F15 Recharge Free Axonics SNM System Clinical Study

Inclusion Criteria:

1. 18 years or older

2. Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, orwho have failed conservative treatment

3. Willing and capable to provide written informed consent and agrees to comply withspecified evaluations at clinical investigational sites and attend all follow-upassessments for up to 1 year.

Exclusion Criteria:

1. Any significant medical condition that is likely to interfere with procedures,device operation, or likely to confound evaluation of endpoints (exclusion ofneurological conditions such as multiple sclerosis)

2. Any psychiatric or personality disorder that is likely to interfere with proceduresat the discretion of the participating physician; this may include poorunderstanding or compliance with requirements

3. Previously underwent an external sacral neuromodulation (SNM) trial and was deemed anon-responder or was previously implanted with a sacral neuromodulation device anddid 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