Stress incontinence

Abstract

Introduction

Stress incontinence, involving involuntary leaking of urine on effort, exertion, sneezing, or coughing, affects 17–45% of adult women. Risk factors include pregnancy (especially with vaginal delivery), smoking, and obesity.

Methods and outcomes

We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-surgical treatments and surgical treatments for women with stress incontinence? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2008 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found 97 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review we present information relating to the effectiveness and safety of the following interventions: adrenoceptor agonists, anterior vaginal repair, laparoscopic colposuspension, needle suspension, oestrogen supplements, pelvic floor electrical stimulation, pelvic floor muscle exercises, retropubic colposuspension, selective serotonin reuptake inhibitors (duloxetine), suburethral slings, tension-free vaginal tape, transobturator foramen procedures, and vaginal cones.

Key Points

Stress incontinence, involving involuntary leaking of urine on effort, exertion, sneezing, or coughing, affects 17–45% of adult women.

• Risk factors include pregnancy (especially with vaginal delivery), smoking, and obesity.

Pelvic floor muscle exercises improve incontinence symptoms compared with no treatment. Pelvic floor electrical stimulation and vaginal cones are also effective compared with no treatment.

• Pelvic floor electrical stimulation can cause tenderness and vaginal bleeding, whereas vaginal cones can cause vaginitis and abdominal pain. Pelvic floor muscle exercises can cause discomfort.

Oestrogen supplements increase cure rates compared with placebo, but there are risks associated with their long-term use. They can be less effective at reducing incontinence compared with pelvic floor muscle exercises.

Serotonin reuptake inhibitors (duloxetine 80 mg/day) reduce incontinence frequency at 4–12 weeks compared with placebo, or compared with pelvic floor muscle exercises, but increase adverse effects, such as headache and gastric problems.

We do not know whether adrenoceptor agonists improve incontinence compared with placebo or with other treatments, but they can cause insomnia, restlessness, and vasomotor stimulation. Phenylpropanolamine has been withdrawn from the US market because of an increased risk of haemorrhagic stroke.

Open retropubic colposuspension may be more likely to cure stress incontinence than non-surgical treatments, anterior vaginal repair or needle suspension at up to 5 years. Complication rates are similar to those with other surgical procedures.

Suburethral slings and open retropubic colposuspension are equally effective in curing stress incontinence at up to 5 years.

Tension-free vaginal tape may be as effective as open retropubic colposuspension in curing stress incontinence. Complications of tension-free vaginal tape include bladder perforation.

Transobturator foramen procedures may be as effective as open retropubic colposuspension and tension-free vaginal tape.

Laparoscopic colposuspension and open retropubic colposuspension seem equally effective.

About this condition

Definition

Stress incontinence is involuntary leakage of urine on effort or exertion, or on sneezing or coughing.[1] Stress incontinence predominantly affects women, and can cause social and hygiene problems. Typically, there is no anticipatory feeling of needing to pass urine. Under urodynamic testing, urodynamic stress incontinence is confirmed by demonstrating loss of urine when intravesical pressure exceeds maximum urethral pressure, in the absence of a detrusor contraction. A confirmed diagnosis of urodynamic stress incontinence is particularly important before surgical treatment,[2] given that the symptoms of stress incontinence can occur in people with detrusor overactivity, which is confirmed by the demonstration of uninhibited bladder contractions. This review deals with stress incontinence in general.

Incidence/ Prevalence

Stress incontinence is a common problem. Prevalence has been estimated at 17–45% of adult women in resource-rich countries.[3] One cross-sectional study (15,308 women in Norway, aged less than 65 years) found that the prevalence of stress incontinence was 4.7% in women who had not borne a child, 6.9% in women who had had caesarean deliveries only, and 12.2% in women who had had vaginal deliveries only.[4]

Aetiology/ Risk factors

Aetiological factors include pregnancy, vaginal or caesarean delivery, cigarette smoking, and obesity.[4] [5] [6] [7] One cross-sectional study (15,308 women in Norway) found that, when compared with women who had not borne a child, the risk of stress incontinence was increased in women who had delivered by caesarean section (age adjusted OR 1.4, 95% CI 1.0 to 2.0) or by vaginal delivery (age adjusted OR 3.0, 95% CI 2.5 to 3.5).[4] The risk of stress incontinence was also increased in women who had a vaginal delivery compared with women who had a caesarean section (adjusted OR 2.4, 95% CI 1.7 to 3.2). One case control study (606 women) found that the risk of “genuine”, now called “urodynamic”, stress incontinence was increased in former smokers (adjusted OR 2.20, 95% CI 1.18 to 4.11) and in current smokers (adjusted OR 2.48, 95% CI 1.60 to 3.84).[7] The risks associated with obesity are unclear.

