Abstract

Abstract Background

Urinary incontinence is a common and potentially debilitating problem. Stress urinary, incontinence as the most common type of incontinence, imposes significant health and economic burdens on society and the women affected. Open retropubic colposuspension is a surgical treatment which involves lifting the tissues near the bladder neck and proximal urethra in the area behind the anterior pubic bones to correct deficient urethral closure to correct stress urinary incontinence.

The review aimed to determine the effects of open retropubic colposuspension for the treatment of urinary incontinence in women. A secondary aim was to assess the safety of open retropubic colposuspension in terms of adverse events caused by the procedure.

We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 5 May 2015), and the reference lists of relevant articles. We contacted investigators to locate extra studies.

Randomised or quasi‐randomised controlled trials in women with symptoms or urodynamic diagnoses of stress or mixed urinary incontinence that included open retropubic colposuspension surgery in at least one trial group.

Studies were evaluated for methodological quality or susceptibility to bias and appropriateness for inclusion and data extracted by two of the review authors. Trial data were analysed by intervention. Where appropriate, a summary statistic was calculated.

This review included 55 trials involving a total of 5417 women.

Overall cure rates were 68.9% to 88.0% for open retropubic colposuspension. Two small studies suggested lower incontinence rates after open retropubic colposuspension compared with conservative treatment. Similarly, one trial suggested lower incontinence rates after open retropubic colposuspension compared to anticholinergic treatment. Evidence from six trials showed a lower incontinence rate after open retropubic colposuspension than after anterior colporrhaphy. Such benefit was maintained over time (risk ratio (RR) for incontinence 0.46; 95% CI 0.30 to 0.72 before the first year, RR 0.37; 95% CI 0.27 to 0.51 at one to five years, RR 0.49; 95% CI 0.32 to 0.75 in periods beyond five years).

Evidence from 22 trials in comparison with suburethral slings (traditional slings or trans‐vaginal tape or transobturator tape) found no overall significant difference in incontinence rates in all time periods evaluated (as assessed subjectively RR 0.90; 95% CI 0.69 to 1.18, within one year of treatment, RR 1.18; 95%CI 1.01 to 1.39 between one and five years, RR 1.11; 95% CI 0.97 to 1.27 at five years and more, and as assessed objectively RR 1.24; 95% CI 0.93 to 1.67 within one year of treatment, RR 1.12; 95% CI 0.82 to 1.54 for one to five years follow up, RR 0.70; 95% CI 0.30 to 1.64 at more than five years). However, subgroup analysis of studies comparing traditional slings and open colposuspension showed better effectiveness with traditional slings in the medium and long term (RR 1.35; 95% CI 1.11 to 1.64 from one to five years follow up, RR 1.19; 95% CI 1.03 to 1.37).

In comparison with needle suspension, there was a lower incontinence rate after colposuspension in the first year after surgery (RR 0.66; 95% CI 0.42 to 1.03), after the first year (RR 0.56; 95% CI 0.39 to 0.81), and beyond five years (RR 0.32; 95% CI 15 to 0.71).

Patient‐reported incontinence rates at short, medium and long‐term follow‐up showed no significant differences between open and laparoscopic retropubic colposuspension, but with wide confidence intervals. In two trials incontinence was less common after the Burch (RR 0.38; 95% CI 0.18 to 0.76) than after the Marshall Marchetti Krantz procedure at one to five year follow‐up. There were few data at any other follow‐up times.

In general, the evidence available does not show a higher morbidity or complication rate with open retropubic colposuspension compared to the other open surgical techniques, although pelvic organ prolapse is more common than after anterior colporrhaphy and sling procedures. Voiding problems are also more common after sling procedures compared to open colposuspension.

Open retropubic colposuspension is an effective treatment modality for stress urinary incontinence especially in the long term. Within the first year of treatment, the overall continence rate is approximately 85% to 90%. After five years, approximately 70% of women can expect to be dry. Newer minimal access sling procedures look promising in comparison with open colposuspension but their long‐term performance is limited and closer monitoring of their adverse event profile must be carried out. Open colposuspension is associated with a higher risk of pelvic organ prolapse compared to sling operations and anterior colporrhaphy, but with a lower risk of voiding dysfunction compared to traditional sling surgery. Laparoscopic colposuspension should allow speedier recovery but its relative safety and long‐term effectiveness is not yet known. A Brief Economic Commentary (BEC) identified five studies suggesting that tension‐free vaginal tape (TVT) and laparoscopic colposuspension may be more cost‐effective compared with open retropubic colposuspension.

