Preventive mesh placement for urogenital prolapse surgery
Official title: Non-inferiority Randomized Double Blind Controlled Trial Comparing Results of Laparoscopic Sacrocolpopexy With or Without Preventive Prerectal Mesh in Women Operated for Urogenital Prolapse Without Significant Posterior Vaginal Wall Prolapse
Run by University Hospital, Lille · NCT03766048 · Data updated 2026-11-12
This study is testing if adding a special mesh during surgery can help women with urogenital prolapse avoid problems with the back wall of the vagina after their operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 75 Years |
| Sex | Women only |
| Enrollment | 834 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 9 sites (Clermont-Ferrand and 8 other locations) |
| Status | Recruiting |
| Started | September 11, 2019 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT03766048 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with stage 2 urogenital prolapse without significant posterior vaginal wall prolapse.
✕Probably not a fit
Patients who have previously undergone surgery for pelvic organ prolapse or have significant posterior wall prolapse may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of using a preventive prerectal mesh in addition to standard laparoscopic sacrocolpopexy for women with urogenital prolapse. The study aims to determine whether this additional mesh can reduce the incidence of posterior vaginal wall prolapse after surgery. Eligible participants are women with specific stages of prolapse who do not have significant posterior wall issues. The trial will compare outcomes between those receiving single-anterior-mesh and double-mesh interventions.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of recurrent prolapse in women undergoing surgery.
How similar studies have gone: Previous studies have shown promising results with similar mesh approaches, but this specific preventive strategy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hopital Estaing
Clermont-Ferrand, France Recruiting -
Ch Dunkerque
Dunkirk, France Recruiting -
Hopital Saint-Louis - La Rochelle
La Rochelle, France Recruiting -
Clinique Du Pre
Le Mans, France Recruiting -
Hop Jeanne de Flandre Chu Lille
Lille, France Recruiting -
Hopital Saint Vincent - Saint Antoine
Lille, France Recruiting
Show 3 more locations
-
Chu de Nice Hopital de L'Archet
Nice, France Recruiting -
Chu Nimes - Nimes
Nîmes, France Recruiting -
Chi Poissy St Germain Site de Poissy
Poissy, France Recruiting
Study contacts
- Principal investigator: Jean-Philippe LUCOT, MD,PhD — University Hospital, Lille
- Study coordinator: Jean-Philippe LUCOT, MD,PhD
- Email: lucot.jean-philippe@ghicl.net
- Phone: (0)3 21 45 62
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.