Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry (NCT04829175)
A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse
🩺 Plain-English Summary (8th-Grade Level)
The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.
Who can join: Review the eligibility criteria below.
Location: Yale University — New Haven, Connecticut
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 (10 Sites)
- Yale University — New Haven, Connecticut
- Duke University — Durham, North Carolina
- University of Pennsylvania — Philadelphia, Pennsylvania
- UPMC — Pittsburgh, Pennsylvania
- Krankenhaus der barmherzigen Schwestern — Linz,
- Herlev Hospital — Hillerød,
- Hopital Jeanne de Flandres — Lille,
- Universitatsklinikum Tubingen — Tübingen,
- Bio-Medical University Rome — Rome,
- Karolinska Institute — Stockholm,
📞 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 Stress Urinary Incontinence
- Desara ® One Single Incision Sling 522 Study — Phoenix, Arizona
- Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence — Tucson, Arizona
- Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy — Coconut Creek, Florida
- Feasibility Study of A VoRo UrologIc ScaffolD (ARID) — Panama City, Punta Pacifica
- Post-Market Clinical Follow-Up onTVT EXACT® Continence System — Durham, North Carolina
- The Anabolic Effect of Testosterone on Pelvic Floor Muscles — Boston, Massachusetts
Explore by condition: All Stress Urinary Incontinence 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.