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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-21

Study Completion Date

2024-11-06

Brief Summary

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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.

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Detailed Description

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This study is a non-interventional, multicenter and post market clinical follow-up in adult women with apical prolapse under normal conditions of use (after a sacrocolpopexy with Restorelle mesh for apical prolapse repair as part of routine care). The patient will be followed for 1 year (or less) by the investigator as per local usual practice. At the same time, the patient will be followed via PRO (Patient Reported Outcomes) over a period of 5 to 8 years.

Conditions

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Genital Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Restorelle Polypropylene Mesh

The Coloplast Restorelle® Polypropylene Mesh is a Class III, implantable, permanent, non-absorbable, single use device indicated to restore female pelvic floor anatomy by providing anatomical support and suspension as a bridging material to support deficient fascia that resulted in descent of the female pelvic organs (pelvic organ prolapse).

Restorelle mesh is a synthetic, macroporous mesh constructed of medical grade knitted, monofilament polypropylene.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No