Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI) (NCT04232696)
Clinical Study of Neuspera's Implantable Sacral Nerve Stimulation (SNS) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
🩺 Plain-English Summary (8th-Grade Level)
Prospective, multi-center, single-arm, seamless phase-pivotal study conducted in participants diagnosed with UUI who have failed or could not tolerate more conservative treatment. The trial will be conducted in two phases. Objective of Phase I: To assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial. Objective of Phase II: To assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary safety and efficacy endpoints.
Who can join: Review the eligibility criteria below.
Location: Genesis Healthcare Partners — Encinitas, California
Age range: 22 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 (34 Sites)
Showing the first 25 of 34 sites.
- Genesis Healthcare Partners — Encinitas, California
- Kaiser Permanente, LAMC — Los Angeles, California
- Kaiser Permanente — San Diego, California
- Clinical Research Center of Florida — Pompano Beach, Florida
- Florida Urology Partners, LLC — Tampa, Florida
- Midtown Urology — Atlanta, Georgia
- Meridian Clinical Research — Savannah, Georgia
- Comprehensive Urologic Care — Lake Barrington, Illinois
- Women's Health Advantage — Fort Wayne, Indiana
- Indiana University School of Medicine — Indianapolis, Indiana
- University of Kansas Hospital — Kansas City, Kansas
- UofL Health System (University of Louisville) — Louisville, Kentucky
- Ochsner Medical — New Orleans, Louisiana
- University of Michigan Health - West — Wyoming, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Minnesota Urology — Woodbury, Minnesota
- Specialty Research of St. Louis — St Louis, Missouri
- Adult & Pediatric Urology P.C. — Omaha, Nebraska
- Weill Cornell Medical College — New York, New York
- Premier Medical Group — Poughkeepsie, New York
- Associated Medical Professionals of NY — Syracuse, New York
- MetroHealth — Cleveland, Ohio
- The Oregon Clinic Urogynecology West — Portland, Oregon
- The Institute for Female Pelvic Medicine and Reconstructive Surgery — North Wales, Pennsylvania
- Southern shores urogynecology — Myrtle Beach, South Carolina
💰 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 Urinary Urgency Incontinence
- Post-Approval Study of the Neuspera Sacral Neuromodulation System — San Diego, California
Explore by condition: All Urinary Urgency 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.