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Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
RecruitingObservational study
Follow-up Revision Experience and Evaluation of Device Outcomes Metrics in Subjects Receiving Replacement of Traditional Sacral Neuromodulation (SNM) With the Neuspera SNM System
Who can join
Ages 22 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Currently have a traditional SNM device and has decided to have the device replaced with the Neuspera SNM System OR previously had an existing traditional SNM implant that was completely removed within the last year 2. Is 22 years of age or older 3. Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system 4. Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling 5. Is capable of participating in all testing and follow-up clinic visits associated with this clinical study. Exclusion Criteria: 1. Has a contraindication for the Neuspera SNM System per the device labeling. 2. Has plans to enroll or is currently enrolled in another investigational device or drug trial during his/her participation in this study
About the study
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
What is being tested
- Neuspera Implantable Sacral Neuromodulation System (device)
Sponsor: Neuspera Medical, Inc. · Participants: 100 · Started: Apr 1, 2026
Contact the study team
- Mark Vollmer · Phone: 408-433-3839
- Shital Patel · Phone: 3235281320
Official record on ClinicalTrials.gov — NCT07383688
Locations in the U.S.
| Missouri | Specialty Clinical Research of St. Louis, St Louis |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.