Low-energy shock wave treatment for overactive bladder in women with metabolic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, sham-controlled trial testing non-invasive low-energy extracorporeal shock wave therapy (LiESWT) in women with overactive bladder linked to metabolic syndrome. Participants are randomly assigned to active LiESWT or a sham procedure and receive treatments at a single center. Outcomes include patient-reported symptom scores (OABSS, ICIQ-SF, UDI-6, IIQ-7), voiding diaries, and objective uroflow and post-void residual measurements assessed at baseline and multiple follow-ups. Safety and tolerability are monitored throughout the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Kaohsiung medical university
  Kaohsiung, Taiwan, Taiwan Recruiting

Study contacts

• Principal investigator: Yung-Chin Lee, MD,PHD — Kaohsiung Medical University
• Study coordinator: Jiunhung Geng, Md
• Email: u9001090@hotmail.com
• Phone: +88673121101 ext.6694

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.