To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Participants aged ≥ 18 years at the time of enrollment
Able to complete bladder diaries and patient questionnaires
Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).
Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year
Any patient that is not a suitable candidate per investigator discretion
Recent prostate therapy or procedure within the last 6 months at the time of enrollment
Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
Previously implanted with a sacral neuromodulation device, including inactive SNM devices
Axonics, Inc.
Lead sponsor