1. Transvaginal prolapse repair with or without the addition of a midurethral sling in women with genital prolapse and stress urinary incontinence : a randomised trial
- Author
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van der Ploeg, J M, Oude Rengerink, K, van der Steen, A, van Leeuwen, J H S, Stekelenburg, J, Bongers, M Y, Weemhoff, M, Mol, B W, van der Vaart, C H, Roovers, J-P W R, and Dutch Urogynaecology Consortium
- Subjects
Questionnaires ,Suburethral Slings ,Urinary Bladder, Overactive ,Urinary Incontinence, Stress ,Research Support, Non-U.S. Gov't ,Middle Aged ,Midurethral sling ,stress urinary incontinence ,Pelvic Organ Prolapse ,Multicenter Study ,Gynecologic Surgical Procedures ,Treatment Outcome ,Randomized Controlled Trial ,Journal Article ,Humans ,Female ,randomised ,Aged ,Netherlands - Abstract
OBJECTIVE: To compare transvaginal prolapse repair combined with midurethral sling (MUS) versus prolapse repair only. DESIGN: Multi-centre randomised trial. SETTING: Fourteen teaching hospitals in the Netherlands. POPULATION: Women with symptomatic stage two or greater pelvic organ prolapse (POP), and subjective or objective stress urinary incontinence (SUI) without prolapse reduction. METHODS: Women were randomly assigned to undergo vaginal prolapse repair with or without MUS. Analysis was according to intention to treat. MAIN OUTCOME MEASURES: The primary outcome at 12 months' 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. RESULTS: One hundred and thirty-four women were analysed at 12 months' 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). CONCLUSIONS: Women 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.
- Published
- 2015