Status:
UNKNOWN
LAparoscopic Preventive PRErectal Mesh
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Urogenital Prolapse
Eligibility:
FEMALE
40-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
834 Patients enrolled
Trial Details
Trial ID
NCT03766048
Start Date
September 11 2019
End Date
December 1 2025
Last Update
February 6 2023
Active Locations (9)
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1
Hopital Estaing
Clermont-Ferrand, France
2
Ch Dunkerque
Dunkirk, France
3
Hopital Saint-Louis - La Rochelle
La Rochelle, France
4
Clinique Du Pre
Le Mans, France