Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Key Inclusion Criteria:

1. Participants aged ≥ 18 years at the time of enrollment

2. Able to complete bladder diaries and patient questionnaires

3. Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).

4. 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

Key Exclusion Criteria:

1. Any patient that is not a suitable candidate per investigator discretion

2. Recent prostate therapy or procedure within the last 6 months at the time ofenrollment

3. Any neurological condition that could interfere with normal bladder function,including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinicallysignificant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)

4. Previously implanted with a sacral neuromodulation device, including inactive SNMdevices

5. Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)

6. Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time ofenrollment

7. Underwent an external trial with any sacral neuromodulation device and was deemed anon-responder by a physician

8. Any significant medical condition that is likely to interfere with study procedures,device operation, or likely to confound evaluation of study objectives at thediscretion of the participating physician.

9. Uncontrolled diabetes

10. Known allergic reactions to components of the Axonics SNM System, includingtitanium, zirconia, polyurethane, epoxy, or silicone