title: Prospective randomised controlled trial of transobturator tapes in management of urodynamic stress incontinence in women: 3-year outcomes from the Evaluation of Transobturator Tapes study.
abstract: BACKGROUND
  There is a lack of information on the long-term outcomes of transobturator tension-free vaginal tape (TO-TVT) in the surgical treatment of female stress urinary incontinence (SUI).
  
  
  OBJECTIVE
  To assess the 3-yr outcomes following TO-TVT and to compare the effectiveness of inside-out versus outside-in approaches.
  
  
  METHODS
  A 3-yr follow-up study of the Evaluation of Transobturator Tapes (E-TOT) trial, a randomised controlled trial (RCT) conducted with women undergoing TO-TVT as a sole procedure between April 2005 and April 2007 in a tertiary urogynaecology centre in the United Kingdom.
  
  
  METHODS
  Patients (n=341) were randomised to undergo either TVT-O (Ethicon Inc., Somerville, NJ, USA) for the inside-out approach or TOT-Aris (Coloplast Corp., Minneapolis, MN, USA) for the outside-in approach.
  
  
  METHODS
  The primary outcome was patient-reported success rate. Secondary outcomes included further treatment for SUI, improvement in quality of life, late complications, and risk factors for late failures. Categorical variables were compared using the chi-square or Fisher exact test. Within-group comparison was undertaken using Wilcoxon and Mann-Whitney tests. Risk factors for late failures were assessed in a multivariate regression model. All statistical analysis was performed using SPSS v.18.0 (IBM Corp., Armonk, NY, USA).
  
  
  CONCLUSIONS
  The 3-yr follow-up was completed by 238 of the 341 women (70%). The overall success rate, based on Patient's Global Impression of Improvement response, was 73.1%, with no significant difference between the inside-out and the outside-in TO-TVT (73.18% vs 72.3%; odds ratio: 0.927; 95% confidence interval, 0.552-1.645; p=0.796). Compared with the 1-yr follow-up, there was a significant reduction in the patient-reported success rate (p=0.005); however, no independent risk factors were identified. A clinically significant improvement (≥10 points) was seen in 80% (n=191) of women, with no significant difference between both groups (p=0.113). Twenty-two women (6%) underwent further surgical treatment within 3 yr. The lack of an objective outcome assessment is a potential limitation of this RCT.
  
  
  CONCLUSIONS
  The E-TOT RCT showed a 73% patient-reported success rate for TO-TVT at 3-yr follow-up, with no significant differences between inside-out and outside-in approaches. There was a significant drop in patient-reported success rates between 1 and 3 yr.
authors.affiliation: Division of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, UK. m.abdelfattah@abdn.ac.uk
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Fattah
authors.forename: Alyaa
authors.initials: A
authors.lastname: Mostafa
authors.forename: Akinbowale
authors.initials: A
authors.lastname: Familusi
authors.forename: Ian
authors.initials: I
authors.lastname: Ramsay
authors.forename: James
authors.initials: J
authors.lastname: N'dow
mesh_terms: D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D016015:Logistic Models; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011183:Postoperative Complications / Q000209:etiology / Q000601:surgery; D011446:Prospective Studies; D011788:Quality of Life; D012086:Reoperation; D018570:Risk Assessment; D012307:Risk Factors; D012606:Scotland; D016037:Single-Blind Method; D053825:Suburethral Slings; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000503:physiopathology / Q000601:surgery*; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000523:psychology / Q000601:surgery*; D014563:Urodynamics; D013520:Urologic Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods