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Can a leg nerve zap curb Post-Prostate surgery leakage?

NCT ID NCT07742176

Disease control Sponsor: Pamukkale 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 03, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This trial tests whether a gentle electrical stimulation of a nerve in the leg, called transcutaneous tibial nerve stimulation (TTNS), can reduce urinary incontinence in men who have had their prostate removed. Participants will receive either active TTNS or a sham (inactive) version, alongside standard pelvic floor muscle training, for 12 weeks. The study measures changes in urine leakage, pelvic floor strength, quality of life, and emotional well-being to see if this approach offers real benefit.

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) delivered via a device, added to pelvic floor muscle training
What this could lead to
If effective, TTNS could offer a non-invasive, drug-free way to reduce post-surgical urinary leakage and improve quality of life in men after prostate removal.
What could go wrong
The trial is relatively small and uses a sham control, so results may not be definitive. TTNS may provide only modest benefit, and individual responses can vary.

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 104 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 to 80 years

Sex

Male participants only

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: * Male patients aged 18-80 years * Urinary incontinence greater than 8 g on the 24-hour pad test after radical prostatectomy * Postoperative catheter removed, between 2 weeks and 1 year after surgery * Willing to complete study questionnaires and able to understand the procedures, benefits, and possible side effects * Able to provide written informed consent Exclusion Criteria: * History of urinary incontinence prior to radical prostatectomy * History of conservative treatment after prostatectomy, including tibial nerve stimulation, magnetic stimulation, or electrical stimulation * Prolonged indwelling urethral catheterization (more than 15 days) * Anatomical/post-traumatic malformations or active skin conditions at electrode sites preventing electrode application or stimulation * History of prior urological surgery * Inability to voluntarily contract pelvic floor muscles on digital rectal examination per ICS terminology * Currently receiving or having received radiotherapy * Urethral stricture or active urinary tract infection * Heart failure, pacemaker, or implanted defibrillator * History of transurethral resection of the prostate (TURP) for benign prostatic hyperplasia * Use of medications that may affect bladder function (antimuscarinics, duloxetine, tricyclic antidepressants, etc.) * History of neurogenic bladder or peripheral/central neurological pathology * Inability to attend treatment sessions regularly due to distance or physical limitations

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Conditions

The condition(s) this trial relates to.

Urinary Incontinence

As listed by the trial registrant

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

Prostatectomy Urinary incontinence (UI)

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

  • Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

    Pamukkale, Denizli, 20160, Turkey (Türkiye)

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