René P Schellart1, Sandra E Zwolsman2, Jean-Philippe Lucot3, Dirk J M K de Ridder4, Marcel G W Dijkgraaf5, Jan-Paul W R Roovers2. 1. Department of Obstetrics and Gynecology, Spaarne Gasthuis, Boerhaavelaan 22, 2035 RC, Haarlem, The Netherlands. rp.schellart@spaarnegasthuis.nl. 2. Department of Obstetrics and Gynecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands. 3. Department of Obstetrics and Gynecology, Jeanne de Flandre Hôpital, Lille Cedex, France. 4. Department of Urology, University Hospitals Leuven, Leuven, Belgium. 5. Clinical Research Unit, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.
Abstract
INTRODUCTION AND HYPOTHESIS: Midurethral sling procedures are the first surgical option in women undergoing surgery for stress urinary incontinence (SUI). Single-incision midurethral-slings (SIMS) were designed to provide similar efficacy to traditional midurethral slings but with reduced morbidity. In this international trial we compared the efficacy of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) in the treatment of SUI in terms of subjective and objective cure rates and morbidity over a long-term follow-up. METHODS: This was a randomized controlled nonblinded extended trial with a follow-up period of 36 months. Women with symptomatic SUI were eligible. The primary outcome was subjective cure, defined as an improvement in the Patient Global Impression of Improvement (PGI-I) score. Secondary outcomes were objective cure (negative cough stress test), disease-specific quality of life, surgical parameters and morbidity. An intention to treat analysis was performed. Differences in dichotomous variables were tested using the chi-squared test. Differences in continuous variables were tested using Student's t test or the Mann-Whitney U test. We hypothesized that MiniArc would be noninferior to Monarc concerning subjective cure. RESULTS: We randomized 97 women to the MiniArc group and 96 to the Monarc group. The attrition rate was 23% in the MiniArc group and 22% in the Monarc group after 3 years. At 36 months, the subjective cure rates were 86% in the MiniArc group and 87% in the Monarc group (risk difference -0.6%, 95% CI -12 to 11%). The objective cure rates were 89% and 88%, respectively (risk difference 1.3%, 95% CI -9 to 11%). Both procedures were associated with low complication rates. CONCLUSIONS: After a follow-up of 36 months, MiniArc (SIMS) is non-inferior to Monarc (SMUS) with respect to subjective and objective cure.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: Midurethral sling procedures are the first surgical option in women undergoing surgery for stress urinary incontinence (SUI). Single-incision midurethral-slings (SIMS) were designed to provide similar efficacy to traditional midurethral slings but with reduced morbidity. In this international trial we compared the efficacy of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) in the treatment of SUI in terms of subjective and objective cure rates and morbidity over a long-term follow-up. METHODS: This was a randomized controlled nonblinded extended trial with a follow-up period of 36 months. Women with symptomatic SUI were eligible. The primary outcome was subjective cure, defined as an improvement in the Patient Global Impression of Improvement (PGI-I) score. Secondary outcomes were objective cure (negative cough stress test), disease-specific quality of life, surgical parameters and morbidity. An intention to treat analysis was performed. Differences in dichotomous variables were tested using the chi-squared test. Differences in continuous variables were tested using Student's t test or the Mann-Whitney U test. We hypothesized that MiniArc would be noninferior to Monarc concerning subjective cure. RESULTS: We randomized 97 women to the MiniArc group and 96 to the Monarc group. The attrition rate was 23% in the MiniArc group and 22% in the Monarc group after 3 years. At 36 months, the subjective cure rates were 86% in the MiniArc group and 87% in the Monarc group (risk difference -0.6%, 95% CI -12 to 11%). The objective cure rates were 89% and 88%, respectively (risk difference 1.3%, 95% CI -9 to 11%). Both procedures were associated with low complication rates. CONCLUSIONS: After a follow-up of 36 months, MiniArc (SIMS) is non-inferior to Monarc (SMUS) with respect to subjective and objective cure.
Authors: R C Bump; A Mattiasson; K Bø; L P Brubaker; J O DeLancey; P Klarskov; B L Shull; A R Smith Journal: Am J Obstet Gynecol Date: 1996-07 Impact factor: 8.661
Authors: Piet Hinoul; Harry A M Vervest; Jan den Boon; Pieter L Venema; Marielle M Lakeman; Alfredo L Milani; Jan-Paul W R Roovers Journal: J Urol Date: 2011-02-22 Impact factor: 7.450
Authors: René P Schellart; Katrien Oude Rengerink; Frank Van der Aa; Jean-Philippe Lucot; Bart Kimpe; Marcel G W Dijkgraaf; Jan-Paul W R Roovers Journal: Int Urogynecol J Date: 2015-12-15 Impact factor: 2.894