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Clinical Trials in the USA / NCT06511141
Recruiting

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

NCT06511141 · tracked via the Priya Life Science USA tracker
Sponsor
Axonics, Inc.
Phase
N/A
Started
2024-10-22
Last updated
2026-09-14

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

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)

Trial sites (23)

FacilityCityRegionStatus
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.

View NCT06511141 on ClinicalTrials.gov ↗ ← All trials in the USA