What is low-energy extracorporeal shock wave therapy (LiESWT) studying for overactive bladder in women with metabolic syndrome?

LiESWT is being studied to see if it can improve symptoms of overactive bladder in women who also have metabolic syndrome. The study compares active LiESWT to a sham procedure to evaluate its impact on urinary urgency, frequency, and nighttime urination. This research aims to provide evidence on whether this non-invasive treatment can benefit this patient group.

Who may be eligible for this overactive bladder clinical trial?

Women aged 20 to 75 years diagnosed with overactive bladder and metabolic syndrome may be eligible. Participants should not have received recent drug or injection treatments for OAB and must be able to follow study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this overactive bladder clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel needs.

Actively Recruiting

Phase Not Applicable

Age: 20Years - 75Years

FEMALE

ID07563764

Study of Low-Energy Shock Wave Therapy for Overactive Bladder in Women with Metabolic Syndrome A Randomized, Double-Blind, Sham-Controlled Trial Evaluating Treatment Safety and Effectiveness

Led by KMUHIRB-F(I)-20230051 · Updated on 2026-05-04

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Overactive bladder OAB is a common condition causing urinary urgency, frequent urination, and nighttime urination, which can greatly impact quality of life. Women with metabolic syndrome, a group of conditions including high blood pressure, high blood sugar, abnormal cholesterol, and abdominal obesity, may have a higher risk of OAB. This study evaluates the safety and effectiveness of low-energy extracorporeal shock wave therapy LiESWT, a non-invasive treatment, in women with metabolic syndrome-associated OAB. Participants are randomly assigned to receive either active LiESWT or a sham inactive procedure that mimics the treatment without delivering shock waves. LiESWT is applied using a focused shock wave device at a specific energy and frequency setting, with 3,000 pulses per session directed at the bladder area. The study is double-blind and sham-controlled to compare outcomes between groups. Participants will complete validated questionnaires measuring OAB symptoms, urinary distress, and impact on daily life at baseline and follow-ups up to 24 weeks. Additional assessments include urine flow rates, bladder ultrasound to measure residual urine volume, and a 3-day voiding diary to track urine output and frequency. These measures will help determine changes in symptoms and bladder function over the study period.

CONDITIONS

Brief Title

Low-Energy Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome

Who Can Participate

Age: 20Years - 75Years

FEMALE

Eligibility Criteria

You may qualify if you...

Female participants aged 20 to 75 years
Diagnosed with overactive bladder, including urinary frequency (≥8 times/day), nocturia (≥2 times/night), and urgency (≥2 episodes/week) for at least 3 months
Diagnosed with metabolic syndrome with at least three of the following: waist circumference ≥80 cm, blood pressure ≥130/85 mmHg or on antihypertensive treatment, fasting glucose ≥100 mg/dL or diabetes treatment, triglycerides ≥150 mg/dL or lipid-lowering treatment, HDL cholesterol <50 mg/dL
No pharmacological or injection treatment for overactive bladder within 3 months prior to enrollment
Able to understand and comply with study procedures and questionnaires
Willing to provide informed consent

You will not qualify if you...

History of kidney 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 urinary tract malignancy
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

Research Team

JIUNHUNG GENG, MD

Yung-Chin Lee, MD, PHD

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Study of Low-Energy Shock Wave Therapy for Overactive Bladder in Women with Metabolic Syndrome A Randomized, Double-Blind, Sham-Controlled Trial Evaluating Treatment Safety and Effectiveness

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria