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A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence.
Int Urogynecol J. 2018 Jan; 29(1):37-44.IU

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.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Spaarne Gasthuis, Boerhaavelaan 22, 2035 RC, Haarlem, The Netherlands. rp.schellart@spaarnegasthuis.nl.Department of Obstetrics and Gynecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.Department of Obstetrics and Gynecology, Jeanne de Flandre Hôpital, Lille Cedex, France.Department of Urology, University Hospitals Leuven, Leuven, Belgium.Clinical Research Unit, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.Department of Obstetrics and Gynecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28577171

Citation

Schellart, René P., et al. "A Randomized, Nonblinded Extension Study of Single-incision Versus Transobturator Midurethral Sling in Women With Stress Urinary Incontinence." International Urogynecology Journal, vol. 29, no. 1, 2018, pp. 37-44.
Schellart RP, Zwolsman SE, Lucot JP, et al. A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence. Int Urogynecol J. 2018;29(1):37-44.
Schellart, R. P., Zwolsman, S. E., Lucot, J. P., de Ridder, D. J. M. K., Dijkgraaf, M. G. W., & Roovers, J. W. R. (2018). A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence. International Urogynecology Journal, 29(1), 37-44. https://doi.org/10.1007/s00192-017-3362-z
Schellart RP, et al. A Randomized, Nonblinded Extension Study of Single-incision Versus Transobturator Midurethral Sling in Women With Stress Urinary Incontinence. Int Urogynecol J. 2018;29(1):37-44. PubMed PMID: 28577171.
* Article titles in AMA citation format should be in sentence-case
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, Y1 - 2017/06/02/ PY - 2016/12/14/received PY - 2017/05/02/accepted PY - 2017/6/4/pubmed PY - 2018/9/8/medline PY - 2017/6/4/entrez KW - Midurethral sling KW - Patient-reported outcomes KW - Randomized controlled trial KW - Stress urinary incontinence surgery SP - 37 EP - 44 JF - International urogynecology journal JO - Int Urogynecol J VL - 29 IS - 1 N2 - 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. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/28577171/A_randomized_nonblinded_extension_study_of_single_incision_versus_transobturator_midurethral_sling_in_women_with_stress_urinary_incontinence_ L2 - https://dx.doi.org/10.1007/s00192-017-3362-z DB - PRIME DP - Unbound Medicine ER -