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Nerve zap device shows promise for bladder and bowel woes

NCT ID NCT05064384

Disease control 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed study looked at how well the Axonics sacral neuromodulation system works for people with bladder or bowel control problems. 272 participants were tracked to see if their symptoms improved and if the device was safe. The device uses mild electrical pulses to calm overactive nerves, aiming to reduce urgent leaks, frequent urination, and fecal incontinence.

What this could mean

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

Active substance
Axonics Sacral Neuromodulation System (implantable device)
What this could lead to
If successful, this could confirm that the Axonics device reliably reduces urgent leaks, frequent urination, and fecal incontinence, offering a long-term management option.
What could go wrong
This is a completed registry study, not a randomized trial, so results may be less definitive. Some participants may not respond or may experience device-related side effects.

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.

Participants

272 people

The number who actually took part.

Started

Nov 2020

Finished

Mar 2024

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.

Who is studied

Participants who are scheduled to undergo an Axonics Trial or Axonics System will be considered candidates for the study and will be recruited from each Investigator's patient population.

Ages

18 years and older

Sex

Anyone

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.

Inclusion Criteria: 1. Patients scheduled to be trialed with the Axonics External Trial System (ETS), or patients scheduled to receive an Axonics Implantable neurostimulator (INS) or Axonics FS implant 2. Willing and capable of providing informed consent 3. Capable of participating in all testing associated with this clinical investigation Exclusion Criteria: For all indications: 1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints 2. Any psychiatric or personality disorder at the discretion of the study physician 3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 4. A female who is breastfeeding 5. A female with a positive urine pregnancy test For OAB \& UR: 6. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) 7. Current symptomatic urinary tract infection (UTI) For FI only: 8. Rectomucosal prolapse or congenital anorectal malformation

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence overactive bladder Urinary Incontinence, Urge Urinary Retention

As listed by the trial registrant

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

Fecal incontinence Urgency-frequency Urinary retention Urinary urge incontinence

Contacts and locations

Locations

  • Adult Pediatric Urology & Urogynecology

    Omaha, Nebraska, 68114, United States

  • Arkansas Urology Research Center

    Little Rock, Arkansas, 72210, United States

  • Center for Pelvic Health

    Franklin, Tennessee, 37067, United States

  • Chesapeake Urology

    Hanover, Maryland, 21076, United States

  • Comprehensive Urology

    Royal Oak, Michigan, 48073, United States

  • Florida Urology Partners

    North Redington Beach, Florida, 33708, United States

  • Florida Urology Partners

    Tampa, Florida, 33606, United States

  • Institute for Female Pelvic Medicine and Reconstructive Surgery

    Allentown, Pennsylvania, 18103, United States

  • LSU Health

    New Orleans, Louisiana, 70112, United States

  • Manatee Medical Research Institute

    Bradenton, Florida, 34205, United States

  • New Jersey Urology

    Englewood, New Jersey, 07631, United States

  • Northwestern

    Chicago, Illinois, 60611, United States

  • Ochsner Health

    New Orleans, Louisiana, 70121, United States

  • Penn State University

    Hershey, Pennsylvania, 17033, United States

  • Pinellas Urology

    St. Petersburg, Florida, 33710, United States

  • Sansum Clinic Urology

    Santa Barbara, California, 93105, United States

  • Southern Urogynecology

    West Columbia, South Carolina, 29169, United States

  • Stanford Medicine

    Redwood City, California, 94063, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • The Female Pelvic Health Center

    Newtown, Pennsylvania, 33606, United States

  • The Urology Center PC

    Omaha, Nebraska, 68114, United States

  • University of Alberta

    Edmonton, Alberta, Canada

  • University of California, Irvine

    Irvine, California, 92697, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0558, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • Urologic Solutions

    Fort Myers, Florida, 33908, United States

  • Urologic Specialists Oklahoma

    Tulsa, Oklahoma, 74146, United States

More trials for these conditions

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