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
Single group
Axonics SNM System
DeviceTo assess clinical outcomes of the Axonics SNM System in the male OAB population.
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Performance/Effectiveness - Reduction in UUI or UF episodes
Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary
Performance/Effectiveness - Improvement in Quality of Life scoring
International Consultation of Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
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