NCT06511141 Sacral Neuromodulation for Male Overactive Bladder (MOAB)
| NCT ID | NCT06511141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Axonics, Inc. |
| Condition | Overactive Bladder |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-12 |
Trial Parameters
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Brief Summary
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Eligibility Criteria
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 peripheral neuropathy, or spinal cord injury (e.g., paraplegia) 4. Previously implanted with a sacral neuromodulation device, including inactive SNM devices 5. Any prior treatment with an Implantable Tibi