J M van der Ploeg1, K Oude Rengerink2, A van der Steen3, J H S van Leeuwen4, J Stekelenburg5, M Y Bongers6, M Weemhoff7, B W Mol8, C H van der Vaart9, J-P W R Roovers2. 1. Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, the Netherlands. 2. Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands. 3. Department of Obstetrics and Gynaecology, Zorggroep Twente, Hengelo, the Netherlands. 4. Department of Obstetrics and Gynaecology, St. Antonius Hospital, Nieuwegein, the Netherlands. 5. Department of Obstetrics and Gynaecology, Leeuwarden Medical Centre, Leeuwarden, the Netherlands. 6. Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, the Netherlands. 7. Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, the Netherlands. 8. School of Pediatrics and Reproductive Health, The Robinson Institute, University of Adelaide, Adelaide, SA, Australia. 9. Department of Gynaecology and Reproductive Medicine, University Medical Centre Utrecht, Utrecht, the 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.
RCT Entities:
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: Jordi Sabadell; Sabina Salicrú; Anabel Montero-Armengol; Núria Rodriguez-Mias; Antonio Gil-Moreno; Jose L Poza Journal: Int Urogynecol J Date: 2018-11-15 Impact factor: 2.894
Authors: J Marinus van der Ploeg; Katrien Oude Rengerink; Annemarie van der Steen; Jules H Schagen van Leeuwen; C Huub van der Vaart; Jan-Paul W R Roovers Journal: Int Urogynecol J Date: 2016-01-06 Impact factor: 2.894
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