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

NCT07563764 | Recruiting

• 2 other identifiers: KMUHIRB-F(I)-20230051KMUH-LiESWT-OAB-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Bladder; Lower Urinary Track Symptoms; Metabolic Syndrome; Urgency-Frequency; Bladder, Overactive

Keywords

Low-energy extracorporeal shock wave therapy; LiESWT; Overactive bladder; Metabolic syndrome; Urinary urgency; Urinary frequency; Nocturia; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in Overactive Bladder Symptom Score (OABSS)

  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 Outcomes (7)

• Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

  Baseline to 24 weeks

• Change in Urinary Distress Inventory (UDI-6)

  Baseline to 24 weeks

• Change in maximum urinary flow rate measured by uroflowmetry (Qmax)

  Baseline to 24 weeks

• Change in post-void residual volume measured by bladder ultrasound (PVR)

  Baseline to 24 weeks

• Change in voided volume per micturition assessed by 3-day voiding diary

  Baseline to 24 weeks

Other Outcomes (1)

• Incidence of treatment-related adverse events

  Baseline to 24 weeks

Study Arms (2)

LiESWT Group

EXPERIMENTAL

Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region.

Device: Low-Energy Extracorporeal Shock Wave Therapy (LiESWT)

Sham Control Group

SHAM COMPARATOR

Participants receive a sham procedure that mimics LiESWT without delivering therapeutic energy.

Device: Sham Shock Wave Therapy

Interventions

Low-Energy Extracorporeal Shock Wave Therapy (LiESWT) DEVICE

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.

LiESWT Group

Sham Shock Wave Therapy DEVICE

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

Sham Control Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KMUHIRB-F(I)-20230051: lead

Study Sites (1)

Kaohsiung medical university

Kaohsiung, Taiwan, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Urinary Bladder, Overactive; Nocturia

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yung-Chin Lee, MD,PHD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JIUNHUNG GENG, MD

CONTACT

+88673121101 ext.6694; u9001090@hotmail.com

Yung-Chin Lee, MD, PHD

CONTACT

+88673121101 ext.6694; leeyc12345@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants, care providers, and investigators are blinded to group allocation. The sham procedure mimics the active treatment without delivering therapeutic energy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital

Model Details: Participants are randomly assigned to either the LiESWT treatment group or a sham control group in a parallel design.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 4, 2026
• Study Start: February 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)