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.