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.
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
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
Study population with 22 years of age or older and who have or have previously had a traditional SNM system.
Cohort
Prospective
Neuspera Implantable Sacral Neuromodulation System
DeviceStimulation of the Sacral Nerve
Primary Study measure
The changes to subject questionnaire responses for the Neuspera SNM system compared to responses regarding traditional SNM systems
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This trial is not recruiting at the moment. You can still explore other options:
