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RecruitingInterventional

Sacral Neuromodulation for Male Overactive Bladder

NCT ID: NCT06511141Sponsor: Axonics, Inc.Last updated: 2026-06-15

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).

Arms & interventions

  • DeviceAxonics SNM System

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

Outcome measures

Primary

  • Adverse event reporting (Safety)

    Device related, procedure-related and all serious adverse events

    Time frame: 6 months, 1 year

  • Performance/Effectiveness - Reduction in UUI or UF episodes

    Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary

    Time frame: 6 months, 1 year

Secondary

  • Performance/Effectiveness - Improvement in Quality of Life scoring

    Time frame: 6 months, 1 year

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy 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

Study locations (20)

University of Alabama at Birmingham

Birmingham, Alabama, 35205

Recruiting
Alisha Hitt · Contact
Adam Baumgarten, MD · Principal Investigator

Urology Associates

Fairhope, Alabama, 36532

Active Not Recruiting

Mayo Clinic

Scottsdale, Arizona, 85259

Recruiting
Sirena Castillo · Contact
Christopher Wolter, MD · Principal Investigator

El Camino Health

Mountain View, California, 94040

Recruiting
Annette West · Contact
Edward Karpman, MD · Principal Investigator

Tri Valley Urology

Murrieta, California, 92562

Recruiting
Vivian Cabral Perez · Contact
Anita Deeds · Contact
Varun Talanki, MD · Principal Investigator

University of Miami

Miami, Florida, 33136

Recruiting
Maria N Odrosgoitia · Contact
Elena Cortizas · Contact
Raveen Syan, MD · Principal Investigator

Advanced Urology Institute

Oxford, Florida, 34481

Recruiting
Josi Cortese · Contact
Caitlyn Gall · Contact
Harvey Taub, MD · Principal Investigator

Louisiana State University

New Orleans, Louisiana, 70112

Recruiting
Jaya Mishra, PhD · Contact
Ryan Krlin, MD · Principal Investigator

WK Clinical Research

Shreveport, Louisiana, 71103

Recruiting
Sherry Stephens · Contact
Gerard Henry, MD · Principal Investigator

Anne Arundel Urology

Annapolis, Maryland, 21401

Recruiting
Megan Lormore · Contact
Mara Holton, MD · Principal Investigator
Kari Bailey, MD · Sub Investigator

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting
Carter Day · Contact
Meghan Cooper, DO · Principal Investigator

Integrated Medical Professionals

New York, New York, 10016

Recruiting
Michael Yang · Contact
Luis Leanez · Contact
Jed Kaminetsky, MD · Principal Investigator
Thomas Rechtschaffen, MD · Sub Investigator

Associated Urologists of North Carolina (AUNC)

Raleigh, North Carolina, 27612

Recruiting
Kiplyne Moffett, RN · Contact
Mark Jalkut, MD · Principal Investigator
John Kaspar, MD · Sub Investigator

University Hospitals Cleveland

Cleveland, Ohio, 44106

Recruiting
Imani Lucas · Contact
Aram Loeb, MD · Principal Investigator

Utica Park Urology

Tulsa, Oklahoma, 74104

Recruiting
Alex Heinze, PA-C · Contact
Melanie Ketchandji, MD · Principal Investigator

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004

Recruiting
Cheryl Zinar · Contact
Kelly Liberatore · Contact
Laurence Belkoff, DO · Principal Investigator

Lowcountry Urology Clinics

North Charleston, South Carolina, 29406

Recruiting
Madalyn Colbert · Contact
Shanteese La Mons · Contact
Justin Ellett, MD · Principal Investigator

Urology Partners of North Texas (UPNT)

Arlington, Texas, 76017

Active Not Recruiting

Texas Oncology

Houston, Texas, 77070

Completed

Potomac Urology

Woodbridge, Virginia, 22191

Recruiting
Annelise Marsh · Contact
Alok Desai, MD · Principal Investigator
Sacral Neuromodulation for Male Overactive Bladder (MOAB) | Cancerify