Evidence map›Paper›PMID 31506808›Full record

Trial reportInternational urogynecology journal2020

Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse.

Lucie Allègre, Geertje Callewaert, Sandrine Alonso, Arnaud Cornille, Hervé Fernandez, Georges Eglin, Renaud de Tayrac

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

Trial report in International urogynecology journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02255994 (Comparison of Long-term Results of UGYTEX® Sub-bladder Mesh Placed Via a Transvaginal Transobturator Approach Versus Subvesical Plication Without Reinforcement in the Surgical Treatment of Bladder Prolapse), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT02255994 nacompletednot on this map

Comparison of Long-term Results of UGYTEX® Sub-bladder Mesh Placed Via a Transvaginal Transobturator Approach Versus Subvesical Plication Without Reinforcement in the Surgical Treatment of Bladder Prolapse

TypeinterventionalSponsorCentre Hospitalier Universitaire de NīmesRan2014 to 2015Enrolled75ConditionsCystoceleArmsUGYTEX, No mesh.
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse.The Cochrane database of systematic reviews · 2024
    Pooled it
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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

7 authors at 4 institutions in 2 countries.

Lucie AllègreDepartment of Obstetrics and Gynecology, CHU Nîmes, University of Montpellier, Nîmes, France.
Geertje CallewaertDepartment of Obstetrics and Gynecology, CHU Nîmes, University of Montpellier, Nîmes, France. geertje.callewaert@chu-nimes.fr.ORCID 0000-0003-0516-4007
Sandrine AlonsoDepartment of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, University of Montpellier, Nîmes, France.
Arnaud CornilleDepartment of Obstetrics and Gynecology, Clinique Beau Soleil, Montpellier, France.
Hervé FernandezDepartment of Obstetrics and Gynecology, Kremin Bicêtre Hospital, Kremin Bicêtre, France.
Georges EglinDepartment of Obstetrics and Gynecology, Clinique Champeau, Béziers, France.
Renaud de TayracDepartment of Obstetrics and Gynecology, CHU Nîmes, University of Montpellier, Nîmes, France.
Université de Montpellier · FRBicêtre Hospital · FRCentre Hospitalier Universitaire de Nîmes · FRClinique du Millénaire · FR

Funding

Nîmes University Hospital Projet Local 2013
6 · The paper itself

Abstract

introduction and hypothesisThe aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair.

methodsProspective, randomized, multicenter study conducted between April 2005 and December 2009 comparing anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5-8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires.

resultsOf the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%).

conclusionSeven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.

Indexed as

Pelvic Organ ProlapseUterine ProlapseFemaleFranceGynecologic Surgical ProceduresHumansProspective StudiesSurgical MeshTreatment OutcomeVaginaAnterior colporrhaphyCystoceleLong-term outcomePelvic organ prolapsePolypropylene meshVaginal surgery

Identifiers

PMID31506808
OpenAlexW2973083104

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.