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

RecruitingNAAges 20 Years - 75 YearsFemaleKMUHIRB-F(I)-20230051
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In plain words

What the trial is, and whether it could suit you

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 measu

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion: * Female participants aged 20 to 75 years * Diagnosed with overactive bladder (OAB), defined as urinary frequency (โ‰ฅ8 times/day), nocturia (โ‰ฅ2 times/night), and urgency (โ‰ฅ2 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 โ‰ฅ80 cm * Blood pressure โ‰ฅ130/85 mmHg or receiving antihypertensive treatment * Fasting glucose โ‰ฅ100 mg/dL or receiving treatment for diabetes * Triglycerides โ‰ฅ150 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: * History of kidney stones or bladder stones * Urinary tract infection within 3 months prior to enrollment or recurrent urinary tract infections (โ‰ฅ3 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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What it tests

  • Low-Energy Extracorporeal Shock Wave Therapy (LiESWT)
  • Sham Shock Wave Therapy
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Where

1 site
Kaohsiung medical university
Kaohsiung, Taiwan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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