title: 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.
  
  
  METHODS
  Multi-centre randomised trial.
  
  
  METHODS
  Fourteen teaching hospitals in the Netherlands.
  
  
  METHODS
  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.
  
  
  METHODS
  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.affiliation: Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, the Netherlands.
authors.forename: J M
authors.initials: JM
authors.lastname: van der Ploeg
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: K
authors.initials: K
authors.lastname: Oude Rengerink
authors.affiliation: Department of Obstetrics and Gynaecology, Zorggroep Twente, Hengelo, the Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: van der Steen
authors.affiliation: Department of Obstetrics and Gynaecology, St. Antonius Hospital, Nieuwegein, the Netherlands.
authors.forename: J H S
authors.initials: JH
authors.lastname: van Leeuwen
authors.affiliation: Department of Obstetrics and Gynaecology, Leeuwarden Medical Centre, Leeuwarden, the Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Stekelenburg
authors.affiliation: Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, the Netherlands.
authors.forename: M Y
authors.initials: MY
authors.lastname: Bongers
authors.affiliation: Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Weemhoff
authors.affiliation: School of Pediatrics and Reproductive Health, The Robinson Institute, University of Adelaide, Adelaide, SA, Australia.
authors.forename: B W
authors.initials: BW
authors.lastname: Mol
authors.affiliation: Department of Gynaecology and Reproductive Medicine, University Medical Centre Utrecht, Utrecht, the Netherlands.
authors.forename: C H
authors.initials: CH
authors.lastname: van der Vaart
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: J-P W R
authors.initials: JP
authors.lastname: Roovers
mesh_terms: D000368:Aged; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D009426:Netherlands; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D053825:Suburethral Slings / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000517:prevention & control; D014550:Urinary Incontinence, Stress / Q000601:surgery*
keywords: Midurethral sling; pelvic organ prolapse; randomised; stress urinary incontinence