Transvaginal mesh or grafts or native tissue repair for vaginal prolapse

Abstract

Background

Pelvic organ prolapse is the descent of one or more of the pelvic organs (uterus, vaginal apex, bladder, or bowel) into the vagina. In recent years, surgeons have increasingly used grafts in transvaginal repairs. Graft material can be synthetic or biological. The aim is to reduce prolapse recurrence and surpass the effectiveness of traditional native tissue repair (colporrhaphy) for vaginal prolapse. This is a review update; the previous version was published in 2016.

Objectives

To determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair or other grafts in the surgical treatment of vaginal prolapse.

Search methods

We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and two clinical trials registers (March 2022).

Selection criteria

Randomised controlled trials (RCTs) comparing different types of vaginal repair (mesh, biological graft, or native tissue).

Data collection and analysis

Two review authors independently selected trials, assessed risk of bias, and extracted data. The primary outcomes were awareness of prolapse, repeat surgery, and recurrent prolapse on examination.

Main results

We included 51 RCTs (7846 women). The certainty of the evidence was largely moderate (ranging from very low to moderate).

Transvaginal permanent mesh versus native tissue repair

Awareness of prolapse at six months to seven years was less likely after mesh repair (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.73 to 0.95; I² = 34%; 17 studies, 2932 women; moderate‐certainty evidence). This suggests that if 23% of women are aware of prolapse after native tissue repair, between 17% and 22% will be aware of prolapse after permanent mesh repair.

Rates of repeat surgery for prolapse were lower in the mesh group (RR 0.71, 95% CI 0.53 to 0.95; I² = 35%; 17 studies, 2485 women; moderate‐certainty evidence). There was no evidence of a difference between the groups in rates of repeat surgery for incontinence (RR 1.03, 95% CI 0.67 to 1.59; I² = 0%; 13 studies, 2206 women; moderate‐certainty evidence). However, more women in the mesh group required repeat surgery for the combined outcome of prolapse, stress incontinence, or mesh exposure (RR 1.56, 95% CI 1.07 to 2.26; I² = 54%; 27 studies, 3916 women; low‐certainty evidence). This suggests that if 7.1% of women require repeat surgery after native tissue repair, between 7.6% and 16% will require repeat surgery after permanent mesh repair. The rate of mesh exposure was 11.8% and surgery for mesh exposure was 6.1% in women who had mesh repairs.

Recurrent prolapse on examination was less likely after mesh repair (RR 0.42, 95% CI 0.32 to 0.55; I² = 84%; 25 studies, 3680 women; very low‐certainty evidence).

Permanent transvaginal mesh was associated with higher rates of de novo stress incontinence (RR 1.50, 95% CI 1.19 to 1.88; I² = 0%; 17 studies, 2001 women; moderate‐certainty evidence) and bladder injury (RR 3.67, 95% CI 1.63 to 8.28; I² = 0%; 14 studies, 1997 women; moderate‐certainty evidence). There was no evidence of a difference between the groups in rates of de novo dyspareunia (RR 1.22, 95% CI 0.83 to 1.79; I² = 27%; 16 studies, 1308 women; moderate‐certainty evidence).

There was no evidence of a difference in quality of life outcomes; however, there was substantial heterogeneity in the data.

Transvaginal absorbable mesh versus native tissue repair

There was no evidence of a difference between the two methods of repair at two years for the rate of awareness of prolapse (RR 1.05, 95% CI 0.77 to 1.44; 1 study, 54 women), rate of repeat surgery for prolapse (RR 0.47, 95% CI 0.09 to 2.40; 1 study, 66 women), or recurrent prolapse on examination (RR 0.53, 95% CI 0.10 to 2.70; 1 study, 66 women).

The effect of either form of repair was uncertain for bladder‐related outcomes, dyspareunia, and quality of life.

Transvaginal biological graft versus native tissue repair

There was no evidence of a difference between the groups at one to three years for the outcome awareness of prolapse (RR 1.06, 95% CI 0.73 to 1.56; I² = 0%; 8 studies, 1374 women; moderate‐certainty evidence), repeat surgery for prolapse (RR 1.15, 95% CI 0.75 to 1.77; I² = 0%; 6 studies, 899 women; moderate‐certainty evidence), and recurrent prolapse on examination (RR 0.96, 95% CI 0.71 to 1.29; I² = 53%; 9 studies, 1278 women; low‐certainty evidence).

There was no evidence of a difference between the groups for dyspareunia or quality of life.

Transvaginal permanent mesh versus any other permanent mesh or biological graft vaginal repair

Sparse reporting of primary outcomes in both comparisons significantly limited any meaningful analysis.

Authors' conclusions

While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, repeat surgery for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of total repeat surgery (for prolapse, stress urinary incontinence, or mesh exposure), bladder injury, and de novo stress urinary incontinence.

While the direction of effects and effect sizes are relatively unchanged from the 2016 version of this review, the certainty and precision of the findings have all improved with a larger sample size. In addition, the clinical relevance of these data has improved, with 10 trials reporting 3‐ to 10‐year outcomes.

The risk‐benefit profile means that transvaginal mesh has limited utility in primary surgery. Data on the management of recurrent prolapse are of limited quality. Given the risk‐benefit profile, we recommend that any use of permanent transvaginal mesh should be conducted under the oversight of the local ethics committee in compliance with local regulatory recommendations.

Data are not supportive of absorbable meshes or biological grafts for the management of transvaginal prolapse.

Plain language summary

Should transvaginal mesh, biological grafts, or native tissue be utilised to repair vaginal prolapse?

Key messages

• Compared to native tissue, transvaginal mesh repair probably reduces (1) the number of women who are aware of prolapse (i.e. they can see or feel a bulge or something falling out in the vaginal area) at 6 months to 7 years after surgery, and (2) the number who need repeat surgery for prolapse. However, transvaginal mesh procedures probably result in more bladder injuries and new incontinence symptoms (unintentional leaking of urine).

• There does not appear to be a benefit in the use of absorbable meshes or biological grafts over native tissue repair. There is insufficient information to draw conclusions when comparing transvaginal permanent meshes to biological grafts.

What is prolapse and how is it surgically treated?

Pelvic organ prolapse refers to the descent of pelvic organs (uterus, bladder, bowel) against the vaginal wall, causing an uncomfortable feeling of a lump or bulge that can be seen on examination. It is a common condition affecting up to 50% of women who have had children.

The traditional method of repairing vaginal prolapse, called 'native tissue repair', uses the patient's own tissue and sutures (stitches). It is associated with high rates of recurrent prolapse. It is thought that the addition of transvaginal grafts, which are made of permanent or absorbable mesh (made of polypropylene – medical‐grade plastic) or biological material (harvested from animals or human organ donors) may improve the outcomes of prolapse surgery.

Many countries (including the UK, Ireland, Australia, New Zealand, the USA, and Canada) have banned the use of transvaginal mesh because of high rates of complications. It remains a treatment option elsewhere, including in some European and Asian countries.

What did we want to find out?

We wanted to find out if any method of prolapse repair (native tissue repair, transvaginal permanent mesh repair, transvaginal graft repair) was better than the other. We also wanted to identify any associated adverse (harmful or unwanted) effects of each method of prolapse repair. This is a review update; the previous version was published in 2016.

What did we do?

We searched for studies that compared any type of transvaginal graft repair with any other transvaginal repair (traditional native tissue suture repair, repair with grafts) for the management of vaginal prolapse (first occurrence or repeat). We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods.

What did we find?

We found 51 studies involving 7846 women. The studies were conducted in 19 countries around the world. The women having surgery ranged in age from 39 to 91 years old. Most had had 2 to 3 children. All permanent meshes were made of polypropylene, except for 1 study which used polytetrafluoroethylene, commonly known by its trade name of Teflon.

Main results

Compared to native tissue repair, transvaginal permanent mesh repair:

• probably reduces the number of women who are aware (i.e. experience symptoms) of prolapse at 6 months to 7 years after surgery;

• probably reduces the number who need repeat surgery specifically for prolapse;

• may lead to a higher rate of repeat surgery for prolapse, incontinence, or mesh erosion (when mesh protrudes through the surgery cut and into the vagina) when considered together. If 7.1% of women undergoing native tissue repair require any repeat surgery, between 7.6% and 16% of women will require repeat surgery after transvaginal permanent mesh repair.

• probably results in more bladder injuries and new incontinence problems.

The most common reason women have permanent mesh implants removed is pain, rather than mesh erosion. Only 1 study in this review reported on women who had mesh removed due to pain.

We conclude that while the use of transvaginal permanent mesh is not supported in most cases, there may be isolated scenarios where women may benefit from this surgical option, due to their particular health and bodily conditions. In these scenarios, transvaginal permanent mesh should be used in compliance with national organisations that regulate medical devices and local ethics committees.

Our conclusions are largely the same as in the 2016 version of this review. We have more confidence in some results because more women have been involved in the studies we analysed.

What are the limitations of the evidence?

Overall, the quality of the evidence was largely moderate (very low to moderate). The main limitations were poor reporting of study methods, inconsistency in reporting, and variability in outcomes.

How up to date is this evidence?

The evidence is current to March 2022.

Summary of findings

Summary of findings 1. Transvaginal permanent mesh compared to native tissue repair for vaginal prolapse.

Transvaginal permanent mesh compared to native tissue repair for vaginal prolapse
Patient or population: vaginal prolapse Setting: clinic Intervention: transvaginal permanent mesh Comparison: native tissue repair
Outcomes		Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
		Risk with native tissue repair	Risk with transvaginal permanent mesh
Awareness of prolapse (0.5 to 7 years)		234 per 1000	194 per 1000 (171 to 222)	RR 0.83 (0.73 to 0.95)	2932 (17 RCTs)	⊕⊕⊕⊝ Moderatea
Repeat surgery (0.5 to 7 years)	Any repeat surgery§	71 per 1000	111 per 1000 (76 to 160)	RR 1.56 (1.07 to 2.26)	3916 (27 RCTs)	⊕⊕⊝⊝ Lowb
	Surgery for recurrent prolapse	80 per 1000	57 per 1000 (42 to 76)	RR 0.71 (0.53 to 0.95)	2485 (17 RCTs)	⊕⊕⊕⊝ Moderatec
	Surgery for urinary incontinence	33 per 1000	34 per 1000 (22 to 52)	RR 1.03 (0.67 to 1.59)	2206 (13 RCTs)	⊕⊕⊕⊝ Moderatec
	Surgery for mesh exposure	2 per 1000	15 per 1000 (8 to 26)	RR 9.51 (5.44 to 16.60)	3853 (27 RCTs)	⊕⊕⊝⊝ Lowd
Recurrent prolapse on examination (any compartment)		462 per 1000	194 per 1000 (148 to 254)	RR 0.42 (0.32 to 0.55)	3680 (25 RCTs)	⊕⊝⊝⊝ Very lowe
Visceral injury	Bladder injury	5 per 1000	18 per 1000 (8 to 42)	RR 3.67 (1.63 to 8.28)	1997 (14 RCTs)	⊕⊕⊝⊝ Lowf
	Bowel injury	0 per 1000	0 per 1000 (0 to 0)	RR 3.26 (0.13 to 78.81)	169 (1 RCT)	⊕⊕⊝⊝ Lowg
Mesh exposure		4 per 1000	44 per 1000 (27 to 72)	RR 11.10 (6.81 to 18.10)	2980 (26 RCTs)	⊕⊕⊕⊝ Moderatec
Bladder function	De novo stress urinary incontinence	96 per 1000	144 per 1000 (114 to 181)	RR 1.50 (1.19 to 1.88)	2001 (17 RCTs)	⊕⊕⊕⊝ Moderatec
	De novo urge incontinence or bladder overactivity	109 per 1000	112 per 1000 (73 to 174)	RR 1.03 (0.67 to 1.60)	597 (6 RCTs)	⊕⊕⊕⊝ Moderatec
	De novo voiding dysfunction	76 per 1000	55 per 1000 (25 to 120)	RR 0.73 (0.33 to 1.59)	344 (4 RCTs)	⊕⊕⊝⊝ Lowh
Painful intercourse ‐ de novo dyspareunia		60 per 1000	73 per 1000 (50 to 108)	RR 1.22 (0.83 to 1.79)	1308 (16 RCTs)	⊕⊕⊕⊝ Moderatec
Quality of life		The mean quality of life in the mesh group was 0.05 standard deviations higher (0.11 lower to 0.22 higher). This is an imprecise finding, consistent with both a small benefit in either group, or no difference between the groups.			1365 (9 RCTs)	⊕⊝⊝⊝ Very lowi
*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; RCT: randomised controlled trial; RR: risk ratio
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.

^§Repeat surgery for prolapse, stress incontinence, and mesh exposure
^aDowngraded one level for risk of selection, performance, and attrition bias. Many studies were at unclear or high risk of bias associated with poor reporting methods, including failure to describe satisfactory methods of allocation concealment as well as the inability to blind participants or assessors from the procedure performed.
^bDowngraded one level for risk of selection, performance, detection, and attrition bias, and one for inconsistency (I² = 54%). Many studies were at unclear or high risk of bias associated with poor reporting methods, including failure to describe satisfactory methods of allocation concealment as well as the inability to blind participants or assessors from the procedure performed.
^cDowngraded one level for risk of performance, detection, and attrition bias
^dDowngraded two levels: one for risk of performance, detection, and attrition bias, and one for imprecision (wide confidence interval)
^eDowngraded three levels: one for risk of performance and detection bias (many studies were unable to blind participants and assessors), one for inconsistency (I² = 84%), and one for publication bias (see Figure 1)
^fDowngraded one level for risk of performance and detection bias and one for imprecision (wide confidence interval)
^gDowngraded two levels: one for indirectness (single study) and one for imprecision (wide confidence interval)
^hDowngraded two levels: one for risk of performance and detection bias and one for imprecision (wide confidence interval)
ⁱDowngraded three levels: one each for serious risk of bias, imprecision, and inconsistency (I² = 46%)

Summary of findings 2. Transvaginal biological graft compared to native tissue repair for vaginal prolapse.

Transvaginal biological graft compared to native tissue repair for vaginal prolapse
Patient or population: vaginal prolapse Setting: clinic Intervention: transvaginal biological graft Comparison: native tissue repair
Outcomes		Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
		Risk with native tissue repair	Risk with transvaginal biological graft
Awareness of prolapse (1 to 3 years)		197 per 1000	208 per 1000 (144 to 307)	RR 1.06 (0.73 to 1.56)	1374 (8 RCTs)	⊕⊕⊕⊝ Moderatea
Surgery for recurrent prolapse (1 to 2 years)		78 per 1000	90 per 1000 (59 to 139)	RR 1.15 (0.75 to 1.77)	899 (6 RCTs)	⊕⊕⊕⊝ Moderateb
Recurrent prolapse on examination	Any compartment	376 per 1000	361 per 1000 (267 to 486)	RR 0.96 (0.71 to 1.29)	1278 (9 RCTs)	⊕⊕⊝⊝ Lowc
	Anterior compartment	292 per 1000	202 per 1000 (158 to 263)	RR 0.69 (0.54 to 0.90)	684 (7 RCTs)	⊕⊕⊕⊝ Moderated
	Posterior compartment	188 per 1000	217 per 1000 (73 to 658)	RR 1.16 (0.39 to 3.51)	283 (3 RCTs)	⊕⊝⊝⊝ Very lowe
Visceral injury	Bladder injury	16 per 1000	5 per 1000 (1 to 51)	RR 0.34 (0.04 to 3.26)	254 (2 RCTs)	⊕⊕⊝⊝ Lowf
	Bowel injury	0 per 1000	0 per 1000 (0 to 0)	RR 3.13 (0.13 to 75.57)	137 (1 RCT)	⊕⊝⊝⊝ Very lowg
Bladder function	De novo stress urinary incontinence	12 per 1000	147 per 1000 (19 to 1000)	RR 12.64 (1.60 to 100.06)	143 (2 RCTs)	⊕⊝⊝⊝ Very lowh
	De novo urge incontinence or bladder overactivity	51 per 1000	107 per 1000 (23 to 498)	RR 2.11 (0.45 to 9.79)	87 (1 RCT)	⊕⊝⊝⊝ Very lowi
	De novo voiding dysfunction	151 per 1000	122 per 1000 (44 to 341)	RR 0.81 (0.29 to 2.26)	93 (2 RCTs)	⊕⊕⊝⊝ Lowd
Painful intercourse ‐ de novo dyspareunia		79 per 1000	103 per 1000 (36 to 289)	RR 1.30 (0.46 to 3.66)	125 (2 RCTs)	⊕⊕⊕⊝ Moderateb
Quality of life		The mean quality of life in the biological repair group was 0.01 standard deviations lower (0.47 lower to 0.27 higher). This is an imprecise finding that is consistent with a small benefit in either group, or else no difference between the groups			112 (3 RCTs)	⊕⊝⊝⊝ Very lowj	Paraiso 2006 reported 2 quality of life outcomes
*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; RCT: randomised controlled trial; RR: risk ratio
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: some studies were at high risk of performance and detection bias due to poor blinding of participants and assessors
^bDowngraded one level: risk of performance, detection, and attrition bias (a few studies were unable to blind the participants or assessors and two studies had high loss to follow‐up)
^cDowngraded two levels: risk of performance and detection bias, and inconsistency (I² = 53%)
^dDowngraded two levels: risk of detection and attrition bias, and imprecision (wide confidence interval)
^eDowngraded three levels: risk of performance bias, inconsistency (I² = 80%), and imprecision (wide confidence interval)
^fDowngraded two levels: risk of performance and detection bias, and imprecision (wide confidence interval)
^gDowngraded three levels: one for indirectness (single study) and two levels for imprecision (wide confidence interval) due to a very low incidence in event rate
^hDowngraded three levels: one for risk of performance and detection bias, and two levels for imprecision (wide confidence interval). One study reported no incidence in either group.
ⁱDowngraded three levels: risk of performance and detection bias, indirectness (single study), and imprecision (wide confidence interval)
^jDowngraded one level due to serious risk of attrition bias, and a further two levels due to very serious imprecision: only 112 participants with one study reporting two quality of life outcomes

Background

Description of the condition

Pelvic organ prolapse is common and is seen on examination in 40% to 60% of parous women (Handa 2004; Hendrix 2002). The annual aggregated rate of associated surgery in the USA is in the range of 10 to 30 per 10,000 women (Brubaker 2002). Pelvic organ prolapse is the descent of one or more of the pelvic organs (uterus, vaginal apex, bladder, or bowel) into the vagina. The different types of prolapse include (Haylen 2010):

• upper vaginal prolapse (apical prolapse), i.e. uterus, vaginal vault (after hysterectomy when the top of the vagina drops down);

• anterior vaginal wall prolapse, i.e. cystocele (bladder descends), urethrocele (urethra descends), paravaginal defect (pelvic fascia defect);

• posterior vaginal wall prolapse, i.e. enterocele (small bowel descends), rectocele (rectum descends).

A woman can present with prolapse of one or more of these sites.

The aetiology of pelvic organ prolapse is complex and multifactorial. Possible risk factors include pregnancy, childbirth, congenital or acquired connective tissue abnormalities, denervation or weakness of the pelvic floor, ageing, hysterectomy, menopause, and factors associated with chronically raised intra‐abdominal pressure (Bump 1998; Deprest 2022; Gill 1998; MacLennan 2000; Vergeldt 2015).

Women with prolapse commonly have a variety of pelvic floor symptoms, only some of which are directly related to the prolapse. Common symptoms of prolapse include pelvic heaviness; bulge, lump, or protrusion coming down from the vagina; a dragging sensation in the vagina; or backache. Symptoms of bladder, bowel, or sexual dysfunction are frequently present. For example, women may need to reduce the prolapse digitally to aid urinary voiding or defecation. These symptoms may be directly related to the prolapsed organ; for example, poor urinary stream when a cystocele is present or obstructed defecation in case of a rectocele. They may also be independent of the prolapse; for example, symptoms of an overactive bladder when a cystocele is present, or irritable bowel when a rectocele is present.

Description of the intervention

Treatment of prolapse depends on the severity of the prolapse, its symptoms, the woman's general health, and surgeon preference and capabilities. Options available for treatment are conservative, mechanical, or surgical interventions.

Generally, conservative or mechanical treatments are considered for women with a mild degree of prolapse or bothersome symptoms, those who wish to have more children, the frail, or those women unwilling to undergo surgery. Conservative and mechanical interventions have been considered in separate Cochrane reviews (Adams 2004; Hagen 2011). There was no good evidence to guide management in either of these reviews.

A wide variety of vaginal and abdominal surgical techniques are available for the treatment of prolapse (see Appendix 1).

• Vaginal approaches include vaginal hysterectomy, anterior or posterior vaginal wall repair (colporrhaphy), McCall culdoplasty, Manchester repair (amputation of the cervix with uterus suspension to the cardinal ligaments), prespinous and sacrospinous colpopexy, enterocele ligation, paravaginal repair, Le Fort's procedure, and perineal reconstruction.

• Abdominal approaches include hysterectomy, sacral colpopexy, paravaginal repair, vault suspending and uterosacral ligament plication, enterocele ligation, and posterior vaginal wall repair. Abdominal surgery can be performed through an open incision or keyhole incisions via the laparoscope or robot.

A combination of these procedures may be employed in the surgical correction of prolapse, as, frequently, more than one type of prolapse may occur.

Over the last decade, in an effort to reduce prolapse recurrence, surgeons have increasingly used grafts in transvaginal repairs, given their successful use in continence surgery, sacral colpopexy, and abdominal hernias. Graft material can be synthetic (for example, permanent polypropylene or absorbable polyglactin mesh) or biological. Biological grafts can be further divided into autologous (using a person's own tissue, such as fascial sheath), alloplastic (from animals; for example, porcine dermis), or homologous (for example, cadaveric fascia lata) grafts.

Previously, the Cochrane review on surgical management of pelvic organ prolapse evaluated all aspects of prolapse surgery (Maher 2004b). This review was subsequently split into six reviews (Baessler 2018; Haya 2018; Maher 2016; Maher 2016b; Maher 2016c; Mowat 2018). This review update evaluates all surgeries conducted using the vaginal approach and where at least one study arm included the use of a graft.

How the intervention might work

The aims of surgery include:

• the restoration of normal vaginal anatomy;

• the restoration or maintenance of normal bladder function;

• the restoration or maintenance of normal bowel function;

• the restoration or maintenance of normal sexual function.

The restoration of normal anatomy is achieved by utilising grafts as an alternative to native tissue repair. The graft is utilised with the aim of reducing the likelihood of the bladder descending into the vagina, the bowel moving forward into the vagina, or the uterus or upper vagina descending towards or beyond the vaginal opening.

To aid the assessment of the success of surgery, clear pre‐ and postoperative site‐specific vaginal grading and details of the operative intervention should be recorded in the reports.

Why it is important to do this review

The wide variety of surgical treatments available for prolapse indicates the lack of consensus as to the optimal treatment. No clinical guidelines exist to identify the preferred surgical intervention. The most reliable evidence is likely to come from the consideration of randomised controlled trials, and this is the basis for our review. The aim is to help identify optimal practice and to highlight where there is a need for further research.

This review should be read as part of a series of six Cochrane reviews relating to the surgical management of prolapse:

• surgery for women with anterior compartment prolapse (Maher 2016b);

• surgery for women with posterior compartment prolapse (Mowat 2018);

• surgery for women with apical vaginal prolapse (Maher 2023);

• surgery for women with pelvic organ prolapse with or without stress urinary incontinence (Baessler 2018);

• transvaginal grafts or mesh compared with native tissue repair for vaginal prolapse (present review);

• peri‐operative interventions in pelvic organ prolapse surgery (Haya 2018).

This review evaluates any transvaginal grafts as compared to any other transvaginal prolapse repair and is an update of the previous version published in 2016 (Maher 2016). We have included 16 new trials (Ahmed 2019; Chen 2020; Chiang 2021; Damiani 2016; Dietz 2020; Galad 2020; Glazener 2017; Glazener 2020; Iyer 2019; Nager 2019; Ouyang 2020; Shaher 2020; Steures 2019; Takeyama 2020; Wei 2019; Yang 2016). We located five new publications for studies included in the 2016 version of the review (da Silveira 2014; Delroy 2013; De Tayrac 2013; Tamanini 2014; Withagen 2011).

Since the last iteration of the review, transvaginal permanent meshes have been removed from the market in many countries due to findings of unacceptable complication rates for women undergoing these procedures (see Appendix 2). This review update evaluates the data from the period during which these findings came to light.

Objectives

To determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair or other grafts in the surgical treatment of vaginal prolapse.

Methods

Criteria for considering studies for this review

Types of studies

We included published and unpublished randomised control trials (RCTs) in which any surgery in one arm included a transvaginal mesh or graft. We excluded quasi‐randomised studies (e.g. studies with evidence of inadequate sequence generation such as alternate days, patient numbers) as they are associated with a high risk of bias. We excluded cross‐over studies, as this design is not valid in the context of this systematic review of surgical interventions.

Trials were required to have at least six months of follow‐up and at least 20 women in each arm to be eligible for inclusion in the review.

We excluded studies that have been published as abstracts only, without a subsequent peer‐reviewed publication within 15 years after abstract publication.

Types of participants

Adult women seeking treatment for symptomatic pelvic organ prolapse (either primary or recurrent).

Pelvic organ prolapse includes:

• anterior vaginal wall prolapse (cystocele, urethrocele, paravaginal defect);

• upper vaginal prolapse (apical prolapse; i.e. prolapse of the uterus or vaginal vault in those who have undergone a hysterectomy);

• posterior vaginal wall prolapse (enterocele, rectocele, perineal deficiency).

Types of interventions

Eligible trials included those comparing any type of transvaginal graft utilised for prolapse repair with any other transvaginal repair. Grafts included absorbable or permanent mesh materials or biological implants.

Types of outcome measures

Primary outcomes

• Awareness of prolapse: defined as affirmative response to questions relating to awareness of prolapse or vaginal bulge, or affirmative response to question three of the Pelvic Floor Distress Inventory (PFDI‐20), “Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?”.

• Repeat surgery

  • Surgery for recurrent prolapse

  • Surgery for stress urinary incontinence

  • Surgery for mesh exposure

• Recurrent prolapse on examination: the finding of a vaginal prolapse of IUGA‐ICS (International Urogynecological Association/International Continence Society) POP‐Q (pelvic organ prolapse quantification) Stage II or higher. Stage II prolapse is defined as when the most distal portion of the prolapse is 1 cm or less proximal or distal to the plane of the hymenal remnant.

Secondary outcomes

• Prolapse outcomes

  • Recurrent prolapse on examination (anterior compartment)

  • Recurrent prolapse on examination (posterior compartment)

• POP‐Q assessment. POP‐Q scores describe nine measurements of the vagina to quantify and describe vaginal prolapse. For simplicity, we have reported four of these basic measurements:

  • Point Ba on POP‐Q assessment (range ‐3 to +10 cm). Point Ba is approximately the midpoint of the anterior vaginal wall.

  • Point Bp on POP‐Q assessment (range ‐3 to +10 cm). Point Bp is approximately the midpoint of the posterior vaginal wall.

  • Point C on POP‐Q assessment (ranges from ‐10 cm to a non‐determined limit). Point C describes the vaginal apex (cervix or upper vagina).

  • Total vaginal length (TVL) in centimetres (range 0 to 14 cm). TVL is the length from the vaginal entrance to the apex (cervix or vaginal cuff).

