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Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women

Clinical Summary

Urinary incontinence is a distressing condition, affecting about one woman in every three. The commonest form is stress urinary incontinence, which causes a leakage of urine during exertion, such as coughing, sneezing or laughing. There are a variety of treatment options and, if other interventions are unsuccessful, one of the treatment options is surgery. In recent years minimally invasive surgical techniques have been developed, and Joseph Ogah, June Cody and Lynne Rogerson from the Cochrane Incontinence Group have drawn together the findings from 62 randomised trials of this type of surgery. They present this evidence in a new Cochrane review.

The initial management of stress urinary incontinence usually includes conservative, mechanical or pharmacological interventions. Conservative management is built around physical methods, such as pelvic floor muscle training, electrical stimulation and biofeedback, whereas mechanical devices to prevent or reduce the leakage of urine include metal plugs or patches, and urethral or vaginal inserts. Many of these approaches have been assessed in Cochrane reviews, which are available as related resources for this issue of Cochrane Journal Club. If these interventions fail for a particular woman, surgery might be needed; several Cochrane reviews examine the relevant research and are also listed as related resources. This new review is the second Cochrane review to focus on sling operations.

The first Cochrane review by Carlos Bezerra and colleagues, published in 2005, studied the traditional suburethral sling operation, which requires a combined abdominal and vaginal approach. This procedure requires open, abdominal surgery, and the slings are biological or synthetic and they are held in place by stitches. The sling is created by tunnelling strips of material under the proximal urethra and attaching these to either the rectus muscle or the iliopectineal ligaments to make the sling. Then, when a woman strains, this sling tightens and her bladder receives more support.

The new Cochrane review investigates a modification of this procedure, using minimally invasive surgery. One of the techniques involves placing a tape underneath the mid-urethra, without the use of sutures. It is performed in some centres using local, rather than general, anaesthesia. The aim is to restore or enhance the woman’s urethral support during sudden movement, such as when she coughs or sneezes, and prevent the leakage of urine. The operation can be done by inserting two needles through the retropubic space from vagina to abdomen or from abdomen to vagina. Another type of operation inserts the tape in a horizontal plane underneath the middle of the urethra between the two obturator foramina. The ends of the tape are inserted through the skin with a curved needle and sutures are not needed. There are also further modifications which insert the tape through different parts of the body.

The new review is restricted to mid-urethral sling operations with synthetic tape materials, applied by minimally invasive surgeries that take place either behind the pubic bone or through the groin, using any type of mesh. It was hoped that this would help identify any differences in the complication rates for the different materials. Furthermore, by setting the eligibility criteria wide enough to capture trials of minimally invasive surgery versus various commonly used open operations as well as trials directly comparing different types of minimally invasive surgery, the authors of the Cochrane review hoped to get closer to answering the question of which type of surgery might be most suitable for particular women.

The 62 trials identified included more than 7,000 women, and covered a variety of comparisons. One of the general conclusions from the review is that minimally invasive surgery is as effective as the more traditional procedures with regard to treating incontinence, with cure rates of around 80%, and may have benefits such as shorter operations and fewer post-operative problems. The direct comparisons of different types of minimally invasive surgery included: 17 trials (2,434 women) of the procedure done through the groin or behind the pubic bone, which showed slightly higher cure rates for the retropubic route but with more complications; five trials (636 women) comparing a retropubic vagina-to-abdomen route with the abdomen-to-vagina route, finding that the former was more effective; and three trials (409 women) of monofilament versus multifilament tapes, with monofilament tapes performing better.

Read the Paper

Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women (Review)
Ogah J, Cody JD, Rogerson L

Background: Stress urinary incontinence (SUI) is a common condition affecting up to 30% of women. Minimally invasive synthetic suburethral sling operations are among the latest forms of procedures introduced to treat SUI.

Objectives: To assess the effects of minimally invasive synthetic suburethral sling operations for treatment of SUI, urodynamic stress incontinence (USI) or mixed urinary incontinence (MUI) in women.

Search Strategy: We searched the Cochrane Incontinence Group Specialised Register (searched 20 March 2008), MEDLINE (January 1950 to April 2008), EMBASE (January 1988 to April 2008), CINAHL (January 1982 to April 2008), AMED (January 1985 to April 2008), the UK National Research Register, ClinicalTrials.gov, and reference lists of relevant articles.

