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Could sound waves calm an overactive bladder? new trial investigates

NCT ID NCT07563764

Symptom relief Sponsor: KMUHIRB-F(I)-20230051 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether low-energy shock wave therapy, a non-invasive treatment, can improve overactive bladder symptoms in women who also have metabolic syndrome. Sixty women will receive either the real therapy or a sham procedure. Researchers will track symptom changes using questionnaires and bladder diaries over 24 weeks.

What this could mean

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

Active substance
Low-Energy Extracorporeal Shock Wave Therapy (LiESWT) device
What this could lead to
If it works, this could offer a non-invasive, drug-free option to ease overactive bladder symptoms in women with metabolic syndrome.
What could go wrong
This is a small, early-stage trial with only 60 participants. The sham control means some may not improve, and results may not apply to all women.

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.

Started

Feb 2025

Expected to finish

Jun 2026

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

20 to 75 years

Sex

Female 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: * Female participants aged 20 to 75 years * Diagnosed with overactive bladder (OAB), defined as urinary frequency (≥8 times/day), nocturia (≥2 times/night), and urgency (≥2 episodes/week) for at least 3 months * Diagnosed with metabolic syndrome, defined by the presence of at least three of the following criteria: * Waist circumference ≥80 cm * Blood pressure ≥130/85 mmHg or receiving antihypertensive treatment * Fasting glucose ≥100 mg/dL or receiving treatment for diabetes * Triglycerides ≥150 mg/dL or receiving lipid-lowering treatment * High-density lipoprotein cholesterol \<50 mg/dL * No pharmacological or injection treatment for OAB within 3 months prior to enrollment * Able to understand and comply with study procedures and questionnaires * Willing to provide informed consent Exclusion: * History of kidney stones or bladder stones * Urinary tract infection within 3 months prior to enrollment or recurrent urinary tract infections (≥3 episodes) * Lower urinary tract surgery within 6 months prior to enrollment * Known or suspected malignancy of the urinary tract * Significant bladder outlet obstruction * Severe coagulopathy, liver failure, or renal failure * Prior pelvic malignancy or pelvic radiation therapy * Intravesical injection or electrical stimulation therapy within the past year * Substance abuse (drug or alcohol) within the past year * Chronic pelvic pain due to other causes * Inability to complete study questionnaires or procedures

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome metabolic syndrome X Nocturia overactive bladder urinary bladder disorder

As listed by the trial registrant

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

Bladder Bladder, overactive Lower urinary track symptoms Metabolic syndrome Urgency-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

  • Kaohsiung medical university

    RECRUITING

    Kaohsiung, Taiwan, 807, Taiwan

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