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A patch-like device zaps a leg nerve to calm an overactive bladder

NCT ID NCT06659536

Symptom relief Sponsor: DJO UK Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests a device called Cefar URO that sends mild electrical pulses to a nerve in the ankle, a method known as transcutaneous tibial nerve stimulation. The goal is to see if it reduces urge incontinence and other overactive bladder symptoms in adults, including those whose condition has not improved with other treatments. Participants will use the device themselves and track their symptoms over 12 weeks. The study focuses on safety and how much symptoms improve.

What this could mean

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

Active substance
Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar URO device
What this could lead to
If it works, this could offer a drug-free option for people with overactive bladder to reduce urgent, frequent urination and accidental leaks.
What could go wrong
This is a post-market study with 53 participants, so results may not apply to everyone. The device may not ease symptoms for all users, and some may experience side effects or discomfort.

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 53 people

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

Started

Jan 2026

Expected to finish

Oct 2026

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: * Adult patients with overactive bladder (including refractory overactive bladder of idiopathic or neurogenic origin) who require symptomatic treatment of urge incontinence and associated symptoms. * Subjects, both male and female, ≥ 18 years of age at the time of consent * Subjects have provided their written consent to participate in the study by signing the Ethics-approved consent form. * Patients are considered able and willing to self-administer transcutaneous tibial nerve stimulator (TTNS) treatment at home, based on Investigator's judgement. * Patients are suitable to receive treatment using the Cefar URO device P4 program pre-set parameters (frequency 20Hz and pulse width 200μs) for 12 weeks, based on Investigator's judgement. * If undergoing pharmacological therapy for incontinence, the therapy must be stabilized for at least 4 weeks before baseline visit Exclusion Criteria: * Pregnancy confirmed by urine test at screening * Urinary tract infection confirmed by urine analysis * Serious secondary illness (such as renal failure, nephrolithiasis, bladder and kidney tumors) * Detrusor-sphincter dyssynergia * Patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD; or other implantable electronic devices * Subjects who are not able to read and understand the Instructions for Use, warnings, cautions and dangers * Subjects who are not able to read and understand indications and contraindications of the device * Subjects who are not able to sense auditory and visual signals * Patients with anti-incontinence surgery planned during the course of the study * Participation in another clinical study within 30 days prior to screening

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Conditions

The condition(s) this trial relates to.

overactive bladder

As listed by the trial registrant

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

Overactive bladder (OAB) Refractory overactive bladder Urinary urgency and frequency

How to take part

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

  1. The places running it

    1 site. 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

  • Neuro-Urology Department, Tenon Hospital

    RECRUITING

    Paris, 75020, France

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