Clinical Trials in the USA / NCT06511141
Recruiting
Not applicable
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
NCT06511141 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Overactive BladderUrinary Urgency IncontinenceBenign Prostatic HyperplasiaProstate CancerProstatectomyUrinary Frequency
Investigational drug(s) / intervention(s)
Axonics SNM System
Axonics SNM System: To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Study summary
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Eligibility
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 Tibial Nerve Stimulation (ITNS)
6. Positive response to 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 at the discretion of the participating physician.
9. Uncontrolled diabetes
10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone
Primary outcome measure(s)
- Adverse event reporting (Safety) — 6 months, 1 year
Device related, procedure-related and all serious adverse events - Performance/Effectiveness - Reduction in UUI or UF episodes — 6 months, 1 year
Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Urology Associates | Fairhope | Alabama | Completed |
| Mayo Clinic | Scottsdale | Arizona | Recruiting |
| USNC | Mountain View | California | Recruiting |
| Tri Valley Urology | Murrieta | California | Recruiting |
| University of California San Francisco | San Francisco | California | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| AdventHealth | Orlando | Florida | Recruiting |
| Advanced Urology Institute | Oxford | Florida | Recruiting |
| Louisiana State University | New Orleans | Louisiana | Recruiting |
| WK Clinical Research | Shreveport | Louisiana | Recruiting |
| Anne Arundel Urology | Annapolis | Maryland | Recruiting |
| Wayne State University | Detroit | Michigan | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Integrated Medical Professionals | New York | New York | Recruiting |
| Associated Urologists of North Carolina (AUNC) | Raleigh | North Carolina | Recruiting |
| University Hospitals Cleveland | Cleveland | Ohio | Recruiting |
| Utica Park Urology | Tulsa | Oklahoma | Recruiting |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | Recruiting |
| Lowcountry Urology Clinics | North Charleston | South Carolina | Recruiting |
| Urology Partners of North Texas (UPNT) | Arlington | Texas | Recruiting |
| Texas Oncology | Houston | Texas | Completed |
| Potomac Urology | Woodbridge | Virginia | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06511141 on ClinicalTrials.gov ↗ ← All trials in the USA