Transvaginal prolapse repair with or without the addition of a midurethral sling in women with genital prolapse and stress urinary incontinence: a randomised trial

摘要

ObjectiveTo compare transvaginal prolapse repair combined with midurethral sling (MUS) versus prolapse repair only. DesignMulti-centre randomised trial. SettingFourteen teaching hospitals in the Netherlands. PopulationWomen with symptomatic stage two or greater pelvic organ prolapse (POP), and subjective or objective stress urinary incontinence (SUI) without prolapse reduction. MethodsWomen were randomly assigned to undergo vaginal prolapse repair with or without MUS. Analysis was according to intention to treat. Main outcome measuresThe primary outcome at 12months' follow-up was the absence of urinary incontinence (UI) assessed with the Urogenital Distress Inventory and treatment for SUI or overactive bladder. Secondary outcomes included complications. ResultsOne hundred and thirty-four women were analysed at 12months' follow-up (63 in MUS and 71 in control group). More women in the MUS group reported the absence of UI and SUI; respectively 62% versus 30% UI (relative risk [RR] 2.09; 95% confidence interval [CI] 1.39-3.15) and 78% versus 39% SUI (RR 1.97; 95% CI 1.44-2.71). Fewer women underwent treatment for postoperative SUI in the MUS group (10% versus 37%; RR 0.26; 95% CI 0.11-0.59). In the control group, 12 women (17%) underwent MUS after prolapse surgery versus none in the MUS group. Severe complications were more common in the MUS group, but the difference was not statistically significant (16% versus 6%; RR 2.82; 95% CI 0.93-8.54). ConclusionsWomen with prolapse and co-existing SUI are less likely to have SUI after transvaginal prolapse repair with MUS compared with prolapse repair only. However, only 17% of the women undergoing POP surgery needed additional MUS. A well-informed decision balancing risks and benefits of both strategies should be tailored to individual women.