Selection Criteria: Randomised or quasi-randomised controlled trials amongst women with SUI,USI or symptoms of stress or mixed urinary incontinence, in which at least one trial arm involved a minimally invasive synthetic suburethral sling operations.

Data collection and analysis: Two review authors assessed the methodological quality of potentially eligible studies and independently extracted data from the included trials.

Main results: Sixty two trials involving 7101 women were included. The quality of evidence was moderate for most trials.Minimally invasive synthetic suburethral sling operations appeared to be as effective as traditional suburethral slings ( trials, n = 599, Risk Ratio (RR) 1.03, 95% Confidence Interval (CI) 0.94 to 1.13) but with shorter operating time and less post-operative voiding dysfunction and de novo urgency symptoms.

Minimally invasive synthetic suburethral sling operations appeared to be as effective as open retropubic colposuspension (subjective cure rate at 12 months RR 0.96, 95% CI 0.90 to 1.03; at 5 years RR 0.91, 95% CI 0.74 to 1.12) with fewer perioperative complications, less postoperative voiding dysfunction, shorter operative time and hospital stay but significantly more bladder perforations (6% versus 1%, RR 4.24, 95% CI 1.71 to 10.52).

There was conflicting evidence about the effectiveness of minimally invasive synthetic suburethral sling operations compared to laparoscopic colposuspension in the short term (objective cure, RR 1.15, 95% CI 1.06 to 1.24; subjective cure RR 1.11, 95% CI 0.99 to 1.24). Minimally invasive synthetic suburethral sling operations had significantly less de novo urgency and urgency incontinence, shorter operating time, hospital stay and time to return to daily activities.

A retropubic bottom-to-top route was more effective than top-to-bottom route (RR 1.10, 95% CI 1.01 to 1.20; RR 1.06, 95% CI 1.01 to 1.11) and incurred significantly less voiding dysfunction, bladder perforations and tape erosions. Monofilament tapes had significantly higher objective cure rates (RR 1.15, 95% CI 1.02 to 1.30) compared to multifilament tapes and fewer tape erosions (1.3% versus 6% RR 0.25, 95% CI 0.06 to 1.00).

The obturator route was less favourable than the retropubic route in objective cure (84% versus 88%; RR 0.96, 95% CI 0.93 to 0.99; 17 trials, n = 2434), although there was no difference in subjective cure rates. However, there was less voiding dysfunction, blood loss, bladder perforation (0.3% versus 5.5%, RR 0.14, 95% CI 0.07 to 0.26) and shorter operating time with the obturator route.

Authors' conclusions: The current evidence base suggests that minimally invasive synthetic suburethral sling operations are as effective as traditional suburethral slings, open retropubic colposuspension and laparoscopic colposuspension in the short term but with less postoperative complications. Women were less likely to be continent after operations performed via the obturator (rather than retropubic) route, but they had fewer complications. Most of the trials had short term follow up and the quality of the evidence was variable.

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Questions and Answers

Q. What is the prognosis of this operation? Are women who undergo this operation satisfied? What is the follow-up?

A. Sorry, our Cochrane Review does not answer this question.


Q.Is it better to perform surgery for stress incontinence along with repair of prolapse or later?

A. Sorry, our Cochrane Review does not answer this question.

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Author Profile

Author

June Cody was born and brought up in East Lothian, Scotland. Following graduation with an MA in Social Sciences from Aberdeen in 1979 and completion of a Post-graduate diploma in information studies in 1991, June worked for several years on various renal projects within the Department of Medicine and Therapeutics at the University of Aberdeen. These included multi centre studies comparing survival of patients on renal replacement therapy across Europe, and developing consensus guidelines for the management of associated conditions of end stage renal disease.

June first started working on systematic reviews in 1995, investigating methods of dialysis therapy and the most effective use of recombinant human erythropoietin. During this time she attended many Cochrane meetings and workshops, and was inspired by the enthusiasm of Iain Chalmers.

June became Managing Editor of the Cochrane Incontinence Group in August 1998 after completing an MSc in Health Services and Public Health Research. At that time the Incontinence Group published their first systematic review in The Cochrane Library. Since then, June has been a review author on a number of reviews for the Incontinence Group, and also led a review of tension free vaginal tape (TVT) commissioned by the National Institute for Clinical Excellence (NICE) in 2001.

June Cody represents the group of authors who collaborated on "Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women". The full author group is as follows: Joseph Ogah, June D Cody, Lynne Rogerson.

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