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Leg patch may ease bladder troubles after prostate surgery

NCT ID NCT07710794

Symptom relief Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether a small, wearable patch that stimulates a nerve in the leg can help men who still have bladder symptoms after prostate surgery. Participants will either receive behavioral therapy alone or behavioral therapy plus the patch for 12 weeks. The goal is to see if the patch reduces frequent urination, urgency, and nighttime bathroom trips.

What this could mean

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

Active substance
a nerve-stimulating patch worn on the leg (transcutaneous tibial nerve stimulation)
What this could lead to
If effective, this patch could offer a non-invasive, at-home option to reduce frequent urination and urgency after prostate surgery.
What could go wrong
This is a small, early-stage study with only 70 participants, so results may not apply to everyone. The patch may not provide additional benefit over behavioral therapy alone.

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 70 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jan 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

50 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: * 1\. Male, aged 50 to 80 years. 2. Diagnosis of benign prostatic hyperplasia (BPH) confirmed by IPSS, imaging, PSA, pathology, or other relevant assessments. 3\. Previous treatment with transurethral laser enucleation of the prostate for BPH. 4\. Persistent overactive bladder symptoms one month after surgery, defined as an average of ≥8 voids per 24 hours documented on a 72-hour voiding diary. 5\. Not currently using, or having discontinued at least 14 days prior to enrollment, all related medications (e.g., β3-adrenoceptor agonists, non-selective β-adrenoceptor agonists, or anticholinergics). 6\. Medically stable and not requiring hospitalization. 7. Voluntary participation in this clinical study, with written informed consent signed by the participant before study initiation. Exclusion Criteria: * 1\. History of urinary tract infection, urinary tract malformation, obstruction, anatomical abnormality, or neurological disorder. 2\. Known allergy to electrode gel or skin breakdown that precludes the use of surface electrodes. 3\. Presence of psychiatric or cognitive impairment that renders the patient unable to cooperate with the study procedures. 4\. Any serious comorbidity or condition that may hinder the patient's participation or increase the risk associated with surgical procedures. 5\. Participation in another clinical trial within 3 months prior to screening that could potentially affect the results of this study. 6\. Other conditions deemed unsuitable for participation by the investigator.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms

As listed by the trial registrant

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

BPH (benign prostatic hyperplasia) Lower urinary tract symptoms (LUTS)

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Qilu Hospital of Shandong University

    Jinan, Shangdong, China

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