomes	Primary outcome Postoperative pain: assessed by VAS at 1 and 2 hours after surgery and awakening from anaesthesia or vanishing of the anaesthesia effect, then daily for the first 3 days and then weekly up to 6 weeks postoperatively Secondary outcomes Objective cure: defined as negative CST result at bladder volume of at least 300 mL Subjective cure: defined as a negative response to the question "Do you experience urine leakage related to physical activity, coughing or sneezing?" on the UDI Subjective improvement: defined as an answer of "(very) much better" on the PGI‐I scale De novo UUI: defined as a positive answer to the question "Do you experience urine leakage related to a feeling of urgency?" on the UDI Bother scores: assessed using the UDI QoL: assessed using the IIQ Symptom severity: assessed using the PGI‐S scale Sexual function: assessed using a short form of the Prolapse and Incontinence Sexual Questionnaire
Notes	Follow‐up: 6 weeks, 6 months and 1 year postoperative Conflicts of interest: "Drs. Schweitzer, van Eijndhoven, Gietelink, and van der Vaart are consultants for Bard (tutor training surgical skills of gynecologist). The other authors did not report any potential conflicts of interest". Study funding source: "Bard Company offered an unrestricted research grant". Seven participants withdrew after randomisation (3 in Ajust and 4 in TVT‐O). Three originally assigned to Ajust received the TVT‐O intervention.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	2:1 design, central telephone randomisation
Allocation concealment (selection bias)	Low risk	Sequentially‐numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Women were blinded to the type of procedure by using a sham skin incision in the Ajust group". Comment: unclear when allocation was revealed for surgeons. However, an "independent research nurse or physician performed all trial assessments before surgery at 6 weeks and at 6 and 12 months after surgery", so it is unlikely assessment would have been affected.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "An independent research nurse or physician performed all trial assessments before surgery, at 6 weeks, and at 6 and 12 months after surgery".
Incomplete outcome data (attrition bias) All outcomes	Low risk	7 women withdrew after randomisation; 3 received the wrong type of sling after allocations and were excluded; and 3 were yet to receive intervention at the time of writing. No ITT analysis
Selective reporting (reporting bias)	Low risk	All specified outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Seo 2012.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: December 2008 to September 2009
Participants	Number of participants: 122 Country: South Korea Setting: NR Type of UI: SUI Mild: TVT‐S: 4 (6.5%); TVT‐O: 4 (6.7%) Moderate: TVT‐S: 34 (54.8%); TVT‐O: 34 (56.7%) Severe: TVT‐S: 24 (38.7%); TVT‐O: 22 (36.6%) Age: TVT‐S: 46.9 years ± 6.5 years; TVT‐O: 46.5 years ± 7.7 years BMI: TVT‐S: 23.8 ± 2.5; TVT‐O: 22.9 ± 2.5 Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: women with SUI Exclusion criteria: NR
Interventions	Group I (n = 62): TVT‐S Group II (n = 60): TVT‐O
Outcomes	Pain: assessed using a 10‐cm linear VAS at 6 hours postoperatively Surgical outcomes: assessed with Sandvik questionnaire Condition‐specific QoL: assessed using the I‐QOL Patient satisfaction: assessed using a 5‐point Likert scale Cure: defined as an absence of any episodes of involuntary urine leakage during stressful activities, no use of pads and a negative cough test result
Notes	Follow‐up: 6 hours, 3 months, 6 months, 12 months and 24 months Conflicts of interest: NR Study funding source: "Specify source of funding or grant: NONE" Abstract only Attempted contact with study authors: we could not find an email address for the authors on hospital websites and via ResearchGate to clarify how objective and subjective cure were defined, as well as to request raw data for both outcomes.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were randomly assigned". Comment: limited information from abstract
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Limited information available from abstract
Selective reporting (reporting bias)	Unclear risk	Limited information available
Other bias	Unclear risk	Limited information available

Sharifiaghdas 2015.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: enroled between January 2009 and December 2011
Participants	Number of participants: 70 Country: Iran Setting: NR Type of UI: SUI Age: Ophira: 55.6 years ± 9.8 years; pubovaginal sling: 52.2 years ± 9.3 years BMI: NR (average weight: Ophira: 71.7 kg ± 11.4 kg; pubovaginal sling: 72.4 kg ± 9.8 kg) Parity (normal vaginal delivery, min‐max): Ophira: 3 (0 to 6); pubovaginal sling: 4 (1 to 8) Duration of SUI: Ophira: 2.4 ± 1.5; pubovaginal sling: 2.8 ± 2.1 Menopause: NR Concomitant POP: NR (notes in eligibility criteria that women with cystocele stage ≥ 3 were excluded from the study) Number receiving concomitant POP surgery: NR Inclusion criteria: history of SUI; unresponsive to conservative managements; urethral hypermobility; positive CST result ≥ 300 mL bladder capacity Exclusion criteria: persistent UTI or active UTI at the time of surgery; evidence of urogynaecological malignancy; cystocele grade ≥ 3; history of neurogenic bladder; abnormal filling or voiding phase in the urodynamic study (low capacity, low compliance or DO of > 100 mL); abnormal cystourethroscopy findings (trabeculated bladder, open bladder neck or both)
Interventions	Group I (n = 35): Ophira Group II (n = 35): autologous rectal fascial sling (pubovaginal sling)
Outcomes	Objective measures: assessed with a CST with a full bladder Subjective measures: assessed using IIQ Satisfaction: assessed using a VAS of 0 to 10 and asking whether they would have the procedure repeated if their incontinence returned and whether they would recommend the procedure to a friend. A VAS of 8 to 10 and positive answers to the questions were defined as satisfaction. Complications Urine culture Ultrasound
Notes	Follow‐up: 1 week, then 1 month, 3 months, 6 months and 12 months postoperatively Conflicts of interest: NR Study funding source: NR Note on participant numbers: the abstract states that 100 women were randomised and 72 were analysed. However, Table 1 notes that the groups have 35 women each, totalling 70 women in the study. Unclear how many women were randomised and analysed Contact with study authors: we contacted the study authors on 14 November 2022 and on 1 December 2022 to clarify the issue surrounding randomisation and analysis, as described above, and also to clarify whether the urgency experienced by participants was new or existing but did not receive a response.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not enough information to assess in publication
Allocation concealment (selection bias)	Low risk	Quote: "Cards sealed in an envelope"
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participant data accounted for
Selective reporting (reporting bias)	Low risk	All specified outcomes reported
Other bias	Low risk	No other bias detected

Shawky 2015.

Study characteristics
Methods	Design: RCT Dates study conducted: May 2008 to April 2012
Participants	Number of participants: 58 Country: Egypt Setting: single centre Type of UI: SUI Age: NR BMI: NR Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: women with SUI Exclusion criteria: NR
Interventions	Group I (n = 30): TVT‐S Group II (n = 28): TVT‐O
Outcomes	Primary outcome SUI on CST Secondary outcomes QoL Symptom questionnaires PFIQ
Notes	Follow‐up: 12 weeks, 6 months, 1 year and 2 years Conflicts of interest: NR Study funding source: NR Poster only
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	NR
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient information to assess
Selective reporting (reporting bias)	Unclear risk	Insufficient information to assess
Other bias	Unclear risk	Insufficient information to assess

Sivaslioglu 2012.