Prognosis

The natural history of stress incontinence is unclear. Untreated stress incontinence is believed to be a persistent, lifelong condition.

Aims of intervention

To improve quality of life and social function; to reduce embarrassment; and to reduce frequency and volume of involuntary urine leakage, with minimal adverse effects.

Outcomes

Primary outcomes: quality of life, social functioning, subjective reduction in urine loss, and adverse effects of treatment. Secondary outcomes: reduced urine leakage on urodynamic testing, and pad tests for objective demonstration of leakage. Excluded proxy/surrogate outcomes: pelvic floor strength, tension, contractility, physiological measures, and perineometry.

Methods

Clinical Evidence search and appraisal June 2008. The following databases were used to identify studies for this systematic review: Medline 1966 to June 2008, Embase 1980 to June 2008, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2008, Issue 2 (1966 to date of issue). An additional search was carried out using these websites: NHS Centre for Reviews and Dissemination (CRD) — for Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the contributor for additional assessment, using pre-determined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews of RCTs and RCTs in any language, at least single blinded, and containing more than 20 individuals of whom more than 80% were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as “open”, “open label”, or not blinded unless blinding was impossible. We excluded RCTs that reported only within-group comparisons (e.g. change from baseline within a group). We have included only RCTs that stated that more than half of the participants had stress incontinence. In the case of three-armed RCT studies, analyses were not included if ANOVA was used to compare results from the three arms. We included systematic reviews of RCTs and RCTs where harms of an included intervention were studied, applying the same study design criteria for inclusion as we did of benefits. In addition we did an observational harms search for specific harms as highlighted by the contributor, peer reviewer and editor. We searched for prospective/retrospective cohort, case control, case, and cross-sectional survey data on harms of tension-free vaginal tape (TVT) and transobturator foramen procedures. We excluded studies comparing different techniques within a single intervention type (e.g. high-intensity v low-intensity pelvic floor muscle training, or Burch colposuspension v Marshall–Marchetti–Krantz urethropexy. In addition we use a regular surveillance protocol to capture harms alerts from organisations such as the US FDA and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table ).

Table 1.

