Evidence map›Paper›PMID 21781314›Full record

Trial reportBMC women's health2011

Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial.

Sue Ross, Magali Robert, Doug Lier, Misha Eliasziw, Philip Jacobs

2 registry-linked trialsOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC women's health, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.3field-weighted citation impact, top 21% 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
NCT02867748 naunknown statusnot on this mapstarted 2016, after this paper: background citation

TVT-ABBREVO Versus SERASIS for the Treatment of Female Urinary Stress Incontinence: 1 Year Outcomes of a Comparative Study With 2 Trans-obturator Sub Mid Urethral Slings

TypeinterventionalSponsorWestern Galilee Hospital-NahariyaRan2016 to 2019Enrolled99ConditionsUrinary Stress IncontinenceArmsTVT-Abbrevo, Serasis
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 19 citations in OpenAlex.

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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

5 authors at 3 institutions in 1 country.

Sue RossDepartment of Obstetrics and Gynaecology, University of Calgary, Calgary, Canada. sue.ross@albertahealthservices.ca
Magali Robert
Doug Lier
Misha Eliasziw
Philip Jacobs
University of Calgary · CAInstitute of Health Economics · CAUniversity of Alberta · CA

Funding

ASPE HHS MOP106620Canadian Institutes of Health Research
6 · The paper itself

Abstract

backgroundWe recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT) versus the trans-obturator tape (TOT) procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial. METHODS/

designAll 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7). Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature. DISCUSSION: This study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes more adverse events, or is less effective, will have a significant impact on individual quality of life, and societal and health care costs.

trial registrationClinicalTrials.gov NCT00234754. Registered October 2005.

Indexed as

Postoperative ComplicationsSuburethral SlingsClinical ProtocolsCost-Benefit AnalysisFemaleFollow-Up StudiesHumansMinimally Invasive Surgical ProceduresQuality of LifeTreatment OutcomeUrinary Incontinence, StressUrologic Surgical Procedures

Identifiers

PMID21781314
PMCPMC3171308
OpenAlexW1976708550

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.