Neuspera Medical, Inc.
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.
Subjects will be enrolled in a single-arm study and followed for 1-month after implant of the Neuspera SNM System. Subjects will complete a questionnaire regarding their experience with the traditional SNM system prior to the Neuspera implant, then undergo an implant of the Neuspera SNM system using standard of care according to the device's commercial labeling. Up to 20 subjects will be enrolled.
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 associa…
Stimulation of the Sacral Nerve
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