Posterior Mesh Fixation at the Levator Ani Level in Apical Pelvic Organ Prolapse (NCT07194343) | Clinical Trial Compass
CompletedNot Applicable
Posterior Mesh Fixation at the Levator Ani Level in Apical Pelvic Organ Prolapse
Spain190 participantsStarted 2022-10-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in anatomical success rate between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.
Timeframe: 12 months after surgery
Trial details
NCT IDNCT07194343
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau