TY - JOUR
T1 - A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence
AU - Schellart, René P.
AU - Zwolsman, Sandra E.
AU - Lucot, Jean-Philippe
AU - de Ridder, Dirk J. M. K.
AU - Dijkgraaf, Marcel G. W.
AU - Roovers, Jan-Paul W. R.
PY - 2018
Y1 - 2018
N2 - 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. 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. 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. After a follow-up of 36 months, MiniArc (SIMS) is non-inferior to Monarc (SMUS) with respect to subjective and objective cure
AB - 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. 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. 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. After a follow-up of 36 months, MiniArc (SIMS) is non-inferior to Monarc (SMUS) with respect to subjective and objective cure
U2 - https://doi.org/10.1007/s00192-017-3362-z
DO - https://doi.org/10.1007/s00192-017-3362-z
M3 - Article
C2 - 28577171
SN - 0937-3462
VL - 29
SP - 37
EP - 44
JO - International urogynecology journal and pelvic floor dysfunction
JF - International urogynecology journal and pelvic floor dysfunction
IS - 1
ER -