Low-Energy Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
A Randomized, Double-Blind, Sham-Controlled Trial of Low-Energy Extracorporeal Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
KMUHIRB-F(I)-20230051
60 participants
Feb 10, 2025
INTERVENTIONAL
Conditions
Summary
Overactive bladder (OAB) is a common condition that causes urinary urgency, frequent urination, and nocturia, which can significantly affect quality of life. Women with metabolic syndrome may have a higher risk of OAB due to vascular and metabolic abnormalities. This study aims to evaluate the effectiveness and safety of low-energy extracorporeal shock wave therapy (LiESWT), a non-invasive treatment, in women with metabolic syndrome-associated OAB. Participants will be randomly assigned to receive either active LiESWT treatment or a sham (inactive) procedure. Symptoms and treatment outcomes will be assessed using validated questionnaires, including the Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire (ICIQ-SF), Urinary Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7), as well as a voiding diary and uroflow measurements. The results of this study may help determine whether LiESWT is an effective treatment option for improving OAB symptoms in this patient population.
Eligibility
Inclusion Criteria11
- 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 Criteria11
- 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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Interventions
LiESWT is delivered using a focused shock wave device at an energy flux density of 0.25 mJ/mm², frequency of 3 Hz, and 3,000 pulses per session.
The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07563764