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RECRUITINGINTERVENTIONAL

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Sacral Neuromodulation for Male Overactive Bladder

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.

Who May Be Eligible (Plain English)

Key Who May Qualify: 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 willing to sign a consent form and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year Key Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Axonics SNM System

To assess clinical outcomes of the Axonics SNM System in the male OAB population.

Locations (19)

University of Alabama at Birmingham
Birmingham, Alabama, United States
Urology Associates
Fairhope, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
El Camino Health
Mountain View, California, United States
Tri Valley Urology
Murrieta, California, United States
University of Miami
Miami, Florida, United States
Advanced Urology Institute
Oxford, Florida, United States
Louisiana State University
New Orleans, Louisiana, United States
WK Clinical Research
Shreveport, Louisiana, United States
Anne Arundel Urology
Annapolis, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Integrated Medical Professionals
New York, New York, United States
Associated Urologists of North Carolina (AUNC)
Raleigh, North Carolina, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Utica Park Urology
Tulsa, Oklahoma, United States
Lowcountry Urology Clinics
North Charleston, South Carolina, United States
Urology Partners of North Texas (UPNT)
Arlington, Texas, United States
Texas Oncology
Houston, Texas, United States
Potomac Urology
Woodbridge, Virginia, United States