Posterior Mesh Fixation at the Levator Ani Level in Apical Pelvic Organ Prolapse

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 be randomized into two groups: Group A: laparoscopic colposacropexy with posterior mesh fixation to the levator ani muscle. Group B: laparoscopic colposacropexy with posterior mesh fixation to the vaginal cuff/cervix, without dissection of the rectovaginal space. The objective of the study is to determine whether a simplified colposacropexy technique is non-inferior to the standard procedure in terms of anatomical and functional outcomes. The primary outcome is anatomical success, defined as a postoperative POP-Q stage 0-I. Secondary outcomes include functional status and sexual function, evaluated using the PFDI-20 and PISQ-12 questionnaires. Data on prolapse anatomy, related symptoms, and sexual function will be collected at baseline and during follow-up visits at 1, 6, and 12 months after surgery. This study is supported by a national health research grant from the Instituto de Salud Carlos III (ISCIII), Ministry of Science and Innovation, Spain.

NCT Number	NCT07194343
Lead Sponsor	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Collaborators: Carlos III Health Institute, Ministry of Science and Innovation, Spain
Conditions	Prolapse Genital, Prolapse Uterovaginal, Prolapse; Female
Enrollment	190 participants
Start Date	2022-10-06
Primary Completion	2025-10-31 (estimated)
Study Completion	2025-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-10