• Adverse events

  • Visceral injury – injury to bladder or bowel

  • Mesh exposure

• Bladder function

  • De novo stress urinary incontinence

  • De novo urgency, urge incontinence, or bladder overactivity

  • De novo voiding dysfunction

• Sexual function

  • Painful intercourse – de novo dyspareunia

  • Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire‐12 (PISQ‐12): range 0 to 48; the higher the score, the better the sexual function

• Quality of life and satisfaction measured by questionnaire

  • Prolapse Quality of Life questionnaire (P‐QoL): range 0 to 100; the higher the score, the greater the dysfunction

  • Pelvic Floor Distress Inventory (PFDI‐20): range 0 to 300; the higher the score, the greater the dysfunction

  • Pelvic Floor Impact Questionnaire‐7 (PFIQ‐7): range 0 to 300; the higher the score, the greater the dysfunction

  • International Consultation on Incontinence Questionnaire – Vaginal Symptoms (ICIQ‐VS)

  • Patient Global Impression of Improvement (PGI‐I): data presented as a 7‐point Likert scale; responses of "much better" or "very much better" were considered affirmative and presented as a dichotomous outcome

• Measures associated with surgery

  • Operating time

  • Length of stay in hospital (measured in days)

  • Blood transfusion

Search methods for identification of studies

We did not impose any language or date restrictions in our searches.

Electronic searches

This review drew on the search strategy developed for the Cochrane Incontinence Group that identified relevant trials from the Group's Specialised Register of controlled trials. This Register contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov (https://clinicaltrials.gov/), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (https://www.who.int/clinical-trials-registry-platform), and handsearching of journals and conference proceedings.

The Incontinence Group Specialised Register was searched on 14 March 2022 using the Group's own keyword system; the search terms used are given in Appendix 3.

Searching other resources

We searched the reference lists of relevant articles, and contacted researchers in the field for further data.

Data collection and analysis

Selection of studies

Two review authors assessed the titles and, if available, the abstracts of all potentially eligible studies for compliance with the review inclusion criteria. Two review authors then independently assessed the full reports of each study likely to be eligible. We have listed excluded studies with the reasons for their exclusion in the Characteristics of excluded studies table.

Data extraction and management

At least two review authors independently undertook data extraction, and compared data to ensure accuracy. We resolved any discrepancies through discussion or by consulting a third review author. Where trial data were inadequately reported, we attempted to acquire the necessary information from the trialist.

Assessment of risk of bias in included studies

Two review authors independently assessed the included studies for risk of bias using the Cochrane risk of bias assessment tool (RoB 1) in order to assess: selection bias (random sequence generation and allocation concealment); performance bias (blinding of participants and personnel); detection bias (blinding of outcome assessors); attrition bias (incomplete outcome data); reporting bias (selective reporting); and other bias (Higgins 2011b). We resolved any disagreements through discussion or by consulting a third review author. We described all judgements fully, presented our conclusions in the risk of bias tables, and incorporated these judgements into our interpretation of review findings by means of sensitivity analyses (see Sensitivity analysis).

Measures of treatment effect

For dichotomous data, we used the numbers of events in the control and intervention groups of each study to calculate Mantel‐Haenszel risk ratios (RRs). For continuous data, if all studies reported exactly the same outcomes, we calculated the mean difference between treatment groups. If similar outcomes were reported on different scales, we planned to calculate the standardised mean difference. We presented 95% confidence intervals (CIs) for all outcomes. We compared the magnitude and direction of effect reported by studies with how they are presented in the review, taking account of legitimate differences. We interpreted the standardised mean difference as follows: an effect size of 0.2 is a small effect, an effect size of 0.5 is a medium effect, and an effect size of 0.8 is a large effect (Cohen 1988).

Unit of analysis issues

All analyses were per woman randomised.

Dealing with missing data

We analysed the data on an intention‐to‐treat basis (once randomised to an intervention, the participants are analysed in that intervention and analysis includes all randomised participants) as far as possible, and made attempts to obtain missing data from the original trialists. Where these were unobtainable, we analysed only the available data.

Assessment of heterogeneity

We considered whether the clinical and methodological characteristics of the included studies were sufficiently similar for meta‐analysis to provide a clinically meaningful summary. We assessed statistical heterogeneity by the measure of the I². An I² measurement greater than 40% was taken to indicate substantial heterogeneity (Higgins 2011a), and a random‐effects calculation was undertaken to express greater uncertainty by widening the confidence intervals.

Assessment of reporting biases

In view of the difficulty of detecting and correcting for publication bias and other reporting biases, we aimed to minimise their potential impact by ensuring a comprehensive search for eligible studies and by being alert to the duplication of data. If there were 10 or more studies in an analysis, we planned to use a funnel plot to explore the possibility of small‐study effects (a tendency for estimates of the intervention effect to be more beneficial in smaller studies).

Data synthesis

We excluded studies with a very high risk of bias – defined as high risk in four or more domains in the risk of bias table – from our primary analysis to minimise the risk of data contamination and, hence, to increase certainty in the results. We included these trials in sensitivity analysis of primary outcomes.

If the studies were sufficiently similar, we combined the data using a fixed‐effect model in the following comparisons.

• Transvaginal permanent mesh versus native tissue repair, stratified by type of repair:

  • anterior compartment permanent mesh versus native tissue

  • multi‐compartment (apical, anterior, and/or posterior) permanent mesh repair versus native tissue

• Transvaginal absorbable mesh versus native tissue repair

• Transvaginal biological graft versus native tissue repair

• Transvaginal permanent mesh versus another vaginal mesh

• Transvaginal permanent mesh versus biological graft vaginal repair

An increase in the risk of a particular outcome, which may be beneficial (for example, the patient's global impression of improvement) or detrimental (for example, reoperation for prolapse), is displayed graphically in the meta‐analyses to the right of the centre‐line, and a decrease in the risk of an outcome to the left of the centre‐line.

Subgroup analysis and investigation of heterogeneity

Where data were available, we considered the separate evidence for the primary outcomes within the following subgroups:

• anterior compartment repair only;

• multi‐compartment repair (apical and/or anterior and/or posterior).

We investigated differences between subgroups by means of a formal test for significance (Chi² test). We interpreted a low P value (< 0.05) as evidence of differences between the subgroups (variation in effect estimates beyond chance). We also computed an I² statistic to describe the percentage of the variability in effect estimates from the different subgroups that is due to genuine subgroup differences rather than sampling error (chance) (Higgins 2011a).

If we detected substantial heterogeneity, we explored possible explanations in sensitivity analyses. We took any statistical heterogeneity into account when interpreting the results, especially if there was any variation in the direction of effect, as described above. Where there was substantial heterogeneity, we used a random‐effects model.

Sensitivity analysis

We conducted sensitivity analyses for the primary outcomes to determine whether the conclusions were robust to arbitrary decisions made regarding study eligibility and analysis. These analyses included consideration of whether the review conclusions would have differed if:

• a random‐effects model had been adopted;

• the summary effect measure had been odds ratio rather than risk ratio;

• meta‐analysis had included all trials, including those with a high risk of bias.

Summary of findings and assessment of the certainty of the evidence

We prepared two summary of findings tables using GRADEpro software and Cochrane methods (GRADEpro GDT 2014; Schünemann 2023). These tables evaluate the overall certainty of the body of evidence for the following review outcomes:

• awareness of prolapse;

• repeat surgery;

• recurrent prolapse on examination;

• visceral injury;

• mesh exposure (if relevant);

• bladder function;

• painful intercourse;

• quality of life.

We used the five GRADE criteria (study limitations (that is, risk of bias), consistency of effect, imprecision, indirectness, and publication bias) for the evaluation of evidence certainty (GRADEpro GDT 2014). Working independently, two review authors evaluated the overall certainty of the body of evidence for the main outcomes of the two core review comparisons (transvaginal permanent mesh versus native tissue repair; transvaginal biological graft versus native tissue repair). If we judged there to be serious risk of bias, inconsistency, imprecision, indirectness, or suspicion of publication bias, we downgraded the evidence by one level (for each domain affected). We downgraded the evidence by two levels if the risk was considered very serious. We justified, documented, and incorporated our judgements about evidence certainty (high, moderate, low, or very low) into the reporting of results for each outcome.

Results

Description of studies

Results of the search

For this review update, the database searches identified 1213 records. After deduplication, 1172 records remained for title and abstract screening. We discarded 1145 records as irrelevant to the review, and obtained the full texts of the remaining 27 records for assessment. Of these, we excluded three studies due to ineligible study design, and three trial registrations that did not proceed to publication. We identified 16 new studies (16 articles) eligible for inclusion in this update (Ahmed 2019; Chen 2020; Chiang 2021; Damiani 2016; Dietz 2020; Galad 2020; Glazener 2017; Glazener 2020; Iyer 2019; Nager 2019; Ouyang 2020; Shaher 2020; Steures 2019; Takeyama 2020; Wei 2019; Yang 2016), and five articles updating studies included in the previous version of the review (da Silveira 2014; Delroy 2013; De Tayrac 2013; Tamanini 2014; Withagen 2011).

The 2016 version of the review included 37 studies (Maher 2016). However, we excluded two of these in this review update (Ali 2006; Meschia 2004), in line with our review criteria (Types of studies). These studies have been published as abstracts only, and more than 15 years have elapsed since abstract publication without a subsequent peer‐reviewed publication. Thus, we have ultimately included 51 studies evaluating transvaginal mesh or graft compared with a transvaginal native tissue, biological, absorbable or permanent meshes in this update. There are now a total of 13 studies excluded with reasons (six in this review update, five from the 2016 version of the review, plus Ali 2006 and Meschia 2004). See Figure 2.

2.

PRISMA flow diagram

Included studies

Study design and setting

All 51 included studies were parallel‐group randomised controlled trials (RCTs). They were conducted in 19 countries (Australia, Belgium, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Italy, India, Japan, Netherlands, Slovakia, Sweden, Turkey, United Kingdom, and USA). Twenty trials were multicentre randomised trials (Altman 2011; Dahlgren 2011; da Silveira 2014; Delroy 2013; De Tayrac 2013; Glazener 2017; Glazener 2020; Guerette 2009; Halaska 2012; Iglesia 2010; Menefee 2011; Meschia 2007; Nager 2019; Nieminen 2008; Ouyang 2020; Rudnicki 2014; Steures 2019; Sung 2012; Vollebregt 2011; Withagen 2011).

Participants

A total of 7846 women were randomised into the 51 included trials. The ages of women undergoing interventions ranged from 39 to 91 years, with a median age between 60 and 66 years old. Most of the women undergoing surgery had a parity of two to three, with a range of zero to 11. Most trials allowed women requiring hysterectomy to be included in the analysis, except for Hviid 2010, Rudnicki 2014, and Vollebregt 2011, which excluded women who required a hysterectomy. Only Galad 2020 evaluated women who had all undergone a previous hysterectomy. In two studies (Steures 2019; Withagen 2011), those allocated mesh interventions were not able to undergo hysterectomy whilst those in the native tissue repair group were able to have a hysterectomy. Women with concomitant stress incontinence were included in 46 of 51 studies (the five exceptions were: Gupta 2014; Hviid 2010; Sivaslioglu 2008; Vollebregt 2011; and Weber 2001). In contrast, two studies included only women who had concomitant stress urinary incontinence (Ahmed 2019; Shaher 2020).

Interventions

• Polypropylene permanent mesh versus native tissue: 31 studies (involving 4538 women) made this comparison (Ahmed 2019; Al‐Nazer 2007; Altman 2011; Carey 2009; Damiani 2016; da Silveira 2014; Delroy 2013; De Tayrac 2008; De Tayrac 2013; Dietz 2020; Galad 2020; Glazener 2017; Glazener 2020; Gupta 2014; Halaska 2012; Iglesia 2010; Lamblin 2014; Menefee 2011; Nager 2019; Nguyen 2008; Nieminen 2008; Qatawneh 2013; Rudnicki 2014; Shaher 2020; Sivaslioglu 2008; Steures 2019; Svabik 2014; Tamanini 2014; Thijs 2010; Turgal 2013; Vollebregt 2011; Withagen 2011).

  • Anterior compartment repair: 18 studies (2302 women) compared permanent mesh versus native tissue for anterior compartment repair (Ahmed 2019; Al‐Nazer 2007; Altman 2011; Delroy 2013; De Tayrac 2013; Gupta 2014; Lamblin 2014; Menefee 2011; Nguyen 2008; Nieminen 2008; Qatawneh 2013; Rudnicki 2014; Shaher 2020; Sivaslioglu 2008; Tamanini 2014; Thijs 2010; Turgal 2013; Vollebregt 2011).

  • Multi‐compartment repair: 13 studies (2236 women) compared permanent mesh versus native tissue for apical, anterior, and/or posterior repair (Carey 2009; Damiani 2016; da Silveira 2014; Dietz 2020; De Tayrac 2008; Galad 2020; Glazener 2017; Halaska 2012; Iglesia 2010; Nager 2019; Steures 2019; Svabik 2014; Withagen 2011).

• Absorbable mesh versus native tissue: three studies (348 women) made this comparison (Allahdin 2008; Sand 2001; Weber 2001).

• Biological graft repair versus native tissue: 13 studies (2074 women) made this comparison (Dahlgren 2011; Damiani 2016; Feldner 2010; Gandhi 2005; Glazener 2017; Guerette 2009; Hviid 2010; Iyer 2019; Menefee 2011; Meschia 2007; Paraiso 2006; Robert 2014; Sung 2012).

• Transvaginal permanent mesh versus another permanent mesh: four studies (412 women) made this comparison (Chen 2020; Ouyang 2020; Takeyama 2020; Yang 2016).

• Transvaginal permanent mesh versus biological graft vaginal repair: two studies (319 women) made this comparison (Damiani 2016; Wei 2019).

Outcomes

Most studies reported at least one of our primary outcomes and reported data in a form suitable for analysis:

• Twenty‐one studies reported awareness of prolapse (Allahdin 2008; Al‐Nazer 2007; Altman 2011; Carey 2009; Dahlgren 2011; De Tayrac 2013; Dietz 2020; Gandhi 2005; Glazener 2017; Glazener 2020; Gupta 2014; Hviid 2010; Iglesia 2010; Lamblin 2014; Meschia 2004; Nager 2019; Nieminen 2008; Paraiso 2006; Qatawneh 2013; Steures 2019; Vollebregt 2011).

• Twenty‐nine reported repeat surgery for prolapse, incontinence, mesh exposure, or for the composite outcome (prolapse, incontinence, or mesh exposure) (Allahdin 2008; Altman 2011; Damiani 2016; Damiani 2016; da Silveira 2014; De Tayrac 2013; Feldner 2010; Galad 2020; Glazener 2017; Glazener 2020; Guerette 2009; Halaska 2012; Hviid 2010; Iglesia 2010; Lamblin 2014; Menefee 2011; Nager 2019; Nguyen 2008; Nieminen 2008; Paraiso 2006; Qatawneh 2013; Robert 2014; Steures 2019; Tamanini 2014; Thijs 2010; Turgal 2013; Vollebregt 2011; Wei 2019; Withagen 2011).

• Thirty‐four reported recurrent prolapse on examination (Allahdin 2008; Al‐Nazer 2007; Carey 2009; Chiang 2021De Tayrac 2008; De Tayrac 2013; Feldner 2010; Gandhi 2005; Glazener 2017; Glazener 2020; Halaska 2012; Hviid 2010; Iglesia 2010; Menefee 2011; Nager 2019; Nguyen 2008; Nieminen 2008; Paraiso 2006; Qatawneh 2013; Ouyang 2020; Robert 2014; Rudnicki 2014; Sand 2001; Shaher 2020; Steures 2019; Sivaslioglu 2008; Svabik 2014; Tamanini 2014; Takeyama 2020; Turgal 2013; Vollebregt 2011; Weber 2001; Wei 2019; Withagen 2011).

Two studies did not report any of our primary outcomes, but did report at least one of our secondary outcomes (Allahdin 2008; Delroy 2013). We could not include Chiang 2021 in any of the review comparisons as it compared mesh surgery with and without fascial plication.

Most of the included studies reported outcomes at 12 months, except for Shaher 2020, which reported 6‐month outcomes. Ten studies reported 2‐year outcomes (Allahdin 2008; Damiani 2016; Delroy 2013; Glazener 2017; Guerette 2009; Lamblin 2014; Menefee 2011; Meschia 2007; Steures 2019; Weber 2001); five studies reported 3‐year outcomes (Dahlgren 2011; Galad 2020; Iglesia 2010; Nieminen 2008; Ouyang 2020); three studies reported 5‐year outcomes (da Silveira 2014; Nager 2019; Tamanini 2014); and two studies reported 7‐ to 10‐year outcome data (Iyer 2019; Withagen 2011).

Where studies reported "mesh erosion" and did not differentiate this from "mesh exposure", we included these data in analyses of mesh exposure.

We excluded Glazener 2020 from our primary analysis as we assessed this study to have a high risk of bias in four of seven domains (Data synthesis). We included studies assessed as having a high risk of bias in the sensitivity analyses.

See Characteristics of included studies for full details of the included studies.

Excluded studies

We excluded 10 studies from the review: three studies excluded in this review update (Lukacz 2020; Reid 2021; Wallace 2021), two studies moved from 'included' to 'excluded' due to the lack of a peer‐reviewed publication (Ali 2006; Meschia 2004), and five excluded in the previous version (Altman 2013; Balci 2011; Chao 2012; Juneja 2010; Tincello 2009). We also excluded three trial registrations that did not proceed to publication (NCT00743535; NCT01497171; NCT01594372). We have provided full details in the Characteristics of excluded studies table.

Risk of bias in included studies

See Figure 3 and Figure 4.

3.

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

4.

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

Allocation

Random sequence generation and allocation concealment

Thirty‐nine of the included studies adequately described their sequence generation method, and 26 described an adequate method of allocation concealment (for example, remote allocation or use of consecutively numbered, sealed, opaque envelopes).

We rated 12 studies that did not clearly describe an adequate method of sequence generation as having an unclear risk of bias in this domain.

We rated 23 studies that did not describe an adequate method of allocation concealment as having an unclear risk in this domain, and two studies as having a high risk of bias, as they either did not use allocation concealment (Tamanini 2014), or we suspected a high potential for bias (Withagen 2011).

Blinding

Blinding of participants, personnel, and outcome assessors

Ten trials performed blinding of women and the postoperative reviewer (Allahdin 2008; Iglesia 2010; Iyer 2019; Menefee 2011; Nguyen 2008; Ouyang 2020; Paraiso 2006; Robert 2014; Sung 2012; Wei 2019). Non‐surgeons conducted outcome assessments in 10 trials (Al‐Nazer 2007; da Silveira 2014; Delroy 2013; Feldner 2010; Iglesia 2010; Meschia 2007; Paraiso 2006; Sung 2012; Svabik 2014; Weber 2001).

We rated 12 studies as having a low risk of performance bias, 23 as unclear risk, and 16 as high risk of bias in this domain.

We rated 15 studies as having a low risk of detection bias, 18 as unclear risk, and 18 as high risk of bias in this domain.

Incomplete outcome data

Loss to follow‐up varied, ranging from zero in Allahdin 2008 to 53% in Guerette 2009 (49/93). Weber 2001 also reported a significantly higher loss to follow‐up in one arm of the trial (ultra‐lateral anterior vaginal wall repair). Low attrition rates of less than 30% at seven years were reported by Iyer 2019 and Withagen 2011.

We rated 32 RCTs as having a low risk of attrition bias, nine as unclear risk, and 10 as high risk of bias in this domain.

Selective reporting

We deemed 41 studies to be at low risk of selective reporting. We rated 10 studies as having an unclear risk of selective reporting because they did not report pre‐trial registration (Ahmed 2019; Chiang 2021; Damiani 2016; Dietz 2020; Galad 2020; Iyer 2019; Ouyang 2020; Shaher 2020; Takeyama 2020; Weber 2001), or did not report data separately for the two groups (Weber 2001).

Other potential sources of bias

All trials reported baseline descriptive characteristics, and there was no evidence of a difference between the groups, except in three trials: in Sand 2001, previous hysterectomy was more common in the mesh overlay group; in Withagen 2011, women in the native tissue group had greater degree prolapse at point A posterior (Ap), point B posterior (Bp), and genital hiatus (GH) compared to the mesh group, and prior sacral colpopexy was three times more frequent in the mesh group; and in Lamblin 2014, the rate of concomitant hysterectomy was twice as common in the vaginal colposuspension group (77%) as in the mesh group (33%, P < 0.001).

All trials reported preoperative prolapse status, but one trial did not specifically report equal distribution and severity of prolapse between groups (Sand 2001), and Weber 2001 included 7% of women with stage 1 anterior vaginal wall prolapse preoperatively (at time of inclusion), which would also have been classified as a postoperative success.

We rated 23 RCTs as having a low risk of other bias, 20 as unclear risk, and eight as high risk of bias in this domain.

Effects of interventions

See: Table 1; Table 2

Comparison 1. Transvaginal permanent mesh versus native tissue repair

Thirty‐one RCTs (4538 women) were included in this comparison. The studies compared permanent mesh versus native tissue repair in women having either anterior or multi‐compartment repair (Ahmed 2019; Al‐Nazer 2007; Altman 2011; Carey 2009; Damiani 2016; da Silveira 2014; Delroy 2013; De Tayrac 2008; De Tayrac 2013; Dietz 2020; Galad 2020; Glazener 2017; Gupta 2014; Halaska 2012; Iglesia 2010; Lamblin 2014; Menefee 2011; Nager 2019; Nguyen 2008; Nieminen 2008; Qatawneh 2013; Rudnicki 2014; Shaher 2020; Sivaslioglu 2008; Steures 2019; Svabik 2014; Tamanini 2014; Thijs 2010; Turgal 2013; Vollebregt 2011; Withagen 2011).

1. Anterior compartment repair: 18 RCTs (2302 women) compared permanent mesh versus native tissue for anterior compartment repair (Ahmed 2019; Al‐Nazer 2007; Altman 2011; Delroy 2013; De Tayrac 2013; Gupta 2014; Lamblin 2014; Menefee 2011; Nguyen 2008; Nieminen 2008; Qatawneh 2013; Rudnicki 2014; Shaher 2020; Sivaslioglu 2008; Tamanini 2014; Thijs 2010; Turgal 2013; Vollebregt 2011).

2. Multi‐compartment repair: 13 RCTs (2236 women) compared permanent mesh versus native tissue for apical, anterior, and/or posterior repair (Carey 2009; Damiani 2016; Dietz 2020; da Silveira 2014; De Tayrac 2008; Galad 2020; Glazener 2017; Halaska 2012; Iglesia 2010; Nager 2019; Steures 2019; Svabik 2014; Withagen 2011).

See Table 1.

Primary outcomes

Awareness of prolapse (6‐month to 7‐year review)

Women who had permanent transvaginal mesh repair were less likely to report awareness of prolapse than women who had native tissue repair (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.73 to 0.95; I² = 34%; 17 studies, 2932 women; moderate‐certainty evidence; Analysis 1.1; Figure 5). This suggests that if 23% of women are aware of prolapse after native tissue repair, between 17% and 22% will be aware of prolapse after permanent mesh repair.

1.1. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 1: Awareness of prolapse (0.5 to 7 years)

5.

1.1 Awareness of prolapse (0.5 to 7 years

Subgroup analysis by location of repair

When we conducted a subgroup analysis by location of repair, there was evidence of a difference between anterior compartment mesh and multi‐compartment mesh: Chi² = 5.71, df = 1 (P = 0.02), I² = 82.5%. Anterior compartment mesh was associated with a lower rate of awareness of prolapse (RR 0.67, 95% CI 0.52 to 0.84) compared to native tissue repair, whilst there was no difference between multi‐compartment mesh and native tissue repair (RR 0.95, 95% CI 0.80 to 1.12).

Repeat surgery (6‐month to 7‐year review)

Surgery for recurrent prolapse

The rate of repeat surgery for prolapse was lower in the mesh group (RR 0.71, 95% CI 0.53 to 0.95; I² = 35%; 17 studies, 2485 women; moderate‐certainty evidence; Analysis 1.2; Figure 6). This suggests that if 8.0% of women require repeat prolapse surgery after native tissue repair, between 4.2% and 7.6% will require repeat prolapse surgery after transvaginal mesh repair.

1.2. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 2: Repeat surgery (0.5 to 7 years)

6.

1.2 Repeat surgery (0.5 to 7 years)

Surgery for stress urinary incontinence

There was no evidence of a difference between the groups in the rate of repeat surgery for stress urinary incontinence (RR 1.03, 95% CI 0.67 to 1.59; I² = 0%; 13 studies, 2206 women; moderate‐certainty evidence; Analysis 1.2; Figure 6). This suggests that if 33% of women require repeat surgery after native tissue repair, between 22% and 52% will require repeat surgery after permanent mesh repair.

Surgery for mesh exposure

The rate of surgery for mesh exposure was higher in the mesh group (RR 9.51, 95% CI 5.44 to 16.60; I² = 0%; 27 studies, 3853 women; low‐certainty evidence; Analysis 1.2; Figure 6). This suggests that if 0.2% of women undergo subsequent surgery for mesh exposure after native tissue repair, between 0.8% and 2.6% would require repeat surgery after transvaginal permanent mesh repair.

Any repeat surgery (recurrent prolapse, stress urinary incontinence, or mesh exposure)

The total rate of repeat surgery was higher in the mesh group (RR 1.56, 95% CI 1.07 to 2.26; I² = 54%; 27 studies, 3916 women; low‐certainty evidence; Analysis 1.20; Figure 7). This suggests that if 7.1% of women require repeat surgery after native tissue repair, between 7.6% and 16% will require repeat surgery after permanent mesh repair.

1.20. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 20: Any repeat surgery (0.5 to 7 years)

7.

1.20 Any repeat surgery (0.5 to 7 years)

Recurrent prolapse on examination (any compartment)

Women who had transvaginal mesh repair were less likely to have stage 2 or greater prolapse on examination in any compartment than after a native tissue repair (random‐effects model; RR 0.42, 95% CI 0.32 to 0.55; I² = 84%; 25 studies, 3680 women; very low‐certainty evidence; Analysis 1.3; Figure 8). This suggests that if 46% of women have prolapse on examination after native tissue repair, between 15% and 25% will have prolapse on examination after transvaginal mesh repair. Heterogeneity was high for this analysis, mainly due to differences in the effect size in studies of multi‐compartment repair. However, the direction of effect was consistent.

1.3. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 3: Recurrent prolapse on examination (any compartment)

8.

1.3 Recurrent prolapse on examination (any compartment)

Subgroup analysis by location of repair

The test for subgroup differences indicated a statistically significant difference between the two subgroups: test for subgroup differences: Chi² = 12.15, df = 1 (P = 0.0004), I² = 92%. When the analysis was limited to anterior compartment, the benefit in the mesh group was more pronounced, and statistical heterogeneity was reduced (random‐effects model; RR 0.31, 95% CI 0.23 to 0.41; I² = 44%; 15 studies, 1925 women). When the analysis was limited to studies of multi‐compartment repair, the benefit in the mesh group persisted but to a lesser magnitude (random‐effects model; RR 0.62, 95% CI 0.48 to 0.80; I² = 80%; 10 studies, 1844 women; Analysis 1.3; Figure 8).

Secondary outcomes

Prolapse outcomes

Recurrent prolapse on examination (anterior compartment)

Women who had a transvaginal mesh repair were less likely to have a stage 2 or greater anterior compartment prolapse on examination than those undergoing a native tissue repair (RR 0.41, 95% CI 0.34 to 0.51; I² = 28%; 13 studies, 1417 women; Analysis 1.4).

1.4. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 4: Recurrent prolapse on examination (anterior compartment)

Recurrent prolapse on examination (posterior compartment)

There was no evidence of a difference between the groups in rates of grade 2 or greater posterior compartment prolapse (RR 0.72, 95% CI 0.31 to 1.67; I² = 0%; 3 studies, 235 women; Analysis 1.5).

1.5. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 5: Recurrent prolapse on examination (posterior compartment)

POP‐Q assessment

Point Ba (mid‐anterior vaginal wall)

Evidence suggested that Point Ba on the mid‐anterior vaginal wall had better support after transvaginal permanent mesh repair than after native tissue repair (random‐effects model; mean difference (MD) ‐0.81, 95% CI ‐1.08 to ‐0.53; I² = 86%; 13 studies, 1953 women; Analysis 1.8). This result should be interpreted very cautiously as there was substantial heterogeneity between studies. However, the direction of effect was consistent.

