Recruiting

Sacral Neuromodulation

Sponsor:

Axonics, Inc.

Code:

NCT06511141

Conditions

Overactive Bladder

Urinary Urgency Incontinence

Benign Prostatic Hyperplasia

Prostate Cancer

Prostatectomy

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Axonics SNM System

Study Details

Brief summary:

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

Conditions

Overactive Bladder

Urinary Urgency Incontinence

Benign Prostatic Hyperplasia

Prostate Cancer

Prostatectomy

Study ID

NCT06511141

Start date

Oct 22, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Post-prostatectomy

History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment

other: Radiation

History of radiation for cancer treatment at least 6 months prior to enrollment

other: Benign Prostatic Hyperplasia (BPH)

History of cytoreductive BPH surgery at least 6 months prior to enrollment

Interventions

Axonics SNM System

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

Primary outcome measure

  • Adverse event reporting (Safety) [ Time Frame: 6 months, 1 year ]
  • Performance/Effectiveness - Reduction in UUI or UF episodes [ Time Frame: 6 months, 1 year ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Principal Investigator:

Adam Baumgarten, MD

Mayo Clinic

Recruiting

Scottsdale, Arizona, United States, 85259

Principal Investigator:

Christopher Wolter, MD

USNC

Recruiting

Mountain View, California, United States, 94040

Principal Investigator:

Edward Karpman, MD

Tri Valley Urology

Recruiting

Murrieta, California, United States, 92562

Principal Investigator:

Varun Talanki, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Raveen Syan, MD

AdventHealth

Recruiting

Orlando, Florida, United States, 32825

Principal Investigator:

Daniel S. Hoffman, MD

Advanced Urology Institute

Recruiting

Oxford, Florida, United States, 34481

Principal Investigator:

Harvey Taub, MD

Louisiana State University

Recruiting

New Orleans, Louisiana, United States, 70112

Principal Investigator:

Ryan Krlin, MD

WK Clinical Research

Recruiting

Shreveport, Louisiana, United States, 71103

Principal Investigator:

Gerard Henry, MD

Anne Arundel Urology

Recruiting

Annapolis, Maryland, United States, 21401

Principal Investigator:

Mara Holton, MD

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Principal Investigator:

Aron Liaw, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Meghan Cooper, DO

Integrated Medical Professionals

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Jed Kaminetsky, MD

Associated Urologists of North Carolina (AUNC)

Recruiting

Raleigh, North Carolina, United States, 27612

Principal Investigator:

Mark Jalkut, MD

University Hospitals Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Aram Loeb, MD

Utica Park Urology

Recruiting

Tulsa, Oklahoma, United States, 74104

Principal Investigator:

Melanie Ketchandji, MD

MidLantic Urology

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Principal Investigator:

Laurence Belkoff, DO

Lowcountry Urology Clinics

Recruiting

North Charleston, South Carolina, United States, 29406

Principal Investigator:

Justin Ellett, MD

Urology Partners of North Texas (UPNT)

Recruiting

Arlington, Texas, United States, 76017

Principal Investigator:

Geoffrey Nuss, MD

Potomac Urology

Recruiting

Woodbridge, Virginia, United States, 22191

Principal Investigator:

Alok Desai, MD

More Information

Sponsor

Axonics, Inc.

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Axonics, Inc. on 2026-08-12.