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Post-Approval Study of the Neuspera Sacral Neuromodulation System
Sponsor: Neuspera Medical, Inc.
Summary
Prospective, multi-center, single-arm, post-approval study is designed to assess the long-term safety and efficacy data of the Neuspera Sacral Neuromodulation (SNM) System following commercial approval of the Neuspera SNM System. Participants in this study received intervention/implanted in Phase I or Phase II of the Neuspera SANS\_UUI (NSM-004) Study.
Official title: Clinical Post- Approval Study of the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2025-09-03
Completion Date
2029-12
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
Neuspera Implantable Sacral Neuromodulation System
Stimulation of the Sacral Nerve.
Locations (20)
Kaiser Permanente Point Loma MOB
San Diego, California, United States
Genesis Healthcare Partners
San Diego, California, United States
Florida Urology Partners
Tampa, Florida, United States
Women's Health Advantage,
Fort Wayne, Indiana, United States
Indiana University, School of Medicine
Indianapolis, Indiana, United States
University of Kansas Medical Center,
Kansas City, Kansas, United States
University of Louisville Health System,
Louisville, Kentucky, United States
Ochsner Medical
New Orleans, Louisiana, United States
University of Michigan Health
Wyoming, Michigan, United States
Minnesota Urology
Woodbury, Minnesota, United States
Specialty Research of St. Louis
St Louis, Missouri, United States
Adult & Pediatric Urology P.C
Omaha, Nebraska, United States
Premier Medical Group,
Poughkeepsie, New York, United States
MetroHealth System,
Cleveland, Ohio, United States
Women's Healthcare Associates,
Portland, Oregon, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery,
North Wales, Pennsylvania, United States
Southern Urogynecology,
West Columbia, South Carolina, United States
Urology Austin,
Austin, Texas, United States
UCNT Dallas,
Dallas, Texas, United States
Virginia Mason Medical Center,
Seattle, Washington, United States