1.8. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 8: POP‐Q assessment

Point Bp (mid‐posterior vaginal wall)

There was no evidence of a difference between the groups at Point Bp (random‐effects model; MD ‐0.01, 95% CI ‐0.29 to 0.27; I² = 82%; 10 studies, 1674 women; Analysis 1.8). This result should be interpreted very cautiously as there was substantial heterogeneity between studies, and the directions of effect were not consistent.

Point C (vaginal apex)

Evidence suggested that Point C at the vaginal apex had better support after transvaginal permanent mesh repair than after native tissue repair (random‐effects model; MD ‐0.52, 95% CI ‐0.95 to ‐0.09; I² = 78%; 11 studies, 1758 women; Analysis 1.8). This result should be interpreted very cautiously as there was substantial heterogeneity between studies, and the directions of effect were not entirely consistent.

Total vaginal length (cm)

There was no evidence of a difference between the groups in total vaginal length (random‐effects model; MD 0.23, 95% CI ‐0.11 to 0.56; I² = 78%; 7 studies, 1397 women; Analysis 1.9). This result should be interpreted very cautiously as there was substantial heterogeneity between studies, and the directions of effect were not consistent.

1.9. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 9: POP‐Q assessment Total Vaginal Length (TVL)

Adverse events

Visceral injury

Bladder injury. Women undergoing a transvaginal permanent mesh repair were more likely to have a bladder injury than those undergoing a native tissue repair (RR 3.67, 95% CI 1.63 to 8.28; I² = 0%; 14 studies, 1997 women; low‐certainty evidence; Analysis 1.6; Figure 9). This suggests that if the bladder injury rate with a native tissue repair is 0.5%, then between 0.8% and 4.2% of women would have a bladder injury with a transvaginal mesh repair.

1.6. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 6: Visceral injury

9.

1.6 Visceral injury

Bowel injury. Only a single trial reported bowel injury as an outcome, and there was no evidence of a difference between the two groups (RR 3.26, 95% CI 0.13 to 78.81; 1 study, 169 women; low‐certainty evidence; Analysis 1.6; Figure 9).

Mesh exposure

Mesh exposure was more likely to occur after transvaginal permanent mesh repair than after native tissue repair (RR 11.10, 95% CI 6.81 to 18.10; I² = 0%; 26 studies, 2980 women; moderate‐certainty evidence; Analysis 1.7; Figure 10). This suggests that if 0.4% of women undergoing native tissue repair have a mesh exposure, then between 2.7% and 7.2% would have a mesh exposure after transvaginal permanent mesh.

1.7. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 7: Mesh exposure

10.

1.7 Mesh exposure

Mesh exposure was reported in the native tissue group in three studies (da Silveira 2014; De Tayrac 2013; Withagen 2011). This was due to concomitant mid‐urethral sling placement or subsequent mesh placement and exposure during the follow‐up period after index surgery.

Bladder function

De novo stress urinary incontinence

De novo stress urinary incontinence was more likely to occur after transvaginal permanent mesh repair than after a native tissue repair (RR 1.50, 95% CI 1.19 to 1.88; I² = 0%; 17 studies, 2001 women; moderate‐certainty evidence; Analysis 1.10; Figure 11). This suggests that if 9.6% of women undergoing native tissue repair develop de novo stress urinary incontinence, then between 11.4% and 18.1% would have de novo stress incontinence after transvaginal permanent mesh.

1.10. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 10: Bladder function: de novo stress urinary incontinence (0.5 to 7 years)

11.

1.10 Bladder function: de novo stress urinary incontinence (0.5 to 7 years)

De novo urgency, urge incontinence, or bladder overactivity

There was no evidence of a difference between the two groups (RR 1.03, 95% CI 0.67 to 1.60; I² = 0%; 5 studies, 597 women; moderate‐certainty evidence; Analysis 1.11; Figure 12).

1.11. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 11: Bladder function: de novo urge incontinence or voiding dysfunction

12.

1.11 Bladder function: de novo urge incontinence or voiding dysfunction

De novo voiding dysfunction

There was no evidence of a difference between the groups in the rate of de novo voiding dysfunction (RR 0.73, 95% CI 0.33 to 1.59; I² = 0%; 4 studies, 344 women; low‐certainty evidence; Analysis 1.11; Figure 12).

Sexual function

Painful intercourse ‐ de novo dyspareunia

There was no evidence of a difference between the groups in the rate of de novo dyspareunia (RR 1.22, 95% CI 0.83 to 1.79; I² = 27%; 16 studies, 1308 women; moderate‐certainty evidence; Analysis 1.12; Figure 13). If 6% of women develop de novo dyspareunia after native tissue repair, between 5% and 10.8% would do so after transvaginal permanent mesh.

1.12. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 12: Painful intercourse ‐ de novo dyspareunia

13.

1.12 Painful intercourse ‐ de novo dyspareunia

Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ‐12)

There was no evidence of a difference between the groups in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (MD ‐0.13, 95% CI ‐0.40 to 0.13; I² = 0%; 7 studies, 857 women; Analysis 1.13).

1.13. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 13: Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ‐12) (0‐48)

Quality of life

Prolapse Quality of Life questionnaire (P‐QoL)

There was no evidence of a difference between groups (MD 1.37, 95% CI ‐3.24 to 5.97; I² = 75%; 3 studies, 331 women; Analysis 1.14). These findings should be interpreted with caution as there was substantial heterogeneity between studies.

1.14. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 14: Quality of life

Pelvic Floor Distress Inventory (PFDI‐20)

No data reported for this outcome.

Pelvic Floor Impact Questionnaire‐7 (PFIQ‐7)

There was no evidence of a difference between groups (MD 0.09, 95 CI ‐5.38 to 5.55; I² = 54%; 4 studies, 334 women; Analysis 1.14). These findings should be interpreted with caution as there was substantial heterogeneity between studies.

International Consultation on Incontinence Questionnaire Vaginal Symptoms (ICIQ‐VS)

There was no evidence of a difference between groups (MD 0.25, 95 CI ‐0.58 to 1.08; I² = 0%; 2 studies, 700 women).

Quality of life (combined)

We combined continuous data to calculate standardised mean differences to provide an overall quality of life analysis measured by post‐treatment scores (end scores) on the Prolapse Quality of Life questionnaire (P‐QoL), Pelvic Floor Impact Questionnaire‐7 (PFIQ‐7), and International Consultation on Incontinence Questionnaire ‐ Vaginal Symptoms (ICIQ‐VS). There was no evidence of a difference between the groups (standardised mean difference (SMD) 0.05, 95% CI ‐0.11 to 0.22; I² = 46%; 9 studies, 1365 women; Analysis 1.15).

1.15. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 15: Quality of life (combined)

Patient Global Impression of Improvement (PGI‐I)

There was no evidence of a difference between the groups (RR 1.06, 95% CI 0.91 to 1.24; I² = 67%; 4 studies, 471 women; Analysis 1.16). These findings should be interpreted with caution as there was substantial heterogeneity between studies.

1.16. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 16: Patient Global Impression of Improvement (PGI‐I) (better or very much better)

Measures associated with surgery

Operating time (minutes)

There was no difference between the two groups in operating times (MD 2.42, 95% CI ‐4.75 to 9.60; I² = 97%; 16 studies, 1860 women; Analysis 1.17).

1.17. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 17: Operating time (minutes)

Length of stay (days)

There was no evidence of a difference between the groups in duration of admission (random‐effects model; MD ‐0.09 days, 95% CI ‐0.3 to 0.12; I² = 64%; 8 studies, 1049 women; Analysis 1.18).

1.18. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 18: Length of stay in hospital (days)

Blood transfusion

There was no evidence of a difference between the groups in the rate of blood transfusion (RR 1.39, 95% CI 0.83 to 2.34; I² = 0%; 10 studies, 1991 women; Analysis 1.19).

1.19. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 19: Blood transfusion

Sensitivity analyses

Awareness of prolapse (6‐month to 7‐year review), including studies at high risk of bias

The inclusion of two additional studies (involving 141 women) at overall high risk of bias in the meta‐analysis did not markedly change the effect estimate for this outcome: women who had permanent transvaginal mesh repair were less likely to report awareness of prolapse than women who had native tissue repair (RR 0.85, 95% CI 0.74 to 0.97; I² = 32%; 19 studies, 3073 women; Analysis 1.21 versus RR 0.83, 95% CI 0.73 to 0.95; I² = 34%; 17 studies, 2932 women; moderate‐certainty evidence; Analysis 1.1; Figure 5).

1.21. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 21: Awareness of prolapse (0.5 to 7 years) including trials at high risk of bias

Repeat surgery (6‐month to 7‐year review), including studies at high risk of bias

The inclusion of one additional study (with 140 women) at overall high risk of bias in the meta‐analysis only minimally changed the effect estimate for rate of repeat surgery for prolapse: women who had permanent transvaginal mesh repair were less likely to undergo repeat surgery for recurrent prolapse than women who had native tissue repair (RR 0.68, 95% CI 0.51 to 0.89; I² = 36%; 18 studies, 2625 women) and were more likely to under surgery for mesh exposure (RR 9.55, 95% CI 5.53 to 16.51; I² = 0%; 28 studies, 3993 women; Analysis 1.22 versus RR 9.51, 95% CI 5.44 to 16.60; I² = 0%; 27 studies, 3853 women; low‐certainty evidence; Analysis 1.2; Figure 6).

1.22. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 22: Repeat surgery (0.5 to 7 years) including trials at high risk of bias

The total rate of repeat surgery was higher in the mesh group (RR 1.48, 95% CI 1.04 to 2.11; I² = 53%; 28 studies, 4056 women; Analysis 1.24 versus RR 1.56, 95% CI 1.07 to 2.26; I² = 54%; 27 studies, 3916 women; low‐certainty evidence; Analysis 1.20; Figure 7).

1.24. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 24: Any repeat surgery (0.5 to 7 years) including trials at high risk of bias

Recurrent prolapse on examination (any compartment), including studies at high risk of bias

Women who had transvaginal mesh repair were less likely to have stage 2 or greater prolapse on examination in any compartment than after a native tissue repair (random‐effects model; RR 0.44, 95% CI 0.34 to 0.57; I² = 84%; 26 studies, 3821 women; Analysis 1.23 versus RR 0.42, 95% CI 0.32 to 0.55; I² = 84%; 25 studies, 3680 women; Analysis 1.3; Figure 8).

1.23. Analysis.

Comparison 1: Transvaginal permanent mesh versus native tissue repair, Outcome 23: Recurrent prolapse on examination (any compartment) including trials at high risk of bias

Comparison 2. Transvaginal absorbable mesh versus native tissue repair

Three trials evaluated the effects of using absorbable polyglactin (Vicryl) mesh inlay to augment prolapse repairs (Allahdin 2008; Sand 2001; Weber 2001). We pooled limited data from these trials. In Weber 2001, data from non‐mesh native tissue arms were combined.

Primary outcomes

Awareness of prolapse (2‐year review)

A single trial reported no evidence of a difference in awareness of prolapse between women undergoing absorbable mesh repair and those undergoing native tissue vaginal repair (colporrhaphy) (RR 1.05, 95% CI 0.77 to 1.44; 1 study, 54 women; Analysis 2.1; Figure 14).

2.1. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 1: Awareness of prolapse (2 years)

14.

2.1 Awareness of prolapse (2 years)

Repeat surgery (2‐year review)

Surgery for recurrent prolapse

A single trial reported no evidence of a difference between the two groups in the rate of repeat surgery for prolapse (RR 0.47, 95% CI 0.09 to 2.40; 1 study, 66 women; Analysis 2.2; Figure 15).

2.2. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 2: Repeat surgery (2 years)

15.

2.2 Repeat surgery (2 years)

Surgery for stress urinary incontinence or mesh exposure

No data reported for these two outcomes.

Recurrent prolapse on examination (any compartment)

A single trial reported no evidence of a difference between the two groups in recurrent prolapse on examination in any compartment (RR 0.53, 95% CI 0.10 to 2.70; 1 study, 66 women; Analysis 2.3; Figure 16).

2.3. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 3: Recurrent prolapse on examination (any)

16.

2.3 Recurrent prolapse on examination (any)

Secondary outcomes

Prolapse outcomes

Recurrent prolapse on examination (anterior compartment)

There was no evidence of a difference between the groups in grade 2 or greater anterior compartment prolapse on examination (RR 0.74, 95% CI 0.46 to 1.18; I² = 57%; 2 studies, 226 women; Analysis 2.4; Figure 17).

2.4. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 4: Recurrent prolapse on examination (anterior compartment)

17.

2.4 Recurrent prolapse on examination (anterior compartment)

Recurrent prolapse on examination (posterior compartment)

There was no evidence of a difference between the groups in grade 2 or greater posterior compartment prolapse on examination (RR 1.13, 95% CI 0.40 to 3.19; 1 study, 132 women; Analysis 2.5; Figure 18).

2.5. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 5: Recurrent prolapse on examination (posterior compartment)

18.

2.5 Recurrent prolapse on examination (posterior compartment)

POP‐Q assessment

None of the included studies for this comparison reported data for any of the four pre‐specified POP‐Q measurements we selected for this outcome.

Adverse events

None of the included studies for this comparison reported data for the review's three adverse events outcomes (i.e. visceral injury (including bladder and bowel injury); mesh exposure).

Bladder function

De novo stress urinary incontinence (2‐year review)

There was no evidence of a difference between the groups in the rate of de novo stress incontinence (RR 1.38, 95% CI 0.95 to 2.00; 1 study, 49 women; very low‐certainty evidence; Analysis 2.10).

2.10. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 10: Bladder function: de novo stress urinary incontinence

De novo urgency, urge incontinence, or bladder overactivity

None of the included studies reported this outcome.

De novo voiding dysfunction

None of the included studies reported this outcome.

Sexual function

None of the studies included in this analysis reported data for the review's two sexual function outcomes (i.e. de novo dyspareunia; Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ‐12)).

Quality of life

None of the studies included in this analysis reported data for the review's five quality of life outcomes (i.e. P‐QoL, PFDI‐20, PFIQ‐7, ICIQ‐VS, PGI‐I).

Measures associated with surgery

None of the studies included in this analysis reported data for the review's three surgery‐related outcomes (i.e. operating time; length of stay; blood transfusion).

Comparison 3. Transvaginal biological graft versus native tissue repair

Thirteen included studies (involving 2074 women) compared biological grafts with native tissue repair (Dahlgren 2011; Damiani 2016; Feldner 2010; Gandhi 2005; Guerette 2009; Glazener 2017; Hviid 2010; Iyer 2019; Menefee 2011; Meschia 2007; Paraiso 2006; Robert 2014; Sung 2012). Nine were porcine grafts (Dahlgren 2011; Damiani 2016; Feldner 2010; Hviid 2010; Menefee 2011; Meschia 2007; Paraiso 2006; Robert 2014; Sung 2012), two cadaveric (Gupta 2014; Iyer 2019), one bovine (Guerette 2009), and one study allowed for porcine acellular graft, porcine small intestine graft, or bovine graft in the graft arm (Glazener 2017). See Table 2.

Primary outcomes

Awareness of prolapse (1‐ to 3‐year review)

There was no evidence of a difference between the groups (RR 1.06, 95% CI 0.73 to 1.56; I² = 0%; 8 studies, 1374 women; moderate‐certainty evidence; Analysis 3.1; Figure 19). This suggests that if 19.7% of women are aware of prolapse after a native tissue repair, between 14.4% and 30.7% would be aware of prolapse after biological graft repair.

3.1. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 1: Awareness of prolapse (1 to 3 years)

19.

3.1 Awareness of prolapse (1 to 3 years)

Subgroup analysis by location of repair

When we conducted a subgroup analysis by location of repair, there was no evidence of a difference between the subgroups: Chi² = 2.34, df = 2 (P = 0.31), I² = 14.7%.

Repeat surgery (1‐ to 2‐year review)

Surgery for recurrent prolapse

There was no evidence of a difference between the groups (RR 1.15, 95% CI 0.75 to 1.77; I² = 0%; 6 studies, 899 women; moderate‐certainty evidence; Analysis 3.2; Figure 20). This suggests that if 7.8% of women require repeat prolapse surgery after native tissue repair, between 5.9% to 13.9% would require repeat prolapse surgery after biological graft repair.

3.2. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 2: Repeat surgery (1 to 2 years)

20.

3.2 Repeat surgery (1 to 2 years)

Surgery for stress urinary incontinence

None of the included studies reported this outcome.

Surgery for mesh exposure

A single study reported no mesh exposure in either arm.

Recurrent prolapse on examination (any compartment)

There was no evidence of a difference between the groups (RR 0.96, 95% CI 0.71 to 1.29; I² = 53%; 9 studies, 1278 women; low‐certainty evidence; Analysis 3.3; Figure 21). This suggests that if 37.6% of women have recurrent prolapse after a native tissue repair, between 26.7% and 48.6% would have recurrent prolapse on examination after a biological graft repair. Caution should be used when interpreting this data due to high heterogeneity.

3.3. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 3: Recurrent prolapse on examination (any compartment)

21.

3.3 Recurrent prolapse on examination (any compartment)

The test for subgroup differences indicated a statistically significant difference between the two subgroups: test for subgroup differences: Chi² = 9.19, df =2 (P = 0.01), I² = 78.2%. When the analysis was limited to studies of posterior compartment repair, there was a lower risk of prolapse in the native tissue group (RR 2.09, 95% CI 1.18 to 3.70; I² = 0%; 2 studies, 218 women).

Secondary outcomes

Prolapse outcomes

Recurrent prolapse on examination (anterior compartment)

Women who had biological graft repair were less likely to have an objective failure of the anterior compartment than women having native tissue repair (RR 0.69, 95% CI 0.54 to 0.90; I² = 29%; 7 studies, 684 studies; moderate‐certainty evidence; Analysis 3.4; Figure 22). This suggests that if 29.2% of women have recurrent anterior prolapse on examination after native tissue repair, between 15.8% and 26.3% would have recurrent prolapse after transvaginal biological graft.

3.4. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 4: Recurrent prolapse on examination (anterior compartment)

22.

3.4 Recurrent prolapse on examination (anterior compartment)

Recurrent prolapse on examination (posterior compartment)

There was no evidence of a difference between the groups (random‐effects model; RR 1.16, 95% CI 0.39 to 3.51; I² = 80%; 3 studies, 283 women; very low‐certainty evidence; Analysis 3.5; Figure 23). This result should be interpreted cautiously as there was substantial heterogeneity between studies, and the directions of effect were not consistent.

3.5. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 5: Recurrent prolapse on examination (posterior compartment)

23.

3.5 Recurrent prolapse on examination (posterior compartment)

POP‐Q assessment

Point Ba (mid‐anterior vaginal wall)

There was no evidence of a difference between the two groups at point Ba (random‐effects model; MD ‐0.17, 95% CI ‐0.75 to 0.42; I² = 78%; 2 studies, 592 women; Analysis 3.8). This result should be interpreted very cautiously as there was substantial heterogeneity between studies.

3.8. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 8: POP‐Q assessment

Point Bp (mid‐posterior vaginal wall)

There was no evidence of a difference between the groups at Point Bp (random‐effects model; MD ‐0.10, 95% CI ‐0.07 to 0.27; I² = 0%; 2 studies, 645 women; Analysis 3.8).

Point C (vaginal apex)

There was no evidence of a difference between the groups at Point C (random‐effects model; MD ‐0.18, 95% CI ‐0.86 to 0.49; I² = 70%; 2 studies, 640 women; Analysis 3.8). This result should be interpreted very cautiously as there was substantial heterogeneity between studies.

Total vaginal length (cm)

There was no evidence of a difference between the groups in total vaginal length (random‐effects model; MD 0.25, 95% CI ‐0.33 to 0.82; I² = 76%; 2 studies, 633 women; Analysis 3.9). This result should be interpreted very cautiously as there was substantial heterogeneity between studies.

3.9. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 9: POP‐Q assessment Total Vaginal Length (TVL)

Adverse events

Visceral Injury

Bladder injury. There was no evidence of a difference between the groups for this outcome (RR 0.34, 95% CI 0.04 to 3.26; I² = 0%; 2 studies, 254 women; low‐certainty evidence; Analysis 3.6).

3.6. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 6: Visceral injury

Bowel injury. A single study demonstrated no evidence of a difference between the groups for this outcome (RR 3.13, 95% CI 0.13 to 75.57; 1 study, 137 women; very low‐certainty evidence; Analysis 3.6).

Mesh exposure

A single study reported no events of mesh exposure in either group (Analysis 3.7).

3.7. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 7: Mesh exposure

Bladder function

De novo stress urinary incontinence

Transvaginal biological graft repair may increase de novo stress urinary incontinence compared to native tissue repair, but we are very uncertain about the result (RR 12.64, 95% CI 1.6 to 100.06; 2 studies, 143 women; very low‐certainty evidence; Analysis 3.10). Caution should be utilised when interpreting this outcome due to very low‐certainty evidence, wide confidence interval, and low rates of events.

3.10. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 10: Bladder function: de novo stress urinary incontinence

De novo urgency, urge incontinence, or bladder overactivity

A single study showed no evidence of a difference between the groups (RR 2.11, 95% CI 0.45 to 9.79; 1 study, 87 women; very low‐certainty evidence; Analysis 3.11).

3.11. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 11: Bladder function: de novo urge incontinence or voiding dysfunction

De novo voiding dysfunction

There was no evidence of a difference between the groups (RR 0.81, 95% CI 0.29 to 2.26; I² = 0%; 2 studies, 93 women; moderate‐certainty evidence; Analysis 3.11).

Sexual function

De novo dyspareunia

There was no evidence of a difference between the groups (RR 1.30, 95% CI 0.46 to 3.66; I² = 0%; 2 studies, 125 women; moderate‐certainty evidence; Analysis 3.12).

3.12. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 12: Painful intercourse ‐ de novo dyspareunia

Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ‐12)

A single study reported no evidence of a difference (MD 1, 95% CI ‐2.33 to 4.33; 1 study, 35 women).

Quality of life

Prolapse Quality of Life questionnaire (P‐QoL)/Pelvic Floor Distress Inventory (PFDI‐20)/Pelvic Floor Impact Questionnaire‐7 (PFIQ‐7)

There were two studies in this group, with Paraiso 2006 reporting two different quality of life outcomes. There was little or no difference between groups for this outcome (SMD ‐0.1, 95% CI ‐0.04 to 0.27; 3 studies, 112 women; Analysis 3.14).

3.14. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 14: Quality of life

International Consultation on Incontinence Questionnaire Vaginal Symptoms (ICIQ‐VS)

None of the studies for this comparison reported this outcome.

Patient Global Impression of Improvement (PGI‐I)

None of the studies for this comparison reported this outcome.

Measures associated with surgery

Operating time

There was no difference between the groups (MD 6.87 minutes, 95% CI ‐2.43 to 16.18; I² = 66%; 5 studies, 319 women; low‐certainty evidence; Analysis 3.16; Figure 24).

3.16. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 16: Operating time (minutes)

24.

3.16 Operating time (minutes

Length of stay (days)

A single study showed no difference between the groups (MD ‐0.50 minutes, 95% CI ‐1.09 to 0.09; 1 study, 87 women; Analysis 3.17).

3.17. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 17: Length of stay (days)

Blood transfusion

There was no evidence of a difference between the groups (RR 0.87, 95% CI 0.13 to 5.74; I² = 0%; 2 studies, 835 women; Analysis 3.18).

3.18. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 18: Blood transfusion

Comparison 4. Transvaginal permanent mesh versus another vaginal mesh

Four included studies (involving 412 women) compared transvaginal permanent mesh with another vaginal mesh (Chen 2020; Ouyang 2020; Takeyama 2020; Yang 2016). All compared polypropylene mesh with a variety of alternate permanent vaginal meshes (two polypropylene mesh kits, one self‐cut titanium‐coated polypropylene, and one polytetrafluoroethylene (PTFE)).

Primary outcomes

Awareness of prolapse

None of the studies reported this outcome.

Repeat surgery

Surgery for recurrent prolapse

None of the studies reported this outcome.

Surgery for stress urinary incontinence

A single study reported no difference between groups (RR 1.10, 95% CI 0.51 to 2.36; 1 study, 100 women; Analysis 4.2).

4.2. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 2: Repeat surgery

Surgery for mesh exposure

None of the studies reported this outcome.

Recurrent prolapse on examination (any compartment)

There was no difference between groups for this outcome (RR 1.29, 95% CI 0.33 to 5.04; I² = 0%; 2 studies, 232 women; Analysis 4.3).

4.3. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 3: Recurrent prolapse on examination (any compartment)

Secondary outcomes

Prolapse outcomes

None of the included studies for this comparison reported data for these two outcomes (i.e. recurrent prolapse on examination: (1) anterior compartment; (2) posterior compartment).

POP‐Q assessment

None of the included studies for this comparison reported data for any of the four pre‐specified POP‐Q measurements we selected for this outcome.

Adverse events

Visceral injury

Bladder injury. There was no evidence of a difference between the two groups (RR 3.00, 95% CI 0.13 to 69.87; 2 studies, 175 women; Analysis 4.6). Caution should be exercised when interpreting the data due to low rate of events and imprecision.

4.6. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 6: Visceral injury

Bowel injury. No studies reported on this outcome.

Mesh exposure

There was no evidence of a difference between the two groups (RR 0.62, 95% CI 0.24 to 1.58; I² = 0%; 2 studies, 365 women; Analysis 4.7).

4.7. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 7: Mesh exposure

Bladder function

De novo stress urinary incontinence

There was no evidence of a difference between the two groups (RR 1.87, 95% CI 0.62 to 5.65; I² = 30%; 2 studies, 175 women; Analysis 4.10).

4.10. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 10: Bladder function: de novo stress urinary incontinence

De novo urgency, urge incontinence, or bladder overactivity

No studies reported on this outcome.

De novo voiding dysfunction

No studies reported on this outcome.

Sexual function

None of the included studies for this comparison reported data for the review's two sexual function outcomes (i.e. painful intercourse – de novo dyspareunia; PISQ‐12).

Quality of life

Pelvic Floor Distress Inventory (PFDI‐20)

A single study reported no evidence of a difference between groups using this instrument (MD ‐2.30, 95% CI ‐9.11 to 4.51; 1 study, 90 women; Analysis 4.14).

4.14. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 14: Quality of life

Pelvic Floor Impact Questionnaire‐7 (PFIQ‐7)

A single study reported no evidence of a difference between groups using this instrument (MD ‐3.30, 95% CI ‐12.75 to 6.15; 1 study, 118 women; Analysis 4.14).

None of the included studies assessed quality of life using the other three of the review's pre‐specified instruments (i.e. P‐QoL, ICIQ‐VS, PGI‐I).

Measures associated with surgery

Operating time (minutes)

There was no difference between the two groups in operating times (MD ‐1.87, 95% CI ‐8.00 to 4.26; I² = 0%; 3 studies, 321 women; Analysis 4.16).

4.16. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 16: Operating time (minutes)

Length of stay (days)

A single study showed that a self‐cut polypropylene mesh resulted in a shorter admission than the polypropylene mesh kit (MD ‐1.28 days, 95% CI ‐2.27 to ‐0.29; 1 study, 90 women; Analysis 4.17).

4.17. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 17: Length of stay (days)

Blood transfusion

A single study showed no difference between the two groups (RR 0.33, 95% CI 0.01 to 7.97; 1 study, 90 women; Analysis 4.18).

4.18. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 18: Blood transfusion

Comparison 5. Transvaginal permanent mesh versus biological graft vaginal repair

Two studies (involving 319 women) evaluated outcomes after transvaginal permanent mesh repair versus biological graft vaginal repair (Damiani 2016; Wei 2019). Damiani 2016 compared transvaginal permanent mesh to porcine dermal collagen, whilst Wei 2019 compared permanent mesh to either porcine collagen matrix or porcine small intestine.

