Status:
ACTIVE_NOT_RECRUITING
Posterior Mesh Fixation at the Levator Ani Level in Apical Pelvic Organ Prolapse
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsors:
Carlos III Health Institute
Ministry of Science and Innovation, Spain
Conditions:
Prolapse Genital
Prolapse Uterovaginal
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a prospective, randomized, multicenter, non-inferiority trial including women with stage II-IV apical pelvic organ prolapse (POP), classified according to the POP-Q system. Participants will b...
Detailed Description
This study is a multicenter, randomized, controlled, evaluator-blinded, non-inferiority clinical trial. The null hypothesis is that colposacropexy with posterior mesh fixation to the vaginal vault (wi...
Eligibility Criteria
Inclusion
- Women with primary or recurrent apical prolapse (uterine or vaginal vault) stage II-IV according to the POP-Q classification.
- Women with symptomatic POP with indication of reconstructive POP surgery.
- Agreement to comply with all scheduled visits and assessments through 12 months post-surgery.
- Understand and accept the study procedures and sign the informed consent.
Exclusion
- History of abdominal reconstructive surgery for pelvic organ prolapse.
- History of vaginal reconstructive surgery for prolapse using mesh.
- Stage I prolapse according to the POP-Q classification, or asymptomatic prolapse.
- Medical contraindication to general anesthesia.
- Patient preference for vaginal surgical treatment.
- Declines participation in the study.
- Patients with disabilities or unable to understand the terms of the study.
Key Trial Info
Start Date :
October 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT07194343
Start Date
October 6 2022
End Date
December 1 2025
Last Update
September 26 2025
Active Locations (6)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
2
Hospital Universitari Dexeus
Barcelona, Barcelona, Spain
3
Hospital Universitari d'Igualada
Igualada, Barcelona, Spain
4
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain