Evidence map›Paper›PMID 26670575›Full record

Trial reportInternational urogynecology journal2016

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, Magali Robert

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International urogynecology journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00234754 (Surgical Management of Stress Urinary Incontinence in Women), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00234754 nacompletednot on this map

Surgical Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial (RCT) of TOT vs TVT

TypeinterventionalSponsorUniversity of CalgaryRan2005 to 2013Enrolled199ConditionsStress Urinary IncontinenceArmsTVT Surgery TOT Surgery
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Surgical Treatment for Stress Urinary Incontinence in Women: A Systematic Review and Meta-analysis.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2018
    Pooled it
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  9. Risk factors for stress urinary incontinence recurrence after midurethral sling revision.International journal of urology : official journal of the Japanese Urological Association · 2023
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  11. Characterization in respect to degradation of titanium-coated polypropylene surgical mesh explanted from humans.Journal of biomedical materials research. Part B, Applied biomaterials · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

Sue RossDepartment of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada. sue.ross@albertahealthservices.ca.ORCID http://orcid.org/0000-0002-0600-4833
Selphee TangDepartment of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.
Misha EliasziwDepartment of Public Health and Community Medicine, Tufts University - School of Medicine, Boston, MA, 02111, USA.
Doug LierInstitute of Health Economics, Edmonton, T6G 2R3, Canada.
Isabelle GirardDepartment of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.
Erin BrennandDepartment of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.
Lorel DedererDepartment of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.
Philip JacobsDepartment of Medicine, University of Alberta, Edmonton, T6G 2R3, Canada.
Magali RobertDepartment of Obstetrics and Gynecology, University of Calgary, Calgary, T2N 2T9, Canada.
University of Calgary · CAInstitute of Health Economics · CATufts University · USUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

AdultFemaleFollow-Up StudiesGynecologic Surgical ProceduresHumansMiddle AgedSuburethral SlingsTreatment OutcomeUrinary Incontinence, StressFemale stress urinary incontinenceFollow-up studyRandomised trialSuburethral slingsTreatment outcome

Identifiers

PMID26670575
OpenAlexW2201003838

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.