Sue Ross1,2, Selphee Tang3, Misha Eliasziw4, Doug Lier5, Isabelle Girard3, Erin Brennand3, Lorel Dederer3, Philip Jacobs6, Magali Robert3. 1. Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada. sue.ross@albertahealthservices.ca. 2. 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. 3. Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada. 4. Department of Public Health and Community Medicine, Tufts University - School of Medicine, Boston, MA, 02111, USA. 5. Institute of Health Economics, Edmonton, T6G 2R3, Canada. 6. Department of Medicine, University of Alberta, Edmonton, T6G 2R3, Canada.
Abstract
INTRODUCTION AND HYPOTHESIS: 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.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: 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: Bernard T Haylen; Robert M Freeman; Steven E Swift; Michel Cosson; G Willy Davila; Jan Deprest; Peter L Dwyer; Brigitte Fatton; Ervin Kocjancic; Joseph Lee; Chris Maher; Eckhard Petri; Diaa E Rizk; Peter K Sand; Gabriel N Schaer; Ralph J Webb Journal: Int Urogynecol J Date: 2011-01 Impact factor: 2.894
Authors: Julien Labrie; Bary L C M Berghmans; Kathelijn Fischer; Alfredo L Milani; Ileana van der Wijk; Dina J C Smalbraak; Astrid Vollebregt; René P Schellart; Giuseppe C M Graziosi; J Marinus van der Ploeg; Joseph F G M Brouns; E Stella M Tiersma; Annette G Groenendijk; Piet Scholten; Ben Willem Mol; Elisabeth E Blokhuis; Albert H Adriaanse; Aaltje Schram; Jan-Paul W R Roovers; Antoine L M Lagro-Janssen; Carl H van der Vaart Journal: N Engl J Med Date: 2013-09-19 Impact factor: 91.245
Authors: Sue Ross; Magali Robert; Cheryl Swaby; Lorel Dederer; Doug Lier; Selphee Tang; Penny Brasher; Colin Birch; Dave Cenaiko; Tom Mainprize; Magnus Murphy; Kevin Carlson; Richard Baverstock; Philip Jacobs; Tyler Williamson Journal: Obstet Gynecol Date: 2009-12 Impact factor: 7.661
Authors: Erin A Brennand; Selphee Tang; Colin Birch; Magnus Murphy; Sue Ross; Magali Robert Journal: Int Urogynecol J Date: 2016-09-29 Impact factor: 2.894
Authors: Vasileios I Sakalis; Michael S Floyd; Philippa Caygill; Chloe Price; Ben Hartwell; Peter J Guy; Melissa C Davies Journal: J Spinal Cord Med Date: 2017-10-27 Impact factor: 1.985