title: Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial.
abstract: OBJECTIVE
  To compare the efficacy of a single-incision mini-sling, placed in the "U" position, with tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence.
  
  
  METHODS
  Women with urodynamic stress incontinence with or without genital prolapse were randomized to receive a mini-sling or TVT (N=263). Those randomized to the mini-sling received two "sham" suprapubic incisions to facilitate blinding. The primary outcome was subjective cure (absence of any urinary incontinence or retreatment) as assessed at 1 year. This trial was a noninferiority study design.
  
  
  RESULTS
  Participants receiving the mini-sling were less likely to have a bladder injury (0.8% compared with 4.8%; P=.0.46), more likely to be discharged without a catheter (78.5% compared with 63%; P=.008), and had less pain for postoperative days 1-3. One year after surgery, the rate of cure was similar between treatment groups (mini-sling 55.8% compared with TVT 60.6%; mean difference, 4.8%; 95% confidence interval, -16.7 to +7.2); however, this did not meet our predefined noninferiority criteria of -12%. Incontinence severity at 1 year was greater with the mini-sling than with TVT (mean severity score ± SD: 2.2±2.7 compared with 1.5±1.9; P=.015), resulting predominantly from a higher proportion of participants with "severe" incontinence postoperatively (16% compared with 5%; P=.025).
  
  
  CONCLUSIONS
  The mini-sling placed in the "U" position results in similar subjective cure rates to TVT 1 year after surgery but postoperative incontinence severity is greater with the mini-sling than with TVT.
  
  
  METHODS
  I.
authors.affiliation: Cleveland Clinic, Cleveland, Ohio, USA. barberm2@ccf.org
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Barber
authors.forename: Alison C
authors.initials: AC
authors.lastname: Weidner
authors.forename: Andrew I
authors.initials: AI
authors.lastname: Sokol
authors.forename: Cindy L
authors.initials: CL
authors.lastname: Amundsen
authors.forename: J Eric
authors.initials: JE
authors.lastname: Jelovsek
authors.forename: Mickey M
authors.initials: MM
authors.lastname: Karram
authors.forename: Mark
authors.initials: M
authors.lastname: Ellerkmann
authors.forename: Charles R
authors.initials: CR
authors.lastname: Rardin
authors.forename: Cheryl B
authors.initials: CB
authors.lastname: Iglesia
authors.forename: Marc
authors.initials: M
authors.lastname: Toglia
mesh_terms: D000328:Adult; D000368:Aged; D016009:Chi-Square Distribution; D016001:Confidence Intervals; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D053825:Suburethral Slings / Q000009:adverse effects; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000293:injuries; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D014563:Urodynamics; D013520:Urologic Surgical Procedures / Q000379:methods*