GRADE evaluation of interventions for stress incontinence

Important outcomes	Quality of life, social functioning, self-reported improvement/cure, episodes of urine loss, adverse effects
Number of studies (participants)	Outcome	Comparison	Type of evidence	Quality	Consistency	Directness	Effect size	GRADE	Comment
What are the effects of non-surgical treatments for women with stress incontinence?
At least 8 RCTs (at least 2587 people)[8]	Incontinence cure rates	SSRIs v placebo	4	0	0	0	0	High
7 (2519)[9] [11] [12] [13] [14] [15] [16] [17]	Incontinence frequency	SSRIs v placebo	4	0	+1	0	0	High	Consistency point added for evidence of dose response
7 (2077)[8] [9] [10]	Quality of life	SSRIs v placebo	4	0	–1	0	0	Moderate	Consistency point deducted for conflicting results
1 (92)[17]	Incontinence frequency	SSRIs plus imitation pelvic floor exercises v pelvic floor exercises plus placebo	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
1 (92)[17]	Quality of life	SSRIs plus imitation pelvic floor exercises v pelvic floor exercises plus placebo	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
2 (112)[19] [23]	Incontinence frequency	Pelvic floor electrical stimulation v no treatment/sham stimulation	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
3 (197)[20] [21] [22]	Cure/improvement of incontinence	Pelvic floor electrical stimulation v no treatment/sham stimulation	4	–2	0	–1	0	Very low	Quality points deducted for sparse data and poor follow-up. Directness point deducted for inclusion of men into one RCT
1 (less than 274 women)[25]	Episodes of incontinence	Pelvic floor electrical stimulation v vaginal cones	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
4 (274)[25]	Cure/improvement of incontinence	Pelvic floor electrical stimulation v vaginal cones	4	0	0	0	0	High
1 (49)[26]	Cure/improvement of incontinence	Pelvic floor electrical stimulation v oestrogen supplements	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
3 (165)[28]	Cure/improvement of incontinence	Pelvic floor muscle exercises v no treatment	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
2 (163)[17] [29]	Incontinence frequency	Pelvic floor muscle exercises v no treatment	4	–1	–1	0	0	Low	Quality point deducted for sparse data. Consistency point deducted for different results
7 (661) [25]	Cure/improvement of incontinence	Pelvic floor muscle exercises v vaginal cones	4	0	0	0	0	High
2 RCTs[25]	Incontinence frequency	Pelvic floor muscle exercises v vaginal cones	4	–1	0	0	0	Moderate	Quality point deducted for incomplete reporting of results
1 (69)[26]	Cure/improvement of incontinence	Pelvic floor muscle exercises v oestrogen supplements	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
2 (191)[30]	Cure/improvement of incontinence	Pelvic floor muscle exercises v adrenoceptor agonists	4	–1	–1	0	0	Low	Quality point deducted for sparse data. Consistency point deducted for different results
2 (252)[25]	Cure/improvement of incontinence	Vaginal cones v no active treatment	4	0	0	0	0	High
2 (252)[25]	Incontinence frequency	Vaginal cones v no active treatment	4	0	0	0	0	High
15 (718)[26]	Cure/improvement of incontinence	Oestrogen supplements v placebo	4	–1	0	–1	0	Low	Quality point deducted for differences in RCT design. Directness point deducted for differences in treatments
1 (417)[31]	Incontinence frequency	Oestrogen supplements v placebo	4	–1	0	0	0	Moderate	Quality point deducted for poor reporting of long-term follow-up
1 (20)[30]	Cure/improvement of incontinence	Oestrogen supplements v adrenoceptor agonists	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
4 (276)[30]	Cure/improvement of incontinence	Adrenoceptor agonists v placebo	4	0	–1	–1	0	Low	Consistency point deducted for conflicting results. Directness point deducted for inclusion of withdrawn and unlicensed treatments
What are the effects of surgical treatments for women with stress incontinence?
12 (at least 1285 people)[36] [40] [41]	Cure/improvement of incontinence	Open retropubic colposuspension v Laparoscopic colposuspension	4	0	0	0	0	High
8 (at least 515 people)[36]	Cure/improvement of incontinence	Laparoscopic colposuspension v tension-free vaginal tape	4	0	–1	0	0	Moderate	Consistency point deducted for different results for objective v subjective assessment of outcomes
2 (97)[39]	Cure of incontinence	Open retropubic colposuspension v pelvic floor muscle exercises/stimulation	4	–3	0	0	0	Very low	Quality points deducted for sparse data, and for non-reporting of method of randomisation and number of withdrawals
8 (929)[37]	Cure of incontinence	Open retropubic colposuspension v anterior vaginal repair	4	0	0	0	0	High
5 (206)[48]	Cure of incontinence	Open retropubic colposuspension v suburethral sling	4	0	0	0	0	High
7 (570)[39]	Cure of incontinence	Open retropubic colposuspension v needle suspension	4	–1	0	0	0	Moderate	Quality point deducted for weak methodology of included RCTs
2 (415)[50]	Cure of incontinence	Open retropubic colposuspension v tension-free vaginal tape	4	–3	0	0	0	Very low	Quality points deducted for randomisation flaws, poor follow-up and other methodological flaws
1 (101)[43]	Cure of incontinence	Open retropubic colposuspension v transobturator foramens procedure	4	–1	0	0	0	Moderate	Quality points deducted for sparse data
1 (20)[48]	Cure of incontinence	Suburethral sling v needle suspension	4	–1	0	–1	0	Low	Quality point deducted for sparse data. Directness point deducted for population restricted to women with vaginal narrowing secondary to either previous interventions or atrophic vaginitis
1 (53)[51]	Cure of incontinence	Suburethral sling v tension-free vaginal tape	4	–2	0	0	0	Low	Quality points deducted for sparse data and incomplete reporting of results
At least 14 RCTs (at least 1661 people) [78] [79] [80] [81] [82]	Cure of incontinence	Tension-free vaginal tape v transobturator foramen procedures	4	0	0	0	0	High
1 (69)[49]	Quality of life	Tension-free vaginal tape v no treatment	4	–2	0	–1	0	Very low	Quality point deducted for sparse data and no intention to treat analysis. Directness point deducted for population restricted to elderly women
2 (469)[37]	Cure of incontinence	Anterior vaginal repair v needle suspension	4	0	0	0	0	High