Study characteristics
Methods	Design: single‐blind prospective RCT Dates study conducted: operations performed between September 2005 and September 2006
Participants	Number of participants: 80 Setting: single centre Country: Turkey Type of UI: SUI Age: TFS: 50 ± 9.8; TOT: 52 ± 11.7 BMI: TFS: 28.6 ± 2.3; TOT: 28.1 ± 1.4 Parity: TFS: 2.5 ± 1.1; TOT: 2.4 ± 1.6 Duration of SUI (years): TFS: 4.9 ± 0.2; TOT: 4.5 ± 2.4 Menopause: Postmenopausal: TFS (n = 39): 29 (74%); TOT (n = 38): 27 (71%) HRT: TFS (n = 39): 7 (18%); TOT (n = 38): 5 (13%) Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: patients with genuine SUI with a VLPP < 60 cm H2O; treated for SUI surgically for the first time; failed to respond to conservative management as physiotherapy or drugs Exclusion criteria: overflow incontinence; neurological lesions; OAB; transient causes of UI (e.g. UTI); pure urge incontinence; MUI; patients with previous surgery to correct UI
Interventions	Group I (n = 40): TFS (tissue fixation system) Group II (n = 40): TOT
Outcomes	Primary outcomes Objective cure: defined as a negative CST result in the supine position and the patient‐reported restoration of continence Subjective cure: defined as a positive CST result in the supine position but the patient‐reported restoration of continence Failure: defined as no change in incontinence postoperatively Secondary outcomes Procedure duration Postoperative groin pain Postoperative urinary retention Mesh extrusion
Notes	Follow‐up: 1, 3, 6 and 12 months, 3 years Conflicts of interest: "Does the presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry? No" Study funding source: "Was this work supported by industry? No" 4 participants from each group lost to follow‐up at 5 years. Not powered, as there were no published long‐term data on TOT/TFS at the time of starting the trial to perform a power analysis. Sample size chosen based on "expectations and practical considerations"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "participants were randomly allocated according to a computer program".
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: notes "single blind"; this is likely the outcome assessor, as the "postoperative assessment was performed by a senior surgeon at the urogynecology clinic who did not participate in the operations. The operating physician was not involved in the followup reviews". However, unclear whether the participants and personnel were blind insofar as possible
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Post‐operative assessment conducted by a senior surgeon at the urogynaecology clinic who did not participate in the operations. The operating physician was not involved in followup reviews".
Incomplete outcome data (attrition bias) All outcomes	Low risk	4 participants in each group lost to follow‐up because of moving away from the area
Selective reporting (reporting bias)	Low risk	All outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Smith 2017.

Study characteristics
Methods	Design: RCT Dates study conducted: offered participation between November 2008 and January 2011
Participants	Number of participants: 98 Country: USA Setting: single centre Type of UI: SUI Urgency: MiniArc: 29 (59%); Monarc: 28 (57%) Age: MiniArc: 52.9 years ± 11.2 years; Monarc: 48.9 years ± 9.4 years BMI: MiniArc: 28.4 ± 5.9; Monarc: 26.3 ± 4.7 Parity (median, range): MiniArc: 2 (0 to 4); Monarc: 2 (0 to 4) Duration of SUI: NR Menopause (postmenopausal): MiniArc: 26 (53%); Monarc: 18 (37%) Concomitant POP (overall preoperative POP stage, median and range): MiniArc: 3 (1 to 4); Monarc: 3 (1 to 4) Number receiving concomitant POP surgery Concomitant POP surgery: MiniArc: 29 (59%); Monarc: 34 (69%) Anterior colporrhaphy: MiniArc: 22 (45%); Monarc: 19 (39%) Inclusion criteria: women with SUI objectively confirmed by urodynamics Exclusion criteria: history of incontinence surgery; diagnosis of IDS or low‐pressure urethra made by urodynamic testing (VLPP < 60 cm H2O or MUCP < 40 cm H2O or both); MUI with predominance of DO
Interventions	Group I (n = 49): single incision (MiniArc) Group II (n = 49): transobturator (Monarc)
Outcomes	Primary outcome Presence of UI: assessed using standardised CST at 1 year. If the CST result was negative in the supine position, the test was repeated with the participant standing and with multiple coughs; any visible sign of leakage was considered to be a positive result. Secondary outcomes Intraoperative data Subjective complaint of recurrent or persistent SUI Subjective cure Validated questionnaire scores Perioperative and postoperative complications (e.g. voiding dysfunction, mesh exposure and need for repeat incontinence procedures) Postoperative urinary retention: assessed with a standard voiding trial protocol implemented at the study authors' institution that measures PVR volumes after spontaneous voiding using a bladder scanner for all participants on the day of discharge. If PVR volume was > 100 mL following 2 voids, the nurses were instructed to insert a Foley catheter and the participant was re‐evaluated after 72 hours.
Notes	Follow‐up: 12 weeks and 24 weeks, then yearly Conflicts of interest: none Study funding source: "Work supported by industry: No" Attempted contact with study authors: we attempted contact with the study authors on 14 November 2022 to clarify which questionnaire was used to measure QoL but received a bounce‐back email. We looked for an email address for the authors on hospital websites and via ResearchGate but could not find an email address for this purpose.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Allocation to treatment group was performed by a computer generated randomsation scheme".
Allocation concealment (selection bias)	Low risk	Quote: "Subject assignments were sequentially placed in sealed envelopes that were delivered to the operating room and opened by the surgeon after induction of anesthesia at the time of the standard 'Time Out' procedure".
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: notes "nonblinded" but "Subject assignments were sequentially placed in sealed envelopes that were delivered to the operating room and opened by the surgeon after induction of anesthesia at the time of the standard ‘Time Out’ procedure". As such, the personnel were blinded insofar as possible. It is unlikely that participants were blinded, but this was NR.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "nonblinded" Comment: unlikely that outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	7/49 lost to follow‐up in Monarc arm and 8/49 lost to follow‐up in MiniArc arm; dropouts balanced between groups
Selective reporting (reporting bias)	Low risk	No evidence of selection bias
Other bias	Low risk	No other bias detected

Sottner 2012.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: March 2010 to December 2011
Participants	Number of participants: 43 Setting: multicentre Country: Czech Republic Type of UI: SUI Age (unclear if mean or median): Ajust (n = 15): 68.27; MiniArc (n = 13): 76.26; TVT‐O (n = 12): 69.38 BMI (unclear if mean or median): Ajust: 28.5; MiniArc: 28.29; TVT‐O: 29 Parity (unclear if mean or median): Ajust: 1.8; MiniArc: 1.74; TVT‐O: 2.23 Duration of SUI: NR in English abstract Menopause: NR in English abstract Concomitant POP: NR in English abstract Number receiving concomitant POP surgery: NR in English abstract Inclusion criteria: "prevailing" SUI Exclusion criteria: NR in English abstract
Interventions	Group I (n = 18): MiniArc Group II (n = 13): Ajust Group III (n = 12): TVT‐O
Outcomes	QoL questionnaires Bleeding Bladder injury Postoperative pain De novo OAB Worsening of pre‐existing symptoms Tape exposure
Notes	Follow‐up: NR in English abstract Conflicts of interest: NR in English abstract Study funding source: "Grant of IGA Czech Ministry of Health NS/10453‐3." Czech article with abstract in English but no usable data in abstract Contact with study authors: we contacted the study authors on 14 November 2022 to clarify how many cases of de novo urgency occurred in each group and in which group the case of tape exposure occurred.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described in abstract
Allocation concealment (selection bias)	Unclear risk	Not described in abstract
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not described in abstract
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described in abstract
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not described in abstract
Selective reporting (reporting bias)	Unclear risk	Not enough information to assess from abstract
Other bias	Unclear risk	Not enough information to assess from abstract

Tang 2014.

