RecruitingNot ApplicableNCT07563764

Low-Energy Shock Wave Therapy 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


Sponsor

KMUHIRB-F(I)-20230051

Enrollment

60 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Low-Energy Extracorporeal Shock Wave Therapy (LiESWT) and a medical device called Sham Shock Wave Therapy for people with bladder, bladder, overactive, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICELow-Energy Extracorporeal Shock Wave Therapy (LiESWT)

LiESWT is delivered using a focused shock wave device at an energy flux density of 0.25 mJ/mm², frequency of 3 Hz, and 3,000 pulses per session.

DEVICESham Shock Wave Therapy

The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.


Locations(1)

Kaohsiung medical university

Kaohsiung, Taiwan, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07563764


Related Trials