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NCT06511141NARecruiting

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Axonics, Inc.

Start Date

10/22/2024

Completion Date

12/1/2028

Summary

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

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Axonics SNM System

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Conditions

Overactive BladderUrinary Urgency IncontinenceBenign Prostatic HyperplasiaProstate CancerProstatectomyUrinary Frequency

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35205

United States

Urology Associates

Fairhope, Alabama 36532

United States

Mayo Clinic

Scottsdale, Arizona 85259

United States

El Camino Health

Mountain View, California 94040

United States

Tri Valley Urology

Murrieta, California 92562

United States

University of Miami

Miami, Florida 33136

United States

Advanced Urology Institute

Oxford, Florida 34481

United States

Louisiana State University

New Orleans, Louisiana 70112

United States

WK Clinical Research

Shreveport, Louisiana 71103

United States

Anne Arundel Urology

Annapolis, Maryland 21401

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Integrated Medical Professionals

New York, New York 10016

United States

Associated Urologists of North Carolina (AUNC)

Raleigh, North Carolina 27612

United States

University Hospitals Cleveland

Cleveland, Ohio 44106

United States

Utica Park Urology

Tulsa, Oklahoma 74104

United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania 19004

United States

Lowcountry Urology Clinics

North Charleston, South Carolina 29406

United States

Urology Partners of North Texas (UPNT)

Arlington, Texas 76017

United States

Texas Oncology

Houston, Texas 77070

United States

Potomac Urology

Woodbridge, Virginia 22191

United States