Evidence map›Paper›PMID 36662272›Full record

Trial reportInternational urogynecology journal2023

Subjective outcomes 12 years after transvaginal mesh versus native tissue repair in women with recurrent pelvic organ prolapse; a randomized controlled trial.

Kirsten B Kluivers, Metteke Kamping, Alfredo L Milani, Joanna IntHout, Mariella I Withagen

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International urogynecology journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 24% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 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 2 countries.

Kirsten B KluiversDepartment of Obstetrics & Gynecology (623), Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands. Kirsten.Kluivers@radboudumc.nl.ORCID 0000-0002-4681-4304
Metteke KampingDepartment of Obstetrics & Gynecology (623), Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands.
Alfredo L MilaniDepartment of Obstetrics & Gynaecology, Reinier de Graaf Gasthuis, P.O. Box 5011, 2600, GA, Delft, the Netherlands.
Joanna IntHoutDepartment for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands.
Mariella I WithagenDepartment of Obstetrics & Gynecology, University Medical Center Utrecht, Heidelberglaan 100, Room F05.126, P.O. Box 85500, Utrecht, the Netherlands.
Radboud University Nijmegen · NLHeidelberg University · DEReinier de Graaf Hospital · NL

Funding

Ethicon Ethicon IIS 13-215: VROUW 1 follow-up study
6 · The paper itself

Abstract

introduction and hypothesisThe present study describes an extended follow-up study after 12 years and focusses on subjective outcomes of women who underwent surgery for recurrent pelvic organ prolapse in the randomized index study.

methodsOne hundred and ninety-four (194) women had been randomized in the original study and in the present study, 45 (47%) in the vaginal mesh repair versus 43 (43%) women with conventional vaginal native tissue repair completed the long-term questionnaires. The mesh used was a first-generation non-absorbable mesh kit. All types of conventional vaginal native tissue repairs were allowed, and additional vaginal native tissue repairs were allowed in the mesh group. The questionnaires as applied at baseline were used. The Patient Global Impression of Improvement questionnaire (PGI-I) was the primary outcome.

resultsAt 12 years, 30 (71%) women in the mesh group versus 23 (59%) women in the native tissue repair group reported to be PGI-I (very) much improved (p=0.24). There were no differences found in any of the questionnaire domains. There was, however, a higher number of women who had had additional operations for recurrent pelvic organ prolapse, stress urinary incontinence, and/or exposure in the mesh group: 18 women (40%) in the mesh group versus 8 women (19%) in the native tissue repair group (p=0.03).

conclusionsThere was no difference in subjective outcome between the groups, but there was a statistically significant higher number of women who had needed further operations. This study confirms that vaginal mesh should not be used in all women with recurrent pelvic organ prolapse.

Indexed as

Pelvic Organ ProlapseUrinary Incontinence, StressFemaleFollow-Up StudiesGynecologic Surgical ProceduresHumansSurgical MeshTreatment OutcomeNative tissue repairNon-absorbable vaginal meshPelvic organ prolapseSubjective outcome

Identifiers

PMID36662272
PMCPMC10287778
OpenAlexW4317567586

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.