Post-Approval Study of the Neuspera Sacral Neuromodulation System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuspera Implantable Sacral Neuromodulation System.
- Who it may be relevant to
- Registry conditions: Urinary Urgency Incontinence. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Post- Approval Study of the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Overview
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
- Device Neuspera Implantable Sacral Neuromodulation System
Stimulation of the Sacral Nerve.
Primary outcome measures
- Primary Safety Endpoint [Time frame: Through 72 months]
- Primary Effectiveness Endpoint: [Time frame: Through 72 months]
Eligibility criteria
Inclusion criteria
- Subjects in the SANS-UUI Phase I or Phase II study
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Kaiser Permanente Point Loma MOB — San Diego
- Genesis Healthcare Partners — San Diego
- Florida Urology Partners — Tampa
- Women's Health Advantage, — Fort Wayne
- Indiana University, School of Medicine — Indianapolis
- University of Kansas Medical Center, — Kansas City
- University of Louisville Health System, — Louisville
- Ochsner Medical — New Orleans
- … and 12 more centers
Identifiers
NCT: NCT07144813 · Neuspera Medical (NSM-005)