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A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up.
Int Urogynecol J. 2016 Jun; 27(6):871-7.IU

Abstract

INTRODUCTION AND HYPOTHESIS

Midurethral sling procedures have become the principal surgical treatment for women with stress urinary incontinence (SUI). The 1-year results of this international trial comparing the efficacy and morbidity of a single-incision midurethral sling (SIMS; MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) showed that MiniArc is non-inferior regarding subjective cure and superior with regard to postoperative pain and recovery. The objective was to compare subjective and objective cure, morbidity and surgery-related discomfort following SIMS and transobturator SMUS up to a 24-month follow-up.

METHODS

We carried out a non-blinded, randomised, controlled trial. Women with symptomatic SUI were eligible. Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I), at 12, 24 and 36 months. Secondary outcomes were objective cure based on the cough stress test, disease-specific quality of life questionnaires, surgical parameters and physical performance during recovery. Analysis was by intent to treat. Differences between the two groups regarding dichotomous variables were Chi-squared tested and presented as relative risks (RR) with corresponding 95 % confidence intervals.

RESULTS

We randomised 97 women to MiniArc and 96 to Monarc. At the 24-month follow-up, subjective cure was 84 % following MiniArc and 89 % following Monarc (RR -5; 95% CI -0.17 to 0.06). Objective cure was 93 % following MiniArc and 94 % following Monarc (RR -1; 95% CI -0.10 to 0.07). Both procedures have low complication rates.

CONCLUSIONS

At the 2-year follow-up, the non-prespecified analysis of this randomised trial showed that the MiniArc, a single-incision sling, had similar subjective and similar objective cure rates, although non-inferiority to Monarc for subjective cure could not be demonstrated.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Spaarne Gasthuis, Boerhaavelaan 22, 2035 RC, Haarlem, The Netherlands. schell@kg.nl.Department of Obstetrics and Gynecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.Department of Urology, University Hospitals Leuven, Leuven, Belgium.Department of Obstetrics and Gynecology, Jeanne de Flandre Hôpital, Lille Cedex, France.Department of Urology, General Hospital Sint Lucas, Bruges, 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)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26670576

Citation

Schellart, René P., et al. "A Randomised Comparison of Single-incision Versus Traditional Transobturator Midurethral Sling in Women With Stress Urinary Incontinence: Results of a 24-month Follow-up." International Urogynecology Journal, vol. 27, no. 6, 2016, pp. 871-7.
Schellart RP, Oude Rengerink K, Van der Aa F, et al. A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up. Int Urogynecol J. 2016;27(6):871-7.
Schellart, R. P., Oude Rengerink, K., Van der Aa, F., Lucot, J. P., Kimpe, B., Dijkgraaf, M. G., & Roovers, J. P. (2016). A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up. International Urogynecology Journal, 27(6), 871-7. https://doi.org/10.1007/s00192-015-2898-z
Schellart RP, et al. A Randomised Comparison of Single-incision Versus Traditional Transobturator Midurethral Sling in Women With Stress Urinary Incontinence: Results of a 24-month Follow-up. Int Urogynecol J. 2016;27(6):871-7. PubMed PMID: 26670576.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up. AU - Schellart,René P, AU - Oude Rengerink,Katrien, AU - Van der Aa,Frank, AU - Lucot,Jean-Philippe, AU - Kimpe,Bart, AU - Dijkgraaf,Marcel G W, AU - Roovers,Jan-Paul W R, Y1 - 2015/12/15/ PY - 2015/06/01/received PY - 2015/11/15/accepted PY - 2015/12/17/entrez PY - 2015/12/17/pubmed PY - 2017/8/31/medline KW - Disease-specific quality of life KW - Midurethral slings KW - Randomised controlled trial KW - Stress urinary incontinence KW - Surgery SP - 871 EP - 7 JF - International urogynecology journal JO - Int Urogynecol J VL - 27 IS - 6 N2 - INTRODUCTION AND HYPOTHESIS: Midurethral sling procedures have become the principal surgical treatment for women with stress urinary incontinence (SUI). The 1-year results of this international trial comparing the efficacy and morbidity of a single-incision midurethral sling (SIMS; MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) showed that MiniArc is non-inferior regarding subjective cure and superior with regard to postoperative pain and recovery. The objective was to compare subjective and objective cure, morbidity and surgery-related discomfort following SIMS and transobturator SMUS up to a 24-month follow-up. METHODS: We carried out a non-blinded, randomised, controlled trial. Women with symptomatic SUI were eligible. Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I), at 12, 24 and 36 months. Secondary outcomes were objective cure based on the cough stress test, disease-specific quality of life questionnaires, surgical parameters and physical performance during recovery. Analysis was by intent to treat. Differences between the two groups regarding dichotomous variables were Chi-squared tested and presented as relative risks (RR) with corresponding 95 % confidence intervals. RESULTS: We randomised 97 women to MiniArc and 96 to Monarc. At the 24-month follow-up, subjective cure was 84 % following MiniArc and 89 % following Monarc (RR -5; 95% CI -0.17 to 0.06). Objective cure was 93 % following MiniArc and 94 % following Monarc (RR -1; 95% CI -0.10 to 0.07). Both procedures have low complication rates. CONCLUSIONS: At the 2-year follow-up, the non-prespecified analysis of this randomised trial showed that the MiniArc, a single-incision sling, had similar subjective and similar objective cure rates, although non-inferiority to Monarc for subjective cure could not be demonstrated. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/26670576/A_randomised_comparison_of_single_incision_versus_traditional_transobturator_midurethral_sling_in_women_with_stress_urinary_incontinence:_results_of_a_24_month_follow_up_ L2 - https://dx.doi.org/10.1007/s00192-015-2898-z DB - PRIME DP - Unbound Medicine ER -