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

April 30, 2026 updated by: KMUHIRB-F(I)-20230051

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Overactive bladder (OAB) is a prevalent urological condition characterized by urinary urgency, frequency, and nocturia, which significantly impairs quality of life. Emerging evidence suggests a strong association between OAB and metabolic syndrome, which is characterized by insulin resistance, hypertension, dyslipidemia, and central obesity. These metabolic abnormalities may contribute to endothelial dysfunction, chronic inflammation, and autonomic dysregulation, potentially affecting bladder function.

Low-energy extracorporeal shock wave therapy (LiESWT) is a novel, non-invasive therapeutic modality that has been shown to promote angiogenesis, improve tissue perfusion, and modulate inflammatory responses. Previous studies have demonstrated its potential benefits in various urological conditions.

This study is designed as a randomized, double-blind, sham-controlled trial to evaluate the efficacy and safety of LiESWT in women with metabolic syndrome-associated OAB. Participants are randomly assigned to receive either LiESWT treatment or a sham procedure.

Clinical outcomes are assessed using validated patient-reported outcome measures, including OABSS, ICIQ-SF, UDI-6, and IIQ-7, along with objective parameters such as uroflowmetry and post-void residual volume. Assessments are performed at baseline and at multiple follow-up time points after treatment.

This study aims to provide clinical evidence on the therapeutic role of LiESWT in improving symptoms and quality of life in this specific patient population.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Taiwan
      • Kaohsiung, Taiwan, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jiun-Hung Geng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LiESWT Group
Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region.
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.
Sham Comparator: Sham Control Group
Participants receive a sham procedure that mimics LiESWT without delivering therapeutic energy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Overactive Bladder Symptom Score (OABSS)
Time Frame: Baseline to 24 weeks
The Overactive Bladder Symptom Score (OABSS; range 0-15, with higher scores indicating more severe symptoms) will be used. The primary outcome is the change in OABSS from baseline to 4, 8, 12, 16, 20, 24 weeks after treatment. Lower scores indicate improvement in symptoms.
Baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time Frame: Baseline to 24 weeks
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; range 0-21, higher scores indicate worse symptoms).
Baseline to 24 weeks
Change in Urinary Distress Inventory (UDI-6)
Time Frame: Baseline to 24 weeks
The Urinary Distress Inventory-6 (UDI-6; range 0-100, higher scores indicate greater symptom distress).
Baseline to 24 weeks
Change in maximum urinary flow rate measured by uroflowmetry (Qmax)
Time Frame: Baseline to 24 weeks
Maximum urinary flow rate (Qmax, mL/s) will be assessed using standard uroflowmetry. Higher values indicate improved urinary flow function.
Baseline to 24 weeks
Change in post-void residual volume measured by bladder ultrasound (PVR)
Time Frame: Baseline to 24 weeks
Post-void residual (PVR, mL) will be measured using bladder ultrasound immediately after voiding. Lower values indicate improved bladder emptying.
Baseline to 24 weeks
Change in voided volume per micturition assessed by 3-day voiding diary
Time Frame: Baseline to 24 weeks
Voided volume (mL) will be calculated from a 3-day voiding diary. Higher values indicate improved bladder capacity.
Baseline to 24 weeks
Change in total daily urine volume assessed by 3-day voiding diary
Time Frame: Baseline to 24 weeks
Total urine volume (mL/day) will be calculated from a 3-day voiding diary.
Baseline to 24 weeks
change in Incontinence Impact Questionnaire short version (IIQ-7)
Time Frame: Baseline to 24 weeks
The IIQ-7 uses a 0-3 scale to measure how urinary incontinence impacts household chores, physical recreation, entertainment, travel, social activities, emotional health, and feelings of frustration to determine an overall quality-of-life score.
Baseline to 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-related adverse events
Time Frame: Baseline to 24 weeks
Adverse events will be recorded throughout the study period and classified according to severity and relationship to treatment.
Baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KMUHIRB-F(I)-20230051

Investigators

  • Principal Investigator: Yung-Chin Lee, MD,PHD, Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-F(I)-20230051
  • KMUH-LiESWT-OAB-2023 (Other Identifier: Kaohsiung Medical University Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data available upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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