Primary outcomes

Awareness of prolapse

Neither of the included studies for this comparison reported this outcome.

Repeat surgery

Surgery for recurrent prolapse

A single study reported no difference between two groups (RR 0.98, 95% CI 0.20 to 4.77; 1 study, 232 women; Analysis 5.2).

5.2. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 2: Repeat surgery

Surgery for stress urinary incontinence

A single study reported no difference between two groups (RR 1.47, 95% CI 0.25 to 8.66; 1 study, 232 women; Analysis 5.2).

Surgery for mesh exposure

There was no difference between women who underwent transvaginal permanent mesh repair compared with biological graft repair for this outcome (RR 5.79, 95% CI 0.71 to 47.14; I² = 0%; 2 studies, 290 women; Analysis 5.2).

Recurrent prolapse on examination (any compartment)

There was no difference between the two groups for this outcome (RR 0.97, 95% CI 0.50 to 1.85; I² = 0%; 2 studies, 290 women; Analysis 5.3).

5.3. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 3: Recurrent prolapse on examination (any compartment)

Secondary outcomes

Prolapse outcomes

Neither of the included studies for this comparison reported data for these two outcomes (i.e. recurrent prolapse on examination: (1) anterior compartment; (2) posterior compartment).

POP‐Q assessment

Neither of the included studies for this comparison reported data for any of the four pre‐specified POP‐Q measurements we selected for this outcome.

Adverse events

Visceral injury

Bladder injury. A single study found no difference between the two groups (RR 2.81, 95% CI 0.12 to 66.17; 1 study, 58 women; Analysis 5.6). Caution needs to be used when interpreting this result due to the low event rate.

5.6. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 6: Visceral injury

Bowel injury. Neither study reported this outcome.

Mesh exposure

There was no evidence of a difference between the two groups for risk of mesh exposure (RR 2.81, 95% CI 0.12 to 66.17; 2 studies, 289 women; Analysis 5.7). Caution needs to be used when interpreting this result due to the low event rate (data are from one included study only; the other reported no events in either arm).

5.7. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 7: Mesh exposure

Bladder function

De novo stress urinary incontinence

A single study found no difference between the two groups (RR 0.78, 95% CI 0.27 to 2.27; 1 study, 58 women; Analysis 5.10).

5.10. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 10: Bladder function: de novo stress urinary incontinence

De novo urgency, urge incontinence or bladder overactivity

A single study found no difference between the two groups (RR 1.24, 95% CI 0.31 to 5.07; 1 study, 58 women; Analysis 5.10).

De novo voiding dysfunction

Neither study reported this outcome.

Sexual function

Painful intercourse ‐ de novo dyspareunia

A single study found no difference between the two groups (RR 8.42, 95% CI 0.47 to 149.62; 1 study, 58 women; Analysis 5.12). Caution should be used in interpreting this result due to imprecision and indirectness.

5.12. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 12: Painful intercourse ‐ de novo dyspareunia

Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ‐12)

Neither study reported this outcome.

Quality of life

Neither study for this comparison assessed quality of life with any of the review's pre‐specified instruments (i.e. P‐QoL, PFDI‐20, PFIQ‐7, ICIQ‐VS, PGI‐I).

Measures associated with surgery

Operating time (minutes)

A single study reported no difference between the two groups in operating times (MD 1.50, 95% CI ‐10.65 to 13.65; 1 study, 58 women; Analysis 5.16).

5.16. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 16: Operating time (minutes)

Length of stay (days)

A single study reported no difference between the two groups in length of admission (MD 0.20, 95% CI ‐0.46 to 0.86; 1 study, 58 women; Analysis 5.17).

5.17. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 17: Length of stay (days)

Blood transfusion

Neither study reported this outcome.

Other analyses

We constructed funnel plots for the three primary outcomes in comparison 1 (transvaginal permanent mesh versus native tissue repair) to investigate non‐reporting bias and evidence of small‐study effects. For awareness of prolapse and repeat surgery (Figure 25; Figure 26), the funnel plots were not suggestive of publication bias and small‐study effects. However, for recurrent prolapse on examination (any compartment), an asymmetrical funnel plot was noted (Figure 1). This is possibly related to the high heterogeneity (I² = 84%). We applied a random‐effects model to investigate this significant heterogeneity and for small‐study effects. The difference between the fixed‐effect model (RR 0.55, 95% CI 0.50 to 0.60) and random‐effects model (RR 0.42, 95% CI 0.32 to 0.55) was minor, indicating that any small‐study effect present had little effect on the intervention effect estimate.

25.

1.1 Awareness of prolapse (0.5 to 7 years)

26.

1.2 Repeat surgery (0.5 to 7 years)

1.

1.3 Recurrent prolapse on examination (any compartment)

Discussion

Summary of main results

Transvaginal permanent mesh versus native tissue repair

Thirty‐one studies compared transvaginal permanent mesh to any native tissue vaginal repair. The advantages of transvaginal permanent mesh included decreased awareness of prolapse, reoperation for prolapse, and recurrent prolapse on examination. However, the rate of bladder injury, de novo stress urinary incontinence, and the composite outcome of reoperation for prolapse, stress urinary incontinence, or mesh exposure was lower after a native tissue repair. This risk profile suggests, at best, that the use of transvaginal permanent mesh needs to be individualised to those who accept the benefits and risks of these interventions. The certainty of the evidence supporting these findings is moderate for most outcomes.

Transvaginal absorbable mesh versus native tissue repair

Three studies compared absorbable mesh with native tissue vaginal repair and described no evidence of a difference between the interventions for the rates of awareness of prolapse, repeat surgery for prolapse, and recurrent prolapse on examination. Since the last iteration of this Cochrane review, there have been no additional eligible publications on this comparison. To date, the utility of absorbable meshes in vaginal prolapse repair has not been demonstrated.

Transvaginal biological graft versus native tissue repair

Thirteen studies compared transvaginal biological grafts and native tissue repair. At one to three years, there was no difference between the groups for awareness of prolapse, repeat surgery for prolapse, and recurrent prolapse on examination in any compartment. When investigating recurrent prolapse limited to the anterior compartment only, there was some evidence that biological grafts reduced the risk of recurrent prolapse. However, Point Ba on the POP‐Q assessment did not reveal the same effect for biological grafts, and there was no difference for this outcome between the two groups. Furthermore, this finding did not translate to a reduction in symptoms of prolapse or reoperation rates. There was also very low‐certainty data that suggested that biological grafts are associated with an increased risk of de novo stress urinary incontinence compared with native tissue repair.

With an additional three studies involving nearly 1000 women since the last review update, the use of biological grafts is currently not supported by the available literature.

Transvaginal permanent mesh versus another vaginal mesh

Four trials compared one transvaginal permanent mesh to another permanent mesh. Sparse reporting of the review's primary outcomes limited meaningful analysis.

Transvaginal mesh versus biological graft vaginal repair

Two studies compared transvaginal permanent mesh to biological graft vaginal repair. Neither study reported on awareness of prolapse. A single study found no difference in rates of recurrent prolapse or stress urinary incontinence. Both studies found no difference in repeat surgery for mesh exposure. No evidence of a difference between the two groups was found for quality of life, bladder function, and measures associated with surgery. Care must be taken interpreting these conclusions due to the small number of studies.

Overall completeness and applicability of evidence

The 51 trials we assessed in this review allowed an extensive review of transvaginal mesh grafts compared to native tissue repairs or alternate graft repairs. The primary outcomes of awareness of prolapse, repeat surgery, and recurrent prolapse were generally well reported. Significant variation exists in the definitions of primary and secondary outcomes, which reduced our ability to include these outcomes in a meta‐analysis. Reporting of standardised anatomical, functional, and adverse events related to pelvic organ prolapse interventions in RCTs may reduce these problems in the future. Nearly all the new studies included in this review update were carried out before mesh was removed from the market in many countries around the world. Three studies mention recruitment dates after 2017: Ahmed 2019, Chen 2020, and Takeyama 2020, which were conducted in Egypt, China, and Japan, respectively. Mesh products are still available for use in these countries, and these studies shed light on the safety and efficacy of mesh interventions for vaginal prolapse where mesh remains an option.

While the rate of mesh exposure reported in this review update is consistent with rates found in the previous version of the review and other reports (Maher 2016), one of the main concerns in the FDA 2011 transvaginal mesh alert was the rate of vaginal pain or dyspareunia, or both, which accounted for over one‐third of the reported adverse events. In contrast to this, in the over 3500 women who had a transvaginal mesh repair in studies analysed in this systematic review, surgery for vaginal pain or dyspareunia related to the transvaginal mesh was barely mentioned. One possible explanation for this disparity is that while the incidence of vaginal pain requiring surgery following transvaginal mesh surgery may be low, the individual morbidity may be greater than with native tissue repairs, resulting in a higher tendency to report this adverse event. In this review, validated quality of life and pelvic floor function questionnaires were unable to detect a difference between the study groups. Finally, the generally short follow‐up time after transvaginal polypropylene mesh intervention may not identify all the potential adverse events.

Certainty of the evidence

The precision of our findings in this review has improved since the previous version. With the addition of new and updated studies, there was generally better reporting of randomisation and allocation processes, Consolidated Standards of Reporting Trials (CONSORT) flow diagrams, and methods for blinding participants and reviewers.

The certainty of the evidence when comparing transvaginal permanent mesh to native tissue or an alternate graft was low to moderate for most outcomes, the most common limitations being poor reporting of methods, imprecision, and inconsistency (Table 1).

The certainty of the evidence comparing biological grafts to native tissue repair ranged from very low to moderate, reflecting poor reporting of study methods, lack of clarity with regard to blinding of assessors, and imprecision (Table 2).

Overall, the main limitations were poor reporting of study methods, inconsistency, and imprecision.

We excluded one study from the primary analysis due to high risk of bias (Glazener 2020). A sensitivity analysis performed to analyse the impact of inclusion of this study demonstrated no material change in the direction or magnitude of the changes in the primary outcomes (see Analysis 1.21; Analysis 1.22; Analysis 1.23; Analysis 1.24).

Potential biases in the review process

The authors of this review did not conduct any of the trials being evaluated. The review authors have no conflicts of interest to report.

Any possible bias is mitigated in the methodology process as two review authors assessed each trial and checked each data entry. Systematic searches of the literature for published and unpublished trials were rigorous, and we do not believe that any publications have been omitted.

Agreements and disagreements with other studies or reviews

Since roughly 2015, multiple international bodies have published reviews evaluating and providing recommendations for the use of transvaginal mesh in the treatment of female pelvic organ prolapse (Appendix 2). In 2015, the New Zealand Accident Compensation Corporation reported on complications related to all surgical meshes for hernia, urinary incontinence, and prolapse surgeries (ACC 2015). They found that the rate of complications related to transvaginal polypropylene mesh was five time higher when utilised in prolapse repairs compared to both urinary incontinence and hernia repairs (ACC 2015). The Scottish Independent Review 2017 of the use, safety, and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women concluded that the current evidence does not indicate any additional benefit from the use of transvaginal implants (polypropylene mesh or biological graft) over native tissue (Scottish Independent Review 2017).

These and other reports have led to authorities worldwide banning the use of transvaginal pelvic mesh. In 2017, the Australian Therapeutic Goods Administration cancelled the approval of two types of transvaginal mesh for the treatment of pelvic organ prolapse (TGA 2017). The National Institute for Health and Care Excellence (NICE) published guidelines in December 2017 recommending that transvaginal mesh should only be used in the context of research (NICE 2017). Subsequently, the Scottish Parliament and the UK's National Health Service (NHS) halted use of vaginal prolapse mesh and incontinence mesh. In mid‐2018, the U.S. Food and Drug Administration (FDA) also ordered manufacturers to stop selling and distributing transvaginal pelvic mesh products used in the posterior compartment (FDA 2024). The Australian Therapeutic Goods Administration cancelled approval of all transvaginal mesh products in December 2018 in Australia (TGA 2017), and the FDA did the same in the USA in April 2019 (FDA 2024).

Currently, in many countries – including the UK, Ireland, Australia, New Zealand, USA, and Canada – transvaginal mesh cannot be utilised for prolapse repair. Within some European and Asian countries, transvaginal mesh for prolapse remains available as a treatment option.

Our review suggests that while permanent transvaginal mesh is associated with a greater reduction in prolapse on examination, awareness of prolapse, and reoperation for prolapse than native tissue repairs, it is associated with increased morbidity, including a higher rate of bladder injury, de novo stress urinary incontinence, and reoperation rates for prolapse, stress urinary incontinence, and/or mesh exposure. The rate of mesh exposure was 11.8%, and surgery for mesh exposure was required in 6.1% of women who had mesh repairs, accounting for most of the reoperations for mesh complications.

We conclude that, while in certain individual cases where the risk‐benefit profile may support the use of transvaginal mesh, its use should be in compliance with national regulatory bodies under the auspices of local ethics committees.

Our findings are largely supportive of the stances taken by the Scottish Independent Review 2017, the Therapeutic Goods Administration in Australia (TGA 2017), NICE in the UK (NICE 2017), and the FDA in the USA (FDA 2024). However, there were some benefits in the utilisation of mesh, with awareness of prolapse, recurrent prolapse on examination, and repeat surgery for prolapse all being reduced for those undergoing transvaginal mesh repair compared with native tissue repair.

Currently, the most common reason for mesh removal is pain rather than mesh erosion (Crosby 2014; Miklos 2016). While further surgery for mesh exposure is well documented in our analysis evaluating more than 4000 women, surgery for removal of mesh for pain was only reported in one trial (Glazener 2017), at a rate of 7/542 (1.3%). Another trial (Maher 2011), which was included in the Cochrane review of surgery for apical vaginal prolapse comparing transvaginal mesh with abdominal mesh placed laparoscopically for vault prolapse Maher 2023, reported a reoperation rate of 5/55 (9%) at two years for transvaginal mesh erosion.

Authors' conclusions

Implications for practice.

Transvaginal permanent mesh is associated with lower rates of awareness of prolapse, repeat surgery for prolapse, and prolapse on examination, compared with native tissue repair. However, it is also associated with higher rates of bladder injury, de novo stress incontinence, and repeat surgery for prolapse, stress urinary incontinence, or mesh exposure.

This risk‐benefit profile means that transvaginal mesh has limited utility in primary surgery. In certain individual cases where the risk‐benefit profile may support the use of transvaginal mesh, this should be done in compliance with national regulatory bodies under the auspices of local ethics committees.

Limited evidence shows no difference between absorbable mesh and native tissue repair for the outcomes of awareness of prolapse, repeat surgery, and recurrent prolapse on examination. There was insufficient evidence on absorbable mesh for us to draw any conclusions about other outcomes.

There was no evidence of a difference between transvaginal biological graft and native tissue repair for awareness of prolapse, repeat surgery for prolapse, or recurrent prolapse on examination.

Whilst our conclusions are largely unchanged from the 2016 review, the certainty of the evidence has improved, with larger sample sizes and narrower confidence intervals for most primary outcomes. This is due to the 16 new and five updated trials included in this review. In addition, five studies have reported long‐term outcomes (≥ five years), allowing greater confidence in the outcomes.

As in 2016, we still believe that if transvaginal mesh is to be utilised, it should be at the discretion of the local ethics committee and outcomes should be reported to national regulatory bodies.

Implications for research.

Whilst the risk‐benefit profile of transvaginal mesh means that it has limited utility in primary surgery, there is limited information on its use in the management of recurrent prolapse. Hence, transvaginal mesh may remain a treatment possibility in certain high‐risk patient groups, once all individual factors, advantages, and disadvantages of its use are considered. However, given the established concerns and morbidity associated with the use of permanent transvaginal mesh, research should be conducted under the oversight of the local ethics committee in compliance with local regulatory recommendations.

Investigations into the newer, lightweight transvaginal mesh products that remain on the market are lacking; only one study in our review looked at products from this class (Nager 2019). Further evaluation of the medium‐ and long‐term effects of these newer mesh products is required.

Due to the concerns with permanent transvaginal mesh, the development of newer, self‐rejuvenating products through tissue engineering and bio‐design should be funded, and the efficacy, safety, and cost of these interventions assessed. Furthermore, cost‐benefit analyses and analyses of the long‐term physical, functional, and psychological impacts of prolapse interventions are needed.

What's new

Date	Event	Description
13 March 2024	New citation required but conclusions have not changed	The addition of 21 new studies has not led to a change in the conclusions of this review.
13 March 2024	New search has been performed	In addition to the 37 trials included in the 2017 version of this Cochrane review, we identified 21 new trials evaluating transvaginal mesh or graft compared with transvaginal native tissue repair, or biological, absorbable or permanent meshes. Sixteen were new trials (Ahmed 2019; Chen 2020; Chiang 2021; Damiani 2016; Dietz 2020; Galad 2020; Glazener 2017; Glazener 2020; Iyer 2019; Nager 2019; Ouyang 2020; Shaher 2020; Steures 2019; Takeyama 2020; Wei 2019; Yang 2016). In addition, five were updated publications (da Silveira 2014; Delroy 2013; De Tayrac 2013; Tamanini 2014; Withagen 2011).

History

Protocol first published: Issue 1, 2003
Review first published: Issue 2, 2016

Date	Event	Description
8 November 2017	Amended	Acknowledgements section edited to recognise the contribution of the Cochrane Incontinence Group's Information Specialist Sheila Wallace; detail added to External sources of support by NIHR, UK
27 May 2016	Amended	Clarified wording re composite outcome "repeat surgery for prolapse or stress urinary incontinence or mesh exposure"
6 July 2015	New search has been performed	A comparison of transvaginal grafts versus native tissue repairs was formerly part of the 2013 Cochrane review "Surgical management of pelvic organ prolapse in women". We now present this as a separate review. Twelve new trials are included that were not in the previous review: Dahlgren 2011, da Silviera 2014,Delroy 2013, De Tayrac 2013, Gupta 2014, Qatawneh 2013,Robert 2014Rudnicki 2014, Sung 2012, Svabik 2014, Tamanini 2014, Turgal 2013 and we also include a three‐year follow‐up of Iglesia 2010.
14 April 2010	Amended	Changed citation, added conflicts
17 November 2009	New citation required but conclusions have not changed	Full reports of 59 potentially eligible studies were assessed; for this update, 23 new eligible studies were assessed (Ali 2006a; Allahdin 2008; Al‐Nazer 2007a; Barber 2006; Biller 2008; Borstad 2008; Braun 2007a; Carramao 2008a; Constantini 2008; De Tayrac 2008; Dietz 2008a; Glavind 2007; Guerette 2006a; Lim 2007a; Meschia 2007a; Natale 2007; Natale 2009; Nguyen 2008; Nieminen 2008; Pantazis 2008a; Schierlitz 2007a; Segal 2007; Sivaslioglu 2008). Overall, 17 studies were excluded from the review, six during this update (Barber 2006; Biller 2008; Carramao 2008a; Glavind 2007; Meschia 2007a; Segal 2007); full details are given in the Characteristics of excluded studies table. In this the second update, 18 new trials were added (Ali 2006; Allahdin 2008; Al‐Nazer 2007; Borstad 2008; Braun 2007a; Constantini 2007; Constantini 2008; De Tayrac 2008; Dietz 2008a; Guerette 2006; Lim 2007; Natale 2007; Natale 2009; Nguyen 2008; Nieminen 2008; Pantazis 2008; Schierlitz 2007; Sivaslioglu 2008), and three previously included studies were updated (Brubaker 2008; Meschia 2007; Roovers 2004).
9 February 2009	New search has been performed	New search Feb 2009
10 October 2008	Amended	Converted to new review format
17 April 2007	New citation required and conclusions have changed	Substantive Update Issue 3 2007. 22 RCTs (8 new included trials). The findings are still insufficient to provide robust evidence to support current and new practice (such as whether to perform a concurrent continence operation, or to use mesh or grafts)

Appendices

Appendix 1. Types of operations

Sacral colpopexy

Aim
To correct upper genital tract prolapse

Indication
Usually reserved for recurrent prolapse of the upper vagina (recurrent cystocele, vault or enterocele) or massive vaginal eversion

Surgical technique

• Usually performed under general anaesthesia

• Performed through an incision on the lower abdomen or keyhole

• The bladder and rectum are freed from the vagina and permanent mesh supports the front and back wall of the vagina

• This mesh is secured to the sacrum (upper tailbone)

• Peritoneum (lining of the abdominal cavity) is closed over the mesh

• Other repairs are performed as required at the same time including paravaginal repair, perineoplasty, colposuspension or rectopexy

• Bowel preparation is required prior to the surgery

McCall culdoplasty

Indications

• Vault prolapse or an enterocele

• Often performed at the time of vaginal hysterectomy to prevent future prolapse

Surgical technique

• After the uterus is removed at the time of hysterectomy the uterosacral ligaments are identified and incorporated into the closure of the peritoneum and upper vagina using one to two sutures

• An anterior or posterior vaginal repair is often performed at the same time

Sacrospinous fixation

Aim
This surgery offers support to the upper vagina, minimising risk of recurrent prolapse at this site. The advantage of this surgery is that vaginal length is maintained.

Indication
Upper vaginal prolapse (uterine or vault prolapse, enteroceles)

This procedure can be used in reconstructive vaginal surgery where increased vaginal length is required.

Procedure

• The procedure can be performed under regional or general anaesthesia.

• A routine posterior vaginal incision is made and extended to the top of the vagina.

• Using sharp dissection, the vagina is freed from the underlying rectovaginal fascia and rectum until the pelvic floor (puborectalis) muscle is seen.

• Using sharp and blunt dissection, the sacrospinous ligament running from the ischial spine to the sacral bone is palpated and identified.

• Two sutures are placed through the strong ligament and secured to the top of the vagina. This results in increased support to the upper vagina. There is no shortening of the vagina.

• Other fascial defects in the vagina are repaired, and the vaginal skin is closed.

Anterior vaginal repair (colporrhaphy)

Indication

• Prolapse of the bladder or urethra

• Sometimes used to treat urinary stress incontinence

Surgical technique

• The procedure can be performed under regional or general anaesthesia

• The vagina overlying the bladder and urethra is incised in the midline

• Dissection in a plane directly below the vagina allows the damaged fascia supporting the bladder and urethra to be exposed

• The fascia is plicated in the midline using delayed absorbable or permanent sutures

• Sometimes excessive vaginal skin is removed

• The vaginal skin is then closed

• Other sites of prolapse are then repaired as required

Posterior vaginal repair and perineoplasty

Indications
Treatment of rectocele (rectum bulges or herniates forward into the vagina) and defects of the perineum (area separating entrance of the vagina and anus)

Aim
Correct defects in the rectovaginal fascia separating rectum and vagina while allowing bowel function to be maintained or corrected without interfering with sexual function

Surgical technique

• An incision is made on the posterior wall of the vagina starting at the entrance and finishing at the top of the vagina

• Dissecting the vagina and rectovaginal fascia from the vagina until the pelvic floor muscles (puborectalis) are located

• Defects in the fascia are corrected by centrally plicating the fascia using delayed absorption sutures

• The perineal defects are repaired by placing deep sutures into the perineal muscles to build up the perineal body

• The overlying vaginal and vulval skin is then closed

• A pack is usually placed into the vagina and a catheter into the bladder at the end of surgery

Anterior or posterior vaginal repair, or both (colporrhaphy)

Indications:

Anterior repair: treatment for prolapse of bladder (bladder bulges forward into the vagina; cystocele) or urethra.

Posterior repair: correction of bowel prolapse (rectum bulges forward into the vagina; rectocele).

Vault repair: treat prolapse of upper vagina.

Depending on the side of the defect, the repair can either be anterior, posterior, vault, or total. The repair is achieved by the placement of permanent mesh, which may result in a stronger repair.

Surgical technique

The procedure can be performed under regional or general anaesthesia.

Anterior vaginal repair

• Midline incision to the vagina overlying the bladder and urethra

• Dissection in a plane directly below the vagina and lateral of the bladder allows the damaged fascia supporting the bladder to be exposed

• The fascia is plicated in the midline using sutures

• Mesh can be used to reinforce the repair and can be used as an inlay or anchored through the obturator foramen and exiting through small incisions at both sides of the upper inner thigh

• The vaginal skin is closed

Posterior and vault repair

• An incision is made to the posterior wall of the vagina

• Dissection below the vagina identifies the rectovaginal fascia and opens the space between the rectum and the pelvic floor muscle to the sacrospinous ligaments

• Defects in the fascia are corrected by centrally plicating the fascia using sutures

• Mesh can be used to reinforce the repair and can be used as an inlay or anchored bilaterally to the pelvic side wall and exiting through a small incision approximately 3 cm lateral and down from the anus

• The vaginal skin is then closed

Vaginal paravaginal repair

Aim 
The objective of this surgery is to reattach detached lateral vaginal fascia to its normal point of insertion on the lateral side wall. This firm area of attachment is termed the white line or arcus tendineus fascia pelvis.

Indication
The repair of anterior wall prolapse due to defects of the lateral supporting tissues

Procedure
The procedure can be performed under regional or general anaesthesia.

Routine anterior repair
The sharp dissection of the vagina from the bladder fascia continues laterally until the pelvic side wall can be identified.

Permanent or delayed absorbable sutures are placed from the lateral vagina to the firm pelvic side wall tissue (white line or arcus tendineus fascia pelvis). Three to four sutures are placed on each side.

A routine anterior repair with midline plication of the fascia, trimming of excess vaginal skin as required, and closure of the vaginal skin.

Appendix 2. Brief timeline of government regulatory actions for pelvic mesh

Oct 2008	U.S. Food and Drug Administration (FDA) Public Health Notification of > 1000 adverse events over a 3‐year period (FDA 2024)
Jul 2011	FDA Safety Communication and Analysis issued (FDA 2011)
Mar 2015	The New Zealand Accident Compensation Corporation reports on complications related to all surgical meshes for hernia, urinary incontinence, and prolapse surgeries (ACC 2015).
Jan 2016	The FDA reclassifies surgical mesh for transvaginal prolapse repair of pelvic organ prolapse to class III (FDA 2024).
Mar 2017	The Scottish Independent Review 2017 of the use, safety, and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse is published. It concluded that the current evidence did not indicate any additional benefit from the use of transvaginal implants over native tissue (Scottish Independent Review 2017).
Nov 2017	The Australian Therapeutic Good Administration (TGA) cancels the approval of two types of transvaginal mesh for the treatment of pelvic organ prolapse (TGA 2017).
Dec 2017	The UK National Institute for Health and Care Excellence (NICE) publishes guidelines recommending that transvaginal mesh should only be used in the context of research (NICE 2017).
July 2018	The FDA orders manufacturers of transvaginal pelvic mesh for treatment of pelvic organ prolapse in the posterior compartment to stop selling and distributing their products (FDA 2024).
Sep 2018	The Scottish Parliament and the NHS halt use of vaginal prolapse mesh and incontinence mesh.
Dec 2018	The TGA cancels the approval of all mesh devices placed transvaginally for pelvic organ prolapse and slings for stress urinary incontinence (TGA 2017).
Apr 2019	The FDA orders manufacturers of final mesh products used for transvaginal treatment of pelvic organ prolapse on the market to stop selling and distributing products (FDA 2024).
July 2020	'First Do No Harm: The Independent Medicines and Medical Devices Safety Review' – known as the Cumberlege Report after its chair Julia Cumberlege – is published (Cumberlege 2020).

Appendix 3. The Incontinence Group Specialised Register search strategy

The Incontinence Group Specialised Register was searched using the Group's own keyword system (all searches were of the keyword field of Reference Manager 2012).

The search terms used were:

({design.cct*} OR {design.rct*})
AND
({topic.prolapse*})
AND
({intvent.surg*})

Date of the most recent search of the register for this review: 9 March 2022.

