Post-Approval Study of the Neuspera Sacral Neuromodulation System
ConditionUrinary Urgency Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorNeuspera Medical, Inc.
About this trial
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 criteria
Qualifiers
Subjects in the SANS-UUI Phase I or Phase II study
Disqualifiers
None
Trial design
Treatments tested in this trial
- Neuspera Implantable Sacral Neuromodulation System
Treatment groups
116 Participants
are divided into 1 treatment groupLocations
20California
Genesis Healthcare Partners92123, San Diego United States
Kaiser Permanente Point Loma MOB92110, San Diego United States
Florida
Florida Urology Partners33615, Tampa United States
Indiana
Women's Health Advantage,46825, Fort Wayne United States
Sponsors and collaborators
Neuspera Medical, Inc.
Lead sponsor
Source ClinicalTrials.gov