PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB

Exclusion Criteria

• •1. 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)
• •2. 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
• •3. 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)
• •4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
• •5. A female who is breastfeeding
• •6. A female with a positive urine pregnancy test