Study characteristics
Methods	Design: RCT Dates study conducted: recruited between October 2008 to October 2010
Participants	Number of participants: 94 Country: China Setting: single centre Type of UI: SUI Age: TVT‐S (n = 39): 49.8 years ± 10.1 years; TVT‐O (n = 42): 51.3 years ± 7.5 years BMI: TVT‐S (n = 39): 25.2 ± 3.0; TVT‐O (n = 42): 24.7 ± 3.3 Parity: TVT‐S (n = 39): 1.4 ± 0.8; TVT‐O (n = 42): 1.2 ± 0.5 Duration of SUI: NR Menopause Postmenopausal status: TVT‐S (n = 39): 13 (33.3%); TVT‐O (n = 42): 20 (47.6%) Hormone therapy: TVT‐S (n = 39): 0; TVT‐O (n = 42): 0 Concomitant POP: NR (Notes that POP requiring more extensive surgery was an exclusion criterion for the study) Number receiving concomitant POP surgery: none ‐ notes in the eligibility criteria that any POP requiring more extensive surgery was an exclusion criterion Inclusion criteria: women with demonstrable SUI; had failed conservative therapy Exclusion criteria: pregnancy; UTI; urge incontinence; PVR volume > 100 mL; POP requiring more extensive surgical treatment; MUI; ISD; history of neurological disease, urogenital malignancy, fistula or pelvic radiotherapy
Interventions	Group I (n = 46): TVT‐S Group II (n = 48): TVT‐O
Outcomes	Cure: defined as a negative cough test result during follow‐up Improvement: defined as when the frequency of the involuntary passage of urine and the urine weight on a 1‐hour pad test decreased by > 50% Failure: defined as when the frequency of the involuntary passage of urine and the urine weight on 1‐hour pad test decreased by < 50% Chinese version of the IIQ‐7: lower score represents a better outcome PISQ‐12 (for sexually‐active women only): contains 12 items covering 3 domains, with a higher score indicating better sexual function
Notes	Follow‐up: 6 months, 12 months and 24 months Conflicts of interest: "None reported" Study funding source: "None" Loss to follow‐up at 6 months: TVT‐O: 1 lost to follow‐up; TVT‐S: 2 lost to follow‐up Loss to follow‐up at 12 months: TVT‐O: 4 lost to follow‐up; TVT‐S: 4 lost to follow‐up Loss to follow‐up at 24 months: TVT‐O: 1 lost to follow‐up; TVT‐S: 1 lost to follow‐up No withdrawals reported in either group
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The eligible patients are randomized into two groups in a 1:1 ratio using a randomization list generated by computer".
Allocation concealment (selection bias)	Unclear risk	NR
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: states "nonblinded" but unclear whether participants and personnel were blinded insofar as possible
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "nonblinded" Comment: unlikely that outcome assessors were blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participant data appear to be reported.
Selective reporting (reporting bias)	Low risk	All specified outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Tommaselli 2010.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: April 2008 to April 2009
Participants	Number of participants: 180 Country: Italy Setting: single centre (note: multicentre in some papers) Type of UI: SUI Concomitant urge: TVT‐S (n = 37): 10 (27.0%); TVT‐O (n = 38): 12 (13.1%) Concomitant urge incontinence: TVT‐S (n = 37): 6 (16.2%); TVT‐O (n = 38): 5 (13.1%) Age: TVT‐S: 56.9 years ± 7.2 years; TVT‐O: 60.4 years ± 8.4 years BMI: TVT‐S: 27.1 ± 2.9; TVT‐O: 28.8 ± 6.0 Parity (median, range): TVT‐S: 2 (0 to 3); TVT‐O: 2 (0 to 4) Duration of SUI (years): TVT‐S (n = 37): 4.0 ± 1.5; TVT‐O (n = 38): 4.2 ± 1.2 Menopause Menopausal status: TVT‐S: 66 (85.7%); TVT‐O: 65 (84.4%) HRT: TVT‐S (n = 37): 8 (21.6%); TVT‐O (n = 38): 10 (26.3%) Concomitant POP: NR (notes in the eligibility criteria that women with POP‐Q stage ≥ 2 were excluded from the study) Number receiving concomitant POP surgery: NR Inclusion criteria: SUI lasting for at least 2 years as diagnosed by clinical evaluation and urodynamics; aged > 30 years; informed consent for randomisation, surgical procedure and chosen type of anaesthesia Exclusion criteria: previous surgical or pharmacological treatment for SUI or both; predominant or isolated urge incontinence; genital prolapse stage ≥ 2 according to the POP‐Q scoring system; serious contraindications to surgical procedures; isolated OAB symptoms; inability to give informed consent for randomisation, surgical procedure and chosen type of anaesthesia
Interventions	Group I (n = 77): TVT‐S Group II (n = 77): TVT‐O
Outcomes	Primary outcome Objective cure: defined as being completely continent during a cough test and during exertion required in urodynamic investigation. Participants were considered improved if they only showed rare leakage, while failure was defined as unchanged or worsened incontinence. Secondary outcomes Duration of procedure Duration of hospitalisation Postoperative and midterm complications (including blood loss and PVR) Subjective pain level Satisfaction level of the participants I‐QOL, PISQ‐12 and PGI‐S scores Ultrasonographic evaluation
Notes	Follow‐up time: 1 month, 3 months, 6 months, 12 months, 36 months, 60 months postoperatively Conflicts of interest: "Giovanni A. Tommaselli and Carmine Nappi accepted paid travel expenses by Gynecare. The other authors state that they have no conflicts of interest regarding this study". Study funding source: "The study was self‐funded and did not receive any sponsorship or funds from any third party". Nine participants (5 in TVT‐S and 4 in TVT‐O group) did not complete follow‐up and were considered excluded. Contact with study authors: we contacted the study authors on 3 November 2022 to clarify which reports were part of a single study and if multiple trials had been conducted by the study authors. The study authors confirmed on 3 November 2022 that the papers were all related to the same study; we followed up on the same day to clarify whether the study was conducted in a single centre or multiple centres but did not receive a response. Note: information from the study authors is that all paper and data relate to the same study. However, it is unclear how the data from each individual paper relate to each over, as recruitment and study dates, number of centres and number of participants reported are not the same across all papers.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomization list generated by a computer assigning a number to the patients"
Allocation concealment (selection bias)	Low risk	Quote: "The allocation sequence was concealed from the researchers who enrolled and assessed participants and attached a sequentially numbered, opaque, sealed and stapled envelope containing the allocated treatment to the clinical record of the patient after having signed the informed consent. The envelope was opened on the morning of the procedure".
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "The code was broken the morning of the procedure, and the surgeon was obviously not blinded to the device to be used. Patients were left blinded to the devices used until the end of the procedure". Quote: "Patients were blinded to the procedure until the end of the study. This single‐blind study design was adopted to reduce bias derived from the patient’s knowledge of which procedure she underwent". Comment: personnel blinded insofar as possible; unclear whether the participants were blinded up to end of study or until end of procedure, as there are conflicting reports across papers
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Patients were left blinded to the devices used until the end of the procedure". Quote: "Patients were blinded to the procedure until the end of the study. This single‐blind study design was adopted to reduce bias derived from the patient’s knowledge of which procedure she underwent". Comment: unclear whether the participants were blinded up to end of study or until end of procedure, as there are conflicting reports across papers
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	5% dropout rate in TVT‐O and 11.9% in TVT‐S. Participant numbers were 38 and 37, respectively. Unclear why participants dropped out
Selective reporting (reporting bias)	Low risk	All specified outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Van Rensburg 2015.

Study characteristics
Methods	Design: RCT Dates study conducted: NR
Participants	Number of participants: 92 Country: South Africa Setting: multicentre Type of UI: SUI Age: Needleless: 54.37 years ± 4.32 years; TVT‐O: 55.71 years ± 11.3 years BMI: Needleless: 31.54 ± 4.32; TVT‐O: 33.78 ± 7.7 Parity: Needleless: 3.19 ± 1.8; TVT‐O: 3.15 ± 1.5 Duration of SUI: NR Menopause: NR Concomitant POP (anterior compartment): Needleless: 1.689 ± 1.02; TVT‐O: 1.67 ± 0.9 Number receiving concomitant POP surgery: NR Inclusion criteria: women with SUI "who met the inclusion and exclusion criteria" Exclusion criteria: NR
Interventions	Group I (n = 51): Needleless Group II (n = 41): TVT‐O
Outcomes	Subjective cure: defined when no or not severe SUI was reported Sandvik Severity KHQ A questionnaire developed to assess the impact of UI on sexual function (SFIQ) Objective cure: defined as a negative CST result and < 1 g on the 1‐hour pad test ISD: diagnosed when abdominal leak point pressure was < 60 cm H2O
Notes	Follow‐up: 6 months and 12 months Conflicts of interest: "Jacobus van Rensburg: Earth Medical: Donation to University, Donation to University. Stephen Jeffery: Boston Scientific: Speaker, Travel Grant. Bard: Surgical Training, Travel Grant. Coloplast: Surgical training, Travel Grant. Karl Storz: Speaker, Support to run a local workshop. Covidien: Speaker, Support to run a local workshop. Herculus Sandenbergh: Nothing to disclose. Leonard Juul: Nothing to disclose. Daniel Steyn: Nothing to disclose." Study funding source: NR Abstract only Contact with study authors: we contacted the study authors to clarify whether there were any additional publications or data that could be shared for use in the review on 31 October 2022.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A computer generated randomised allocation" Comment: adequate method
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "A computer generated randomised allocation in each stratified group was made available to the surgeon prior to the procedure and neither surgeon nor patient was blinded". Comment: participants not blinded but surgeons seemed to be blinded insofar as possible up to the point of the procedure
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unclear who recorded the follow‐up outcomes
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for
Selective reporting (reporting bias)	Low risk	All specified outcomes reported
Other bias	Low risk	No other bias identified in abstract

