Sacral Neuromodulation for Male Overactive Bladder (MOAB)
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
| Condition(s) | Overactive Bladder, Urinary Urgency Incontinence, Benign Prostatic Hyperplasia, Prostate Cancer, Prostatectomy, Urinary Frequency |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients. |
| Who can participate | 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 with specified evaluations at clinical investigational sites and attend all follow-up assessments 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 of enrollment 3. Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peri |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Axonics, Inc. |
| Locations | Birmingham, Alabama, United States; Fairhope, Alabama, United States; Scottsdale, Arizona, United States; Mountain View, California, United States; Murrieta, California, United States; Miami, Florida, United States (+14 more sites) |
| Start date | 2024-10-22 |
| NCT ID | NCT06511141 |
| Official listing | https://clinicaltrials.gov/study/NCT06511141 |