-
Randomized Controlled Trial Comparative Study
Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial.
- Sue Ross, Selphee Tang, Misha Eliasziw, Doug Lier, Isabelle Girard, Erin Brennand, Lorel Dederer, Philip Jacobs, and Magali Robert.
- Department of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada. sue.ross@albertahealthservices.ca.
- Int Urogynecol J. 2016 Jun 1; 27 (6): 879-86.
Introduction And HypothesisIn 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.MethodsAll 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.ResultsOne 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.ConclusionsSerious 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.
Notes
Knowledge, pearl, summary or comment to share?You can also include formatting, links, images and footnotes in your notes
- Simple formatting can be added to notes, such as
*italics*
,_underline_
or**bold**
. - Superscript can be denoted by
<sup>text</sup>
and subscript<sub>text</sub>
. - Numbered or bulleted lists can be created using either numbered lines
1. 2. 3.
, hyphens-
or asterisks*
. - Links can be included with:
[my link to pubmed](http://pubmed.com)
- Images can be included with:
![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
- For footnotes use
[^1](This is a footnote.)
inline. - Or use an inline reference
[^1]
to refer to a longer footnote elseweher in the document[^1]: This is a long footnote.
.