Clinical Research Directory
Browse clinical research sites, groups, and studies.
Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Sponsor: Neuspera Medical, Inc.
Summary
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.
Official title: Clinical Study of Neuspera's Implantable Sacral Nerve Stimulation (SNS) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
331
Start Date
2019-12-13
Completion Date
2026-12
Last Updated
2025-11-03
Healthy Volunteers
No
Conditions
Interventions
Neuspera Implantable Sacral Nerve Stimulation System
Stimulation of the Sacral Nerve.
Locations (34)
Genesis Healthcare Partners
Encinitas, California, United States
Kaiser Permanente, LAMC
Los Angeles, California, United States
Kaiser Permanente
San Diego, California, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Florida Urology Partners, LLC
Tampa, Florida, United States
Midtown Urology
Atlanta, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Comprehensive Urologic Care
Lake Barrington, Illinois, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kansas Hospital
Kansas City, Kansas, United States
UofL Health System (University of Louisville)
Louisville, Kentucky, United States
Ochsner Medical
New Orleans, Louisiana, United States
University of Michigan Health - West
Wyoming, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, 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
Weill Cornell Medical College
New York, New York, United States
Premier Medical Group
Poughkeepsie, New York, United States
Associated Medical Professionals of NY
Syracuse, New York, United States
MetroHealth
Cleveland, Ohio, United States
The Oregon Clinic Urogynecology West
Portland, Oregon, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery
North Wales, Pennsylvania, United States
Southern shores urogynecology
Myrtle Beach, South Carolina, United States
Southern Urogynecology
West Columbia, South Carolina, United States
Center for Pelvic Health
Franklin, Tennessee, United States
Urology Austin
Austin, Texas, United States
Urology Clinics of North Texas (Dallas Center for Pelvic Medicine)
Dallas, Texas, United States
Virginia Mason
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Universiteit Antwerpen
Antwerp, Belgium
Maastricht University Medical Center
Maastricht, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands