Evidence map›Paper›PMID 29167974›Full record

Trial reportInternational urogynecology journal2018

Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial.

Alfredo L Milani, Anne Damoiseaux, Joanna IntHout, Kirsten B Kluivers, Mariella I J Withagen

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International urogynecology journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00372190 (A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
7.1field-weighted citation impact, top 2% 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.

NCT00372190 nacompletednot on this map

A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse

TypeinterventionalSponsorRadboud University Medical CenterRan2006 to 2015Enrolled194ConditionsPelvic Organ ProlapseArmsTensionfree vaginal mesh kit (Prolift), classic vaginal prolapse surgery (fascia plication)
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse.The Cochrane database of systematic reviews · 2024
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  17. Endometrial SUSD2Journal of personalized medicine · 2021
    Review
  18. Timing of recurrence after surgery in pelvic organ prolapse.International urogynecology journal · 2021
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  19. Article
  20. Article
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 4 institutions in 2 countries.

Alfredo L MilaniDepartment of Obstetrics & Gynecology, Reinier de Graaf Hospital, P.O. Box 5011, 2600, GA, Delft, The Netherlands. fredmilani@me.com.
Anne DamoiseauxDepartment of Obstetrics & Gynecology, Catharina Hospital, P.O. Box 1350, 5602, ZA, Eindhoven, The Netherlands.
Joanna IntHoutDepartment for Health Evidence (133), Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands.
Kirsten B KluiversDepartment of Obstetrics & Gynecology (791), Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands.
Mariella I J WithagenDepartment of Obstetrics & Gynecology, University Medical Center Utrecht, Heidelberglaan 100 P.O. Box 85500, Room F05.126, Utrecht, The Netherlands.
Radboud University Nijmegen · NLRadboud University Medical Center · NLReinier de Graaf Hospital · NLUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisOur aim was to evaluate clinically relevant long-term outcomes of transvaginal mesh or native tissue repair in women with recurrent pelvic organ prolapse (POP).

methodsWe performed a 7-year follow-up of a randomized controlled trial on trocar-guided mesh placement or native tissue repair in women with recurrent POP. Primary outcome was composite success, defined as absence of POP beyond the hymen, absence of bulge symptoms, and absence of retreatment for POP. Secondary outcomes were adverse events, pain, and dyspareunia. Multiple imputation was used for missing data of composite success and pain; estimates are presented with 95% confidence intervals (CI).

resultsBetween August 2006 and July 2008, 194 women were randomized; 190 underwent surgery. At 7 years, 142 (75%) were available for analysis, of whom, the primary outcome could be calculated in 127. Composite success was 53% (95% CI 41, 66) for mesh and 54% (95% CI 42, 65) for native tissue. Repeat surgery for POP was 25% for mesh and 16% for native tissue (difference 9%; 95% CI -5, 23) and occurred in untreated compartments in the mesh group and treated compartments in the native tissue group. Mesh exposure rate was 42%; pain with mesh 39% and native tissue 50% (difference - 11%, 95% CI -27, 6); dyspareunia with mesh 20% and native tissue 17% (difference 3%, 95% CI -9, 17).

conclusionsSeven-year composite success rates appeared similar for mesh and native tissue. Mesh did not reduce long-term repeat surgery rates due to de novo POP in nonmesh-treated vaginal compartments. Mesh exposure rates were high, though significant differences in pain and dyspareunia were not detected. CLINICAL

trial registrationClinicalTrials.gov , NCT00372190.

Indexed as

Surgical MeshAdultFemaleFollow-Up StudiesGynecologic Surgical ProceduresHumansMiddle AgedPelvic Organ ProlapsePlastic Surgery ProceduresPostoperative ComplicationsRecurrenceRetrospective StudiesTime FactorsTreatment OutcomeUterine ProlapseVaginaLong-term outcomeMeshNative tissuePainPelvic organ prolapseSurgery

Identifiers

PMID29167974
PMCPMC5948295
OpenAlexW2769099482

What OpenQuestion holds

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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.