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RECRUITING
NCT07563764
NA

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

Sponsor: KMUHIRB-F(I)-20230051

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Sham-Controlled Trial of Low-Energy Extracorporeal Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome

Key Details

Gender

FEMALE

Age Range

20 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-02-10

Completion Date

2026-06-30

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DEVICE

Low-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.

DEVICE

Sham 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