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Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial.
Int Urogynecol J. 2016 Jun; 27(6):879-86.IU

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.

Authors+Show Affiliations

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.Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.Department of Public Health and Community Medicine, Tufts University - School of Medicine, Boston, MA, 02111, USA.Institute of Health Economics, Edmonton, T6G 2R3, Canada.Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.Department of Medicine, University of Alberta, Edmonton, T6G 2R3, Canada.Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26670575

Citation

Ross, Sue, et al. "Transobturator Tape Versus Retropubic Tension-free Vaginal Tape for Stress Urinary Incontinence: 5-year Safety and Effectiveness Outcomes Following a Randomised Trial." International Urogynecology Journal, vol. 27, no. 6, 2016, pp. 879-86.
Ross S, Tang S, Eliasziw M, et al. Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial. Int Urogynecol J. 2016;27(6):879-86.
Ross, S., Tang, S., Eliasziw, M., Lier, D., Girard, I., Brennand, E., Dederer, L., Jacobs, P., & Robert, M. (2016). Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial. International Urogynecology Journal, 27(6), 879-86. https://doi.org/10.1007/s00192-015-2902-7
Ross S, et al. Transobturator Tape Versus Retropubic Tension-free Vaginal Tape for Stress Urinary Incontinence: 5-year Safety and Effectiveness Outcomes Following a Randomised Trial. Int Urogynecol J. 2016;27(6):879-86. PubMed PMID: 26670575.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial. AU - Ross,Sue, AU - Tang,Selphee, AU - Eliasziw,Misha, AU - Lier,Doug, AU - Girard,Isabelle, AU - Brennand,Erin, AU - Dederer,Lorel, AU - Jacobs,Philip, AU - Robert,Magali, Y1 - 2015/12/15/ PY - 2015/07/31/received PY - 2015/11/15/accepted PY - 2015/12/17/entrez PY - 2015/12/17/pubmed PY - 2017/8/31/medline KW - Female stress urinary incontinence KW - Follow-up study KW - Randomised trial KW - Suburethral slings KW - Treatment outcome SP - 879 EP - 86 JF - International urogynecology journal JO - Int Urogynecol J VL - 27 IS - 6 N2 - 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. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/26670575/Transobturator_tape_versus_retropubic_tension_free_vaginal_tape_for_stress_urinary_incontinence:_5_year_safety_and_effectiveness_outcomes_following_a_randomised_trial_ L2 - https://dx.doi.org/10.1007/s00192-015-2902-7 DB - PRIME DP - Unbound Medicine ER -