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

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.

• Authors: J M van der Ploeg, K Oude Rengerink, A van der Steen, J H S van Leeuwen, J Stekelenburg, M Y Bongers, M Weemhoff, B W Mol, C H van der Vaart, J-P W R Roovers, Dutch Urogynaecology Consortium
• Journal: BJOG : an international journal of obstetrics and gynaecology (BJOG) Vol. 122 Issue 7 Pg. 1022-30 (Jun 2015) ISSN: 1471-0528 [Electronic] England
• PMID: 25754458 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 Royal College of Obstetricians and Gynaecologists.

Topics

• Aged
• Female
• Gynecologic Surgical Procedures (methods)
• Humans
• Middle Aged
• Netherlands
• Pelvic Organ Prolapse (surgery)
• Suburethral Slings (statistics & numerical data)
• Surveys and Questionnaires
• Treatment Outcome
• Urinary Bladder, Overactive (prevention & control)
• Urinary Incontinence, Stress (surgery)