Post-Approval Study of the Neuspera Sacral Neuromodulation System
- Conditions
- Urinary Urgency Incontinence
- Registration Number
- NCT07144813
- Lead Sponsor
- Neuspera Medical, Inc.
- Brief 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.
- Detailed Description
The Neuspera SNM System received FDA PMA approval for the treatment of urinary urge incontinence in subjects who have failed, could not tolerate, or were not a candidate for more conservative treatment. The study will serve as the Post Approval Study (PAS) requirement of the PMA Approval.
This post approval study (PAS) is designed to assess the long-term safety and effectiveness data out to 72 months post-implant, in consenting subjects implanted in Phase I or Phase II study.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 116
- Subjects in the SANS-UUI Phase I or Phase II study
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint Through 72 months Incidence of device- and procedure-related AEs
Primary Effectiveness Endpoint: Through 72 months Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more
- Secondary Outcome Measures
Name Time Method