Wang 2011.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: October 2008 to December 2009
Participants	Number of participants: 102 Country: China Setting: multicentre Type of UI: Pure SUI: TVT‐S: 27/34; TVT: 25/32; TVT‐O: 28/36 MUI: TVT‐S: 7/34; TVT: 7/32; TVT‐O: 8/36 Age: TVT‐S: 57.3 years ± 9.5 years; TVT: 56.6 years ± 9.6 years; TVT‐O: 56.0 years ± 9.1 years BMI: TVT‐S: 26.6 ± 2.3; TVT: 25.3 ± 2.0; TVT‐O: 27.3 ± 1.9 Parity: TVT‐S: 2.7 ± 1.3; TVT: 2.6 ± 1.0; TVT‐O: 2.3 ± 0.9 Duration of SUI (symptom duration): TVT‐S: 4.8 years ± 4.4 years; TVT: 6.1 years ± 5.5 years; TVT‐O: 4.4 years ± 3.6 years Menopause: NR Concomitant POP: NR (unclear what is meant by "concomitant relaxation of the pelvic floor" in exclusion criteria) Number receiving concomitant POP surgery: NR Inclusion criteria: women with SUI Exclusion criteria: previous surgical procedures; concomitant relaxation of the pelvic floor in participants who had received pelvic floor−repairing surgeries
Interventions	Group I (n = 34): TVT‐S Group II (n = 32): TVT Group III (n = 36): TVT‐O
Outcomes	Cure: defined as a negative CST result and the absence of leakage according to participants' report Improvement: defined as negative or positive CST result with reduced urine leakage as reported by the participant Failure: defined as positive CST result and unchanged urine leakage as reported by the participant Operative time (minutes) Blood loss Perioperative and postoperative complications (bladder perforation, urine retention, mild dysuria, thigh pain, frequency urgency or UUI)
Notes	Follow‐up: 1 month, 3 months, 6 months and 12 months, then yearly Conflicts of interest: none Study funding source: NR 102 completed follow‐up.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "patients were assigned by random allocation (computer generated)". Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote: "allocation was concealed using opaque sealed envelopes". Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcome data available for all 102 participants
Selective reporting (reporting bias)	Low risk	All outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Xin 2016.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: January 2012 to October 2013
Participants	Number of participants: 368 Country: China Setting: single centre Type of UI: SUI: Ajust: 162; TVT‐O: 169 MUI: Ajust: 22; TVT‐O: 15 Age: Ajust: 57.6 years ± 6.8 years; TVT‐O: 56.5 years ± 5.8 years BMI: Ajust: 26.5 ± 5.1; TVT‐O: 27.4 ± 5.8 Parity: NR Duration of SUI (months): Ajust: 4.1 ± 2.4; TVT‐O: 4.4 ± 1.9 Menopause: Menopause: Ajust: 169 (91.8%); TVT‐O: 173 (94.0%) HRT: Ajust: 9 (4.9%); TVT‐O: 6 (3.3%) Concomitant POP: NR (notes in the eligibility criteria that women with POP‐Q stage ≥ 2 were excluded from the study) Number receiving concomitant POP surgery: NR Inclusion criteria: BMI < 35; aged > 18 years; corresponding clinical symptoms (leakage of urine on coughing and sneezing) and urodynamically diagnosed with SUI; received PFMT but failed to achieve efficacy; patients who refused to receive PFMT Exclusion criteria: patients with POP‐Q score ≥ 2; history of UI surgery (e.g. Burch surgery and mid‐urethral sling surgery); history of pelvic irradiation; patients with MUI (SUI < UUI); patients who received prolapse therapy; patients with disseminated sclerosis and other neurological diseases
Interventions	Group I (n = 184): Ajust Group II (n = 184): TVT‐O
Outcomes	Primary outcome Subjective cure: defined as significant improvement or improvement in UI on PGI‐I scale 12 months postoperatively Secondary outcomes Objective cure: assessed using a stress test and if participant stated no leakage of urine during an involuntary cough at 12 months PVR volume 24 hours after surgery Pain: assessed using VAS at 1 day, 1 week, 2 weeks and 4 weeks postoperatively, where > 5/10 was considered to be severe pain Surgery data Perioperative complications
Notes	Follow‐up: 1 day, 1 week, 2 weeks, 1 month, 1 year postoperatively Conflicts of interest: none Study funding source: NR Loss to follow‐up at 12 months: Ajust 180 completed; TVT‐O: 182 completed (data for 184 participants reported in each arm; reason for discrepancy not explained)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The patients were simply randomized using table of random numbers". Comment: this approach seems adequate.
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Scale filling and VAS measurement were conducted by trained professionals, and they were blinded to the surgical approaches".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Flowchart describes 4 (Ajust) and 2 (TVT‐O) participants not completing 12 month follow‐up. Quote: "All patients received 12 months follow up".
Selective reporting (reporting bias)	Low risk	All outcomes appear to be reported.
Other bias	Low risk	No other bias detected

Yoon 2011.

Study characteristics
Methods	Design: prospective RCT Dates study conducted: NR
Participants	Number of participants: 103 Country: South Korea Setting: NR Type of UI: SUI Age: Needleless: 52.9 years ± 9.7 years; TOT: 56.95 years ± 9.64 years BMI: NR Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: women with SUI Exclusion criteria: NR
Interventions	Group I (n = 52): C‐NDL Group II (n = 51): TOT
Outcomes	3‐day frequency‐volume chart Uroflow with PVR volume Symptom questionnaire Operation‐related complications Operative time Postoperative voiding symptoms
Notes	Follow‐up: 4 weeks Conflicts of interest: NR Study funding source: "Specify source of funding or grant: none" Abstract only
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "(patients) were randomly divided into two groups according to their procedure". Comment: methods unclear
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR for participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Limited information available from abstract
Selective reporting (reporting bias)	Unclear risk	Limited information available from abstract
Other bias	Unclear risk	Limited information available from abstract

BMI: body mass index; C‐NDL: Contasure Needleless; CST: cough stress test; DO: detrusor overactivity; EFA: endopelvic free anchorage; FSFI: Female Sexual Function Index; GA: general anaesthetic; HRT: hormone replacement therapy; ICIQ‐6: International Consultation on Incontinence Modular Questionnaire‐6; ICIQ‐FLUTS: International Consultation on Incontinence Questionnaire – Female Lower Urinary Tract Symptoms; ICIQ‐OAB: International Consultation on Incontinence Questionnaire – Overactive Bladder; ICIQ‐SF: International Consultation on Incontinence Questionnaire – Short Form; ICIQ‐UI‐SF: International Consultation on Incontinence Questionnaire – Urinary Incontinence – Short Form; ICS: International Continence Society; IIQ‐7: Incontinence Impact Questionnaire; I‐QOL: Incontinence Quality of Life questionnaire; ISD: intrinsic sphincter deficiency; ITT: intention‐to‐treat; IUGA: International Urogynecological Association; KHQ: King's Health Questionnaire; LA: local anaesthetic; MS: multiple sclerosis; MUCP: mean urethral closure pressure; MUI: mixed urinary incontinence; NR: not reported; OAB: overactive bladder; PFDI‐20: Pelvic Floor Distress Inventory; PFIQ‐7: Pelvic Floor Impact Questionnaire – Short Form 7; PFMT: pelvic floor muscle training; PGI‐I: Patient Global Impression of Improvement; PGI‐S: Patient Global Impression of Severity; PISQ‐12: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; POP: pelvic organ prolapse; POP‐Q: Pelvic Organ Prolapse Quantification; PPIUS: Patient Perception of Intensity of Urgency Scale; PVR: postvoid residual; QoL: quality of life; RCT: randomised controlled trial; SFIQ: Sexual Function Inventory Questionnaire; SIMS: single‐incision mini‐sling; SIS: single‐incision sling; SMUS: standard mid‐urethral sling; SUI: stress urinary incontinence; TOT: transobturator tape; TVT: tension‐free vaginal tape; TVT‐O: tension‐free vaginal tape obturator; TVT‐S: tension‐free vaginal tape Secur; UDI: urinary distress inventory; UI: urinary incontinence; USI: urodynamic stress incontinence; UTI: urinary tract infection; UUI: urge urinary incontinence; VAS: visual analogue scale; VLPP: Valsalva leak point pressure

