title: Multicenter prospective randomized study of single-incision mini-sling vs tension-free vaginal tape-obturator in management of female stress urinary incontinence: a minimum of 1-year follow-up.
abstract: OBJECTIVE
  To compare an adjustable anchored single incision mini-sling (SIMS-Ajust) vs tension-free vaginal tape-obturator (TVT-O) in the management of female stress urinary incontinence (SUI) with a minimum of 1-year follow-up.
  
  
  METHODS
  We conducted a multicenter prospective randomized control trial (RCT) performed in 6 United Kingdom centers in the period between October 2009 and October 2011. Women were randomized to either SIMS-Ajust (C. R. Bard) performed under local anesthesia or TVT-O (Ethicon Inc.) performed under general anesthesia. Women completed validated symptom-severity and quality of life (QOL) questionnaires preoperatively and at 1 year. In addition, women completed the Patient Global Impression of Improvement (PGI-I) and underwent the Cough Stress Test (CST) at 1 year. The primary outcome at 12 months was the patient-reported success rate. Secondary outcomes included objective cure, reoperation rate, impact on women's urinary symptoms, QOL, and sexual function. Data was analyzed using SPSS-19 with significance level set at 5%.
  
  
  RESULTS
  One hundred thirty-seven women were randomized into 2 groups: the SIMS-Ajust group (n = 69) and the TVT-O group (n = 68). At 1 year, there were no significant differences in the patient-reported success rate (odds ratio [OR] 0.895, 95% confidence interval [CI] 0.344-2.330, P = 1.000), objectives success rate (OR 0.929, 95% CI 0.382-2.258, P = 1.00), and reoperation rates (OR 0.591, 95% CI 0.136-2.576, P = .721) between the SIMS-Ajust and the TVT-O groups, respectively. A comparable number of women reported cure/improvement of urgency (P = .658), significant improvement in QOL (P = .190), and sexual function (P = .699) in both groups.
  
  
  CONCLUSIONS
  Adjustable-anchored SIMS (Ajust) is associated with comparable patient-reported and objective success rates when compared to standard midurethral sling (SMUS, TVT-O) at a minimum of 1-year follow-up. The results should be interpreted with caution due to the relatively small cohort size. Long-term follow-up of this RCT is required to ascertain the durability of these results.
authors.affiliation: University of Aberdeen, Aberdeen, Scotland, UK.
authors.forename: Alyaa
authors.initials: A
authors.lastname: Mostafa
authors.forename: Wael
authors.initials: W
authors.lastname: Agur
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-All
authors.forename: Karen
authors.initials: K
authors.lastname: Guerrero
authors.forename: Chu
authors.initials: C
authors.lastname: Lim
authors.forename: Mohamed
authors.initials: M
authors.lastname: Allam
authors.forename: Mohamed
authors.initials: M
authors.lastname: Yousef
authors.forename: James
authors.initials: J
authors.lastname: N'Dow
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Fattah
mesh_terms: D000328:Adult; D016001:Confidence Intervals; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D016017:Odds Ratio; D011788:Quality of Life; D012086:Reoperation; D012720:Severity of Illness Index; D012725:Sexual Behavior; D018709:Statistics, Nonparametric; D053825:Suburethral Slings; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*