title: Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial.
abstract: OBJECTIVE
  In a randomised trial comparing transobturator tape (TOT) to retropubic tension-free vaginal tape (TVT) for women with stress urinary incontinence (SUI), vaginal examination at 12 months showed that tapes were palpable for 80.0 % of the TOT group versus 26.7 % of the TVT group. We hypothesized that this difference would lead to more women in the TOT group experiencing vaginal mesh erosion or other serious adverse events compared to women in the TVT group 5 years after surgery.
  
  
  METHODS
  All participants were invited to join the follow-up study after being randomised to receive TOT or TVT for SUI. Consenting women had a vaginal examination, a pad test for urinary incontinence (UI) and completed Health-related Quality of Life Questionnaires (HRQOL). Women unable to attend the clinic completed questionnaires only. The primary composite outcome incorporated mesh exposure, urinary retention, repeat incontinence surgery and moderate to severe pelvic pain. Assuming 80 % follow-up, our study would have 67 % power to detect a difference in primary outcome (two-sided 5 % level of significance). Comparisons between groups used chi-square tests and t tests.
  
  
  RESULTS
  One hundred and seventy-six (88.4 %) women participated in the 5-year follow-up (83 TOT, 93 TVT). The primary composite outcome occurred in 21.8 % of the TOT and 27.6 % of the TVT groups [difference =-5.8 %, 95 % confidence interval (CI) -18.9 % to 7.3 %, p value 0.39)] Vaginal examination found more women with palpable tapes in the TOT versus the TVT group (48.5 % versus 22.4 %, p value 0.001). There were no other significant differences between groups.
  
  
  CONCLUSIONS
  Serious adverse events and tape effectiveness did not differ between groups at 5 years. Palpable tape remains a concern for women who receive TOT for treating SUI.
authors.affiliation: Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada. sue.ross@albertahealthservices.ca.|Department of Obstetrics and Gynecology, University of Alberta, 5S141 Lois Hole Hospital for Women, Robbins Pavilion, Royal Alexandra Hospital, 10240 Kingsway Avenue NW, Edmonton, Alberta, T5H 3V9, Canada. sue.ross@albertahealthservices.ca.
authors.forename: Sue
authors.identifier: http://orcid.org/0000-0002-0600-4833
authors.initials: S
authors.lastname: Ross
authors.affiliation: Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.
authors.forename: Selphee
authors.initials: S
authors.lastname: Tang
authors.affiliation: Department of Public Health and Community Medicine, Tufts University - School of Medicine, Boston, MA, 02111, USA.
authors.forename: Misha
authors.initials: M
authors.lastname: Eliasziw
authors.affiliation: Institute of Health Economics, Edmonton, T6G 2R3, Canada.
authors.forename: Doug
authors.initials: D
authors.lastname: Lier
authors.affiliation: Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Girard
authors.affiliation: Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.
authors.forename: Erin
authors.initials: E
authors.lastname: Brennand
authors.affiliation: Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.
authors.forename: Lorel
authors.initials: L
authors.lastname: Dederer
authors.affiliation: Department of Medicine, University of Alberta, Edmonton, T6G 2R3, Canada.
authors.forename: Philip
authors.initials: P
authors.lastname: Jacobs
authors.affiliation: Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.
authors.forename: Magali
authors.initials: M
authors.lastname: Robert
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D008875:Middle Aged; D053825:Suburethral Slings / Q000009:adverse effects* / Q000706:statistics & numerical data; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*
keywords: Female stress urinary incontinence; Follow-up study; Randomised trial; Suburethral slings; Treatment outcome