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New device aims to quiet overactive bladder in men

NCT ID NCT06511141

Symptom relief Sponsor: Axonics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times

Summary

This study tests a device called the Axonics SNM System, which uses mild electrical pulses to calm the nerves that control the bladder. It is for men with overactive bladder, including those with urgency incontinence or frequent urination. The trial will enroll 150 men and track how well the device reduces symptoms and improves quality of life over one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Axonics SNM System (a nerve-stimulating device implanted near the sacrum)
What this could lead to
If successful, this could offer men with overactive bladder a long-term option to reduce sudden urges and frequent urination, improving daily comfort.
What could go wrong
This is a post-market study, not a randomized controlled trial, so results may be less definitive. The device requires surgery and carries risks like infection or device malfunction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia overactive bladder prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign prostatic hyperplasia Overactive bladder Prostate cancer Prostatectomy Urinary frequency Urinary urgency incontinence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Urology Institute

    RECRUITING

    Oxford, Florida, 34481, United States

  • AdventHealth

    RECRUITING

    Orlando, Florida, 32825, United States

  • Anne Arundel Urology

    RECRUITING

    Annapolis, Maryland, 21401, United States

  • Associated Urologists of North Carolina (AUNC)

    RECRUITING

    Raleigh, North Carolina, 27612, United States

  • Integrated Medical Professionals

    RECRUITING

    New York, New York, 10016, United States

  • Louisiana State University

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Lowcountry Urology Clinics

    RECRUITING

    North Charleston, South Carolina, 29406, United States

  • Mayo Clinic

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MidLantic Urology

    RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Potomac Urology

    RECRUITING

    Woodbridge, Virginia, 22191, United States

  • Texas Oncology

    COMPLETED

    Houston, Texas, 77070, United States

  • Tri Valley Urology

    RECRUITING

    Murrieta, California, 92562, United States

  • USNC

    RECRUITING

    Mountain View, California, 94040, United States

  • University Hospitals Cleveland

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • Urology Associates

    COMPLETED

    Fairhope, Alabama, 36532, United States

  • Urology Partners of North Texas (UPNT)

    RECRUITING

    Arlington, Texas, 76017, United States

  • Utica Park Urology

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • WK Clinical Research

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Wayne State University

    RECRUITING

    Detroit, Michigan, 48201, United States

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