GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study (NCT04829058)
A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
🩺 Plain-English Summary (8th-Grade Level)
The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.
Who can join: Review the eligibility criteria below.
Location: Institute for Female Pelvic Medicine — North Wales, Pennsylvania
Age range: 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- Institute for Female Pelvic Medicine — North Wales, Pennsylvania
- UMPC — Pittsburgh, Pennsylvania
- Universitatsklinikum Tubingen — Tübingen,
📞 Contact the Study Coordinator
Phone: (908) 808-6219
Email: cromanow@its.jnj.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Pelvic Organ Prolapse
- POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment — Birmingham, Alabama
- Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse — Rochester, Minnesota
- Composite Outcomes of Mesh vs Suture Techniques for Prolapse Repair: A Randomized Controlled Multicentre Trial — Vancouver, British Columbia
- Vaginal Orthosis Use After Vaginal Reconstructive Surgery — Birmingham, Alabama
- Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery — Birmingham, Alabama
- Pessary Experience Study — Charlottesville, Virginia
Explore by condition: All Pelvic Organ Prolapse clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.