Sacral Neuromodulation for Male Overactive Bladder (MOAB)
Purpose
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Conditions
- Overactive Bladder
- Urinary Urgency Incontinence
- Benign Prostatic Hyperplasia
- Prostate Cancer
- Prostatectomy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants aged ≥ 18 years at the time of enrollment 2. Able to complete bladder diaries and patient questionnaires 3. Primary diagnosis of Urinary Urgency Incontinence (UUI) 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 5. Underwent prostatectomy for prostate cancer at least 6 months prior to enrollment 6. Underwent radiation therapy for prostate cancer at least 6 months prior to enrollment 7. Underwent cytoreductive surgical intervention for BPH at least 6 months prior to enrollment
Exclusion Criteria
- 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 Tibial Nerve Stimulation (ITNS) 6. Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment 7. Underwent an external trial with any sacral neuromodulation device and was deemed a non-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 (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain) 9. Uncontrolled diabetes 10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Single Arm |
Clinical outcomes with use of Axonics SNM system for the male OAB population. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Axonics, Inc.
Detailed Description
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (BPH).