Low-energy shock wave treatment 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
This trial tests whether low-energy extracorporeal shock wave therapy (LiESWT) can reduce urgency, daytime frequency, and nighttime urination in women who have metabolic syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | Female |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Kaohsiung, Taiwan) |
| Trial ID | NCT07563764 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 20–75 with clinically defined overactive bladder (frequency ≥8/day, nocturia ≥2/night, urgency ≥2/week for ≥3 months) who meet criteria for metabolic syndrome and have not used OAB drugs or injections in the prior 3 months.
Not a fit: Patients with recent or recurrent urinary tract infections, bladder stones, significant lower urinary tract pathology, or other excluded conditions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, LiESWT could provide a non-drug, non-invasive option to reduce OAB symptoms and improve quality of life for affected women.
How similar studies have performed: Early pilot and small clinical studies in urology suggest LiESWT may improve symptoms in some conditions, but robust randomized evidence for OAB is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kaohsiung, Taiwan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.