Data and analyses

Comparison 1. Transvaginal permanent mesh versus native tissue repair.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Awareness of prolapse (0.5 to 7 years)	17	2932	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.73, 0.95]
1.1.1 Anterior compartment mesh	11	1399	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.52, 0.84]
1.1.2 Multi‐compartment mesh	7	1533	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.80, 1.12]
1.2 Repeat surgery (0.5 to 7 years)	27		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.2.1 Surgery for recurrent prolapse	17	2485	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.53, 0.95]
1.2.2 Surgery for urinary incontinence	13	2206	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.67, 1.59]
1.2.3 Surgery for mesh exposure	27	3853	Risk Ratio (M‐H, Fixed, 95% CI)	9.51 [5.44, 16.60]
1.3 Recurrent prolapse on examination (any compartment)	25	3680	Risk Ratio (M‐H, Random, 95% CI)	0.42 [0.32, 0.55]
1.3.1 Anterior compartment mesh	15	1836	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.23, 0.41]
1.3.2 Multi‐compartment mesh	10	1844	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.48, 0.80]
1.4 Recurrent prolapse on examination (anterior compartment)	13	1417	Risk Ratio (M‐H, Fixed, 95% CI)	0.41 [0.34, 0.51]
1.4.1 Anterior compartment mesh	9	990	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.27, 0.45]
1.4.2 Multi‐compartment mesh	4	427	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.43, 0.91]
1.5 Recurrent prolapse on examination (posterior compartment)	3	235	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.31, 1.67]
1.5.1 Anterior compartment mesh	2	190	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.32, 1.84]
1.5.2 Multi‐compartment mesh	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.02, 8.83]
1.6 Visceral injury	14		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.6.1 Bladder injury	14	1997	Risk Ratio (M‐H, Fixed, 95% CI)	3.67 [1.63, 8.28]
1.6.2 Bowel injury	1	169	Risk Ratio (M‐H, Fixed, 95% CI)	3.26 [0.13, 78.81]
1.7 Mesh exposure	26	2980	Risk Ratio (M‐H, Fixed, 95% CI)	11.10 [6.81, 18.10]
1.8 POP‐Q assessment	13		Mean Difference (IV, Random, 95% CI)	Subtotals only
1.8.1 Point Ba	13	1953	Mean Difference (IV, Random, 95% CI)	‐0.81 [‐1.08, ‐0.53]
1.8.2 Point Bp	10	1674	Mean Difference (IV, Random, 95% CI)	‐0.01 [‐0.29, 0.27]
1.8.3 Point C	11	1758	Mean Difference (IV, Random, 95% CI)	‐0.52 [‐0.95, ‐0.09]
1.9 POP‐Q assessment Total Vaginal Length (TVL)	7	1397	Mean Difference (IV, Random, 95% CI)	0.23 [‐0.11, 0.56]
1.10 Bladder function: de novo stress urinary incontinence (0.5 to 7 years)	17	2001	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [1.19, 1.88]
1.10.1 Anterior compartment mesh	8	1064	Risk Ratio (M‐H, Fixed, 95% CI)	1.44 [0.97, 2.15]
1.10.2 Multi‐compartment mesh	9	937	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [1.16, 2.02]
1.11 Bladder function: de novo urge incontinence or voiding dysfunction	6		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.11.1 De novo urgency, urge incontinence or bladder overactivity	6	597	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.67, 1.60]
1.11.2 De novo voiding dysfunction	4	344	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.33, 1.59]
1.12 Painful intercourse ‐ de novo dyspareunia	16	1308	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.83, 1.79]
1.12.1 Anterior compartment mesh	10	813	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.63, 1.80]
1.12.2 Multi‐compartment mesh	6	495	Risk Ratio (M‐H, Fixed, 95% CI)	1.45 [0.83, 2.54]
1.13 Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ‐12) (0‐48)	7	857	Mean Difference (IV, Fixed, 95% CI)	‐0.13 [‐0.40, 0.13]
1.14 Quality of life	9		Mean Difference (IV, Random, 95% CI)	Subtotals only
1.14.1 Prolapse Quality of Life Questionnaire (P‐QoL) 0‐100	3	331	Mean Difference (IV, Random, 95% CI)	1.37 [‐3.24, 5.97]
1.14.2 Pelvic Floor Impact Questionnaire‐7 (PFIQ‐7) 0‐300	4	334	Mean Difference (IV, Random, 95% CI)	0.09 [‐5.38, 5.55]
1.14.3 International Consultation on Incontinence Questionnaire Vaginal Symptoms (ICIQ‐VS)	2	700	Mean Difference (IV, Random, 95% CI)	0.25 [‐0.58, 1.08]
1.15 Quality of life (combined)	9	1365	Std. Mean Difference (IV, Random, 95% CI)	0.05 [‐0.11, 0.22]
1.16 Patient Global Impression of Improvement (PGI‐I) (better or very much better)	4	471	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.91, 1.24]
1.17 Operating time (minutes)	16	1860	Mean Difference (IV, Random, 95% CI)	2.42 [‐4.75, 9.60]
1.17.1 Anterior compartment mesh	11	1265	Mean Difference (IV, Random, 95% CI)	8.37 [0.18, 16.56]
1.17.2 Multi‐compartment mesh	5	595	Mean Difference (IV, Random, 95% CI)	‐10.53 [‐23.32, 2.26]
1.18 Length of stay in hospital (days)	8	1049	Mean Difference (IV, Random, 95% CI)	‐0.09 [‐0.30, 0.12]
1.19 Blood transfusion	10	1991	Risk Ratio (M‐H, Fixed, 95% CI)	1.39 [0.83, 2.34]
1.20 Any repeat surgery (0.5 to 7 years)	27	3916	Odds Ratio (M‐H, Fixed, 95% CI)	1.70 [1.36, 2.12]
1.21 Awareness of prolapse (0.5 to 7 years) including trials at high risk of bias	18	3073	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.74, 0.97]
1.21.1 Anterior compartment mesh	11	1399	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.52, 0.84]
1.21.2 Multi‐compartment mesh	8	1674	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.82, 1.12]
1.22 Repeat surgery (0.5 to 7 years) including trials at high risk of bias	28		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.22.1 Surgery for recurrent prolapse	18	2625	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.51, 0.89]
1.22.2 Surgery for urinary incontinence	13	2206	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.67, 1.59]
1.22.3 Surgery for mesh exposure	28	3993	Risk Ratio (M‐H, Fixed, 95% CI)	9.55 [5.53, 16.51]
1.23 Recurrent prolapse on examination (any compartment) including trials at high risk of bias	26	3821	Risk Ratio (M‐H, Random, 95% CI)	0.44 [0.34, 0.57]
1.23.1 Anterior compartment mesh	15	1836	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.23, 0.41]
1.23.2 Multi‐compartment mesh	11	1985	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.51, 0.81]
1.24 Any repeat surgery (0.5 to 7 years) including trials at high risk of bias	28	4056	Risk Ratio (M‐H, Random, 95% CI)	1.48 [1.04, 2.11]

Comparison 2. Transvaginal absorbable mesh versus native tissue repair.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Awareness of prolapse (2 years)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.2 Repeat surgery (2 years)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.2.1 Surgery for recurrent prolapse	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.09, 2.40]
2.2.2 Surgery for urinary incontinence	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.2.3 Surgery for mesh exposure	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.3 Recurrent prolapse on examination (any)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.4 Recurrent prolapse on examination (anterior compartment)	2		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
2.4.1 Anterior compartment mesh	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
2.4.2 Multi‐compartment mesh	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
2.5 Recurrent prolapse on examination (posterior compartment)	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.40, 3.19]
2.5.1 Anterior compartment mesh	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.5.2 Multi‐compartment mesh	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.40, 3.19]
2.6 Visceral injury	0		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.6.1 Bladder injury	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.6.2 Bowel injury	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.7 Mesh exposure	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.8 POP‐Q assessment	0		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
2.8.1 Point Ba	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
2.8.2 Point Bp	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
2.8.3 Point C	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
2.9 POP‐Q assessment Total Vaginal Length (TVL)	0		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
2.10 Bladder function: de novo stress urinary incontinence	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.11 Bladder function: de novo urge incontinence or voiding dysfunction	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.11.1 De novo urgency, urge incontinence or bladder overactivity	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.11.2 De novo voiding dysfunction	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.12 Painful intercourse ‐ de novo dyspareunia	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.13 Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ‐12) (0‐48)	0		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
2.14 Quality of life	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
2.15 Patient Global Impression of Improvement (PGI‐I) (better or very much better)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.16 Operating time (minutes)	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
2.17 Length of stay (days)	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
2.18 Blood transfusion	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

2.6. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 6: Visceral injury

2.7. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 7: Mesh exposure

2.8. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 8: POP‐Q assessment

2.9. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 9: POP‐Q assessment Total Vaginal Length (TVL)

2.11. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 11: Bladder function: de novo urge incontinence or voiding dysfunction

2.12. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 12: Painful intercourse ‐ de novo dyspareunia

2.13. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 13: Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ‐12) (0‐48)

2.14. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 14: Quality of life

2.15. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 15: Patient Global Impression of Improvement (PGI‐I) (better or very much better)

2.16. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 16: Operating time (minutes)

2.17. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 17: Length of stay (days)

2.18. Analysis.

Comparison 2: Transvaginal absorbable mesh versus native tissue repair, Outcome 18: Blood transfusion

Comparison 3. Transvaginal biological graft versus native tissue repair.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Awareness of prolapse (1 to 3 years)	8	1374	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.73, 1.56]
3.1.1 Anterior compartment repair	4	429	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.45, 1.22]
3.1.2 Multi‐compartment repair	2	723	Risk Ratio (M‐H, Random, 95% CI)	1.96 [0.62, 6.20]
3.1.3 Posterior compartment repair	2	222	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.22, 3.15]
3.2 Repeat surgery (1 to 2 years)	7	986	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.75, 1.77]
3.2.1 Surgery for recurrent prolapse	6	899	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.75, 1.77]
3.2.2 Surgery for stress urinary incontinence	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
3.2.3 Surgery for mesh exposure	1	87	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
3.3 Recurrent prolapse on examination (any compartment)	9	1278	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.71, 1.29]
3.3.1 Anterior compartment repair	5	369	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.54, 1.05]
3.3.2 Multi‐compartment repair	2	691	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.73, 1.47]
3.3.3 Posterior compartment repair	2	218	Risk Ratio (M‐H, Random, 95% CI)	2.09 [1.18, 3.70]
3.4 Recurrent prolapse on examination (anterior compartment)	7	684	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.54, 0.90]
3.5 Recurrent prolapse on examination (posterior compartment)	3	283	Risk Ratio (M‐H, Random, 95% CI)	1.16 [0.39, 3.51]
3.6 Visceral injury	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.6.1 Bladder injury	2	254	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.04, 3.26]
3.6.2 Bowel injury	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	3.13 [0.13, 75.57]
3.7 Mesh exposure	1	87	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
3.8 POP‐Q assessment	2		Mean Difference (IV, Random, 95% CI)	Subtotals only
3.8.1 Point Ba	2	648	Mean Difference (IV, Random, 95% CI)	‐0.17 [‐0.75, 0.42]
3.8.2 Point Bp	2	645	Mean Difference (IV, Random, 95% CI)	0.10 [‐0.07, 0.27]
3.8.3 Point C	2	640	Mean Difference (IV, Random, 95% CI)	‐0.18 [‐0.86, 0.49]
3.9 POP‐Q assessment Total Vaginal Length (TVL)	2	633	Mean Difference (IV, Random, 95% CI)	0.25 [‐0.33, 0.82]
3.10 Bladder function: de novo stress urinary incontinence	2	143	Risk Ratio (M‐H, Fixed, 95% CI)	12.64 [1.60, 100.06]
3.11 Bladder function: de novo urge incontinence or voiding dysfunction	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.11.1 De novo urgency, urge incontinence or bladder overactivity	1	87	Risk Ratio (M‐H, Fixed, 95% CI)	2.11 [0.45, 9.79]
3.11.2 De novo voiding dysfunction	2	93	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.29, 2.26]
3.12 Painful intercourse ‐ de novo dyspareunia	2	125	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [0.46, 3.66]
3.13 Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ‐12) (0‐48)	1	35	Mean Difference (IV, Fixed, 95% CI)	1.00 [‐2.33, 4.33]
3.14 Quality of life	2	112	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.47, 0.27]
3.15 Patient Global Impression of Improvement (PGI‐I) (better or very much better)	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
3.16 Operating time (minutes)	5	319	Mean Difference (IV, Random, 95% CI)	6.87 [‐2.43, 16.18]
3.17 Length of stay (days)	1	87	Mean Difference (IV, Fixed, 95% CI)	‐0.50 [‐1.09, 0.09]
3.18 Blood transfusion	2	835	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.13, 5.74]

3.13. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 13: Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ‐12) (0‐48)

3.15. Analysis.

Comparison 3: Transvaginal biological graft versus native tissue repair, Outcome 15: Patient Global Impression of Improvement (PGI‐I) (better or very much better)

Comparison 4. Transvaginal permanent mesh versus another vaginal mesh.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Awareness of prolapse	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.2 Repeat surgery	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.2.1 Surgery for recurrent prolapse	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.2.2 Surgery for urinary incontinence	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.51, 2.36]
4.2.3 Surgery for mesh exposure	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.3 Recurrent prolapse on examination (any compartment)	2	232	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.33, 5.04]
4.4 Recurrent prolapse on examination (anterior compartment)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.5 Recurrent prolapse on examination (posterior compartment)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.6 Visceral injury	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.6.1 Bladder injury	2	175	Risk Ratio (M‐H, Fixed, 95% CI)	3.00 [0.13, 69.87]
4.6.2 Bowel injury	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.7 Mesh exposure	4	365	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.24, 1.58]
4.8 POP‐Q assessment	0		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
4.8.1 Point Ba	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
4.8.2 Point Bp	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
4.8.3 Point C	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
4.9 POP‐Q assessment Total Vaginal Length (TVL)	0		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
4.10 Bladder function: de novo stress urinary incontinence	2	175	Risk Ratio (M‐H, Fixed, 95% CI)	1.87 [0.62, 5.65]
4.11 Bladder function: de novo urge incontinence or voiding dysfunction	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.12 Painful intercourse ‐ de novo dyspareunia	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
4.13 Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ‐12) (0‐48)	0		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
4.14 Quality of life	2	208	Mean Difference (IV, Random, 95% CI)	‐2.64 [‐8.17, 2.89]
4.14.1 Prolapse Quality of Life Questionnaire (P‐QoL) 0‐100	0	0	Mean Difference (IV, Random, 95% CI)	Not estimable
4.14.2 Pelvic Floor Distress Inventory (PFDI‐20) 0‐300	1	90	Mean Difference (IV, Random, 95% CI)	‐2.30 [‐9.11, 4.51]
4.14.3 Pelvic Floor Impact Questionnaire 7 (PFIQ‐7) 0‐300	1	118	Mean Difference (IV, Random, 95% CI)	‐3.30 [‐12.75, 6.15]
4.15 Patient Global Impression of Improvement (PGI‐I) (better or very much better)	0	0	Risk Ratio (IV, Fixed, 95% CI)	Not estimable
4.16 Operating time (minutes)	3	321	Mean Difference (IV, Fixed, 95% CI)	‐1.87 [‐8.00, 4.26]
4.17 Length of stay (days)	1	90	Mean Difference (IV, Fixed, 95% CI)	‐1.28 [‐2.27, ‐0.29]
4.18 Blood transfusion	1	90	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.97]

4.1. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 1: Awareness of prolapse

4.4. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 4: Recurrent prolapse on examination (anterior compartment)

4.5. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 5: Recurrent prolapse on examination (posterior compartment)

4.8. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 8: POP‐Q assessment

4.9. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 9: POP‐Q assessment Total Vaginal Length (TVL)

4.11. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 11: Bladder function: de novo urge incontinence or voiding dysfunction

4.12. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 12: Painful intercourse ‐ de novo dyspareunia

4.13. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 13: Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ‐12) (0‐48)

4.15. Analysis.

Comparison 4: Transvaginal permanent mesh versus another vaginal mesh, Outcome 15: Patient Global Impression of Improvement (PGI‐I) (better or very much better)

Comparison 5. Transvaginal permanent mesh versus biological graft vaginal repair.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Awareness of prolapse	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
5.2 Repeat surgery	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
5.2.1 Surgery for recurrent prolapse	1	232	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.20, 4.77]
5.2.2 Surgery for urinary incontinence	1	232	Risk Ratio (M‐H, Fixed, 95% CI)	1.47 [0.25, 8.66]
5.2.3 Surgery for mesh exposure	2	290	Risk Ratio (M‐H, Fixed, 95% CI)	5.79 [0.71, 47.14]
5.3 Recurrent prolapse on examination (any compartment)	2	290	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.50, 1.85]
5.4 Recurrent prolapse on examination (anterior compartment)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
5.5 Recurrent prolapse on examination (posterior compartment)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
5.6 Visceral injury	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
5.6.1 Bladder injury	1	58	Risk Ratio (M‐H, Fixed, 95% CI)	2.81 [0.12, 66.17]
5.6.2 Bowel injury	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
5.7 Mesh exposure	2	289	Risk Ratio (M‐H, Fixed, 95% CI)	2.81 [0.12, 66.17]
5.8 POP‐Q assessment	0		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
5.8.1 Point Ba	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
5.8.2 Point Bp	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
5.8.3 Point C	0	0	Mean Difference (IV, Fixed, 95% CI)	Not estimable
5.9 POP‐Q assessment Total Vaginal Length (TVL)	0		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
5.10 Bladder function: de novo stress urinary incontinence	1	58	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.27, 2.27]
5.11 Bladder function: de novo urge incontinence or voiding dysfunction	1	58	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.31, 5.07]
5.11.1 De novo urgency, urge incontinence or bladder overactivity	1	58	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.31, 5.07]
5.11.2 De novo voiding dysfunction	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
5.12 Painful intercourse ‐ de novo dyspareunia	1	58	Risk Ratio (M‐H, Fixed, 95% CI)	8.42 [0.47, 149.62]
5.13 Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ‐12) (0‐48)	0		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
5.14 Quality of life	0	0	Mean Difference (IV, Random, 95% CI)	Not estimable
5.15 Patient Global Impression of Improvement (PGI‐I) (better or very much better)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
5.16 Operating time (minutes)	1	58	Mean Difference (IV, Fixed, 95% CI)	1.50 [‐10.65, 13.65]
5.17 Length of stay (days)	1	58	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐0.46, 0.86]
5.18 Blood transfusion	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

5.1. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 1: Awareness of prolapse

5.4. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 4: Recurrent prolapse on examination (anterior compartment)

5.5. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 5: Recurrent prolapse on examination (posterior compartment)

5.8. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 8: POP‐Q assessment

5.9. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 9: POP‐Q assessment Total Vaginal Length (TVL)

5.11. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 11: Bladder function: de novo urge incontinence or voiding dysfunction

5.13. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 13: Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ‐12) (0‐48)

5.14. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 14: Quality of life

5.15. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 15: Patient Global Impression of Improvement (PGI‐I) (better or very much better)

5.18. Analysis.

Comparison 5: Transvaginal permanent mesh versus biological graft vaginal repair, Outcome 18: Blood transfusion

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ahmed 2019.

Study characteristics
Methods	RCT with 1:1 computer‐generated block design Group I: concomitant transobturator tape (TOT) + anterior colporrhaphy Group II: transobturator 4‐armed subvesical mesh fixation Group allocator, participants, outcome assessors blinded Operators not blinded Success defined as: objective: negative CST + no need for pads subjective: ICIQ‐SF ≤ 12 anatomical: absence of all of: descent of vaginal wall beyond hymen + bothersome vaginal bulge symptoms + re‐treatment of prolapse
Participants	Inclusion criteria: stage 2‐3 cystocele and SUI Exclusion criteria: detrusor overactivity, neurological deficit, genitourinary malignancy, concomitant stage or higher apical prolapse, bladder pathology, history of pelvic irradiation 8.3% previous prolapse surgery, concomitant urge incontinence 94% 69% women premenopausal (average age 42.96) Concomitant apical prolapse in 8.3% No participants included had previous hysterectomy N = 90 total Group I (41) 4/45 lost to follow‐up in group I Group II (43) 2/45 loss to follow‐up in group II
Interventions	GA or spinal Group I: anterior repair ‐ 2.0 polydioxanone plication, 2.0 polygalactin closure vagina, TOT (Gynaecare, Ethicon) inside‐out Group II: 4‐armed subvesical transobturator mesh (Dynamesh‐PR4), polyglactin sutures
Outcomes	Follow‐up at 1, 3, 6, 9, 12 months ICIQ‐SF, examination + CST Abdominal USS + uroflow at 3 and 12 months, full UDS if de novo urge incontinence Clavien‐Dindo postop complications Operating time Intraoperative bleeding Blood transfusion Urethral/bladder injury Urinary retention, delayed IDC removal De novo dyspareunia De novo urinary urgency
Notes	Local ethics committee approval
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	1:1 computer‐generated block design
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Allocator, participants blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Not possible: 4 cuts in 4‐armed mesh
Incomplete outcome data (attrition bias) All outcomes	Low risk	Group 1: 4/45; Group 2: 2/45 at 12 months
Selective reporting (reporting bias)	Unclear risk	No trial registration
Other bias	Low risk	No conflict of interest

Al‐Nazer 2007.

Study characteristics
Methods	Single‐centre RCT for stage 2 POPQ prolapse Computer‐generated randomisation 2‐year follow‐up No CONSORT statement Blinding not stated Authors state power of 85% need sample size of 20 in each arm
Participants	40 randomised in abstract. However, 44 were randomised, 4 of whom failed to return postoperatively and were excluded Inclusion criteria: stage 2 POPQ cystocele with no plans of pregnancy in 12 months Exclusion criteria: contemplating pregnancy, women with paravaginal defects, needing continence surgery, prior colposuspension or vaginal surgery, immunocompromised, or diabetics
Interventions	A (n = 23): anterior colporrhaphy (AC) 0 polyglactin (Vicryl) suture B (n = 21): self‐styled armless soft polypropylene (Gynemesh) mesh without AC
Outcomes	Assessed at 6 weeks, 3 months, then every 6 months to 2 years postoperatively Reports the following review outcomes: Awareness of prolapse (subjective persistence of symptoms of vaginal bulge) Recurrent prolapse at 1 to 3 years Mesh erosion Bladder injury (cystotomy) Objective failure rate stage 2 POPQ at Aa, Ba, Ap, or Bp Bladder function (de novo SUI) Sexual function (de novo dyspareunia) Quality of life: PQOL questionnaire; change scores Hospital stay Operating time
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated number tables
Allocation concealment (selection bias)	Low risk	Sealed envelopes to ensure allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Reviewers blinded except when mesh exposure occurred
Incomplete outcome data (attrition bias) All outcomes	Low risk	At 1 year: group A 20/23, group B 20/21
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	Funding not stated; authors have no conflict of interest

Allahdin 2008.

Study characteristics
Methods	Single‐centre RCT comparing vaginal fascial repair with or without polyglactin mesh and with polydioxanone or polyglactin sutures, 2 x 2 factorial design Computer‐generated randomisation, "secure" remote concealment Blinded women, ward staff, and follow‐up assessor Follow‐up at 3 months with exam, 6 months with non‐validated questionnaire, 2 years with validated questionnaire
Participants	73 randomised, 7 ineligible after randomisation, 66 in trial Lost to follow‐up: 8 at 3 months; 4 at 6 months; 12 at 2 years Inclusion criteria: grade 2 or more prolapse (unclear examination technique), anterior or posterior prolapse, or both Concomitant procedures: vaginal hysterectomy 14; cervical amputation (Manchester) 18; tension‐free vaginal tape 13
Interventions	Comparing vaginal fascial repair with or without polyglactin mesh and with polydioxanone or polyglactin sutures, 2 x 2 factorial design A (32): fascial repair plus polyglactin mesh overlay B (34): fascial repair without mesh C (33): repair of fascia with polydioxanone sutures D (33): repair of fascia with polyglactin sutures
Outcomes	Assessed at 3 months', 6 months', and 2 years' postop Reports the following review outcomes: Awareness of prolapse (residual feeling of something coming down) at 2 years Repeat prolapse surgery at 2 years Recurrent prolapse on objective examination at 3 months Death (any cause) by 2 years Objective failure rate stage 2 POPQ at Aa, Ba, Ap, or B Bladder function: urinary incontinence at 2 years Bowel function: faecal incontinence (no comparative data) Sexual function: dyspareunia at 2 years (not de novo) Quality of life at 6 months and 2 years. QoL score: end scores on 0 to 10 scale (0 = not at all)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Low risk	Secure method of concealment of randomisation (remote computer allocation)
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Not possible
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Participant‐completed questionnaires, data entry blinded to randomisation
Incomplete outcome data (attrition bias) All outcomes	High risk	Equal non‐response between the groups at 2 years, medical records seen for all non‐responders
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	Unfunded study

Altman 2011.

Study characteristics
Methods	Multicentre RCT: 53 centres, 58 surgeons 90% powered to detect 20% difference between groups with 1% type 1 error, central computer‐generated randomisation Participants blinded Reviews conducted at 2 and 12 months, by surgeon 1/3, non‐surgeon 2/3 Completed preoperative and 1‐year UDI and PISQ‐12
Participants	1685 screened; 389 randomised Underwent surgery: A 182, B 191 Lost to follow‐up: A 7, B 14 (1 year: A 182, B 186) Inclusion criteria: > 18 years old, ≥ stage 2 symptomatic cystocele POPQ Exclusion criteria: previous cancer of any pelvic organ, systemic glucocorticoid treatment, insulin‐treated diabetes, an inability to participate or to provide consent, or need concomitant surgery
Interventions	A (182): anterior colporrhaphy, slow absorption monofilament thread, sham skin markings, excessive vaginal trimming discouraged B (191): Gynecare transvaginal anterior mesh (Prolift), absorbable sutures, excessive vaginal trimming discouraged, catheter care at discretion of surgeon
Outcomes	Assessed at 1‐year postop Reports the following review outcomes at 1 year: Awareness of prolapse (woman‐reported vaginal bulge) Repeat prolapse surgery Mesh exposure (obtained by personal communication) Repeat continence surgery Objective failure of anterior compartment ≥ stage 2 Bladder injury (perforation) Bladder function: new SUI Sexual function: dyspareunia, PISQ (end scores with 95% CI)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Secure concealment with remote computer
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Women blinded (sham skin markings)
Blinding of outcome assessment (detection bias) All outcomes	High risk	Reviewers: surgeon 1/3, non‐surgeon 2/3 Woman‐completed questionnaires
Incomplete outcome data (attrition bias) All outcomes	Low risk	1 year: anterior colporrhaphy (AC) 174/182; mesh 186/191
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	High risk	Funded by Karolinska Institute and Ethicon; conflict of interest statements of members of Nordic transvaginal mesh group who were reviewers of surgery were not reported

Carey 2009.

Study characteristics
Methods	Single‐centre RCT CONSORT: no Randomisation: computer generated Allocation concealment: N/S Women, surgeons, and reviewers not blinded 12 months' follow‐up
Participants	Inclusion criteria: women who were recommended vaginal surgery for anterior and posterior compartment with ≥ grade 2 prolapse Exclusion criteria: only requiring anterior or posterior compartment surgery, apical prolapse beyond the hymen, or those requiring abdominal mesh surgery Randomised: 139 (A 70, B 69); 10 women breached study protocol, and 11 more recruited. All were analysed Lost to follow‐up: A 6, B 9 Analysed at 12 months: A 63, B 61
Interventions	A (70): traditional anterior and posterior fascial plication using polydioxanone sutures B (69): anterior and posterior repair with Gynemesh PS augmentation
Outcomes	Assessed at 6 months and 1 year postop Reports the following review outcomes at 1 year: Awareness of prolapse Recurrent prolapse Mesh erosion Objective failure of anterior compartment Sexual function: new dyspareunia
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	Native tissue 63/70; mesh 63/69 at 1 year
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	High risk	Funding not stated: authors' conflict of interest ‐ financial agreement with Ethicon, manufacturer of product evaluated in study

Chen 2020.

