Low-Energy Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome (NCT07563764) | Clinical Trial Compass
RecruitingNot Applicable
Low-Energy Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
Taiwan60 participantsStarted 2025-02-10
Plain-language 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.
Who can participate
Age range
20 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion:
* 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:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Overactive Bladder Symptom Score (OABSS)