Overview
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
Description
This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.
Eligibility
Inclusion Criteria:
- 18 years or older
- Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
- Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments
Exclusion Criteria:
- Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)
- Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
- Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
- History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- A female who is breastfeeding
- A female with a positive urine pregnancy test