Study characteristics
Methods	Single‐centre Chinese RCT comparing self‐cut titanium‐coated mesh (Ti‐mesh) with mesh kit for POP stage 3‐4 anterior or apical prolapse with 12‐month review
Participants	Stage 3‐4 apical or anterior symptomatic prolapse
Interventions	Group A: 46 self‐cut titanium‐coated polypropylene mesh (Ti‐Mesh) Group B: 44 standard care polypropylene mesh kit
Outcomes	No awareness of prolapse No retreatment of prolapse POPQ points beyond hymen Mesh exposure cystotomy PFIQ‐7 PFDI ‐20
Notes	Funded by Medstron Medical Shanghai
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Unclear risk	No statement
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not described
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	5 women randomised to complete 12‐month review. Unclear which group
Selective reporting (reporting bias)	Low risk	Consistent reporting with pre‐trial registration
Other bias	High risk	Sponsored by manufacturer of device

Chiang 2021.

Study characteristics
Methods	Single‐centre Taiwianese RCT comparing polypropylene mesh kits with and without fascial plication for anterior compartment prolapse Randomisation with envelopes 64 participants allowed 80% power to detect 0.8 cm difference in Point Ba at 12 months with an error of 5%
Participants	Inclusion criteria: 50 to 75 years of age POPQ stage 2 or greater Exclusion criteria: prior vaginal surgery, prior implants for prolapse, coagulation or renal disorder, cognitive impairment, prior radiotherapy
Interventions	Group A: 32. Avulta solo polypropylene trans‐obturator mesh kit (Bard) Group B: 32. As above, except anterior colporrhaphy with interrupted 2.0 vicryl
Outcomes	Anatomic failure anterior vaginal wall PFDI‐20 POPQ points Mesh exposure Dyspareunia
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Envelope‐generated randomisation
Allocation concealment (selection bias)	Unclear risk	Envelope only
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unblinded study
Incomplete outcome data (attrition bias) All outcomes	Low risk	18 months: 31/32 mesh only; 30/32 plication + mesh
Selective reporting (reporting bias)	Unclear risk	No trial registration
Other bias	Low risk	No funding or conflict of interest

da Silveira 2014.

Study characteristics
Methods	Multicentre (4) RCT for stage 3 to 4 POPQ (any compartment), Brazil Computerised randomisation Sample size n = 90 in each group, 90% power and allowing 20% loss to follow‐up No ITT analysis Women unblinded Reviewers blinded
Participants	Inclusion criteria: grade 3 to 4 POP (any POPQ measurement > +1) No exclusion criteria 199 screened, 184 randomised Native tissue n = 90 randomised, n = 81 completed 1 year Mesh n = 94 randomised, n = 88 1 year 5‐year follow‐up: native tissue repair n = 59; mesh n = 63
Interventions	Group A: site‐specific native tissue: site‐specific anterior and/or posterior 1.0 non‐absorbable suture (polypropylene), apical 1.0 non‐absorbable sacrospinous right Group B: mesh group: polypropylene macro‐porous monofilament Prolift mesh Uterine prolapse hysterectomy in both groups Concomitant surgery allowed Prior to study, each centre performed at least 3 surgeries Hb 24 hours postop Assessed at 1 week 1, 6, 12 months Pain assessed with variable rating scale Group A: 74/90 anterior compartment prolapse ∓ other surgery, posterior alone n = 7, apical alone n = 9 Group B: mesh group similar breakdown Mid‐urethral slings: 5/90 native tissue, 9/94 mesh Vaginal hysterectomy: 32/90 native tissue, 29/94 mesh
Outcomes	Assessed at 1‐year postop Reports the following review outcomes: Repeat prolapse surgery Repeat surgery for prolapse, SUI, or mesh exposure Bladder injury Rectal injury (bowel loop injury) Repeat continence surgery Surgery for mesh exposure Objective failure of anterior compartment (Pt Ba) POPQ assessment of prolapse: point C, point Ba, point Bp Sexual function: Quality of Sexual Function questionnaire (not PISQ), data not entered; no one uses this questionnaire and not described; only included PQOL) Quality of life: PQOL end score Operating time Blood transfusion
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants not able to be blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Native tissue: randomised 90, 81 completed 1 year Mesh: randomised 94, 88 completed 1 year At 5‐year follow‐up: 59 native tissue repair; 63 mesh
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	J&J donated product; no financial input in study

Dahlgren 2011.

Study characteristics
Methods	Multicentre (8) Swedish open‐label RCT Computer‐generated block randomisation stratified for each centre Allocation concealment in opaque, sealed envelopes Sample size was based on the assumption that a 15% difference in objective cure rate after 3 years between the implant‐augmented repair and the traditional colporrhaphy with 90% power should be significant at a 5% level. It was estimated that 160 women, 80 in each arm of the study, including a dropout of 10%, were needed. 3‐year review ITT and CONSORT guidelines reporting not stated
Participants	Inclusion criteria: recurrent (prior surgery on the prolapsing site) POP in anterior or posterior compartment, or both No exclusion criteria 135 randomised Group A: native tissue repair: 64. At 3 years 60/64 Group B: porcine dermis repair: 68. At 3 years 65/68
Interventions	Standardised surgery with 2 meeting workshops prior to study Native tissue repair: midline fascial plication interrupted polydioxanone suture, vagina closed polyglactin absorbable suture Porcine: porcine dermal implant (Pelvicol, Bard Sweden) as inlay with no fascial plication: inlay anchored to vaginal wall and fascia 6‐8 polydioxanone sutures, vagina closed polyglactin suture Concomitant mid‐urethral sling, apical support, hysterectomy and levator plication performed as required
Outcomes	Assessed at 3 months and 3 years Reports the following review outcomes: Awareness of prolapse (awareness of vaginal lump) at 3 years (presented in graph) Objective failure posterior compartment (Pt Bp median and range reported) Bladder function (urinary incontinence presented in graph) Bowel function (faecal incontinence presented in graph) Dyspareunia (presented in graph) Days in hospital (mean and range)
Notes	Did not reach sample size as slow to recruit
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated blocked randomisation list stratified for each centre
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Nil
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	Group A 60/64 and Group B 65/68 completed 3‐year review
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	No conflict of interest; funded by local research institutes

Damiani 2016.

Study characteristics
Methods	Multicentre (3) Italian RCT comparing graft and native tissue repair for stage 2 prolapse. Graft group randomised to Avulta (Bard) polypropylene mesh and Pelvisoft porcine dermal acellular collagen matrix (Bard) Sample size of 103 participants without specified calculation of power or type one error
Participants	Inclusion criteria: symptomatic stage 2 or greater POPQ at 24‐month review Exclusion criteria: has not completed family, systemic infection, compromised immune system, connective tissue disorder, poorly controlled diabetes, prior cancer
Interventions	Group A: n = 30. Avulta Solo polypropylene mesh transobturator mesh fixed with 2.0 prolene sutures anterior and posterior, or Pelvisoft porcine dermal collagen n = 28 4x7cm anchored with 2.0 PDS sutures secured to underlying anterior or posterior tissue Group B: n = 59. Fascial plication anteriorly and/or posteriorly with interrupted delayed absorbable material > vagina closed 2.0 polyglactin sutures Concomitant hysterectomy: 46% Pelvisoft, 36% Avulta, 60% native tissue
Outcomes	POPQ stage 2 or greater Transfusion Cystotomy Mesh exposure Stress urinary incontinence Dyspareunia De novo dyspareunia
Notes	No conflict of interest
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unable to blind for mesh arm ‐ groin incisions
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unable to blind for mesh arm ‐ groin incisions
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up in either group
Selective reporting (reporting bias)	Unclear risk	No pre‐trial registration
Other bias	Low risk	No conflict of interest

De Tayrac 2008.

Study characteristics
Methods	Multicentre RCT comparing infracoccygeal sacropexy and sacrospinous suspension for uterine or vaginal vault prolapse No CONSORT statement Power calculation: yes, 77 required in each arm. Recruitment stopped after change in mesh material (multi‐filament mesh replaced by monofilament) No ITT analysis No data on type of randomisation, blinding strategy, or allocation concealment No definition of cure or failure Mean follow‐up 16.8 months (range 1.5 to 32) both arms Prolapse assessment: POPQ Validated questionnaires: PFDI, PFIQ, PISQ‐12, French version
Participants	Inclusion criteria: symptomatic uterine or vaginal vault prolapse (stage 2 or higher) Exclusion criteria: isolated cystocele, stage 1 prolapse, rectal prolapse, and intestinal inflammatory disease 49 randomised 4 lost to follow‐up 45 analysed
Interventions	A (21): infracoccygeal sacropexy (multi‐filament polypropylene tape, posterior IVS) B (24): sacrospinous suspension Concomitant surgery: cystocele repair, posterior repair, hysterectomy, suburethral tape Types of repair and indications for repair were not described
Outcomes	Assessed at "medium term" follow‐up (mean 16.8 months postop, range 1.5 to 32) Reports the following review outcomes: Repeat surgery for prolapse Recurrent prolapse on objective examination (not defined) Bladder injury Objective failure anterior compartment (cystocele) Objective failure posterior compartment (rectocele) Bladder function: de novo SUI, de novo voiding disorder Sexual function: PISQ‐12 end scores Quality of life: POPIQ ‐ reports rate of 50% or more improvement Operating time Days in hospital
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Participant‐completed questionnaires
Incomplete outcome data (attrition bias) All outcomes	Low risk	At 1 year 45/49 completed review
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	Conflict of interest and funding not stated

De Tayrac 2013.

Study characteristics
Methods	Multicentre (12 French hospitals) RCT 12‐month review Randomisation by drawing lots, stratified by centre; allocation concealment not discussed Intention to treat stated yes, but women already randomised were removed if cystotomy occurred during surgery CONSORT guidelines Sample size of 194 provided 80% power to detect 20% difference with an alpha error 5% and dropout rate 10% Assessors not clear 5‐year follow‐up
Participants	Inclusion criteria: symptomatic stage 2 anterior wall prolapse, aged 60 years or older Exclusion criteria: steroids, poorly controlled diabetes, prior pelvic radiation, untreated vaginal or urinary infection, ascites, bladder injury during the procedure All used preoperative oestrogen therapy 163 included, 162 randomised Group A: n = 82, 1 year 67/82 Group B: n = 80, 1 year 66/80 Preop demographics and potential confounders similar in both groups, except colorectal impact was greater in group A At 5 years: Group A 36/82 Group B 39/80
Interventions	Group A: anterior colporrhaphy no mesh (plication of fascia with 2.0 polyglactin absorbable suture), uterosacral colpopexy and hysterectomy as required Group B: anterior polypropylene macro‐porous mesh (Ugtex, Sofradim, Covidien) 4‐armed transobturator mesh fixed with 2 x 2.0 permanent polypropylene sutures to uterine isthmus or uterosacral ligaments and 2 x 2.0 polyglactin sutures to inferior edge of pubic rami; vaginal trimming minimised Concomitant surgery mid‐urethral sling, hysterectomy, and any native tissue repair. However, no other transvaginal mesh intervention included
Outcomes	Assessed at 1‐year follow‐up Reports the following review outcomes: Awareness of prolapse ("functional recurrence") Repeat continence surgery Repeat surgery for prolapse, SUI, or mesh exposure Recurrent prolapse: stage 2 or more anterior prolapse Mesh exposure Repeat surgery for mesh exposure Objective failure of anterior compartment POPQ assessment of prolapse: point Ba POPQ assessment of prolapse: total vaginal length Bladder function: de novo SUI Bowel function: obstructed defecation Sexual function: de novo dyspareunia Operating time Blood transfusion Days in hospital At 5 years Functional recurrence ‐ composite score of reintervention and 'yes' on PFDI question 5 Recurrence of prolapse POPQ stage 2 or more Reintervention for prolapse Postoperative complications ‐ reintervention, rehospitalisation PGI‐I PFDI PFIQ PISQ‐12 Mesh exposure, contraction, prominence, pain during examination
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation by drawing lots?
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unable to blind
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	High risk	Group A 82, 1 year 67/82 Group B 80, 1 year 66/80 (20% attrition). 2 women who had bladder injury were excluded from analysis At 5 years > 50% attrition both groups
Selective reporting (reporting bias)	Low risk	Reports main review outcomes, registered at clinicaltrials.gov
Other bias	High risk	Author conflict of interest with Sofradim, who provided partial funding and whose product was being evaluated. 2 women who had bladder injury were excluded from analysis; this outcome not reported clearly in both groups

Delroy 2013.

Study characteristics
Methods	Single‐centre non‐inferiority RCT Computer‐generated 1:1 randomisation table using SPSS Allocation at inclusion, with surgeon aware only in operating theatre Envelopes allocation Sample size: 35 in each group, 80% power to detect 5% significant change with 10% dropout ITT analysis Assessors blinded Women unblinded 2‐year study not quite an update ‐ further 1 year of enrolment of patients (up to 2010)
Participants	Any anterior POP point Ba ≥ +1 on POPQ Excluded malignant urogenital disease, prior radiation, acute genitourinary infection, connective tissue disorders, steroid treatments, insulin‐dependent diabetes
Interventions	All procedures under spinal by 3 experienced surgeons 1. Anterior colporrhaphy (AC) native tissue repair: plicate fascia purse string 0 polyglactin (Vicryl), vaginal trimming, transvaginal trocar‐guided polypropylene mesh (kits donated by Promedon) Nazca TC (Promedon, Córdoba, Argentina) I prepubic and 2 transobturator macro‐porous monofilament; vagina closed overlapping fashion 355 accessed, 79 randomised. AC: 39 completed, 1‐year review n = 39 2. Anterior mesh: 40 randomised, 40 completed 1‐year review Concomitant surgery as required: hysterectomy/trachelectomy: 36% AC group, 20% in mesh
Outcomes	Assessed at 1 year Reports the following review outcomes: Anatomical success (anterior vaginal wall stage 0‐1) Awareness of prolapse: positive answer to at least 1 PQOL question on vaginal bulge, pelvis pain, sensation of prolapse (unusual combined measure ‐ data not used) Mesh exposure Bladder injury POPQ assessment of prolapse: point Ba, C, Bp, total vaginal length Sexual function: de novo dyspareunia Operating time Blood transfusion Days in hospital 2 years Anatomical success Ba < ‐1 or Ba < 0 Awareness of prolapse ‐ vaginal bulge, vaginal pressure Objective cure of SUI PQOL
Notes	Devices donated by Promedon to Federal University of Sao Paulo
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerised randomisation table
Allocation concealment (selection bias)	Unclear risk	Envelopes (opaque?, sealed?)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Non‐blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded assessors
Incomplete outcome data (attrition bias) All outcomes	Low risk	79 randomised, and all completed 1‐year review
Selective reporting (reporting bias)	Low risk	Reported as registered at clinicaltrials.gov
Other bias	Low risk	Funded by Federal University of Sao Paulo, Brazil; Promedon contributed product free of charge No author conflicts of interest

Dietz 2020.

Study characteristics
Methods	Multicentre Australian RCT comparing prolapse surgery with or without puborectalis sling
Participants	Group A: n = 91; prolapse surgery alone Group B: n = 109; prolapse surgery + puborectalis sling 3 x 25 cm strip polypropylene mesh (Ethicon JNJ) Evaluated 1.9 years
Interventions	Inclusion criteria: women undergoing prolapse surgery at the discretion of the surgeon with preoperative hiatal area on valsalva of > 30 cm Exclusion criteria: no details given
Outcomes	POPQ and translabial 4D ultrasound
Notes	Nil
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unable to blind assessors
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not stated
Selective reporting (reporting bias)	Unclear risk	Not stated
Other bias	Unclear risk	Not stated

Feldner 2010.

Study characteristics
Methods	Single‐centre RCT Randomisation and allocation concealment described Evaluated 1 year after AC as compared to small intestine submucosa graft Blinded reviewers Sample size of 60 women was required to achieve a significance level of 0.05 and a power of 80%. This was based on the assumptions of a 25% difference in cure rates between the groups with a 10% loss to follow‐up rate
Participants	Inclusion criteria: women with point Ba ≥ ‐1 Exclusion criteria: hypertension, prior radiation, pelvic sepsis, diabetes, and chronic illness Concomitant surgery allowed, including vaginal hysterectomy if greater than stage 2 uterine prolapse
Interventions	Group A: (27) AC with interrupted 0 polyglactin (Vicryl) sutures Group B: (29) non‐cross‐linked xenograft porcine small intestine submucosa 7 x 10 cm with dissection to suprapubic arch fixed with 0 prolene x 3 each side
Outcomes	Assessed at 1 year Reports the following review outcomes at 1 year: Repeat prolapse surgery (no events) Recurrent prolapse (at point Ba) Mesh exposure (no events) Dyspareunia (any ‐ no separate data for de novo) POPQ assessment of prolapse: point Ba, C, Bp, total vaginal length Quality of life: PQOL questionnaire end scores Operating time
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list
Allocation concealment (selection bias)	Low risk	Centrally controlled allocation concealment appropriate
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded reviewers and participant‐completed validated questionnaires
Incomplete outcome data (attrition bias) All outcomes	High risk	1 year: Group A 20/27 (74%); Group B 22/29 (76%)
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	No conflict of interest and no external funding

Galad 2020.

Study characteristics
Methods	Single‐centre Slovakian RCT comparing sacrospinous colpopexy and single incision mesh for anterior/apical post hysterectomy prolapse with 3‐year review Envelopes allocation 146 participants allowed 90% power to detect 20% superiority in mesh group with 5% significance and 15% dropout Group A: attrition 27/73; Group B: 28/73 at 3 years
Participants	Inclusion criteria: > 18 years old, stage 3 anterior or stage 2 or greater apical prolapse
Interventions	Group A: n = 73; elevate anterior apical Group B: n = 73; sacrospinous colpopexy with anterior repair
Outcomes	POPQ points QoL ‐ VAS unvalidated Organ injury Operating time Blood loss Mesh exposure and mesh exposure surgery Dyspareunia Surgery for SUI
Notes	Funded by Ministry of Education Slovakia
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Two parallel groups formed
Allocation concealment (selection bias)	Low risk	Sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No statement
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No statement
Incomplete outcome data (attrition bias) All outcomes	High risk	Group A: 27/73, Group B: 28/73 at 3 years
Selective reporting (reporting bias)	Unclear risk	No pre‐trial registration
Other bias	Low risk	Funded by Ministry of Education Slovakia

Gandhi 2005.

Study characteristics
Methods	Single‐centre RCT (computer‐generated, opaque envelopes, adequate concealment) AC with and without fascia lata for primary or recurrent anterior vaginal wall prolapse
Participants	162 signed consent form 154 randomised Group A: 76, Group B: 78 Loss to follow‐up: 2 in Group B, but in results, 78 and 77 analysed, respectively Inclusion criteria: anterior vaginal wall prolapse to hymen or beyond on straining; > 18 years of age; willing to comply with return visits Concomitant surgery: vaginal hysterectomy in 49%/47%; sacrospinous fixation in 43%/42% (all cases with vaginal vault prolapse to mid‐vagina or beyond); posterior repair in 99%/94%; Coopers' ligament sling in 67%/55%; mid‐urethral sling 13%/10% Enterocele: Group A 75%, Group B 73% Baseline voiding dysfunction (slow stream): Group A 48/68, Group B 42/65
Interventions	Group A (76): "ultra‐lateral" midline plication of anterior endopelvic connective tissue using polyglactin (Vicryl) buttress sutures (as described by Weber 2001), plus additional cadaveric fascia lata patch (Tutoplast) anchored at the lateral limits of the colporrhaphy Group B (78): as above without allograft
Outcomes	Assessed at 1 year Reports the following review outcomes: Awareness of prolapse (vaginal bulging) Recurrent prolapse (POPQ stage 2 anterior prolapse) Objective failure of anterior compartment (same data as recurrent prolapse) Bladder function: postvoid fullness
Notes	Unclear participant numbers (disparity with loss to follow‐up) Questionnaires not used in all participants
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Low risk	Sealed, opaque, consecutive envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data largely complete; 2/155 lost to follow‐up
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	No conflict of interest or funding statement

Glazener 2017.

Study characteristics
Methods	Multicentre (35) UK parallel‐group RCT comparing grafts and native tissue repair for anterior and/or posterior compartment prolapse with 2‐year review Computer‐generated randomisation Web‐based allocation, stratified for age > 60 years, type of intervention, type of repair (anterior posterior), surgeon 1450 participants allowed 90% power with type 1 error 0.05 to detect difference in POP SS score of 2.0 points with 17.5% dropout rate Assigned 1:1:1 or 1:1 within 3 strata (standard repair, standard repair with mesh, standard repair with biological graft) A) women assigned to all 3 interventions B) comparison of standard repair with mesh C) comparison of standard repair with graft Measured outcomes by participant‐completed postal questionnaire at baseline (before surgery), 6 months, 1 year, 2 years and clinic review at 1 year (POP‐Q)
Participants	Inclusion criteria: women under care of collaborating surgeon who were to undergo primary anterior or posterior vaginal compartment prolapse repair Exclusion criteria: those unwilling or unable to consent or comply with study reviews
Interventions	Group A: n = 430 native tissue vaginal repair with usual surgical technique Group B: n = 435 graft repair type 1 polypropylene mesh usual technique below fascial layer and secured with peripheral sutures Group C: n = 368 biological graft below fascial layer secured with peripheral sutures. Graft options: porcine acellular graft, porcine small intestine graft, or bovine graft
Outcomes	POP‐SS Awareness of POP (something coming down) Reoperation for prolapse Reoperation for mesh complication Mesh erosion Severe urinary incontinence Faecal incontinence Severe dyspareunia ICI Vaginal Symptoms Score EQ‐5D‐3L score POP‐Q
Notes	Funded by grant from Scottish Government
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	Low risk	Web‐based allocation
Blinding of participants and personnel (performance bias) All outcomes	High risk	Many unable to be blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Many unable to be blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	79% to 82% completed 24‐month follow‐up
Selective reporting (reporting bias)	Low risk	Nothing detected
Other bias	Unclear risk	Conflicts of interest of surgeons performing and those reviewing participants not reported

Glazener 2020.

Study characteristics
Methods	Multicentre (n = 33) RCT comparing native tissue repair versus polypropylene mesh (mesh kit, mesh inlay) in patients with recurrent anterior and/or posterior compartment prolapse Participants (n = 620) had a power of 90% to detect a 3‐point difference in POP‐SS.
Participants	Inclusion criteria: any woman who was listed for transvaginal repair of an anterior and/or posterior prolapse if at least one of the compartments requiring surgery had been previously repaired
Interventions	N = 155 (total randomised), 154 included in analysis This study reported 2 'trials': Mesh Inlay Trial which compared NTR versus mesh inlay (n = 107) and Mesh Kit Trial which compared NTR versus mesh kit (n = 71) NTR versus mesh inlay (n = 55, 52) NTR versus mesh kit (n = 25, 46) Concomitant surgery: uterine/vault/continence surgery allowed
Outcomes	Follow‐up: 6 months (questionnaire), 1 year (examination + questionnaire), 2 years (questionnaire) Primary outcome: POP‐SS @ 1 year Secondary outcomes: VAS, EQ‐5D‐3L [a quality of life questionnaire], PGI‐I, ICIQ, POPQ, adverse events (IUGA/ICS complications classification), need for readmission/further treatment, prolapse recurrence (reported by surgeon or woman)
Notes	Funded by Chief Scientist's Office of the Scottish Government Health and Social Care Directorates
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation planned into three interventions: standard repair, mesh inlay, and mesh kit on a 1:1:2 basis.
Allocation concealment (selection bias)	Low risk	Remote web‐based computer system used for group allocation
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants in the mesh kit arm were unable to be blinded due to trocar incisions. Quote: "Masking for the surgeon with respect to treatment allocated by randomisation was not feasible, but the participants and ward staff were not informed about the randomised allocation or the actual treatment received unless there was a clinical need or requested by the woman. The clinical examination at 1 year was done by an observer unaware of the allocated treatment where possible."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Assessors "blinded as to randomisation as far as possible"; however, assessors aware of mesh kit allocation due to groin incisions on examination.
Incomplete outcome data (attrition bias) All outcomes	High risk	15% or more of the women failed to complete 12‐month assessment in the three groups.
Selective reporting (reporting bias)	Low risk	Trial registration Controlled‐Trials.com number ISRCTN60695184
Other bias	High risk	High risk of bias due to deviations from intended interventions. High risk of women not undergoing allocated intervention. In the mesh inlay group, 27%, and in the mesh kit group, 31%, did not receive allocated intervention.

Guerette 2009.

Study characteristics
Methods	Multicentre RCT 24‐month follow‐up Randomisation was computer generated Allocation concealment without blinding of women or surgeon Not according to CONSORT "Sample size was calculated by estimating a recurrence rate of 35% with AC and 10% with graft reinforcement. Assuming a 2‐tailed hypothesis test with 5% type 1 error and 80% power, 80 women would be required. We enrolled 94 women assuming a drop‐out rate of 15%"
Participants	Randomised: Group A 47, Group B 47 2 years: Group A 33, Group B 26 Examination: Group A 27, Group B 17 Inclusion criteria: point Ba ≥ ‐1 Exclusion criteria: total vaginal length < 6 cm, severe atrophy, isolated paravaginal defect, allergic to bovine material, prior vaginal implant surgery, or ulceration
Interventions	A (n = 46): AC B (n = 44): AC with bovine pericardium collagen matrix graft reinforcement
Outcomes	Assessed at 6 months, 1 year, and 2 years Reports the following review outcomes: Awareness of prolapse: measure unclear Repeat surgery for prolapse Graft erosion/exposure ‐ no events POPQ assessment of prolapse: point Ba, C (reports median and range, no SDs) Sexual function: PISQ‐12 (no SDs reported); de novo dyspareunia at 1 year Quality of life: UDI‐6 (no SDs reported) Operating time ‐ reported as median and range
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list
Allocation concealment (selection bias)	Low risk	Opaque envelopes opened in theatre (not consecutive)
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated if assessors blinded, participant‐completed questionnaire
Incomplete outcome data (attrition bias) All outcomes	High risk	Equal losses in both groups; only 50% completed 2‐year review
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	High risk	Extensive conflicts of interest reported; study partly funded by Synovis Life Technologies, whose bovine pericardium product was being evaluated

Gupta 2014.

Study characteristics
Methods	Single‐centre RCT in India Computer‐generated randomisation Allocation concealment: not stated Blinding of participants and reviewers: not stated Sample size 106 with 80% power to detect 21% difference between the groups with 5% type 1 error
Participants	Inclusion criteria: stage 2 or greater anterior compartment prolapse Exclusion criteria: SUI, dominant post‐vaginal prolapse, suspected malignancy, vaginal infections
Interventions	Group A: AC 2.0 polyglactin (Vicryl); n = 54, 1 year n = 41 Group B: self‐styled 4‐armed monofilament polypropylene mesh (Vypro mesh, J&J); n = 52, 1 year n = 44
Outcomes	Assessed at 6 months, 1 year Reports the following review outcomes: Awareness of prolapse (vaginal bulge) at 1 year Repeat prolapse (anterior) Mesh erosion Surgery for mesh exposure Objective failure of anterior compartment (cystocele) Operating time Blood transfusion
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Unclear risk	No statement
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No statement
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No statement
Incomplete outcome data (attrition bias) All outcomes	High risk	Group A 41/54, Group B 44/52 at 1 year (20% attrition)
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	No conflict of interest statement

Halaska 2012.

