Preventive mesh placement for urogenital prolapse surgery
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 834 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | Female |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 9 sites (Clermont-Ferrand and 8 other locations) |
| Trial ID | NCT03766048 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with stage 2 urogenital prolapse without significant posterior vaginal wall prolapse.
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.
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 performed: Previous studies have shown promising results with similar mesh approaches, but this specific preventive strategy is relatively novel.
Eligibility criteria
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 this trial is running
Clermont-Ferrand and 8 other locations
- Hopital Estaing — Clermont-Ferrand, France (Recruiting)
- Ch Dunkerque — Dunkerque, 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.