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Can a nerve stimulation device outdo pelvic floor exercises for overactive bladder?

NCT ID NCT07788560

Disease control Sponsor: Marmara University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial compares two non-invasive treatments for overactive bladder (OAB): transcutaneous peroneal electrical neuromodulation, which uses surface electrodes to stimulate a nerve in the leg, and pelvic floor exercises, a standard behavioral therapy. Adults with idiopathic OAB will be randomly assigned to one of the two treatments for three months. Researchers will measure changes in bladder symptoms using diaries and questionnaires to see if the nerve stimulation offers comparable or better relief than exercises.

What this could mean

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

Active substance
Transcutaneous peroneal electrical neuromodulation (a device that delivers electrical stimulation to the peroneal nerve) and pelvic floor exercises (a behavioral therapy)
What this could lead to
If effective, this could offer a non-invasive, drug-free option to reduce overactive bladder symptoms, potentially improving quality of life for many adults.
What could go wrong
This is a small, early-stage trial, so results may not be conclusive or widely applicable. The treatment may not outperform standard exercises, and electrical stimulation could cause discomfort or skin irritation.

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 60 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Adults aged 18 years or older. * Diagnosis of idiopathic overactive bladder (OAB) based on clinical evaluation. * Presence of urinary urgency, with or without urgency urinary incontinence, usually accompanied by increased urinary frequency and/or nocturia. * OAB symptoms present for at least 3 months. * Ability to complete bladder diaries and symptom questionnaires. * Willingness to participate in the study and provide written informed consent. * Ability to comply with the assigned treatment protocol and scheduled follow-up visits. Exclusion Criteria: * Neurogenic lower urinary tract dysfunction or a known neurological disease affecting bladder function. * Active urinary tract infection at the time of enrollment. * Significant pelvic organ prolapse. * Predominant stress urinary incontinence or mixed urinary incontinence with predominant stress symptoms. * Clinically significant bladder outlet obstruction or urinary retention. * History of major pelvic surgery or pelvic radiotherapy that may affect lower urinary tract function. * Previous treatment with botulinum toxin injection or neuromodulation within the predefined washout period. * Current use of OAB medications that cannot be discontinued or appropriately washed out before enrollment. * Pregnancy. * Presence of a cardiac pacemaker, implanted defibrillator, or another implanted electrical device incompatible with electrical stimulation. * Any condition that, in the investigator's judgment, would prevent safe participation or adherence to the study protocol.

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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.

Neuromodulation Overactive bladder (OAB)

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

  • Marmara University School of Medicine Urology Department

    Istanbul, Pendik, 34854, Turkey (Türkiye)

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