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Ahn 2014	Ineligible study design: not an RCT
Araco 2011	Ineligible intervention: no single‐incision sling arm
Castañeda 2014	Ineligible study design: cost‐effectiveness analysis of results of 2 separate cohorts
De Leval 2011	Ineligible intervention: comparator was not a single‐incision sling
Dogan 2018b	Ineligible intervention: compared surgical techniques
Feng 2018	Ineligible intervention: neither arm was a single‐incision sling
Lee JS 2010	Ineligible comparison: single‐incision sling versus single‐incision sling
Lee KS 2010	Ineligible intervention: compared surgical techniques
Lian 2020	Ineligible study design: not an RCT
Liapis 2010	Ineligible intervention: compared surgical techniques
Martan 2008	Ineligible study design: non‐randomised study correlating ultrasound findings with clinical signs of cure or failure in a subset of participants who had undergone TVT‐Secur (mini‐sling) from an RCT
Martan 2011	Ineligible comparison: single‐incision sling versus single‐incision sling
Melon 2022	Ineligible study design: comparative historical cohort study
NCT01054833	Ineligible study design
NCT01384084	Ineligible intervention: compared POP repair plus mini‐sling versus POP repair alone
NCT02867748	Ineligible intervention: no single‐incision sling arm
NCT03052985	Ineligible study design: observational study design
Okulu 2011	Ineligible intervention: experimental interventions did not conform to the definition of single‐incision slings
Palomba 2012	Ineligible comparison: single‐incision sling versus single‐incision sling
Palomba 2014	Ineligible study design: non‐randomised study (allocation to retropubic TVT or single‐incision sling based on participant choice)
Pardo 2010	Ineligible comparison: single‐incision sling versus single‐incision sling
Tommaselli 2012a	Ineligible comparison: compared TVT‐O with a modification in position of TVT‐O
Tommaselli 2012b	Ineligible comparison: compared TVT‐O with TVT‐Abbrevo; we are not classifying TVT‐Abbrevo as a single‐incision sling
Zullo 2020	Ineligible comparison: compared TVT‐O with TVT‐Abbrevo; we are not classifying TVT‐Abbrevo as a single‐incision sling

POP: pelvic organ prolapse; RCT: randomised controlled trial; TVT: tension‐free vaginal tape; TVT‐O: tension‐free vaginal tape obturator

Characteristics of studies awaiting classification [ordered by study ID]

Huser 2020.

Methods	Design: RCT Dates study conducted: January 2015 to December 2019
Participants	Number of participants: 168 Country: Czech Republic Setting: single centre Type of UI: SUI (pure urodynamic) Age: SIS: 61.3 years ± 10.0 years; TOT: 62.5 years ± 10.4 years BMI: SIS: 28.7 ± 6.7; TOT: 29.5 ± 6.0 Parity: SIS: 2.2 ± 1.2; TOT: 2.3 ± 1.1 Duration of SUI: NR Menopause: NR Concomitant POP: NR (notes in exclusion criteria that POP stage > 2 excluded) Number undergoing concomitant POP surgery: none (notes in intervention procedure that no planned concomitant surgeries were performed) Inclusion criteria: Caucasian (central European) women with pure urodynamic SUI confirmed during cystometry by positive standardised cough stress test result with urinary bladder filling of 250 mL in lithotomy position Exclusion criteria: urgency of predominant urgency incontinence; ISD (MUCP < 20 cm H2O); POP of stage > 2; previous SUI surgery or POP surgery; presence of other pelvic organ pathology
Interventions	Group I (n = 84): SIS − Ophira Group II (n = 84): TOT − Ethicon
Outcomes	Primary outcomes Objective cure: absence of urinary leakage on a standardised cough stress test Subjective cure: assessed with PGI‐I using a 7‐point satisfaction scale. Cure was defined with a response of 1 ("very much improved"), 2 ("much improved") or 3 ("improved") Secondary outcomes Change in QoL: assessed using ICIQ‐SF Postoperative de novo urgency: measured by the PPIUS, ranging from 0 (no urgency) to 4 (urge incontinence) Major intraoperative and postoperative complications: recorded according to ICS/IUGA classifications. Related to the insertion of prosthesis distinguishing urinary tract compromise or postoperative urine retention, infection, abscess, rectum or bowel perforation; skin or musculoskeletal damage; heavy bleeding (including haematoma or systemic participant compromise) Tape exposure: defined as mesh visualised through separated epithelium Tape extrusion: defined as the gradual passage of mesh out of the body tissue Surgical reinterventions: reported differentiating procedures performed because of primary surgery failure and procedures related to mesh or surgical complications
Notes	Follow‐up time: 4 years and 5 years Conflicts of interest: "The authors declare no personal interests, financial or non‐financial, relating to this research and its publication. This is not the industry‐sponsored research, all authors have maintained ethical and transparent publication practices." Study funding sources: "supported by Czech Republic Ministry of Health, No. FNBr65269705" Reason for awaiting classification: the trial registration for these papers is the same as that of Jurakova 2016, but other details surrounding the study dates, number of participants and the sources of funding are different. We are unclear whether these papers are further reports of Jurakova 2016 or part of a separate study. Contact with study authors: we contacted the study authors on 30 November 2022 to establish the relationship between these papers and Jurakova 2016.

Pushkar 2011.

Methods	Design: NR Dates study conducted: January 2009 to September 2009
Participants	Number of participants: 75 Country: Russia Setting: NR Type of UI: UI (unclear what type) Age: NR BMI: NR Parity: NR Duration of SUI: NR Menopause: NR Concomitant POP: NR Number receiving concomitant POP surgery: NR Inclusion criteria: women with UI Exclusion criteria: NR
Interventions	Group I (n = 35): TVT‐S Group II (n = 40): TVT‐O
Outcomes	A "positive result" or "good result": unclear from abstract what this is measuring QoL: method not described Reoperation rate: reoperations for UI
Notes	Follow‐up time: postoperative and 6 months Conflicts of interest: NR Funding sources: NR Reason for awaiting classification: only the abstract is available in English, which does not make the study design or type of UI included clear.

BMI: body mass index; ICS: International Continence Society; ICIQ‐SF: International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form; ISD: intrinsic sphincter deficiency; IUGA: International Urogynecological Association; MUCP: maximum urethral closure pressure; NR: not reported; PGI‐I: Patient Global Impression of Improvement; POP: pelvic organ prolapse; PPIUS: Patient Perception of Intensity of Urgency Scale; QoL: quality of life; RCT: randomised controlled trial; SIS: single‐incision sling; SUI: stress urinary incontinence; TOT: transobturator tape; TVT: tension‐free vaginal tape; TVT‐O: tension‐free vaginal tape obturator; TVT‐S: tension‐free vaginal tape Secur; UI: urinary incontinence

Characteristics of ongoing studies [ordered by study ID]

Matthews 2018.

