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Could one mesh be enough? new trial tests simpler prolapse surgery

NCT ID NCT03766048

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two surgical approaches for women with urogenital prolapse but without significant posterior vaginal wall prolapse. One group receives a single mesh in the front, while the other gets an additional mesh in the back as a preventive measure. The goal is to see if the simpler single-mesh approach is just as effective at preventing recurrence, while potentially reducing complications and surgery time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
synthetic non-absorbable mesh
What this could lead to
If successful, this could show that using only one mesh is just as effective as two, reducing surgery time and risk of complications like pain or mesh exposure.
What could go wrong
This is a non-inferiority trial, so it may only confirm that the simpler approach is not worse, not necessarily better. The results may not apply to women with more severe prolapse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 834 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women with a urogenital prolapse (anterior wall and/or uterus or vaginal apex) stage = 2 (Ba and/or C points ≥ - 1 cm using the POP-Q system), * without significant posterior vaginal wall prolapse (Bp \< -1 cm when apical prolapse is reduced using a retractor leaving the posterior vaginal wall free), Exclusion Criteria: * Previous surgical repair for Pelvic Organ Prolapse * Any associated prolapse requiring any non-authorized additional surgical repair (Authorized additional surgical procedures are hysterectomy, ovariectomy, adnexectomy, salpingectomy, myomectomy, or suburethral vaginal tape.) * Wish for future pregnancy * Lack of health insurance * Woman not reading French or unable to consent * Woman under law protection

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urogenital prolapse

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ch Dunkerque

    RECRUITING

    Dunkirk, France

  • Chi Poissy St Germain Site de Poissy

    RECRUITING

    Poissy, France

  • Chu Nimes - Nimes

    RECRUITING

    Nîmes, France

  • Chu de Nice Hopital de L'Archet

    RECRUITING

    Nice, France

  • Clinique Du Pre

    RECRUITING

    Le Mans, France

  • Hop Jeanne de Flandre Chu Lille

    RECRUITING

    Lille, 59037, France

  • Hopital Estaing

    RECRUITING

    Clermont-Ferrand, France

  • Hopital Saint Vincent - Saint Antoine

    RECRUITING

    Lille, 59037, France

  • Hopital Saint-Louis - La Rochelle

    RECRUITING

    La Rochelle, France

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