Actively Recruiting
A Randomized, Double-Blind, Sham-Controlled Trial of Low-Energy Extracorporeal Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
Led by KMUHIRB-F(I)-20230051 · Updated on 2026-05-04
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive either low-energy extracorporeal shock wave therapy or a sham procedure applied to the bladder region.
6 weekly visits (in-person)
Duration - 18 weeks
Participants are monitored for symptom changes and safety after completing treatment.
4 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Kaohsiung medical university
Kaohsiung, Taiwan, Taiwan, 807
Actively Recruiting
Research Team
J
JIUNHUNG GENG, MD
Y
Yung-Chin Lee, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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