TerminatedNot Applicable

Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair

Stopped: From June 08, 2024, the study device was no longer marketed in France. Therefore, the sponsor decided to terminate the study prematurely.

France39 participantsStarted 2023-11-21

Plain-language summary

The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery.

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: * Female patient of at least 18 years old * Patient presenting apical pelvic organ prolapse and being eligible to surgical treatment * Surgeon having decided to treat the patient with a Restorelle mesh as per its CE mark indication and IFU, before patient inclusion * Patient having received appropriate information and counselling before mesh implantation * Patient has been provided written informed consent Exclusion Criteria: * Patient currently pregnant or breastfeeding * Patient being deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection

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

The incidence rate of a surgical reintervention related to Restorelle mesh use over at least the 5 first years of post-index procedure follow-up

Timeframe: up to 5 years

Trial details

NCT IDNCT06296316

SponsorColoplast A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-11-06

View on ClinicalTrials.gov More Genital Prolapse trials