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

NCT07194343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-02-10

No results posted yet for this study

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 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.

Conditions

  • Prolapse Genital
  • Prolapse Uterovaginal
  • Prolapse; Female

Interventions

PROCEDURE

Laparoscopic colposacropexy with levator ani muscle mesh fixation

The standard technique includes dissection of the rectovaginal space and bilateral mesh fixation to the levator ani muscle at the deep limit of the pararectal fossae dissection.

PROCEDURE

Simplified modification of laparoscopic colposacropexy

Rectovaginal dissection is avoided, and the mesh is anchored to the posterior aspect of the cervix or vaginal vault rather than to the levator ani muscle, representing the specific modification from the standard technique.

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Ministry of Science and Innovation, Spain

    collaborator OTHER_GOV

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07194343 on ClinicalTrials.gov