A Randomized, Double-Blind, Sham-Controlled Trial of Low-Energy Extracorporeal Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
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.
• 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