René P Schellart1, Katrien Oude Rengerink2, Frank Van der Aa3, Jean-Philippe Lucot4, Bart Kimpe5, Dirk J M K de Ridder3, Marcel G W Dijkgraaf6, Jan-Paul W R Roovers2. 1. Department of Obstetrics and Gynecology, Kennemer Gasthuis, Haarlem, The Netherlands. Electronic address: schell@kg.nl. 2. Department of Obstetrics and Gynecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands. 3. Department of Urology, University Hospitals Leuven, Leuven, Belgium. 4. Department of Obstetrics and Gynecology, Jeanne de Flandre Hôpital, Lille Cedex, France. 5. Department of Urology, General Hospital Sint Lucas, Bruges, Belgium. 6. Clinical Research Unit, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.
Abstract
BACKGROUND:Midurethral sling procedures have become the prime surgical treatment for women with stress urinary incontinence (SUI). Single-incision mini-slings (SIMS) potentially offer similar efficacy with reduced morbidity. This international multicenter trial compared the efficacy and morbidity of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS) (Monarc). OBJECTIVE: To compare subjective and objective cure, morbidity, and surgery-related discomfort following SIMS and transobturator SMUS. DESIGN, SETTING, AND PARTICIPANTS: Prospective randomized controlled trial with an initial follow-up period of 12 mo. Women with symptomatic SUI were eligible. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I). Coprimary outcome was the mean visual analog scale (VAS) pain score (0-100) during 3 d after surgery. Secondary outcomes were objective cure based on the cough stress test (CST), disease-specific quality of life determined by the Urogenital Distress Inventory (UDI-6) score, surgical parameters, and physical performance during recovery. Analysis was by intent to treat. Differences between the MiniArc and Monarc groups on dichotomous variables were chi-square tested and presented as relative risks (RR) with corresponding 95% confidence intervals. We hypothesized that MiniArc was noninferior to Monarc concerning subjective cure and superior concerning postoperative pain. RESULTS AND LIMITATIONS: We randomized 97 women to MiniArc and 96 to Monarc. At 12-mo follow-up, subjective cure was 83% following MiniArc and 86% following Monarc (p=0.46). Objective cure was 89% following MiniArc and 91% following Monarc (p=0.65). The mean painVAS score during the first three postoperative days was 9 following MiniArc and 22 following Monarc (Mann-Whitney U test, p<0.01). CONCLUSIONS: At 1-yr follow-up, MiniArc was noninferior to Monarc with respect to subjective and objective cure and superior with respect to postoperative pain. PATIENT SUMMARY: This 1-yr randomized clinical trial showed that MiniArc, a single-incision midurethral sling, is noninferior to Monarc, a transobturator sling, with respect to cure and superior with respect to pain and recovery.
RCT Entities:
BACKGROUND: Midurethral sling procedures have become the prime surgical treatment for women with stress urinary incontinence (SUI). Single-incision mini-slings (SIMS) potentially offer similar efficacy with reduced morbidity. This international multicenter trial compared the efficacy and morbidity of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS) (Monarc). OBJECTIVE: To compare subjective and objective cure, morbidity, and surgery-related discomfort following SIMS and transobturator SMUS. DESIGN, SETTING, AND PARTICIPANTS: Prospective randomized controlled trial with an initial follow-up period of 12 mo. Women with symptomatic SUI were eligible. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I). Coprimary outcome was the mean visual analog scale (VAS) pain score (0-100) during 3 d after surgery. Secondary outcomes were objective cure based on the cough stress test (CST), disease-specific quality of life determined by the Urogenital Distress Inventory (UDI-6) score, surgical parameters, and physical performance during recovery. Analysis was by intent to treat. Differences between the MiniArc and Monarc groups on dichotomous variables were chi-square tested and presented as relative risks (RR) with corresponding 95% confidence intervals. We hypothesized that MiniArc was noninferior to Monarc concerning subjective cure and superior concerning postoperative pain. RESULTS AND LIMITATIONS: We randomized 97 women to MiniArc and 96 to Monarc. At 12-mo follow-up, subjective cure was 83% following MiniArc and 86% following Monarc (p=0.46). Objective cure was 89% following MiniArc and 91% following Monarc (p=0.65). The mean pain VAS score during the first three postoperative days was 9 following MiniArc and 22 following Monarc (Mann-Whitney U test, p<0.01). CONCLUSIONS: At 1-yr follow-up, MiniArc was noninferior to Monarc with respect to subjective and objective cure and superior with respect to postoperative pain. PATIENT SUMMARY: This 1-yr randomized clinical trial showed that MiniArc, a single-incision midurethral sling, is noninferior to Monarc, a transobturator sling, with respect to cure and superior with respect to pain and recovery.
Authors: René P Schellart; Sandra E Zwolsman; Jean-Philippe Lucot; Dirk J M K de Ridder; Marcel G W Dijkgraaf; Jan-Paul W R Roovers Journal: Int Urogynecol J Date: 2017-06-02 Impact factor: 2.894
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