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
Plain Language Summary
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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)
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NCT07563764