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Implant zaps bladder nerves to stop sudden leaks

NCT ID NCT03327948

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device that uses mild electrical pulses to calm the nerves controlling the bladder. It was for people with sudden, strong urges to urinate that cause leaks, who didn't get help from other treatments. The goal was to see if the device safely reduces leaks by at least half.

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

129 people

The number who actually took part.

Started

Nov 2017

Finished

Jun 2020

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

21 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.

Primary Inclusion Criteria: 1. Diagnosis of UUI demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, at least 50% of all leaking episodes associated with urgency, and at least one leaking episode each 24-hour period. 2. Greater than or equal to 6 months' history of UUI diagnosis 3. For male subjects only: Peak flow rate \> 15 cc/s as verified by uroflowmetry within 6 months prior to enrollment; Residual bladder volume \< 150 cc tested within 6 months prior to enrollment 4. 21 years of age and older 5. Willing and capable of providing informed consent 6. Capable of participating in all testing associated with this clinical investigation Primary Exclusion Criteria: 1. Stress incontinence or mixed incontinence. 2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) 3. Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines 4. A female who is breastfeeding 5. A female with a positive urine pregnancy test

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Conditions

The condition(s) this trial relates to.

overactive bladder Urinary Incontinence, Urge

As listed by the trial registrant

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

Urinary incontinence, urge

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Maastricht University Medical Center

    Maastricht, Netherlands

  • UC Irvine Health

    Irvine, California, 95134, United States

  • UCLH

    London, United Kingdom

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