title: Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial.
abstract: OBJECTIVE
  We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI).
  
  
  METHODS
  This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King's Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by >15 %. Statistical significance was fixed at 5 % (p < 0.05).
  
  
  RESULTS
  Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) -15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI -11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain (p < 0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups (p < 0.001).
  
  
  CONCLUSIONS
  TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.
authors.affiliation: Sector of Urogynecology and Vaginal Surgery, Department of Gynecology, Federal University of São Paulo, Alameda Jaú 759, apt 71, São Paulo, SP, Brazil, 01420-001. anamariahmb@yahoo.com.br
authors.forename: Ana Maria H M
authors.initials: AM
authors.lastname: Bianchi-Ferraro
authors.forename: Zsuzsanna I K
authors.initials: ZI
authors.lastname: Jarmy-Di Bella
authors.forename: Rodrigo de A
authors.initials: Rde A
authors.lastname: Castro
authors.forename: Maria Augusta T
authors.initials: MA
authors.lastname: Bortolini
authors.forename: Marair G F
authors.initials: MG
authors.lastname: Sartori
authors.forename: Manoel J B C
authors.initials: MJ
authors.lastname: Girão
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D053825:Suburethral Slings / Q000145:classification*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000601:surgery*; D014563:Urodynamics / Q000502:physiology