| NCT ID | NCT03766048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Urogenital Prolapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 834 participants |
| Start Date | 2019-09-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 834 participants in total. It began in 2019-09-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior vaginal wall and the uterus in most cases. Posterior vaginal wall prolapse is present in only 50% of cases. Surgery is an option for women with troublesome prolapse. A woman's lifetime risk of undergoing surgery for pelvic organ prolapse (POP) surgery by the age of 80 is around 19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the gold standard, with a composite success rate of 85% at one year (Prospere study). Based on early experience and historical habits, a prerectal mesh was used to be systematically placed in the rectovaginal space, in addition to the anterior and apical mesh placed in the vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to 33%). The benefit of preventive prerectal mesh is questionned on the basis of a single retrospective study comparing 68 LS with double-mesh (anterior \& posterior, DM) to 32 LS with a single anterior mesh (SAM): posterior recurrence rates were respectively 5.9 vs. 31.3% (p\<0,01), and total recurrence rates 16.2 vs. 43.8% (p\<0.01). However, as this difference was not significant in the subgroup of patients without associated cervicocystopexy, the authors concluded that the risk of posterior failure was only due to the cervicocystopexy itself (anti-urinary incontinence procedure which has been abandoned since). On the other hand, a prerectal mesh increases the risk for specific complications: rectal injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data). The rate of de-novo obstructed defecation after LS with prerectal mesh is reported up to 25%. It could be explained by the mesh itself, but also by nerve injuries during the dissection of the rectovaginal space and rectal stalks.
Eligibility 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
Contact & Investigator
Jean-Philippe LUCOT, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT03766048 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 75 Years, studying Urogenital Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03766048 currently recruiting?
Yes, NCT03766048 is actively recruiting participants. Contact the research team at lucot.jean-philippe@ghicl.net for enrollment information.
Where is the NCT03766048 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France, Dunkirk, France, La Rochelle, France, Le Mans, France and 5 additional locations.
Who is sponsoring the NCT03766048 clinical trial?
NCT03766048 is sponsored by University Hospital, Lille. The principal investigator is Jean-Philippe LUCOT, MD,PhD at University Hospital, Lille. The trial plans to enroll 834 participants.