ProACT Post-Approval Study (NCT03767595)
Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men
🩺 Plain-English Summary (8th-Grade Level)
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.
Who can join: Review the eligibility criteria below.
Location: University of Colorado — Denver, Colorado
Age range: 50 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 (6 Sites)
- University of Colorado — Denver, Colorado
- University of Florida — Gainesville, Florida
- Emory University — Atlanta, Georgia
- University of Kansas Medical Center — Kansas City, Kansas
- University of Michigan — Ann Arbor, Michigan
- CentraCare- St. Cloud — Saint Cloud, Minnesota
📞 Contact the Study Coordinator
Phone: (763) 694-9880
Email: pgora@uromedica-inc.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.
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💡 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.