About this trial
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.
Eligibility criteria
Qualifiers
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
Is 22 years of age or older
Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system
Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling
Disqualifiers
Has a contraindication for the Neuspera SNM System per the device labeling.
Has plans to enroll or is currently enrolled in another investigational device or drug trial during his/her participation in this study
Trial design
Treatments tested in this trial
- Neuspera Implantable Sacral Neuromodulation System