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No more charging: new implant aims to ease bladder and bowel leaks

NCT ID NCT06186765

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 16, 2026 · Updated 7 times

Summary

This study is testing a new, recharge-free nerve stimulator (Axonics SNM system) in 144 adults with overactive bladder or fecal incontinence. The device is implanted to stimulate sacral nerves and improve control. Researchers will measure quality of life and symptom changes over one year, along with safety.

What this could mean

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

Active substance
Axonics recharge-free sacral neuromodulation (SNM) system (Model 4101)
What this could lead to
If successful, this device could offer a more convenient, long-term option for managing bladder and bowel control without needing to recharge the implant.
What could go wrong
This is a single-arm, non-randomized study with no placebo group, so results may be less reliable. The device may not work for everyone, and risks include infection or device-related complications.

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

144 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Dec 2027

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

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. 18 years or older 2. Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment 3. 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. Exclusion Criteria: 1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of neurological conditions such as multiple sclerosis) 2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements 3. Previously underwent an external sacral neuromodulation (SNM) trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder) 4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 5. A female who is breastfeeding 6. A female with a positive urine pregnancy test

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence overactive bladder Urinary Incontinence, Urge

As listed by the trial registrant

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

Fecal incontinence (FI) Urinary frequency (UF) Urinary urge incontinence (UUI)

Contacts and locations

Locations

  • Adult Pediatric Urology & Urogynecology

    Omaha, Nebraska, 68114, United States

  • Atrium Health

    Macon, Georgia, 31201, United States

  • Bristol Urological Institute

    Bristol, BS105NB, United Kingdom

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • East Coast Institute of Research

    Jacksonville, Florida, 32216, United States

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Florida Bladder Institute

    Naples, Florida, 34109, United States

  • Florida Gulf Clinical Research

    Bradenton, Florida, 34205, United States

  • Hartford Healthcare

    Waterford, Connecticut, 06385, United States

  • Houston Colon

    Houston, Texas, 77030, United States

  • Minnesota Urology

    Coon Rapids, Minnesota, 55433, United States

  • Northern General Hospital

    Sheffield, S5 7AU, United Kingdom

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Southern Shores Urogynecology

    Myrtle Beach, South Carolina, 29572, United States

  • The Oregon Clinic

    Portland, Oregon, 97225, United States

  • University College London Hospital

    London, W1G 8PH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.