Evidence map›Paper›PMID 12114234›Full record

Trial reportBMJ (Clinical research ed.)2002

Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence.

Karen Ward, Paul Hilton, United Kingdom and Ireland Tension-free Vaginal Tape Trial Group

2 registry-linked trialsOpen access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2002. 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 133 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
133citing papers in PubMed, 6 pooled it
25.4field-weighted citation impact, top 1% 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.

NCT00441454 nacompletednot on this mapstarted 2004, after this paper: background citation

Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial

TypeinterventionalSponsorAustrian Urogynecology Working Group (AUWG)Ran2004 to 2012Enrolled564ConditionsStress Urinary IncontinenceArmsTransobturator Tension-free vaginal tape (TVT-O), Retropubic Tension-free vaginal tape (TVT)
NCT00734968 phase4completednot on this mapstarted 2008, after this paper: background citation

Does Prophylaxis With Macrobid Reduce the Incidence of Urinary Tract Infection in Patients Who Receive a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: Randomized, Double Blinded Placebo Controlled Clinical Trial

TypeinterventionalSponsorUniversity of Missouri-ColumbiaRan2008 to 2010Enrolled161ConditionsStress IncontinenceArmsNitrofurantoin, Placebo
3 · Its place in the literature

Who cites it

133 citing papers in PubMed, 6 syntheses or guidelines pooled it, 509 citations in OpenAlex.

  1. Pooled it
  2. Traditional suburethral sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Traditional suburethral sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Open retropubic colposuspension for urinary incontinence in women.The Cochrane database of systematic reviews · 2017
    Pooled it
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73 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Karen WardDepartment of Obstetrics and Gynaecology, University of Newcastle upon Tyne.
Paul Hilton
United Kingdom and Ireland Tension-free Vaginal Tape Trial Group
Newcastle University · GBRoyal Victoria Infirmary · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare tension-free vaginal tape with colposuspension as primary treatment for stress incontinence.

designMulticentred randomised comparative trial.

settingGynaecology or urology departments in 14 centres in the United Kingdom and Eire, including university teaching hospitals and district general hospitals.

participants344 women with urodynamic stress incontinence; 175 randomised to tension-free vaginal tape and 169 to colposuspension

main outcome measuresAssessment before treatment and at six months postoperatively with the SF-36, the Bristol female lower urinary tract symptoms questionnaire, the EQ-5D health questionnaire, a one week urinary diary, one hour perineal pad test, cystometry, and, in some centres, urethral profilometry.

results23 women in the colposuspension group and 5 in the vaginal tape group withdrew before surgery. No significant difference was found between the groups for cure rates: 115 (66%) women in the vaginal tape group and 97 (57%) in the colposuspension group were objectively cured (95% confidence interval for difference in cure -4.7% to 21.3%). Bladder injury was more common during the vaginal tape procedure; postoperative complications, in particular delayed resumption of micturition, were more common after colposuspension. Operation time, duration of hospital stay, and return to normal activity were all longer after colposuspension than after the vaginal tape procedure.

conclusionSurgery with tension-free vaginal tape is associated with more operative complications than colposuspension, but colposuspension is associated with more postoperative complications and longer recovery. Vaginal tape shows promise for the treatment of urodynamic stress incontinence because of minimal access and rapid recovery times; cure rates at six months were comparable with colposuspension.

Indexed as

AdultFemaleHumansLength of StayMiddle AgedPolypropylenesProspective StudiesTreatment OutcomeUrinary Incontinence, StressUrodynamicsVaginaPolypropylenes

Identifiers

PMID12114234
PMCPMC117136
OpenAlexW2033906730

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.