Study characteristics
Methods	Multicentre randomised trial Computer‐generated randomisation table Allocation concealment not defined 70% power to detect 20% difference in groups
Participants	Inclusion criteria: central post‐hysterectomy vault prolapse: POPQ greater or equal to stage 2 Exclusion criteria: pelvic malignancy, < 18 years, prior radiotherapy, requiring hysterectomy Allocated: Group A 83, Group B (mesh) 85 1 year: Group A 72, Group B 79 Recurrence defined as stage 2 or greater POPQ Not clear who performed the assessments
Interventions	Group A (83) anterior repair. Sacrospinous colpopexy (2x non‐absorbable sutures Nurolon) ± posterior repair (approximation of levator muscles) and moderate excision of redundant vagina Group B (85) total Prolift mesh secured with 2.0 PDS Intervention performed by surgeons with greater than 20 cases experience of each type of surgery
Outcomes	Assessed at 1 year Reports the following review outcomes: Repeat surgery for prolapse Recurrence of prolapse (stage 2 or more in any compartment) Mesh exposure Bladder injury Bowel injury (no events) POPQ assessment of prolapse: reported graphically and without SDs Bladder function: de novo SUI; de novo overactive bladder Sexual function: any dyspareunia (no de novo data); PISQ‐12 (no SDs reported) Quality of life: POPIQ (no SDs reported) Operating time (reported as median and range)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	1 year Group A 72/83; Group B 79/85 (89%)
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	Funded by grant from Czech Ministry of Health, authors had no conflicts of interest

Hviid 2010.

Study characteristics
Methods	Single‐centre RCT Computer‐generated randomisation and allocation concealment were appropriate, with sealed envelopes opened in operating room Reviews by non‐blinded surgeon No concomitant surgery 80% power to detect 20% difference between the groups with 5% type 1 error: 60 randomised
Participants	Inclusion criteria: symptomatic prolapse point Ba ≥ ‐1 Exclusion criteria: defects posterior or apical compartment, prior pelvic surgery, history of collagen or endocrine disorders Allocated: Group A 31, Group B 30 1 year: Group A 26, Group B 28
Interventions	A (31): 2.0 interrupted polyglactin (Vicryl) plication B (30): no plication, Pelvicol porcine dermis 4 x 7 cm anchored with 2.0 polyglactin (Vicryl) sutures No concomitant surgery
Outcomes	Assessed at 1 year Reports the following review outcomes: Repeat prolapse surgery Awareness of prolapse (vaginal bulging or lump) Recurrence of prolapse (POPQ Ba ≥ ‐1.0) Repeat surgery for incontinence Objective failure of anterior compartment POPQ assessment of prolapse: point Ba at 12 months (states median and range) Quality of life: King's Health Questionnaire (graphical results and P values only) Operating time
Notes	Irregularities exist: methods failure defined as e Ba ≥ ‐1 results > ‐1; in table 2 Group A range Ba 2 to 8, and states in table 3 that 4 had stage 2 prolapse
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list
Allocation concealment (selection bias)	Low risk	Sealed, non‐transparent, consecutive envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	High risk	Reviewers not blinded, participant‐completed questionnaires
Incomplete outcome data (attrition bias) All outcomes	Low risk	1 year: Group A 26/31, Group B 28/30 (88%)
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	No conflict of interest declared; no funding statement

Iglesia 2010.

Study characteristics
Methods	Multicentre RCT Double blinded Power calculation included Randomisation was computer‐generated, stratified for presence of uterine prolapse Allocation concealment CONSORT guidelines met No ITT analysis
Participants	173 excluded for a variety of reasons Group A 33, Group B 32 Lost to follow‐up: Group A 0, Group B 0 Prior to surgery, all demographic details were similar between the 2 groups, except Group B had lower POPDI‐6 score than Group A Inclusion criteria: ≥ 21 years, grade 2 to 4 (POPQ) uterovaginal or vaginal prolapse who agreed to undergo vaginal surgery, available for 12 months' review, and can complete questionnaires Exclusion criteria: multiple medical contraindications, short vagina, uterus > 12 weeks size, desire future fertility, and postpartum
Interventions	Group A: uterosacral colpopexy with polytetrafluoroethylene sutures or sacrospinous colpopexy (Gortex sutures) and hysterectomy performed if uterus present Group B: if point C or D on POPQ was ≥ ‐3 apical suspension with total vaginal mesh (Prolift), and if C or D was < ‐3 anterior Prolift was utilised. No T incisions were performed, and hysterectomy performed if uterus present
Outcomes	Assessed at 1, 2, and 3 years Reports the following review outcomes (at 3 years unless otherwise stated): Awareness of prolapse (vaginal bulge) Repeat prolapse surgery Repeat surgery for SUI Repeat surgery for prolapse, SUI, or mesh exposure surgery Recurrent prolapse (POPQ > stage 1) Death Mesh exposure POPQ assessment of prolapse pts Ba, Bp, C at 1 year (states medians and range) Bladder injury (perforation) Rectal injury (no events) Surgery for mesh exposure Bladder function: de novo SUI Sexual function: de novo dyspareunia; PISQ (median and range) Quality of life: PFDI; PFIQ (median and range) Transfusion (in 3‐month data): 0 vs 1 Days in hospital (Mann‐Whitney P value only)
Notes	The ethics committee stopped the study prior to completion due to predetermined stopping criteria of mesh erosion rate of > 15% being reached, with 65 of the desired sample size of 90 having undergone interventions.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list
Allocation concealment (selection bias)	Low risk	Consecutive, sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double‐blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	3 years: Group A 26/32, Group B 25/33
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	Funded by American Urogynecologic Society Foundation and MedStar research; authors reported no conflicts of interest

Iyer 2019.

Study characteristics
Methods	Single‐centre American RCT comparing native tissue repair with and without dermal allograft for management of cystocele with 7‐ to 10‐year review Computer‐generated randomisation with opaque envelopes for allocation 160 participants provided 80% power with a type 1 error of 0.05 to detect a difference of 35% in recurrence rate with 14% loss to follow‐up. Attrition: Group A 13/70 at 1 year, 36/70 at 7 to 10 years. Group B: 8/44 at 1 year, 25/44 at 7 to 10 years.
Participants	Inclusion criteria: symptomatic anterior compartment prolapse at or beyond hymen, planning surgical correction; English speaking and able to comply with study requirements for review Exclusion: prior pelvic radiation or radical hysterectomy; current steroid use; vesico‐vaginal fistula
Interventions	Group A: n = 70 native tissue anterior repair with 0.0 polyglactin interrupted plication fascia Group B: n = 44 as above plus bilateral 2.0 PDS sutures to sacrospious ligament with Capio device (Boston Scientific) and through the mid and proximal arcus tendinous fascia pelvis (ATFP) bilaterally to anchor a trapezoid Repliform dermal graft (Boston Scientific)
Outcomes	Anatomic recurrence Aa or Ba ≥ ‐1; Aa or Ba ≥ 0
Notes	Authors had no conflicts of interest Products supplied by Boston Scientific (dermal allograft and Capio)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes centrally
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Unaware of intervention
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Unaware of intervention
Incomplete outcome data (attrition bias) All outcomes	Low risk	AC alone: 1 year 32/44 ; 7 to 10 years 19/44 AC + dermal graft: 1 year 57/70; 7 to 10 years 34/70
Selective reporting (reporting bias)	Unclear risk	No pre‐trial registration
Other bias	Low risk	Authors had no conflicts of interest

Lamblin 2014.

Study characteristics
Methods	Single‐centre RCT, France Computer‐generated, 6‐block randomisation Allocation concealment: not stated No blinding of women or reviewers Intention to treat: not stated
Participants	Inclusion criteria: stage 3 or greater anterior compartment prolapse Exclusion criteria: pregnancy, family not completed, prior cancer or radiation, poorly controlled diabetes mellitus, polypropylene sensitivity, immunocompromised Concomitant surgery performed
Interventions	Group A: AC with bilateral vaginal colposuspension (Ethibond suture) n = 35, at 2 years n = 32 Group B: polypropylene transobturator mesh (Perigee AMS) n = 33, at 2 years n = 31 More women underwent hysterectomy (77%) in the colposuspension group compared with 33% in the mesh group. P < 0.001
Outcomes	Assessed at 3 months, 1 year, and 2 years Reports the following review outcomes at 2 years: Awareness of prolapse at 2 years (vaginal bulge or something falling out) Repeat continence surgery Repeat prolapse, SUI, or mesh exposure surgery Recurrence of prolapse (POPQ Ba > 1.0) Mesh exposure Bladder injury (no events) Surgery for mesh exposure POPQ assessment of prolapse: point Ba Sexual function: de novo dyspareunia (1 vs 1) Quality of life: PFIQ (end scores) Operating time Blood transfusion (no events) Hospital stay
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	At 2 years: Group A 32/35, Group B 31/33
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	Funding by the Claude Bernard University. Authors had no conflicts of interest. Measures of variance very low for some outcomes; attempt to check data with primary authors unsuccessful

Menefee 2011.

Study characteristics
Methods	Double‐blind, triple‐arm RCT Randomisation, allocation concealment N/S power. 33 participants in each group. 80% power to detect 35% difference with 5% type 2 error 2‐year review
Participants	Inclusion criteria: women ≥ 18 years of age with a POPQ point Ba of ≥ 0 Exclusion criteria: N/S Concomitant surgery: hysterectomy, colpopexy, posterior repair, continence at surgeons discretion
Interventions	99 randomised Group A: 32 standard AC using midline plication with delayed absorbable suture Group B: 31 vaginal paravaginal repair using free‐hand‐formed porcine dermis graft (PelvicolTM) Group C: 36 vaginal paravaginal repair using free‐formed polypropylene mesh. All graft material was secured to the arcus tendineus fascia pelvis using a CapioTM device with permanent monofilament suture
Outcomes	Assessed at 2 years Reports the following review outcomes at 2 years: Repeat surgery for prolapse Recurrence of prolapse (POPQ Ba stage 2 or more) Bladder injury (no events) Mesh erosion Objective failure of anterior compartment Sexual function: de novo dyspareunia (data not used as no denominator reported); PISQ‐12 (median and range) Quality of life: PFIQ (median and range) Operating time Blood transfusion (no events)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated sequence
Allocation concealment (selection bias)	Low risk	Opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double‐blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 years: Group A 24/32; Group B 26/31; Group C 28/36
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	High risk	Authors report conflicts of interest, with companies producing product evaluated, and funded by Boston Scientific, whose product Capio was being evaluated

Meschia 2007.

Study characteristics
Methods	Multicentre RCT on primary surgery anterior vaginal wall prolapse Computer‐generated randomisation Allocation concealed Power calculation: 90 in each arm required Follow‐up: 2 years ITT analysis: yes, including those women with missing data at 2 years but with 1 year follow‐up completed
Participants	206 randomised Lost to follow‐up: n = 5: Group A 2, Group B 3 Inclusion criteria: primary anterior prolapse POPQ point Ba ‐1 (≥ stage 2) Exclusion criteria: none Baseline SUI: A 22/100, B 18/106 Baseline overactive bladder: A 44/100, B 35/106 Baseline sexually active: A 65/100, B 74/106; with dyspareunia: A 12/65, B 11/74 No differences between the 2 groups with respect to demographic and clinical characteristics At 2 years, number available for analysis: 176 (A 91, B 85) ITT analysis: 201 analysed (A 103, B 98)
Interventions	A (100): interrupted fascial plication polyglactin (Vicryl) 00 with porcine dermis graft (Pelvicol overlay) fixed with PDS suburethrally and uterosacral cardinal ligament distally B (106): surgery as above without Pelvicol overlay Concomitant surgery standardised Vaginal hysterectomy McCall culdoplasty, posterior compartment defect fascial plication
Outcomes	Assessed at 1 year Reports the following review outcomes at 1 year: Awareness of prolapse (sensation of prolapse) Objective failure of anterior compartment Bladder function: SUI Sexual function: dyspareunia Days in hospital
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Adequate
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No participant‐completed questionnaires
Incomplete outcome data (attrition bias) All outcomes	Low risk	At 2 years: 91/100 native tissue versus biological 85/106
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	No statement about funding

Nager 2019.

Study characteristics
Methods	Multicentre (n = 9) superiority RCT comparing anterior mesh with vaginal hysteropexy and vaginal hysterectomy and vault suspension with 3‐year review Computer‐generated randomisation, stratified for sites Computer allocation Participants blinded? Assessors unable to be masked Groups similar preoperatively At 3 years, Group A 88/93 reviewed; Group B 87/90 reviewed 180 participants allowed 86% power to detect 12% superior outcome for hysteropexy group
Participants	Inclusion criteria: > 21 years old; amenorrhoeic 12 months symptomatic (Q3 PFDI) with uterine descent beyond lower half of vagina (Stage 1 POPQ) and point Ba Bp or C > 0 cm Exclusion criteria: prior uterine suspensions, prior synthetic grafts for prolapse repair, or uterine or cervical abnormalities, cervical elongation
Interventions	Group A: n= 93, sacrospinous hysteropexy anterior polypropylene mesh Uphold lite Group B: n= 90, vaginal hysterectomy with uterosacral ligament suspension 1 permanent and 1 delayed suture (0.0 or 2.0) bilaterally Group B had less concomitant anterior repairs (61%) compared to mesh group (90%). Other surgeries were equal in both groups.
Outcomes	POPq Q points Ba Bp C TVL (total vaginal length) Subjective recurrence PFDI PGI‐I PISQ‐IR Dyspareunia Mesh exposure Suture exposure
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Online allocation
Blinding of participants and personnel (performance bias) All outcomes	High risk	30% unable to be blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unable to blind reviewers
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition: Group A 5/93; Group B 4/90 at 3 years
Selective reporting (reporting bias)	Low risk	Reporting consistent with trial registration
Other bias	Low risk	Funded by National Institute of Child Health and Human Development – Pelvic Floor Disorders Network. Partial support by Boston Scientific through unrestricted grant, but Boston Scientific Corporation had no role in study design, data collection, data management, data analysis, data interpretation, writing of the report or decision to submit the manuscript.

Nguyen 2008.

Study characteristics
Methods	Single‐centre RCT on anterior vaginal prolapse CONSORT statement: yes Power calculation: 38 in each arm Type of randomisation: computer generated Blinding strategy: primary surgeon ‐ until the surgery day; women, research nurse, and medical assistant remained blinded Allocation concealment: sealed, opaque envelopes Definition of cure: anterior wall POPQ stage < 2, "Optimal support" = Aa and Ba at stage 0, "Satisfactory" = Aa and Ba at stage 1 and improved from preop staging Follow‐up: 12 months (full publication) and 24 months (abstract only) Prolapse assessment: POPQ
Participants	Inclusion criteria: 21 years and older with POPQ stage 2 or greater anterior prolapse requiring surgical correction Exclusion criteria: pregnancy (present or contemplated), prior repair with graft, systemic infection, compromised immune system, uncontrolled diabetes mellitus, previous pelvic irradiation/cancer, polypropylene allergy, scheduled for concomitant Burch or pubovaginal sling Randomised: 76 Withdrawals: 1 Lost to follow‐up: 1 Analysed: 76
Interventions	Group A (38): AC with delayed absorbable (PDS) sutures Group B (38): AC + polypropylene 4‐armed mesh kit repair (Perigee, American Medical Systems) Concomitant surgery: vaginal hysterectomy, bilateral salpingo‐oophorectomy, uterosacral suspension, mid‐urethral tape, site‐specific rectocele repair, perineoplasty, Apogee mesh kit repair Concomitant prolapse and suburethral tape surgeries were performed in both groups
Outcomes	Assessed at 1 year Reports the following review outcomes at 1 year: Repeat prolapse surgery Recurrent prolapse (anterior prolapse stage 2 or more) Death (no events) Mesh exposure Objective failure of anterior compartment POPQ assessment of prolapse: pts Ba, C, Bp, vaginal length (reports median and range) Sexual function: de novo dyspareunia; PISQ Quality of life: PFIQ (and other measures): end scores Operating time (median and range) Blood transfusion Days in hospital (median and range)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Women blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors blinded; participant‐completed questionnaires
Incomplete outcome data (attrition bias) All outcomes	Low risk	1 year: Group A 37/38, Group B 37/38
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	No statement about funding

Nieminen 2008.

Study characteristics
Methods	Multicentre RCT on anterior vaginal prolapse CONSORT statement: yes Power calculation: 101 in each arm Type of randomisation: computer generated Allocation concealment: opaque envelopes Blinding strategy: not specified, but lack of a non‐surgical blinded outcome reviewer Definition of cure: less than stage 2 prolapse at Aa or Ba Follow up: 24 months Prolapse assessment: POPQ
Participants	Inclusion criteria: postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond Exclusion criteria: apical defect indicating vaginal fixation or SUI necessitating surgery or the main symptomatic prolapse component was in the posterior vaginal wall. Also women with gynaecological tumour or malignancy calling for laparotomy or laparoscopy, and those with untreated vaginal infection Randomised: 202 Withdrawals: 1 Lost to follow‐up: 1 Analysed: 200 No significant differences in baseline demographics, prior hysterectomy, or prolapse surgeries between the 2 groups
Interventions	Group A (96): AC using a 0 or 2/0 multifilament suture Group B (104): AC + self‐tailored (from a 6 x 11 cm mesh patch) 4‐armed low‐weight polypropylene mesh Type of mesh: non‐absorbable monofilament polypropylene (Parietene light, Sofradim, France) Sutures for AC: absorbable 0 or 2/0 multifilament suture Concomitant surgery: vaginal hysterectomy, posterior repair, culdoplasty as required, no concomitant continence surgeries were performed
Outcomes	Assessed at 2 months, 1, 2, and 3 years Reports the following review outcomes at 3 years: Awareness of prolapse (bulge) Repeat prolapse surgery Repeat continence surgery Recurrent prolapse (any compartment stage 2 or more) Mesh exposure Bladder injury Repeat surgery for mesh exposure Objective failure of anterior compartment POPQ assessment of prolapse: pts Ba, C, vaginal length Bladder function: de novo SUI
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	3 years: 95/104 (92%) vs 85/96 (89%)
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	Some inconsistencies in data across publications at different follow‐up times

Ouyang 2020.

Study characteristics
Methods	Multicentre (n = 2) Chinese non‐inferiority RCT comparing one polypropylene kit material (Avulta) with a new self‐developed polypropylene mesh (Condiner Medical) at 3 years Randomisation and allocation by web‐based program Blinding of participants and reviewers 116 participants offered 80% power with 5% type 1 error of detecting the new mesh was non‐inferior to Avulta mesh by more than 10% with a 10% dropout rate 3‐year attrition: Group A 16/66, Group B 18/66
Participants	Inclusion criteria: agreed to participate in the trial and signed the informed consent; female patient of 35 to 85 years of age; pelvic floor dysfunction and POP stage ≥ II that required pelvic reconstructive surgery; normal heart, liver, and kidney functions; able to communicate well with investigators and complied with the study requirements Exclusion criteria: acute or severe infection; metabolic disorders, immune dysfunction, or substance abuse; haematopoietic, endocrine or any other serious primary diseases or mental illness; allergic to implant or a variety of drugs, or patients with allergic constitution; malignant disease of uterine appendages; pregnant or lactating women; or unwilling or unable to restrict activities or follow the doctor’s advice
Interventions	Group A: n = 66. Self‐developed polypropylene mesh (6 arms total, 4 obturator arms anterior and 2 arms posterior to sacrospinous ligament) without tension Group B: n = 66. Avulta polypropylene mesh kit (C.R. Bard) as per manufacturer's instructions
Outcomes	PFIQ‐7 Operating time Cystotomy Urinary retention Mesh erosion Stress urinary incontinence Dyspareunia Pain Reoperation
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Web‐based allocation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants blinded to grouping
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Postoperative assessors did not participate in surgery and were blinded to grouping
Incomplete outcome data (attrition bias) All outcomes	Low risk	3‐year attrition: A 16/66 B 18/66
Selective reporting (reporting bias)	Unclear risk	Trial registration not reported
Other bias	Unclear risk	Authors' conflicts of interest not reported

Paraiso 2006.

Study characteristics
Methods	Single‐centre RCT (computer‐generated randomisation by sealed envelopes with blinded research nurse) 106 randomised to posterior colporrhaphy (37), site‐specific repair (37), site‐specific repair augmented with porcine small intestine submucosa (32) (Fortagen, Organogenesis). Study funded with unrestricted research grant from Organogenesis
Participants	106 women Inclusion criteria: grade 2 or greater posterior vaginal wall prolapse with or without other prolapse or incontinence or gynaecological procedures Exclusion criteria: concomitant colorectal procedures, allergy to pork
Interventions	Group A (37): posterior colporrhaphy as per Maher 2‐0 Ethibond Group B (37): site‐specific repair Cundiff 2‐0 Ethibond Group C (32): as in B with 4 x 8 cm porcine small intestine submucosa graft inlay (Fortagen)
Outcomes	Assessed at 1 year and 2 years (sparse 2‐year data reported) Reports the following review outcomes at 1 year: Awareness of prolapse (worsening prolapse or colorectal symptoms) Repeat prolapse surgery Recurrent prolapse (POPQ pt Bp ≥ ‐2) Objective failure of posterior compartment (POPQ pt Bp ≥ ‐2) POPQ assessment of prolapse: pts Bp, C, vaginal length (reports median and range) Sexual function: PISQ‐12 Sexual function Quality of life: PFDI end scores (also reports PFIQ) Operating time Blood transfusion Days in hospital (reports median and range)
Notes	Ongoing study: initial full‐text review after 1 year ITT basis CONSORT statement Independent nurse review Limited sample size
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Low risk	Adequate
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded non‐surgeon reviewer
Incomplete outcome data (attrition bias) All outcomes	Low risk	At 17 months, 99/106 completed; groups unclear
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	Unrestricted research grant from Organogenesis, whose product was being evaluated

Qatawneh 2013.

Study characteristics
Methods	Single‐centre RCT, Jordan 57 in each group had 80% power to detect 25% difference between the groups with a 5% type 1 error with a 10% dropout rate No ITT analysis
Participants	Inclusion criteria: symptomatic stage 3 or greater utero‐vaginal prolapse in all compartments: primary and recurrent Exclusion criteria: less than grade 3 prolapse in any compartment, any prior surgery with implants for pelvic floor defects, prior radiation, those wishing uterine preservation
Interventions	AC group (n = 65): 2.0 PDS plication Mesh group (n = 64): self‐shaped polypropylene (Gynemesh) 15 x 3 cm with 2 arms retropubic space without suturing Concomitant continence surgery if needed and vaginal hysterectomy in those with uterine prolapse All underwent sacrospinous colpopexy and posterior colporrhaphy
Outcomes	Assessed at 6 weeks, then every 6 months. Median follow‐up 28/29 months Reports the following review outcomes at 1 year: Awareness of prolapse ("prolapse sensation") Repeat prolapse surgery Recurrent prolapse (stage 2 or more prolapse any compartment) Mesh exposure Objective failure (stage 2 or more prolapse) of anterior compartment, vault, posterior compartment POPQ assessment of prolapse: pts Ba, C, Bp De novo SUI Operating time Days in hospital (reports median and range)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated: POPQ assessment by independent investigator
Incomplete outcome data (attrition bias) All outcomes	High risk	AC group: 63/65; mesh group 53/64 at median 28‐month review; follow‐up times variable
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	Funded by Cook Medical

Robert 2014.

Study characteristics
Methods	Parallel‐group RCT
Participants	Included: women with a cystocele requiring surgical management Excluded: women with allergy to graft material, immunocompromised, non‐English speaking, unavailable for follow‐up Concomitant surgery or previous non‐anterior prolapse surgery were not exclusion criteria.
Interventions	Small intestine mesh‐augmented procedure vs same anterior repair without mesh. Vicryl plication Mesh n = 28, non‐mesh n = 29
Outcomes	Assessed at 1 year Reports the following review outcomes at 1 year: Awareness of prolapse (bulge) Recurrent anterior prolapse (stage 2 or more prolapse) POPQ assessment of prolapse: pt Ba (reports change from baseline as median and range) Sexual function: PISQ‐12 (reports change from baseline as median and range) Quality of life: PFDI (reports change from baseline as median and range) Quality of life: PFDI (reports change from baseline as median and range)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random allocation sequence generated through university obstetrics & gynaecology department data manager SAS 9.3 using permuted block randomisation with blocks of varying size 2‐4, stratified by surgeon
Allocation concealment (selection bias)	Unclear risk	Operating physician informed in operating room, no mention of allocation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants blinded to treatment allocation
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Follow‐up assessment by examining physician blinded to allocation with no involvement in clinical care
Incomplete outcome data (attrition bias) All outcomes	Low risk	55/57 women randomised (96%) were included in analysis for objective outcomes and 57/57 (100%) for subjective outcomes
Selective reporting (reporting bias)	Low risk	Reports expected review outcomes
Other bias	Low risk	Supplier of product (Cook) partially funded study. However, the blinded nature of participants and reviewers overcomes potential biases

Rudnicki 2014.

Study characteristics
Methods	Multicentre (6) international RCT. Nordic countries: Norway, Sweden, Denmark, and Finland Block computer‐generated randomisation list Allocation concealment: opaque, sealed envelopes ITT analysis Sample size: 130 women allowed 80% power to detect 20% difference with an alpha error of 5% and a dropout rate of 15% Assessors: surgeons Women unblinded Surgeons trained to ensure uniform surgery performed
Participants	Inclusion criteria: ≳ 55 years, anterior wall prolapse stage 2 POPQ Aa or Ba ≳ ‐1 Exclusion criteria: previous major pelvic surgery with the exception of a hysterectomy for reasons other than genital prolapse, previous vaginal surgery, or hysterectomy for POP; concomitant prolapse of the uterus or an enterocele of stage 1 or higher; previous incontinence sling surgery performed through the obturator membrane; current treatment with corticosteroids; or a history of genital or abdominal cancer All surgery covered intra‐operative antibiotics and pre‐ and post‐local oestrogens. Concomitant surgery allowed: posterior repair
Interventions	AC group: interrupted absorbable suture fascial plication, vaginal trimming and closure with running unlocked absorbable suture Mesh group: biosynthetic system monofilament polypropylene mesh with central portion coated in absorbable hydrophylic porcine collagen film (Bard Avaulta Plus anterior) 169 available for randomisation with 161 randomised AC: 79 randomised, 1 year 76 Mesh: 82 randomised, 1 year 78
Outcomes	Assessed at 3 months, 1 year, and 3 years Reports the following review outcomes at 1 year: Awareness of prolapse (vaginal bulge) (only P value reported) Recurrent prolapse (POPQ stage 2 or more) Mesh exposure Bladder injury (perforation) Surgery for mesh exposure POPQ assessment of prolapse: pts Ba, C, Bp, total vaginal length Bladder function: de novo stress incontinence Sexual function: PISQ, de novo dyspareunia Quality of life: PFIQ; PFDI Operating time Blood transfusion Days in hospital (reports rates of over or under 12‐hour stay)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Blocked computer‐generated randomisation list for each of 4 countries
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unblinded (unable to blind)
Blinding of outcome assessment (detection bias) All outcomes	High risk	Surgeons evaluated
Incomplete outcome data (attrition bias) All outcomes	Low risk	1‐year evaluation/randomised AC 76/79, mesh 78/82
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	No conflict of interest statement

Sand 2001.

Study characteristics
Methods	Single‐centre RCT (computer‐generated number table) Vaginal repair with or without polyglactin (Vicryl) mesh overlay for cystocele and rectocele Follow‐up: Group A 12 months, Group B 12 months
Participants	143 women Inclusion criteria: cystocele to or beyond hymenal ring on standing Exclusion criteria: less than 18 years of age, pregnancy, contemplating pregnancy within 1 year, paravaginal defect only, anterior enterocele 161 randomised 1 excluded (anterior enterocele) 17 lost to follow‐up
Interventions	Group A (70): no mesh: Vicryl plication of anterior endopelvic fascia Group B (73): mesh: as above with Vicryl mesh folded underneath trigone and cuff and secured Vicryl to fascia; also added to posterior wall if posterior repair performed Posterior repair performed: A: 67/70, B: 65/73 Standardised concomitant surgery Review by surgeon
Outcomes	Assessed at 2, 6, 12 weeks and 1 year Reports the following review outcomes at 1 year: Recurrent prolapse (grade 2 or 3 cystocele or rectocele using BW scale) Mesh erosion (no events)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	143/170 (84%) completed 1‐year review
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	No conflict of interest statement

Shaher 2020.

