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 range18 Years

SexFEMALE

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

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