MedTrace Logo

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

NCT07563764 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • KMUHIRB-F(I)-20230051

    lead OTHER

Principal Investigators

  • Yung-Chin Lee, MD,PHD · Kaohsiung Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Taiwan

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563764 on ClinicalTrials.gov