Evaluation of GYNEMESH PS Mesh for pelvic organ prolapse surgery outcomes

A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh

This study is testing how well GYNEMESH PS Mesh works for women having surgery for pelvic organ prolapse and looking at their recovery and any problems that might come up.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 21 Years and up
• Sex: Female
• Sponsor: Ethicon, Inc. (Industry-sponsored)
• Locations: 3 sites (North Wales, Pennsylvania and 2 other locations)
• Trial ID: NCT04829058 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the outcomes of women who have undergone surgery for vaginal or uterine prolapse using GYNEMESH PS Mesh. It includes both retrospective and prospective data collection from multiple centers. The study will evaluate the effectiveness and safety of the mesh in treating pelvic organ prolapse in eligible female patients. Participants will be monitored for their recovery and any complications associated with the use of the mesh.

Who should consider this trial

Good fit: Ideal candidates for this study are women who have undergone abdominal sacrocolpopexy for apical vaginal or uterine prolapse using GYNEMESH PS Mesh.

Not a fit: Patients who had a transvaginal approach for surgery or uterus-sparing procedures will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of GYNEMESH PS Mesh, potentially improving surgical outcomes for women with pelvic organ prolapse.

How similar studies have performed: Other studies have explored the use of mesh in pelvic organ prolapse surgery, but the specific outcomes of GYNEMESH PS Mesh in this context are still being evaluated.

Eligibility criteria

Inclusion Criteria:

Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:

1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
2. GYNEMESH PS Mesh was used as a bridging material according to the IFU.
3. Able and willing to participate in follow-up
4. Subject or authorized representative has signed the approved informed consent

Exclusion Criteria

Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:

1. Subjects \< 21 years of age at the time of informed consent
2. Subjects who had transvaginal approach for surgery
3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

Where this trial is running

North Wales, Pennsylvania and 2 other locations

• Institute for Female Pelvic Medicine — North Wales, Pennsylvania, United States (Recruiting)
• Umpc — Pittsburgh, Pennsylvania, United States (Recruiting)
• Universitatsklinikum Tubingen — Tübingen, Germany (Recruiting)

Study contacts

• Study coordinator: Christine Romanowski

Conditions Pelvic Organ Prolapse; GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh; POP