Long-term follow-up of the Neuspera sacral neuromodulation system for urinary urgency incontinence.
Clinical Post- Approval Study of the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
NA · Neuspera Medical, Inc. · NCT07144813
This follow-up will track people who already received the Neuspera sacral neuromodulation implant to see if it stays safe and keeps reducing urinary urgency incontinence symptoms for up to 72 months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Neuspera Medical, Inc. (industry) |
| Locations | 20 sites (San Diego, California and 19 other locations) |
| Trial ID | NCT07144813 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, single-arm post-approval follow-up of subjects previously implanted with the Neuspera sacral neuromodulation system during the Phase I or Phase II SANS-UUI studies. Enrolled participants will have scheduled visits out to 72 months post-implant to collect safety data, device performance metrics, and patient-reported urinary outcomes. The protocol focuses on long-term adverse events, device-related complications, and durability of symptom improvement. Results will fulfill the FDA post-approval study requirement and inform long-term use of the device.
Who should consider this trial
Good fit: Ideal candidates are adults who were implanted with the Neuspera SNM System in the SANS-UUI Phase I or Phase II studies and who consent to long-term follow-up.
Not a fit: People who have not received the Neuspera implant or who did not participate in the earlier Phase I or II SANS-UUI studies are not eligible and would not receive direct benefit from this follow-up.
Why it matters
Potential benefit: If successful, the study could confirm that the Neuspera implant remains safe and provides lasting symptom relief for people with urinary urgency incontinence, giving patients and clinicians more confidence in long-term outcomes.
How similar studies have performed: Previous Phase I/II data for the Neuspera system supported FDA PMA approval, and sacral neuromodulation with other devices has previously shown benefit for urinary urgency incontinence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects in the SANS-UUI Phase I or Phase II study Exclusion Criteria: * None
Where this trial is running
San Diego, California and 19 other locations
- Kaiser Permanente Point Loma MOB — San Diego, California, United States (ACTIVE_NOT_RECRUITING)
- Genesis Healthcare Partners — San Diego, California, United States (ACTIVE_NOT_RECRUITING)
- Florida Urology Partners — Tampa, Florida, United States (ACTIVE_NOT_RECRUITING)
- Women's Health Advantage, — Fort Wayne, Indiana, United States (ACTIVE_NOT_RECRUITING)
- Indiana University, School of Medicine — Indianapolis, Indiana, United States (ACTIVE_NOT_RECRUITING)
- University of Kansas Medical Center, — Kansas City, Kansas, United States (ACTIVE_NOT_RECRUITING)
- University of Louisville Health System, — Louisville, Kentucky, United States (ACTIVE_NOT_RECRUITING)
- Ochsner Medical — New Orleans, Louisiana, United States (ACTIVE_NOT_RECRUITING)
- University of Michigan Health — Wyoming, Michigan, United States (ACTIVE_NOT_RECRUITING)
- Minnesota Urology — Woodbury, Minnesota, United States (ACTIVE_NOT_RECRUITING)
- Specialty Research of St. Louis — St Louis, Missouri, United States (ACTIVE_NOT_RECRUITING)
- Adult & Pediatric Urology P.C — Omaha, Nebraska, United States (ACTIVE_NOT_RECRUITING)
- Premier Medical Group, — Poughkeepsie, New York, United States (ACTIVE_NOT_RECRUITING)
- MetroHealth System, — Cleveland, Ohio, United States (ACTIVE_NOT_RECRUITING)
- Women's Healthcare Associates, — Portland, Oregon, United States (ACTIVE_NOT_RECRUITING)
- The Institute for Female Pelvic Medicine and Reconstructive Surgery, — North Wales, Pennsylvania, United States (ACTIVE_NOT_RECRUITING)
- Southern Urogynecology, — West Columbia, South Carolina, United States (ACTIVE_NOT_RECRUITING)
- Urology Austin, — Austin, Texas, United States (RECRUITING)
- UCNT Dallas, — Dallas, Texas, United States (ACTIVE_NOT_RECRUITING)
- Virginia Mason Medical Center, — Seattle, Washington, United States (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Osvaldo Padron, MD — Florida Urology Partners
- Study coordinator: Mark Vollmer
- Email: mark.vollmer@neuspera.com
- Phone: 408-433-3839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urinary Urgency Incontinence, UUI