Clinical Post- Approval Study of the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
• Subjects in the SANS-UUI Phase I or Phase II study
Locations
United States
California
Genesis Healthcare Partners
ACTIVE_NOT_RECRUITING
San Diego
Kaiser Permanente Point Loma MOB
ACTIVE_NOT_RECRUITING
San Diego
Florida
Florida Urology Partners
ACTIVE_NOT_RECRUITING
Tampa
Indiana
Women's Health Advantage,
ACTIVE_NOT_RECRUITING
Fort Wayne
Indiana University, School of Medicine
ACTIVE_NOT_RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center,
ACTIVE_NOT_RECRUITING
Kansas City
Kentucky
University of Louisville Health System,
ACTIVE_NOT_RECRUITING
Louisville
Louisiana
Ochsner Medical
ACTIVE_NOT_RECRUITING
New Orleans
Michigan
University of Michigan Health
ACTIVE_NOT_RECRUITING
Wyoming
Minnesota
Minnesota Urology
ACTIVE_NOT_RECRUITING
Woodbury
Missouri
Specialty Research of St. Louis
ACTIVE_NOT_RECRUITING
St Louis
Nebraska
Adult & Pediatric Urology P.C
ACTIVE_NOT_RECRUITING
Omaha
New York
Premier Medical Group,
ACTIVE_NOT_RECRUITING
Poughkeepsie
Ohio
MetroHealth System,
ACTIVE_NOT_RECRUITING
Cleveland
Oregon
Women's Healthcare Associates,
ACTIVE_NOT_RECRUITING
Portland
Pennsylvania
The Institute for Female Pelvic Medicine and Reconstructive Surgery,
ACTIVE_NOT_RECRUITING
North Wales
South Carolina
Southern Urogynecology,
ACTIVE_NOT_RECRUITING
West Columbia
Texas
Urology Austin,
RECRUITING
Austin
UCNT Dallas,
ACTIVE_NOT_RECRUITING
Dallas
Washington
Virginia Mason Medical Center,
ACTIVE_NOT_RECRUITING
Seattle
Contact Information
Primary
Mark Vollmer
mark.vollmer@neuspera.com
408-433-3839
Backup
Shital Patel
shital.patel@neuspera.com
323-528-1320
Time Frame
Start Date: 2025-09-03
Estimated Completion Date: 2029-12
Participants
Target number of participants: 116
Treatments
Other: Neuspera Implantable Sacral Neuromodulation Stimulation System
Long term follow-up for the FDA approved Neuspera Sacral Neuromodulation Stimulation system
Related Therapeutic Areas
Sponsors
Leads: Neuspera Medical, Inc.