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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.