Study name	Randomized trial of retropubic versus single‐incision mid‐urethral sling (Altis™) for concomitant management of stress urinary incontinence during native tissue vaginal repair
Methods	Design: RCT
Participants	Estimated enrolment: 280 Country: USA Setting: multicentre Inclusion criteria: women at least 21 years old; considered for native tissue vaginal repair in any vaginal compartment or colpocleisis; POP of stage ≥ II in any vaginal compartment according to POP‐Q; vaginal bulge symptoms; positive standardised CST result on clinical examination or on urodynamic testing; understanding and acceptance of the need to return for all scheduled follow‐up visits; English‐speaking and able to give informed consent; willing and able to complete all study questionnaires Exclusion criteria: prior surgery for SUI; status post reconstructive pelvic surgery with transvaginal mesh kits or sacrocolpopexy with synthetic mesh for prolapse; any serious disease or chronic condition that could interfere with study compliance; unwilling to have synthetic sling; inability to give informed consent; pregnancy or planning pregnancy in first postoperative year; untreated UTI (may be included after resolution); poorly controlled diabetes mellitus (glycosylated haemoglobin > 9 within 3 months of surgery date); prior pelvic irradiation; incarcerated; neurogenic bladder, preoperative self‐catheterisation or both; elevated PVR (> 150 mL) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study); prior augmented prolapse repair (synthetic mesh, autologous graft, xenograft, allograft); planned concomitant bowel‐related surgery (including sphincteroplasty and perineal rectal prolapse repair, rectovaginal prolapse repair, haemorrhoidectomy)
Interventions	Group I: SIS Group II: retropubic sling
Outcomes	Primary outcomes Number of participants with subjectively bothersome incontinence: assessed at 12 months as a dichotomous yes‐or‐no answer. Answer derived from a positive response of > 1 to question 17 on the PFDI‐20 (response scale 0 to 4, with 0 = not present and 4 = symptoms present quite a bit) Retreatment for stress incontinence: assessed at 12 months and includes pelvic floor physical therapy, incontinence pessary, urethral bulking injection or repeat continence surgery De novo or worsening urge incontinence symptoms: assessed at 12 months as a dichotomous yes‐or‐no answer. Derived from a worsening change in response to question 16 on PFDI‐20 with at least somewhat bothersome symptoms. Response scale from 0 to 4 with 0 = symptoms not present and 4 = symptoms present quite a bit Requirement for bladder drainage: beyond 2 weeks postoperatively with PVR > 150 mL or > 1/3 total voided volume up to 12 months postoperatively Surgical intervention for urinary retention: defined as sling lysis or revision at any time postoperatively up to 12 months Secondary outcomes Adverse events: intraoperatively and postoperatively up to 12 months and includes events measured by the Dindo classification system Change in pain: measured by VAS for 14 days postoperatively, then at 6 weeks and 12 months postoperatively. Scores from 0 to 10 with 0 = no pain and 10 = worst pain Surgeon satisfaction: assessed with a 10‐point Likert scale at 12 months. Scores range from 0 to 10 with 0 = no satisfaction and 10 = extremely satisfied.
Starting date	12 December 2018
Contact information	Sachin Vyas Tel: 336‐713‐4098 Email: svyas@wakehealth.edu Catherine Matthews Tel: NR Email: camatthe@wakehealth.edu
Notes	Follow‐up time: up to 12 months postoperative Sponsors and collaborators: Wake Forest University Health Sciences; Foundation for Female Health Awareness

Matthews 2020.

Study name	SASS: randomized trial of single‐incision versus retropubic mid‐urethral sling (Solyx) for concomitant management of stress urinary incontinence during minimally invasive sacrocolpopexy
Methods	Design: RCT
Participants	Estimated enrolment: 180 Country: USA and South Africa Setting: multicentre Inclusion criteria: women aged at least 21 years; vaginal bulge symptoms as indicated by an affirmative response of > 1 to question 3 of PFDI‐SF20; POP stage ≥ II according to POP‐Q with evidence of apical descent; considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy); objective SUI as measured by a standardised CST on clinical examination or on urodynamic study with reduced prolapse; understanding and acceptance of the need to return for all scheduled follow‐up visits and willing to complete study questionnaires; able to give informed consent Exclusion criteria: prior surgery for SUI (including mid‐urethral sling, Burch/MMK [Marshall‐Marchetti‐Krantz] procedure, fascial pubovaginal sling (autologous, xenograft or allograft) and urethral bulking injection); any serious disease or chronic condition that could interfere with study compliance; unwilling to have a synthetic sling; untreated and unresolved UTI; poorly controlled diabetes mellitus (glycosylated haemoglobin > 9 within 3 months of surgery date); neurogenic bladder, preoperative self‐catheterisation or both; elevated PVR > 150 mL that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study); prior pelvic radiation; inflammatory bowel disease; current genitourinary fistula or urethral diverticulum; planned concomitant bowel‐related surgery (including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, haemorrhoidectomy); pregnant or planning to conceive
Interventions	Group I: SIS (Solyx) Group II: retropubic sling
Outcomes	Primary outcome Number of participants with subjectively bothersome incontinence: assessed at 6 weeks, then 1 year, 3 years and 5 years. Answer derived from a positive response of > 1 to question 17 on the PFDI‐20 (response scale 0 to 4, with 0 = not present and 4 = symptoms bother quite a bit) Secondary outcomes Satisfaction on VAS: assessed at baseline, surgery, then postoperative week 2, week 6, 1 year, 2 years, 3 years and 5 years. Assessed using a numeric rating scale of 0 to 10 with higher scores indicating greater degrees of satisfaction PISQ‐IR: assessed at baseline, surgery, then postoperative week 2, week 6, 1 year, 2 years, 3 years and 5 years. Consisting of 20 questions regarding sexual function. In Part 1, for non–sexually active women, higher scores indicate greater impact on sexual inactivity. In Part 2, for sexually active women, higher scores equal better sexual function. QoL relating to pelvic floor: assessed at baseline, surgery, then postoperative week 2, week 6, 1 year, 2 years, 3 years and 5 years using the PFIQ‐7. The total score is a sum of the 3‐scale score with a range of 0 to 300. Higher scores indicate greater degree of bother. PGI‐I: assessed at baseline, surgery, then postoperative 2, week 6, 1 year, 2 years, 3 years and 5 years to determine how much the participant's illness has improved or worsened relative to baseline. Lower scores indicate improvement. PVR assessment: assessed at baseline, surgery, then postoperative week 2, week 6, 1 year, 2 years, 3 years and 5 years and collected via bladder scan or clean intermittent catheterisation. Can be a minimum 0 mL or an average bladder capacity of 400 mL Number of participants needing retreatment: from 6 months up to 5 years postoperative. Defined as surgical intervention for urinary retention (sling lysis) at any point after surgery Number of participants needing bladder drainage: need for urinary catheter due to incontinence or retention beyond 6 weeks postsurgery PFDI‐SF20: assessed at baseline, surgery, then postoperative week 2, week 6, 1 year, 2 years, 3 years and 5 years and includes 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory and Colorectal‐Anal Distress Inventory), which will be evaluated and stratified by compartment. Total score is a range between 0 and 300 with higher scores indicating a greater degree of bother.
Starting date	23 December 2020
Contact information	Sachin N Vyas Tel: 336‐713‐4098 Email: svyas@wakehealth.edu Catherine A Matthews Tel: NR Email: NR
Notes	Follow‐up time: postoperative week 2, week 6, 1 year, 2 years, 3 years and 5 years Sponsors and collaborators: Wake Forest University Health Sciences; Boston Scientific Corporation

NCT01799122.