Study characteristics
Methods	Egyptian RCT comparing polypropylene transobturator mesh versus AC for cystocele and stress urinary incontinence at 6 months
Participants	Cystocele and stress urinary incontinence
Interventions	Group A: n = 110: anterior colporrhaphy and kelly plication Group B: n = 125: transobturator 4‐armed polypropylene mesh
Outcomes	Transfusion Hospital stay Urinary retention Mesh erosion Mesh removal Stress urinary incontinence Awareness of prolapse
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unable to blind
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unable to blind
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not stated
Selective reporting (reporting bias)	Unclear risk	Not stated
Other bias	Unclear risk	Not stated

Sivaslioglu 2008.

Study characteristics
Methods	Single‐centre RCT comparing polypropylene mesh surgery with site‐specific surgery in the treatment of cystocele CONSORT statement: yes Power calculation: 45 in each arm Type of randomisation: computer generated Blinding strategy: no (assessment was performed by non‐blinded reviewers) Allocation concealment: not specified Definition of cure/failure: "Acceptable cure" defined as cystocele less than ‐1 cm (stage 1 POPQ) Follow‐up: mean 12 months (range 8 to 16) Prolapse assessment: POPQ
Participants	Inclusion criteria: primary cystocele Exclusion criteria: SUI, concomitant rectocele or enterocele or recurrent cystocele Randomised: 90 (45 to each arm) Analysed: 85 Lost to follow‐up: 5
Interventions	A (42): site‐specific polyglactin 910 anterior repair B (43): self‐styled 4‐armed polypropylene (Parietene, Sofradim, France) mesh, no anterior repair Concomitant surgery not standardised. Management of concomitant apical prolapse was not specified in either group
Outcomes	Assessed at 6 weeks, 6 months, and annually Reports the following review outcomes at mean follow‐up of 1 year (range 8 to 16 months): Recurrent prolapse (stage 2 or more POPQ) Mesh erosion Surgery for mesh erosion POPQ assessment of points Ba, C, Bp, total vaginal length (P values only) Bladder function: de novo SUI Sexual function: de novo dyspareunia Quality of life: PQOL end‐score
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	High risk	Non‐blinded reviewers; objective assessment was participant‐completed questionnaires
Incomplete outcome data (attrition bias) All outcomes	Low risk	Flow diagram: 1 year Group A: 42/45, Group B: 43/45
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	No funding and no conflicts of interest

Steures 2019.

Study characteristics
Methods	Multicentre (n = 5) Dutch RCT comparing partially absorbed polypropylene mesh and native tissue suture repair for stage 2 or greater vaginal prolapse with 2‐year review 176 participants offered 80% power with 5% type one error to detect an 18% difference in recurrence between groups with 15% drop‐out at 2 years Computer‐generated randomisation with web‐based central allocation Attrition at 2 years: Group A 13/82; Group B 10/81
Participants	Inclusion criteria: symptomatic stage 2 or greater prolapse Exclusion criteria: prior vaginal repair or mid‐urethral sling; compromised immunity; malignancy
Interventions	Group A: n = 82: native tissue colporrhaphy with 2.0 Vicryl with all concomitant surgeries including hysterectomy allowed Group B: n = 81: insertion mesh (Prolift‐M Ethicon) as described by Fatton et al. with no concomitant hysterectomy ot T‐incisions performed
Outcomes	Anatomical success = less than stage 2 prolapse on examination PGI‐I Awareness of prolapse Blood loss Operation time Admission time Stress urinary incontinence Dyspareunia Pelvic pain Cystotomy Mesh exposure Surgery for SUI Surgery for POP
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Low risk	Allocation centrally‐based; however, 15% of mesh group didn't recieve allocation
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Unable to be blinded due to trocar incisions in mesh group
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unblinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	At 2 years: Group A 13/82; Group B 10/81
Selective reporting (reporting bias)	Low risk	Consistent with pre‐trial registration
Other bias	High risk	Funded by unrestricted grant from Ethicon whose product was being evaluated Authors had no conflicts of interest

Sung 2012.

Study characteristics
Methods	2‐centre, double‐blinded randomised control trial Allocation concealment: sealed envelopes Randomisation block and stratified site Women and assessors blinded (women unblinded 12 months) "Based on a study by Kohli et al (Kohli 2003) assuming that graft use is associated with a 93% anatomic success rate, 63 women per group would be needed to detect a 20% difference at .05 and.20. We aimed to recruit 160 women (80 women per group) to account for drop‐out"
Participants	Inclusion criteria: women with stage 2 or greater symptomatic rectocele (defined as vaginal bulge, defecatory symptoms, or both) electing surgical repair were eligible Exclusion criteria: < 18 years, women undergoing concomitant sacrocolpopexy or colorectal procedures, history of porcine allergy, connective tissue disease, pelvic malignancy, pelvic radiation, inability to understand English, or unable or unwilling to consent or comply with follow‐up. All other vaginal prolapse repairs and anti‐incontinence procedures were included
Interventions	Group A: 70 controls midline plication or site‐specific repair Group B: 67 midline plication or site‐specific repair with 4 x 7 cm subintestinal submucosal graft over the repair and secured to levator ani fascia using interrupted No. 2‐0 polyglycolic acid and inferiorly to the perineal body using No. 2‐0 polyglycolic acid sutures. Excess vaginal tissue was trimmed in all women, and the posterior vaginal incision was closed using 2‐0 polyglycolic acid sutures. The deep and superficial transverse perineal muscles and bulbocavernosus muscles were re‐approximated using No. 0 polyglycolic acid sutures, and concomitant perineorrhaphy was performed in all women
Outcomes	Assessed at 6 months and 1 year Reports the following outcomes at median 12.2 to 12.5 months (range 10 to 43 months): Awareness of prolapse (vaginal bulge) Recurrent prolapse (objective failure of posterior vaginal wall) Bladder injury 0 vs 1 Rectal injury 1 vs 0 Objective failure of posterior vaginal wall (POPQ stage 2 or more) Ap or pt Bp POPQ assessment of prolapse at pt Bp (reports median and range) Bowel function assessed with Pelvic Distress Index defecatory function questions
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random sequence
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded reviewers
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	1 year: Group A 70/80, Group B 67/79
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	No financial conflicts of interest; grant funding from National Institute of Child and Human Health

Svabik 2014.

Study characteristics
Methods	Single‐centre RCT Computer randomisation on patient hospitalisation numbers Allocation concealment: not stated Women unblinded Postop unblinded due to surgeries Sample size 30 in each group allowed 80% power to detect a 45% difference with an alpha error of 5% ITT analysis: not stated
Participants	Inclusion criteria: symptomatic post‐hysterectomy patients with at least 2‐compartment prolapse (with affected apical/vault compartment, stage 2 or higher (POPQ)), requesting pelvic floor reconstructive surgery, and diagnosed with a complete unilateral or bilateral avulsion injury Exclusion criteria: nil further stated Assessment pre‐ and postoperative POPQ examination, 4D ultrasonography with acquisition of volume data sets at rest, during pelvic floor muscle contraction, and on maximum Valsalva manoeuvre, PISQ‐12, POPDI, UDI, CRADI 142 reviewed and 72 excluded (70 no avulsion, 2 refused) Sacrospinous fixation: 34, 1 year 31 Mesh: 36, 1 year 36
Interventions	Native tissue sacrospinous fixation: all cases: anterior repair with 2.0 polyglactin (Vicryl Plus) (Ethicon), posterior high levatorplasty Vicryl Plus 1: 2x Nurolon 1.0 (Ethicon) permanent R sacrospinous ligament Mesh: Prolift total (Ethicon): 3 arms each side with mesh secured to apex with Vicryl Plus 2.0 and to introitus posteriorly Primary outcome: failure defined: Ba, C, or Bp at hymen or below Uterosacral suspension definition ≳ 10 mm descent of the bladder below the lower margin of the symphysis pubis on maximum Valsalva
Outcomes	Assessed at 3 months and at 1 year Reports the following review outcomes at 1 year: Recurrent prolapse: (POPQ > grade 2) Mesh exposure Surgery for mesh exposure POPQ assessment of prolapse: pt Ba, C, Bp, total vaginal length Bladder function: de novo stress incontinence Sexual function: PISQ‐12 end score Quality of life (including UDI, POPDI, and CRADI questionnaires): mean and SDs
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Computer randomisation based on hospital number?
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	No, could not be blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	No, could not be blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	1 year 31/34 sacrospinous fixation, mesh 36/36
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	Funded by Czech Ministry of Health and Charles University in Prague; 1 author had financial conflict of interest

Takeyama 2020.

Study characteristics
Methods	Single‐centre Japanese RCT comparing polypropylene (PP polyform) mesh and polytetrafluoroethylene (PTFE ORIHIME) with 12‐month review Abstract only with no data on randomisation, allocation and assessment of outcomes and attrition
Participants	Women scheduled to undergo vaginal mesh surgery repair for prolapse
Interventions	Group A: n = 50 PTFE mesh Group B: n = 50 polypropylene mesh repair
Outcomes	Anatomic prolapse: stage 2 or greater prolapse Mesh exposure Complications Operating time Surgery for SUI
Notes	No industry funding
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not stated
Selective reporting (reporting bias)	Unclear risk	Not stated
Other bias	Unclear risk	No statement

Tamanini 2014.

Study characteristics
Methods	Single‐unit raffle randomisation prior to surgery No allocation concealment described Surgeons and women unblinded Unclear who performed assessments (blinded?) 2 surgeons performed 2 surgeries with mesh kit prior to surgery Sample size: 100 women allowed 80% power to detect 26% difference between the groups with alpha error of 5% with 20% loss to follow‐up at 2 years
Participants	122 reviewed, 100 randomised AC 55, 1 year 54, 2 years 50 Mesh 45, 1 year 43, 2 years 42 Inclusion criteria: 45 years old or older, with AVWP ≥ 2 (POPQ stage) without previous surgical correction or with previous surgical treatment of AVWP without the use of polypropylene mesh Exclusion criteria: women who were previously treated (due to AVWP or SUI) using polypropylene mesh, who were receiving oncological treatment, with altered Papanicolaou smear exam or with uterine bleeding, with genital or acute urinary infection, women who didn't commit to ambulatory follow‐up or who refused the written informed consent All had preop urodynamics
Interventions	Spinal anaesthesia with antibiotics Mesh group: Nazca TC kit (Promedon, Córdoba, Argentina) monofilament macroporous 4 arms (1 prepubic and 1 transobturator each side) concomitant surgery as required: hysterectomy, apical or posterior repair AC group: 2.0 polyglactin (Vicryl) fascial plication mid‐urethral sling if SUI on preop urodynamics (14/55)
Outcomes	Assessed at 1 year and 2 years Reports the following review outcomes at 2 years: Repeat prolapse surgery (no events) Recurrent prolapse: anterior vaginal wall (POPQ Ba stage 2 or more) Mesh exposure Surgery for mesh exposure Objective failure of anterior compartment (POPQ Ba stage 2 or more) POPQ assessment of prolapse: pt Ba
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Raffle randomisation 55 in AC and 45 in mesh
Allocation concealment (selection bias)	High risk	No allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unblinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unblinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	AC: 2 years 43/50; 5 years 43/50 Mesh: 2 years 33/42; 5 years 33/42
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	No conflict of interest reported

Thijs 2010.

Study characteristics
Methods	Multicentre and multinational RCT Randomisation and allocation concealment: N/S 90% power to detect 20% difference UDI prolapse domain at 1 year with 5% type 1 error with 38 in each group
Participants	Group A (48): AC Group B (48): Perigee transobturator polypropylene mesh Group A: 35 AC only, 5 SSF, 5 hysterectomy, 6 mid‐urethral sling Group B: 34 Perigee only, 4 SSF, 8 hysterectomy, 1 mid‐urethral sling
Interventions	Inclusion criteria: stage 2 or more cystocele Excluded if anterior was not the leading prolapse Concomitant surgery allowed Stage 2 or more uterine prolapse hysterectomy or SSF SUI mid‐urethral sling
Outcomes	Assessed at 6 months and 1 year Reports the following review outcomes at 1 year: Repeat continence surgery Mesh erosion Surgery for mesh erosion POPQ assessment of prolapse: points Ba, C, Bp (reports median and variance) Quality of life (UDI)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	High risk	No clear numbers supplied in abstract
Selective reporting (reporting bias)	Low risk	Reports 1 of our primary review outcomes
Other bias	Unclear risk	No statement about funding

Turgal 2013.

Study characteristics
Methods	Parallel‐group RCT
Participants	Inclusion: grade 2 or 3 cystocele Exclusion: urinary incontinence, previous gynaecological operation, concomitant rectocele or enterocele, recurrent cystocele
Interventions	Polypropylene mesh surgery (20 women) vs AC (20 women)
Outcomes	Assessed at 6 weeks, 6 months, 1 year Reports the following review outcomes at 1 year: Awareness of prolapse (bulging) 5/20 vs 1/20 Repeat prolapse (> stage 1 on examination) 1/20 vs 5/20 Mesh erosion n = 3 Surgery for mesh erosion n = 3 Operating time 44 ∓ 5 21 ∓ 2 De novo urinary incontinence 0/20 vs 2/20 Days in hospital: reports means but no SDs
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Allocated by computer programme"
Allocation concealment (selection bias)	Unclear risk	Method not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding not mentioned
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding not mentioned
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	All 40/40 randomised women were included in analysis
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	Reports "no conflict of interest". No other potential bias identified

Vollebregt 2011.

Study characteristics
Methods	Multicentre RCT Randomisation was computerised, and stratification was performed for the presence of uterine descent ≥ 2. No blinding of group assignment was performed Allocation concealment: N/S Power 80 to detect 25% difference in groups with 5% type 1 error from sample size of 50 in each group
Participants	Inclusion criteria: ≥ stage 2 cystocele Exclusion criteria: history of urogynaecological surgery for pelvic organ prolapse or incontinence, cancer or COPD, concomitant urinary stress incontinence with an indication for surgical correction, recurrent lower urinary tract infections (> 3 culture‐proven infections/year), maximum bladder capacity < 300 mL, an indication for hysterectomy, and women with childbearing potential and inadequate birth control measures Randomised: A 64, B 61 Withdrawals prior to surgery: A 2, B 2 12 months: A 51, B 53
Interventions	Group A: AC Group B: trocar‐guided transobturator synthetic mesh (Avaulta)
Outcomes	Assessed at 6 months and 1 year Reports the following review outcomes at 1 year: Awareness of prolapse (feeling a vaginal bulge): 9% in each group Repeat surgery for prolapse Recurrent prolapse (cystocele grade 2 or more) Mesh exposure Surgery for mesh exposure Sexual function: de novo dyspareunia Quality of life: Incontinence Impact Questionnaire
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Low risk	Research nurse from online list
Blinding of participants and personnel (performance bias) All outcomes	High risk	No
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Reviewers blinded by strapping thighs prior to review
Incomplete outcome data (attrition bias) All outcomes	Low risk	1 year: AC 55/56, mesh 55/58
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	No funding and no conflict of interest

Weber 2001.

Study characteristics
Methods	RCT (computer‐generated random number tables. Sealed envelopes concealed assignment) comparing 3 surgical techniques 3 arms, 1 centre Length of follow‐up: A + B + C, 23.3 months
Participants	83 women Inclusion: all women undergoing cystocele repair Exclusion: continence surgery, i.e. colposuspension or sling 114 randomised 5 withdrawals 26 lost to follow‐up (A: 2. B: 15. C: 9), leaving 83 in trial
Interventions	Group A (33): anterior repair: midline plication without tension 0 PDS Group B (24): ultra‐lateral: dissection to pubic rami laterally, plication paravaginal with tension 0 PDS interrupted Group C (26): anterior repair plus mesh: standard plication midline polyglactin (Vicryl) mesh overlay, Vicryl sutures Number and level of surgeons unknown
Outcomes	Assessed at 6 months, 1 year, and 2 years Reports the following review outcomes at median follow‐up 23 months (range 4.5 to 44.4 months) Awareness of prolapse (reports symptom severity on visual analogue scale but no comparative data) Recurrent prolapse (grade 2 or more prolapse at points Aa or Ba or worse than preoperative staging) Death Mesh erosion
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Low risk	Adequate
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	High risk	83/114 randomised women included in analysis (73%)
Selective reporting (reporting bias)	Unclear risk	Main review outcomes reported, but no comparative data for most outcomes
Other bias	Unclear risk	No statement about funding. Significant disparity between total numbers in Table 1 and actual numbers with prolapse reported

Wei 2019.

Study characteristics
Methods	Single‐centre Chinese RCT comparing polypropylene mesh and porcine collagen matrix or porcine small intestine with 1‐year review 214 participants offered power 80% and type one error of 5% to detect 20% difference between groups with 5‐10% attrition at 12 months Randomisation unclear Allocation by sealed envelopes Blinded participants and assessors Attrition at 1 year: A 7/117; B 7/115
Participants	Inclusion criteria: unclear Exclusion criteria: prior pelvic floor surgery; prior pelvic radiation previous 6 months; uterine prolapse with overactive bladder; vaginal bleeding, infection; coagulation disorder; uncontrolled hypertension; diabetes mellitus; abnormal ECG; economic or ideological concerns
Interventions	Group A: n = 117. Hernia polypropylene transobturator mesh 50% hysterectomy Group B: n = 115. Porcine collagen or small intestine graft 50% hysterectomy
Outcomes	Anatomic success: less than stage 2 prolapse Mesh exposure Surgery for mesh exposure Surgery for SUI Pelvic pain
Notes	Funded from development fund from Nanjing Medical University
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Sealed envelopes allocation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants blinded to allocation
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Reviewers blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition at 1 year: A 7/117 B 7/115
Selective reporting (reporting bias)	Low risk	Reporting consistent with retrospective trial registration
Other bias	Low risk	Funded by Nanjing Medical University grant

Withagen 2011.

Study characteristics
Methods	Multicentre RCT 13 centres; 22 surgeons Randomisation list was computer‐generated for each centre. Allocation concealment not discussed and woman, surgeon, and assessor (surgeons) not blinded Surgeons underwent specific Prolift mesh training Full power calculation completed
Participants	Randomised: Group A 99, Group B 95 1‐year examination: A 84, B 83 Inclusion criteria: recurrent stage 2 or higher anterior or posterior wall prolapse, or both Exclusion criteria: pregnancy, future pregnancy, prior vaginal mesh repair, a compromised immune system or any other condition that would compromise healing, previous pelvic irradiation or cancer, blood coagulation disorders, renal failure, upper urinary tract obstruction, renal failure and upper urinary tract obstruction, or presence of large ovarian cysts or myomas
Interventions	Group A: conventional surgery was performed at the discretion of the surgeon, although absorbable sutures were specified and hysterectomies permitted Group B: standardised and structured in the tension‐free vaginal mesh: performed as described by Fatton and colleagues (Fatton 2007), and no hysterectomies were performed nor T incisions allowed
Outcomes	Assessed at 6 months and 1 year Reports the following review outcomes at 1 year: Repeat prolapse surgery Repeat surgery for prolapse, SUI, or mesh exposure Mesh exposure Bladder injury (perforation) Surgery for mesh exposure POPQ assessment of prolapse: points Ba, Bp, C (reports median and range) Bladder function: de novo SUI Sexual function: de novo dyspareunia; PISQ‐12 (Milani 2011 reports mean and SD) Quality of life: PGI‐I questionnaire: rate of "much or very much better" (and other questionnaires) Duration of surgery (reports median and range)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	High risk	Allocation concealment not described. Preoperatively, group A is significantly different from group B, as demonstrated by having greater degree prolapse at Ap, Bp, and GH in Table 1; having a significantly higher number of women with ≥ stage 2 apical compartment prolapse in those in Table I undergoing prior apical surgery, (36% (16/45) in group A versus 18% (10/56) in group B (P = 0.04, odds ratio 2.54)); and finally prior sacral colpopexy was 3 times as frequent in group B. Only the final anomaly is acknowledged
Blinding of participants and personnel (performance bias) All outcomes	High risk	Non‐blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Non‐blinded reviewers; participant‐completed questionnaires
Incomplete outcome data (attrition bias) All outcomes	Low risk	Group A 84/99, Group B 83/98. At 7 years 75% attended
Selective reporting (reporting bias)	Low risk	Reporting consistent with trial registration
Other bias	Low risk	Funded by university research fund; all authors reported financial support from Ethicon, which manufactures product being evaluated by non‐blinded reviewers at 1 year At seven years, authors report no conflict of interest

Yang 2016.

Study characteristics
Methods	Data extraction from full‐text paper in Chinese Single‐centre trial Blinding and randomisation method not stated No CONSORT statement 90 women in 2‐arm trial comparing PP mesh (Gynae mesh) vs partially absorbable PP mesh (Prolift) with 1 year follow‐up
Participants	40 to 80‐year old women undergoing pelvic floor reconstruction Inclusion: Stage 1‐4 multi‐compartment prolapse (apical, anterior, posterior or combination). Only 5/90 patients were stage I and had severe symptoms and were allowed to be offered an operation Exclusion criteria: active malignancy, and severe heart, liver, renal and immunological condition and previous adverse reaction to mesh
Interventions	Group A: n = 45. Polypropylene mesh Gynemesh only Group B: n = 45. Prolift partially absorbable mesh polypropylene and polyglactin
Outcomes	Perioperative outcomes: operative time, blood loss, days of hospitalisation and IDC insertion Postoperative: 3 month PFDI 20 QoL 11‐month follow‐up with recurrent prolapse, de novo stress incontinence, mesh exposure as outcome measures
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of randomisation not stated in paper
Allocation concealment (selection bias)	Unclear risk	Not stated in paper
Blinding of participants and personnel (performance bias) All outcomes	High risk	Clinicians unable to be blinded to type of mesh inserted in the groups
Blinding of outcome assessment (detection bias) All outcomes	High risk	Participants unable to be blinded to type of mesh inserted
Incomplete outcome data (attrition bias) All outcomes	Low risk	No attrition at 1 year
Selective reporting (reporting bias)	Low risk	No change in data reporting compared to methods
Other bias	Low risk	No conflicts of interest declared and no statement on funding

AC = anterior colporrhaphy
AVWP = anterior vaginal wall prolapse
BW = Baden‐Walker
CI = confidence interval
CONSORT = Consolidated Standards of Reporting Trials
CRADI = Colorectal‐Anal Distress Inventory
CST = cough stress test
GA = general anaesthetic
Hb = haemoglobin
ICIQ‐SF = International Consultation on Incontinence Questionnaire Short Form
ICS = International Continence Society
IDC = indwelling urinary catheter
ITT = intention to treat
IVS = intravaginal slingplasty
N/S = not specified
NTR = native tissue repair
PDS = absorbable polydioxanone surgical suture
PFDI = Pelvic Floor Distress Inventory
PFIQ = Pelvic Floor Impact Questionnaire
PGI‐I = Patient Global Impression of Improvement
PISQ = Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
POP = pelvic organ prolapse
POPDI = Pelvic Organ Prolapse Distress Inventory
POPIQ = Pelvic Organ Prolapse Impact Questionnaire
POPQ = Pelvic Organ Prolapse Quantification (according to ICS)
POP‐SS = Pelvic Organ Symptom Score
PQOL= Prolapse Quality of Life Questionnaire
QOL = quality of life
RCT = randomised controlled trial
SD = standard deviation
SSF = sacrospinous fixation
SUI = stress urinary incontinence (symptom diagnosis)
TOT = transobturator tape
UDI = Urogenital Distress Inventory
UDS = urodynamic study
USS = ultrasound sonography
VAS = visual analogue scale

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Ali 2006	Published as an abstract only, with no subsequent peer‐reviewed publication within 15 years of abstract publication
Altman 2013	Not a randomised controlled trial
Balci 2011	Not a randomised controlled trial
Chao 2012	Assessment of impact of traction on uterine prolapse without any surgical intervention
Juneja 2010	Juneja and colleagues compared hysterectomy (n = 9) versus no hysterectomy (n = 7) for uterine prolapse in conjunction with posterior infracoccygeal colpopexy in a pilot randomised study. We excluded this study on the grounds of our prespecified decision that papers with fewer than 20 women in each treatment group would not be included in the review.
Lukacz 2020	Ineligible study design: secondary analysis of four randomised controlled trials
Meschia 2004	Published as an abstract only, with no subsequent peer‐reviewed publication within 15 years of abstract publication
NCT00743535	Registered trial. Study terminated due to low recruitment rate
NCT01497171	Registered trial. Early termination of study due to changes in funding. Five participants enroled.
NCT01594372	Registered trial. Unable to offer laparoscopic intervention and hence unable to randomise patients
Reid 2021	Ineligible study design: prospective study of complications
Tincello 2009	Tincello and colleagues report a pilot randomised patient preference study comparing colposuspension or tension‐free vaginal tape for urinary incontinence at time of anterior repair for prolapse. The study recruited 31 women; however, only four (two in each arm) were randomised. We excluded this study on the grounds of our prespecified decision that papers with fewer than 20 women in each treatment group would not be included in the review.
Wallace 2021	Not a randomised controlled trial

Characteristics of ongoing studies [ordered by study ID]

NCT00955448.

Study name	Trial of small intestine submucosa (SIS) mesh for anterior repair
Methods	Randomised controlled trial
Participants	Anterior prolapse
Interventions	Anterior repair versus SIS biograft (Cook)
Outcomes
Starting date	2009
Contact information	clinicaltrials.gov/show/NCT00955448
Notes	Study completed; unable to identify publication as yet

NCT01095692.

Study name	ATHENA
Methods	Randomised controlled trial
Participants	Women with occult urinary incontinence
Interventions	Pelvic organ prolapse + stress urinary incontinence surgery versus pelvic organ prolapse surgery alone
Outcomes
Starting date
Contact information
Notes	Study complicated; unable to identify publication as yet

Differences between protocol and review

This review should be read as part of a series of six Cochrane reviews relating to surgical management of prolapse, including:

1. Surgery for women with anterior compartment prolapse (Maher 2016b);

2. Surgery for women with posterior compartment prolapse (Mowat 2018);

3. Surgery for women with apical vaginal prolapse (Maher 2023);

4. Surgery for women with pelvic organ prolapse with or without stress urinary incontinence (Baessler 2018);

5. Transvaginal grafts or mesh compared with native tissue repair for vaginal prolapse (Maher 2016);

6. Perioperative interventions in pelvic organ prolapse surgery (Haya 2018).

We have attempted to standardise the 19 outcomes between all six reviews. This review includes any type of transvaginal graft compared with any other transvaginal repair.

For the 2023 update, we decided to restrict primary analyses to studies judged to be at low risk of bias, such that studies defined as high risk in four or more categories in the risk of bias (ROB) table would not be included.

Contributions of authors

All review authors contributed to writing the protocol. Seven review authors (E Yeung, K Baessler, C Schmid, N Haya, Z Chen, A Mowat, C Maher) assessed the relevance and eligibility of studies for inclusion in the review. They then assessed the quality of included studies; independently extracted data from trial reports, interpreted the results and contributed to the writing of the draft version of the review.

Sources of support

Internal sources

• Cochrane, UK

  Cochrane Review Support Programme: Pelvic organ prolapse reviews

External sources

• National Institute for Health Research (NIHR), UK

  This project was supported by the NIHR, via Cochrane Infrastructure funding to the Cochrane Incontinence Group. The views and opinions expressed herein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, the NIHR, the NHS or the Department of Health.

Declarations of interest

EY, KB, CC, NH, ZC, SW, AM, and CM have no conflicts of interests to declare

New search for studies and content updated (no change to conclusions)