title: Randomised prospective single-blinded study comparing 'inside-out' versus 'outside-in' transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study.
abstract: OBJECTIVE
  To compare the 'inside-out' versus 'outside-in' routes for transobturator tape insertion for urodynamic stress incontinence, and to identify independent risk factors for failure at 1 year.
  
  
  METHODS
  Prospective single-blinded randomised trial.
  
  
  METHODS
  Tertiary urogynaecology centre.
  
  
  METHODS
  A cohort of 341 women undergoing transobturator tape procedures between April 2005 and April 2007.
  
  
  METHODS
  Women were randomised to tension-free vaginal tape-obturator (TVT)-O for the 'inside-out' route (n = 170) and transobturator tape (TOT)-ARIS for the 'outside-in' route (n = 171). Participants completed validated symptom-severity, quality-of-life and sexual-function questionnaires before and after surgery. In addition, they completed the patient global impression of improvement questionnaire (PGI-I) and standard 1-hour pad test postoperatively.
  
  
  METHODS
  The primary outcome was the patient-reported success rate reported on the PGI-I scale. Secondary outcomes included objective cure rate and improvement in King's Health Questionnaire scores.
  
  
  RESULTS
  A total of 341 women were recruited: 171 women to the 'outside-in' (TOT-ARIS) group and 170 to the 'inside-out' (TVT-O) group; 299 completed the 1-year follow up. The patient-reported success rate was 80% with no statistically significant differences between the groups ('outside-in' 77.6% versus 'inside-out' 81.2%; OR 1.25; 95% CI 0.71, 2.20; P = 0.54). The objective cure rate was 91% with no statistically significant difference between the groups ('outside-in' 88% versus 'inside-out' 94%; OR 2.21; 95% CI 0.85, 5.75; P = 0.157). Previous incontinence surgery (OR 1.41; 95% CI 1.18, 1.91; P = 0.029) and preoperative urgency incontinence (OR 1.78; 95% CI 1.21, 3.91, P = 0.048) were significant risk factors for failure of transobturator tape at the 1-year follow up.
  
  
  CONCLUSIONS
  There are no significant differences in patient reported and objective cure rates between 'inside-out' and 'outside-in' transobturator tapes. Quality of life and sexual function significantly improved following surgery. Both previous incontinence surgery and preoperative urgency incontinence are associated with significantly lower patient-reported cure rates.
authors.affiliation: Division of Applied Health Science, University of Aberdeen, Aberdeen, UK. m.abdelfattah@abdn.ac.uk
authors.forename: M
authors.initials: M
authors.lastname: Abdel-Fattah
authors.forename: I
authors.initials: I
authors.lastname: Ramsay
authors.forename: S
authors.initials: S
authors.lastname: Pringle
authors.forename: C
authors.initials: C
authors.lastname: Hardwick
authors.forename: H
authors.initials: H
authors.lastname: Ali
authors.forename: D
authors.initials: D
authors.lastname: Young
authors.forename: A
authors.initials: A
authors.lastname: Mostafa
mesh_terms: D005260:Female; D006801:Humans; D007431:Intraoperative Complications / Q000209:etiology; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012307:Risk Factors; D012735:Sexual Dysfunction, Physiological / Q000209:etiology; D016037:Single-Blind Method; D053825:Suburethral Slings; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*