Sacral Neuromodulation for Male Overactive Bladder (MOAB)

September 10, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Completed
        • 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
        • USNC
        • Principal Investigator:
          • Edward Karpman, MD
        • Contact:
          • Annette West
      • Murrieta, California, United States, 92562
        • Recruiting
        • Tri Valley Urology
        • Contact:
          • Anita Deeds
        • Principal Investigator:
          • Varun Talanki, MD
        • Contact:
          • Kristi Dalton
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Contact:
          • Natalie Rios
        • Contact:
          • Jennette Sison
        • Principal Investigator:
          • Michelle Van Kuiken, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Raveen Syan, MD
        • Contact:
          • Elena Cortizas
        • Contact:
          • Maria N Odrosgoitia
      • Orlando, Florida, United States, 32825
        • Recruiting
        • AdventHealth
        • Contact:
          • Genevieve Rexford
        • Principal Investigator:
          • Daniel S. Hoffman, MD
      • 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
        • Contact:
          • Patricia Johnson
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Anne Arundel Urology
        • Principal Investigator:
          • Mara Holton, MD
        • Contact:
          • Megan Lormore
        • Sub-Investigator:
          • Kari Bailey, MD
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University
        • Contact:
          • Matthew Kronick
        • Principal Investigator:
          • Aron Liaw, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Meghan Cooper, DO
        • Contact:
          • Carter Day
        • Contact:
          • Miranda Smith
    • 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:
          • Twishasri Dasgupta
    • 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:
          • Josi Cortese
    • Texas
      • Arlington, Texas, United States, 76017
        • Recruiting
        • Urology Partners of North Texas (UPNT)
        • Contact:
          • Grace Yoon
        • Principal Investigator:
          • Geoffrey Nuss, MD
        • Contact:
          • Michelle Le
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Axonics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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