🏛️ Verified NIH Record • Updated 2026-07-02
Post-Market Clinical Follow-Up onTVT EXACT® Continence System (NCT04829994)
A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence
🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Ethicon, Inc.
🩺 Plain-English Summary (8th-Grade Level)
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
Who can join: Review the eligibility criteria below.
Location: Duke University — Durham, North Carolina
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 (8 Sites)
- Duke University — Durham, North Carolina
- Institute for Female Pelvic Medicine — North Wales, Pennsylvania
- UPMC — Pittsburgh, Pennsylvania
- Ordensklinikum Linz — Linz,
- Herlev Hospital — Hillerød,
- Hopital Jeanne de Flandres — Lille,
- Universitatsklinikum Tubingen — Tübingen,
- Karolinska Institute — Stockholm,
💰 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
- 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.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.