Pivotal Study of Voro Urologic Scaffold (NCT06873581)
A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)
🩺 Plain-English Summary (8th-Grade Level)
The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm. The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic — Phoenix, Arizona
Age range: 45 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 (19 Sites)
- Mayo Clinic — Phoenix, Arizona
- Academic Urology — Sun City, Arizona
- University of California Los Angeles — Los Angeles, California
- University of California San Diego — San Diego, California
- Tampa General Hospital — Tampa, Florida
- University of Chicago Medicine — Chicago, Illinois
- IU school of Medicine, Department of Urology — Indianapolis, Indiana
- University of Maryland — Baltimore, Maryland
- John Hopkins — Baltimore, Maryland
- BMHCC/ Mississippi Urology Clinic — Jackson, Mississippi
- Northwell Health — New Hyde Park, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- University of Rochester Medical Center — Rochester, New York
- Erlanger Urology — Chattanooga, Tennessee
- The Conrad Pearson Clinic — Germantown, Tennessee
- Urology Associates PC Nashville — Nashville, Tennessee
- Urology of Austin — Austin, Texas
- Potomac Urology Center — Alexandria, Virginia
- Urology of Virginia, PLLC — Virginia Beach, Virginia
📞 Contact the Study Coordinator
Phone: (800) 664-4580
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.
Explore by condition: All Radical Prostatectomy 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.