RecruitingNot ApplicableNCT06511141

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Sacral Neuromodulation for Male Overactive Bladder


Sponsor

Axonics, Inc.

Enrollment

150 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria4

  • Participants aged ≥ 18 years at the time of enrollment
  • Able to complete bladder diaries and patient questionnaires
  • Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).
  • 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

Exclusion Criteria10

  • Any patient that is not a suitable candidate per investigator discretion
  • Recent prostate therapy or procedure within the last 6 months at the time of enrollment
  • 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)
  • Previously implanted with a sacral neuromodulation device, including inactive SNM devices
  • Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)
  • Positive response to Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment
  • Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician
  • 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.
  • Uncontrolled diabetes
  • Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone

Interventions

DEVICEAxonics 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

View Full Details on ClinicalTrials.gov

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NCT06511141


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