title: A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up.
abstract: OBJECTIVE
  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.affiliation: Department of Obstetrics and Gynecology, Spaarne Gasthuis, Boerhaavelaan 22, 2035 RC, Haarlem, The Netherlands. schell@kg.nl.
authors.forename: René P
authors.identifier: http://orcid.org/0000-0003-3060-9223
authors.initials: RP
authors.lastname: Schellart
authors.affiliation: Department of Obstetrics and Gynecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.
authors.forename: Katrien
authors.initials: K
authors.lastname: Oude Rengerink
authors.affiliation: Department of Urology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Frank
authors.initials: F
authors.lastname: Van der Aa
authors.affiliation: Department of Obstetrics and Gynecology, Jeanne de Flandre Hôpital, Lille Cedex, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Lucot
authors.affiliation: Department of Urology, General Hospital Sint Lucas, Bruges, Belgium.
authors.forename: Bart
authors.initials: B
authors.lastname: Kimpe
authors.affiliation: Clinical Research Unit, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.
authors.forename: Marcel G W
authors.initials: MG
authors.lastname: Dijkgraaf
authors.affiliation: Department of Obstetrics and Gynecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.
authors.forename: Jan-Paul W R
authors.initials: JP
authors.lastname: Roovers
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D053825:Suburethral Slings / Q000009:adverse effects* / Q000706:statistics & numerical data; D014550:Urinary Incontinence, Stress / Q000601:surgery*
keywords: Disease-specific quality of life; Midurethral slings; Randomised controlled trial; Stress urinary incontinence; Surgery