Urinary Urgency Incontinence
Conditions
Keywords
UUI
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.
Interventions
Stimulation of the Sacral Nerve.
Sponsors
Neuspera Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects in the SANS-UUI Phase I or Phase II study
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTMark Vollmer
CONTACTShital Patel
PRINCIPAL_INVESTIGATOROsvaldo Padron, MD
Florida Urology Partners
Outcome results
None listed