Study name	Randomized clinical trial comparing Mini‐Arc Precise Pro and the trans vaginal obturator tape for surgical management of stress urinary incontinence
Methods	Design: RCT
Participants	Enrolment: NR Country: Canada Setting: unclear (Manitoba; no further details) Inclusion criteria: 25 years or older; women with SUI with a positive cough test result; patient requesting treatment with surgery Exclusion criteria: predominantly OAB; previous failed procedure; MUCP < 20 cm H2O; presence of vaginal prolapse stage > 1; voiding dysfunction (PVR > 100 mL)
Interventions	Group I: MiniArc Precise Pro Group II: TVT‐O
Outcomes	Primary outcome Cough test: assessed 1 year from surgery Secondary outcomes Subjective symptoms: assessed 1 year and 2 years postoperatively Quality‐of‐life questionnaires: assessed 1 year and 2 years postoperatively
Starting date	NR (first posted 26 February 2013)
Contact information	Ken Maslow Tel: 204‐235‐3039 Email: maslow@sbgh.mb.ca
Notes	Follow‐up time: 1 year and 2 years Sponsors and collaborators: University of Manitoba

NCT02263534.

Study name	Randomized controlled trial comparing mini‐sling to tension‐free vaginal tape in management of stress urinary incontinence
Methods	Design: RCT
Participants	Actual enrolment: 48 Country: Egypt Setting: single centre Inclusion criteria: women with urodynamic SUI, with or without POP Exclusion criteria: OAB on urodynamic study; voiding dysfunction; ISD; previous anti‐incontinence surgery; anticoagulant therapy; immune‐compromised patients (diabetes mellitus, on corticosteroid treatment); refusal of surgery
Interventions	Group I: mini‐sling Group II: tension‐free vaginal tape
Outcomes	Primary outcomes Objective cure of UI: assessed at 12 months postoperatively and indicated by a negative stress test result and the absence of any additional surgical or nonsurgical treatment for SUI Subjective cure of SUI: assessed at 12 months postoperatively and indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for SUI Secondary outcomes Number of participants with short‐term complications: assessed at < 6 weeks; includes postoperative pain, urinary retention, de novo urgency and wound sepsis Number of participants with long‐term complications: assessed at 12 months; includes erosion, dyspareunia and recurrence
Starting date	10 November 2014
Contact information	Ahmed Reda Tel: NR Email: NR
Notes	Follow‐up time: 6 weeks and 12 months Sponsors and collaborators: Ain Shams University

NCT03515109.

Study name	Prospective randomized trial of Altis minisling with the TVTO transobturator tape procedure for the management of genuine stress urinary incontinence in women
Methods	Design: RCT
Participants	Estimated enrolment: 40 Country: Greece Setting: single centre (Aretaueio University Hospital) Inclusion criteria: genuine SUI proven by urodynamics; willing to be operated on and participate in the study Exclusion criteria: history of previous irradiation in the lower genital tract; BMI > 30; previous anti‐incontinence surgery; previous vaginal surgery; having MUCP < 30 cm H2O or Valsalva leak point pressure < 60 cm H2O; MUI
Interventions	Group I: Altis Group II: TVT‐O
Outcomes	Primary outcome Objective UI rate: measured at 12 months with a CST during urodynamics Secondary outcomes Subjective urinary continence rate: measured at 12 months with the PGI‐I questionnaire Preoperative and postoperative assessment of sexual function: measured at 12 months with the FSFI (minimum score 2.0, maximum 36.0, with higher scores representing a better outcome)
Starting date	25 November 2017
Contact information	Panagiotis Vakas Tel: 2107473204 Email: P_BAKAS@YAHOO.COM Emmanouil Papadakis Tel: 6944864531 Email: papadakisemm2@gmail.com
Notes	Follow‐up time: 12 months Sponsors and collaborators: Aretaieio Hospital

NCT03916471.

Study name	Comparison of efficacy and side effects between the Obtryx and Solyx band with 5‐year follow‐up. Prospective, randomized and non‐inferiority study
Methods	Design: RCT
Participants	Estimated enrolment: 166 Country: Spain Setting: single centre Inclusion criteria: diagnosed with symptomatic SUI and candidates for stress‐free bands; aged ≥ 40 years; informed consent signed by the participant Exclusion criteria: pregnant or wish to become pregnant; require anticoagulants; acute vaginal or urinary infection; previous surgical interventions for treating incontinence; BMI > 35
Interventions	Group I: Solyx Group II: Obtryx II (obturator sling)
Outcomes	Primary outcome Objective continence rate: measured at 1 month and 6 months, then 1 year, 2 years, 3 years, 4 years and 5 years using an effort test carried out through 3 coughs with a bladder volume between 200 mL and 300 mL in a lithotomy position Secondary outcomes Subjective continence rate: measured at 1 month and 6 months, then 1 year, 2 years, 3 years, 4 years and 5 years with the ICIQ‐SF. Participants considered continent when the reduction is ≥ 50% of the value before the intervention 1‐hour pad test: measured at 1 month and 6 months, then 1 year, 2 years, 3 years, 4 years and 5 years. Participants will be asked to drink half a litre of water in 15 minutes, then between 15 minutes and 45 minutes to walk or go up and down stairs or both. Between 45 minutes and 60 minutes, they have to get up and sit 10 times, cough 10 times, run 1 minute, lift an object from the ground 10 times and wash their hands for 1 minute. Pad weights will be measured as follows: ≤ 1 g = continent; 1.1 g to 9.9 g = mild incontinence; 10 g to 49.9 g = moderate incontinence; > 50 g = severe incontinence. Patient satisfaction: measured at 1 month and 6 months, then 1 year, 2 years, 3 years, 4 years and 5 years with the PGI‐I and "Global Satisfaction Test". On PGI‐I, assessed based on answer of "better or much better" on "Global Satisfaction Test", 1 = very satisfied and 5. QoL: measured at 1 month and 6 months, then 1 year, 2 years, 3 years, 4 years and 5 years with the I‐QOL. Validated in Spanish. Higher scores mean better QoL. Evaluation of sexual life: measured at 1 month and 6 months, then 1 year, 2 years, 3 years, 4 years and 5 years with the PISQ‐12. Scores are "always = 0" to "never = 4" but used inversely in items 1 to 4. PMR: assessed at day 0, 7 days to 10 days postintervention and 1 month. Considered as the urinary urgency, inability to void, presence of PMR > 50% of total volume after spontaneous voiding or presence of pain that prevents ambulation in first 30 days postintervention OAB‐Q: early and late complications assessed at day 0, 7 days to 10 days postintervention, then 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years. Score 0 = lowest and 5 = highest; if scoring ≥ 8, the participant will proceed according to usual practice. Early complications on VAS: assessed at day 0, 7 days to 10 days postintervention and 1 month only if the participant has pain that prevents ambulation. VAS ranges from 0 to 10 with 0 = no pain, 5 = distressing pain and 10 = unbearable pain. Extrusion: measured at 1 month and 6 months, 1 year, 2 years, 3 years, 4 years and 5 years. Extrusion is measured by checking the integrity of the vaginal mucus at all visits. If there is evidence of extrusion, it will be classified as either asymptomatic or symptomatic and according to its size (> 1 cm or < 1 cm) UTIs: measured at 1 month and 6 months, 1 year, 2 years, 3 years, 4 years and 5 years. Defined as the presence of at least 1 monthly UTI. The participant will be considered to have developed repeat UTIs. Emptying dysfunction: measured at 1 month and 6 months, 1 year, 2 years, 3 years, 4 years and 5 years and defined as persistent urinary retention at 30 days
Starting date	21 December 2018
Contact information	Maria Cortell Tel: 0034961246711 Email: investigacion_clinica@iislafe.es
Notes	Follow‐up time: day 0, 7 days to 10 days postintervention, then 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years Sponsors and collaborators: Instituto de Investigacion Sanitaria La Fe

NCT05225168.

