Sacral Neuromodulation for Male Overactive Bladder (MOAB)

May 11, 2026 updated by: Axonics, Inc.

Sacral Neuromodulation for Male Overactive Bladder

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Adam Baumgarten, MD
        • Contact:
          • Alisha Hitt
      • Fairhope, Alabama, United States, 36532
        • Active, not recruiting
        • Urology Associates
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Sirena Castillo
        • Principal Investigator:
          • Christopher Wolter, MD
    • California
      • Mountain View, California, United States, 94040
        • Recruiting
        • El Camino Health
        • Principal Investigator:
          • Edward Karpman, MD
        • Contact:
          • Annette West
      • Murrieta, California, United States, 92562
        • Recruiting
        • Tri Valley Urology
        • Contact:
          • Anita Deeds
        • Contact:
          • Vivian Cabral Perez
        • Principal Investigator:
          • Varun Talanki, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Raveen Syan, MD
        • Contact:
          • Elena Cortizas
        • Contact:
          • Maria N Odrosgoitia
      • Oxford, Florida, United States, 34481
        • Recruiting
        • Advanced Urology Institute
        • Contact:
          • Josi Cortese
        • Contact:
          • Caitlyn Gall
        • Principal Investigator:
          • Harvey Taub, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University
        • Contact:
          • Jaya Mishra, PhD
        • Principal Investigator:
          • Ryan Krlin, MD
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • WK Clinical Research
        • Principal Investigator:
          • Gerard Henry, MD
        • Contact:
          • Sherry Stephens
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Anne Arundel Urology
        • Principal Investigator:
          • Mara Holton, MD
        • Contact:
          • Megan Lormore
        • Sub-Investigator:
          • Kari Bailey, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Meghan Cooper, DO
        • Contact:
          • Carter Day
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • Integrated Medical Professionals
        • Principal Investigator:
          • Jed Kaminetsky, MD
        • Contact:
          • Michael Yang
        • Contact:
          • Luis Leanez
        • Sub-Investigator:
          • Thomas Rechtschaffen, MD
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • Associated Urologists of North Carolina (AUNC)
        • Principal Investigator:
          • Mark Jalkut, MD
        • Contact:
          • Kiplyne Moffett, RN
        • Sub-Investigator:
          • John Kaspar, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland
        • Principal Investigator:
          • Aram Loeb, MD
        • Contact:
          • Imani Lucas
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Utica Park Urology
        • Contact:
          • Alex Heinze, PA-C
        • Principal Investigator:
          • Melanie Ketchandji, MD
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • MidLantic Urology
        • Principal Investigator:
          • Laurence Belkoff, DO
        • Contact:
          • Cheryl Zinar
        • Contact:
          • Kelly Liberatore
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Recruiting
        • Lowcountry Urology Clinics
        • Principal Investigator:
          • Justin Ellett, MD
        • Contact:
          • Madalyn Colbert
        • Contact:
          • Shanteese La Mons
    • Texas
      • Arlington, Texas, United States, 76017
        • Active, not recruiting
        • Urology Partners of North Texas (UPNT)
      • Houston, Texas, United States, 77070
        • Completed
        • Texas Oncology
    • Virginia
      • Woodbridge, Virginia, United States, 22191
        • Recruiting
        • Potomac Urology
        • Principal Investigator:
          • Alok Desai, MD
        • Contact:
          • Annelise Marsh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Post-prostatectomy
History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment
Device: Axonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Other: Radiation
History of radiation for cancer treatment at least 6 months prior to enrollment
Device: Axonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Other: Benign Prostatic Hyperplasia (BPH)
History of cytoreductive BPH surgery at least 6 months prior to enrollment
Device: Axonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event reporting (Safety)
Time Frame: 6 months, 1 year
Device related, procedure-related and all serious adverse events
6 months, 1 year
Performance/Effectiveness - Reduction in UUI or UF episodes
Time Frame: 6 months, 1 year
Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary
6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance/Effectiveness - Improvement in Quality of Life scoring
Time Frame: 6 months, 1 year
International Consultation of Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axonics, Inc.

Investigators

  • Study Director: Gita Ghadimi, OD, Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105-0141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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