Author(s)

Marie Carmela M Lapitan, June D Cody, Atefeh Mashayekhi

Abstract

Plain language summary

Open retropubic colposuspension for urinary incontinence in women

Stress urinary incontinence is losing urine when coughing, laughing, sneezing or exercising. It can be caused by changes to muscles and ligaments holding up the bladder. Mixed urinary incontinence is also losing urine when there is an urge to void as well as when coughing and laughing. Muscle‐strengthening exercises can help, and there are surgical procedures to improve support or correct problems. A significant amount of a woman's and their family's income can be spent on management of stress urinary incontinence. Open retropubic colposuspension is an operation which involves lifting the tissues around the junction between the bladder and the urethra.

The review of trials found that this is an effective surgical technique for stress and mixed urinary incontinence in women, resulting in long‐term cure for most women. It provides better cure rates compared to anterior colporrhaphy a (suturing of the top wall of the vagina) and needle suspension surgery (passing a needle with sutures at the sides of the urethra to lift up the tissues beside it).New techniques, particularly sling operations (including the use of tapes to lift up the urethra)and keyhole (laparoscopic) colposuspension, look promising but need further research particularly on long‐term performance. Procedures involving surgery to insert a tape under the urethra showed better cure rates in the medium and long term, compared to open colposuspension. In terms of costs, a non‐systematic review of economic studies suggested that open retropubic colposuspension would be cheaper than laparoscopic colposuspension, but more expensive than tension‐free vaginal tape (TVT).

Laparoscopic colposuspension allows for faster recovery compared to open colposuspension. Studies did not reveal a higher complication rate with open colposuspension compared with the other surgical techniques, although pelvic organ prolapse was found to be more common. Abnormal voiding was less common after open colposuspension compared to sling surgery.

Limited information was available on the long term adverse events of open colposuspension and its effect on the quality of life.

Author(s)

Marie Carmela M Lapitan, June D Cody, Atefeh Mashayekhi

Reviewer's Conclusions

Authors' conclusions

Implications for practice

1. The evidence available indicates that open retropubic colposuspension is an effective treatment for stress urinary incontinence, especially in the long term. Within the first year of treatment, the overall continence rate is approximately 85% to 90%. After five years, approximately 80% of women can expect to be dry. The review showed better cure and improvement rates after open retropubic colposuspension compared to conservative management, anterior colporrhaphy, and needle suspension surgery without any significant increase in morbidity. Therefore, retropubic colposuspension could be offered to women seeking open surgical treatment for urinary incontinence.

2. The minimally invasive sling procedures confer similar success rates in comparison to open colposuspension. However, traditional slings provide better cure rates at the expense of more voiding dysfunction in the short term. The long‐term adverse event profile of the sling procedures, in particular with the use of the TVT, is still unclear.

3. Laparoscopic colposuspension should allow speedier recovery, and available evidence shows comparable effectiveness with open surgery.

4. In general, the evidence available does not show a higher morbidity or complication rate with open retropubic colposuspension compared to the other surgical techniques, as has often been claimed. However, we found greater risk for post‐operative pelvic organ prolapse after open colposuspension, when compared with anterior colporrhaphy and sling procedures.

5. The available evidence suggests that the Burch procedure should be the preferred technique for open colposuspension. The Burch colposuspension provides better cure rates compared to the Marshall‐Marchetti‐Krantz procedure. There was no evidence on paravaginal repair.

Implications for research

1. The methodology of the trials in the review could have been more scientifically valid. Future trials of incontinence surgery should have a well‐described sequence generation and secure concealment of allocation, standardised procedures with minimal co‐interventions and confounders, larger sample sizes to provide sufficiently precise estimates of effects, proper blinding, and longer follow‐up of all women randomised irrespective of the treatment actually received, intention‐to‐treat analyses, and detailed accounts of dropouts and withdrawals with explicit description of handling attrition.

It was not clear whether the methodological limitations in the trials reviewed were actual study design errors or poor reporting. It is highly recommended that clinical trials should be reported following the CONSORT guidelines (Schulz 2010).

2. There is an urgent need for further trials of adequate power to assess the effectiveness, safety and cost‐effectiveness of open retropubic colposuspension in comparison with (a) suburethral slings, using both traditional and minimally invasive approaches, and (b) the laparoscopic technique. In addition, the long‐term outcomes of existing trials could and should be reported: this would be a cost‐effective way of providing the information that is most important to women, i.e. for how long the operations remain effective, and at what cost in terms of adverse effects or the need for further treatment for urinary incontinence, prolapse or adverse effects.

Future trials should be designed in ways that allow exploration of effects in specific subgroups of women characterised by prognostic factors, and potential confounding by these factors. These include previous anti‐incontinence surgery, co‐existing prolapse, mixed incontinence, and low maximal urethral closure pressure (MUCP) or leak point pressures, or suspicion of having a significant component of intrinsic sphincter deficiency.

3. Future research on surgical treatment of urinary incontinence must provide more information on long‐term outcomes, particularly on adverse events and quality of life.