Post-Approval Study of the Neuspera Sacral Neuromodulation System
Purpose
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.
Condition
- Urinary Urgency Incontinence
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subjects in the SANS-UUI Phase I or Phase II study
Exclusion Criteria
- None
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Neuspera Implantable Sacral Neuromodulation Stimulation System |
Long term follow-up for the FDA approved Neuspera Sacral Neuromodulation Stimulation system |
|
Recruiting Locations
Austin 4671654, Texas 4736286 78759
Brian Mazzarella, MD
(502)-569-7904
More Details
- Status
- Recruiting
- Sponsor
- Neuspera Medical, Inc.
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.