Study name	Comparison of minisling suburethral sling use and laparoscopic Buch [sic] colposuspension application in terms of surgical efficacy and side effects in true stress urinary incontinence surgery
Methods	Design: RCT
Participants	Estimated enrolment: 80 Country: Turkey Setting: single centre Inclusion criteria: aged 18 years to 80 years; isolated genuine stress incontinence or accompanying POP; accepted surgery for SUI Exclusion criteria: previously undergone POP surgery; chronic lung disease (e.g. asthma or chronic obstructive pulmonary disorder (COPD)); juvenile diabetes mellitus; history of gynaecological cancer; mesh allergy
Interventions	Group I: suburethral mini‐sling Group II: laparoscopic Burch colposuspension
Outcomes	Primary outcome Objective cure: measured at 6 months and 12 months using urodynamics. An absence of incontinence is considered cure. Secondary outcomes Subjective continence: assessed at 6 months and 12 months. Patient satisfaction measured by keeping a urinary diary and questioning QoL P‐QoL scale: assessed at 6 and 12 months. Questions are scored from 1 to 4, with higher scores indicating worse QoL. King's Health Questionnaire: assessed at 6 months and 12 months Sexual function: assessed at 6 months and 12 months, measured on FSFI. The FSFI is scored from 2 to 36, with higher scores indicating a better sexual life.
Starting date	6 March 2021
Contact information	Gamze Nur Cimilli Senocak Tel: +905305880025 Email: gncimilli@gmail.com Yakup Kumtepe Tel: +905336526614 Email: ykumtepe@gmail.com
Notes	Follow‐up time: 6 months and 12 months Sponsors and collaborators: Ataturk University

PACTR201607001696163.

Study name	Modified Needleless single‐incision mini‐sling compared to standard trans‐obturator mid‐urethral sling in the surgical management of female stress urinary incontinence
Methods	Design: controlled clinical trial
Participants	Actual sample size: 100 Country: Egypt Setting: NR Inclusion criteria: 20 years to 40 years old; diagnosed with SUI and positive CST result; with or without associated genital prolapse (grade 1 only) Exclusion criteria: women with OAB; aged < 25 years or > 35 years; normal vaginal deliveries > 3; BMI > 30; has undergone previous surgical procedures for treating SUI; POP grade > 2
Interventions	Group I (n = 50): mini‐sling Group II (n = 50): TOT
Outcomes	Primary outcome Correction of stress incontinence: measured at 1 month, 3 months and 6 months; method not described Secondary outcome Time of the operation: measured at 1 hour, no further details
Starting date	1 February 2013
Contact information	Mohammed Elsokkary Tel: 0201001574386 Email: mohammedelsokkary1@yahoo.com
Notes	Follow‐up time: 1 hour, 1 month, 3 months and 6 months Funding: "N/A" Sponsors: Ain Shams University, Ramses, Cairo, Egypt Collaborators: Ain Shams University, Ramses, Cairo, Egypt

Shen 2015.

Study name	Single‐incision mini‐slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a prospective randomized controlled trail to evaluate the efficiency and safety
Methods	Design: RCT
Participants	Enrolment: 60 (unclear if actual or anticipated) Country: China Setting: NR Inclusion criteria: women between 25 years and 75 years old; urinary dynamics showing SUI characterised by detrusor without stable contraction, increasing abdominal pressure and involuntary leakage of urine; moderately severe SUI according to clinical judgement (abdominal pressure increases and there is UI during activities plus a need to wear pads); "invalid" PFMT Exclusion criteria: neurogenic factors (e.g. hardening of the arteries, neurogenic bladder); POP of POP‐Q stage ≥ 2; history of surgery for UI; radiation to pelvic viscera; "The pregnancy women were recently have a pregnancy plan"; blood coagulation disorder; severe lung disease; kidney function failure
Interventions	Group I (n = 30): SIMS TVT‐Ajust Group II (n = 30): TVT‐O
Outcomes	Primary outcome Patient‐reported cure rate: method of measurement NR Secondary outcomes NR
Starting date	Registered 16 March 2015
Contact information	Jian Fu Tel: +86 18580108266 Email: xingzhu007@163.com Wenhao Shen Tel: +86 13983842766 Email: chongqingswh@aliyun.com
Notes	Follow‐up time: NR Primary sponsor: the First Affiliated Hospital to the Third Military Medical University, Chongqing, China

BMI: body mass index; ICS: International Continence Society; ICIQ‐SF: International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form; ISD: intrinsic sphincter deficiency; IUGA: International Urogynecological Association; MUCP: maximum urethral closure pressure; NR: not reported; PGI‐I: Patient Global Impression of Improvement; POP: pelvic organ prolapse; PPIUS: Patient Perception of Intensity of Urgency Scale; QoL: quality of life; RCT: randomised controlled trial; SIS: single‐incision sling; SUI: stress urinary incontinence; TOT: transobturator tape; TVT: tension‐free vaginal tape; TVT‐O: tension‐free vaginal tape obturator; TVT‐S: tension‐free vaginal tape Secur; UI: urinary incontinence

Differences between protocol and review

For this version of the review, published in 2023, we made the following changes.

Comparisons: we removed the comparisons between different single‐incision slings and between different surgical approaches. Subsequent research has highlighted the equivalence of the 'medial to lateral' and 'lateral to medial' obturator sling (OS) approaches and the superiority of the 'bottom to top' over the 'top to bottom' retropubic sling (RPS) approach (Ford 2017). There is no evidence for a difference in efficacy between different single‐incision slings, apart from TVT‐S (Bai 2018).

Outcomes: we streamlined the outcomes of the review to those that are of most importance to clinicians and patients. We have also categorised outcome measures into separate time points, and as a result, removed the sensitivity analyses for time points.

Stratified results: we presented as stratified analyses trials which included TVT‐Secur (TVT‐S) and trials which did not. TVT‐S was removed from the market in 2012 due to evidence from trials of reduced efficacy. To reduce the risk of biassing outcomes, trials including TVT‐S should be categorised separately. It remains important to continue to publish long‐term data from these trials for the women who have had these meshes inserted.

Risk of bias: we conducted full assessments for all domains in Cochrane's risk of bias tool, both for already‐included studies and for newly‐included studies.

Methods: we substantially modified the methodology of the review in accordance with current Cochrane guidance, including adding summary of findings tables and assessing the certainty of the body of evidence using the GRADE approach.

Contributions of authors

EC: protocol update, selection of studies for inclusion, collection of data, assessment of risk of bias, data analysis, data interpretation and GRADE assessments, write‐up of results for review, interpretation of review findings

EEJ: selection of studies for inclusion in the review, collection of data, assessment of risk of bias, data analysis, data interpretation and GRADE assessments, write‐up of results of review

MS: selection of studies for inclusion in the review, collection of data, assessment of risk of bias, data interpretation and GRADE assessments, contributed to write‐up of results of review

AB: study selection, collection of data for the review (2020 to 2022 studies), risk of bias assessments, data analysis

ASA: study selection, collection of data for the review (2020 to 2022 studies), risk of bias assessments

PA: conducted the brief economic commentary

SJ: data interpretation, author of 2012 review, contributed to write‐up

AN: data interpretation, author of 2012 review, contributed to write‐up

Sources of support

Internal sources

• No sources of support provided

External sources

• National Institute for Health Research (NIHR), UK

  This project was supported by the National Institute for Health Research, via Cochrane infrastructure funding to Cochrane Incontinence. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Evidence Synthesis Programme, the NIHR, National Health Service (NHS) or the Department of Health and Social Care.

Declarations of interest

In accordance with Cochrane's Commercial Sponsorship Policy, the following declarations are applicable for the three years prior to the publication date of this review.

• EC: no conflicts of interest to declare.

• EEJ: is Assistant Managing Editor for Cochrane Incontinence. However, she did not take part in the editorial process for this review.

• MS: no conflicts of interest to declare.

• AB: no conflicts of interest to declare.

• ASA: no conflicts of interest to declare.

• PA: no conflicts of interest to declare.

• SJ: is an author of a study included in this review (Van Rensburg 2015). He did not take part in eligibility decisions, data extraction, or risk of bias and GRADE assessments.

• AN: no conflicts of interest to declare.

Cochrane’s Funding Arbiters have judged that previous versions of this review are not compliant with Cochrane’s Commercial Sponsorship Policy, specifically the clause ‘The lead author and more than 50% of all authors must not have received other types of financial support from an industry sponsor with an interest in the review’ (Nambiar 2017; Nambiar 2014). As declared in both versions of the review, this funding took the form of grants for travel to conferences and meetings.

New search for studies and content updated (conclusions changed)