Type of evidence: 4 = RCT; 2 = Observational Consistency: similarity of results across studies Directness: generalisability of population or outcomes Effect size: based on relative risk or odds ratio

Glossary

Anterior vaginal repair (anterior colporrhaphy)

The vaginal mucosa below the urethra is dissected, ending just in front of the cervix. Sutures are placed in the periurethral tissue and the pubocervical fascia to support and elevate the bladder neck. Excess vaginal tissue is removed and then the dissected area is closed. The operation can be performed under general, regional, or local anaesthetic.

High-quality evidence

Further research is very unlikely to change our confidence in the estimate of effect.

Laparoscopic colposuspension

An endoscope is inserted into or through the abdominal wall to view abdominal and pelvic organs. Sutures are inserted into the paravaginal tissues on either side of the bladder neck and then attached to the ileopectineal ligaments on the same side. The operation is performed under general anaesthetic.

Low-quality evidence

Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Moderate-quality evidence

Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

Needle suspension

To support the bladder neck, a needle threads sutures from the vagina to the anterior abdominal fascia through the paraurethral tissue of the bladder neck. The operation is performed under general or regional anaesthetic.

Open retropubic colposuspension

Involves lifting the tissues near the bladder neck and proximal urethra in the area of the pelvis behind the anterior pubic bones through an incision over the lower abdomen. The operation is performed under general or regional anaesthetic.

Pad test

After the placement of a preweighed sanitary pad, the woman is asked to exercise. The pad is then reweighed to determine the amount of urine loss.

Pelvic floor electrical stimulation

A recurrent electrical pulse is delivered by vaginal probe to stimulate pelvic floor muscle contractions.

Pelvic floor muscle exercises

Repetitive contraction exercises designed to strengthen the pelvic floor muscles, based on the rationale that a strong, fast pelvic floor muscle contraction will clamp the urethra, thus increasing the intraurethral pressure, preventing leakage during abrupt increases in intra-abdominal pressure.

Pelvic floor muscle training (PFMT)

the subject is instructed to cross her legs at the ankles, with her knees and hips flexed, while sitting or supine, and to abduct the hips, holding the contraction for 6–8 seconds while the therapist palpates the hip abductors and abdominal muscles and confirms that the abductors are contracted without dominant contractions of the abdominal muscles. Once proper contractions are confirmed, the subject receives written instructions and a training log. Three sets of 10 long and two sets of 10 rapid contractions 4 days a week are recommended.

Suburethral slings

Strips of material are tunnelled under the urethra, attached either to the rectus muscle or the ileopectineal ligaments, resulting in a tightening of the sling and increased bladder support every time the woman contracts her rectus muscles. The operation is performed under general or regional anaesthetic.

Tension free vaginal tape (TVT)

A minimal access surgical sling procedure, in which a tape is passed beneath the urethra, aiming to restore the urethra to its normal position. The TVT is placed with minimal tension, and support is thought to be achieved by causing a tissue reaction with a subsequent collagen scar. The operation is performed under general or regional anaesthetic.

Tension-free vaginal tape obturator route (TVT-O)

This procedure is similar to transobturator tape (TOT) except that it uses an inside-out insertion technique, rather than the outside-in technique used with TOT; a needle is passed in through a vaginal incision and out through the obturator foramen.

Transobturator foramen procedures (TOT or TVT-O)

These procedures use tape similar to tension-free vaginal tape, but the tape is inserted differently. Although it avoids the space behind the pubic bone (the retropubic space), the tape is positioned without tension beneath the urethra, in order to maintain its correct position.

Urge incontinence

Urge incontinence is typically caused by a spontaneous or inappropriately provoked involuntary bladder contraction (detrusor instability). Urge incontinence, unlike stress incontinence, is associated with a feeling of needing to void. It can exist alone, or more commonly as mixed urinary incontinence, when it is combined with stress incontinence.

Vaginal cones

A women inserts a weighted cone into the vagina. When she can successfully retain that cone while standing, moving around, and coughing, she will move onto the next heaviest cone, and so on.

Very low-quality evidence

Any estimate of effect is very uncertain.

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