Actively Recruiting

Phase Not Applicable
Age: 20Years - 75Years
FEMALE
NCT07563764

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

Led by KMUHIRB-F(I)-20230051 · Updated on 2026-05-04

60

Participants Needed

1

Research Sites

72 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 20Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 20 to 75 years
  • Diagnosed with overactive bladder defined by urinary frequency (8 or more times/day), nocturia (5 or more times/night), and urgency (2 or more episodes/week) for at least 3 months
  • Diagnosed with metabolic syndrome with at least three of the following: waist circumference 80 cm or more, blood pressure 130/85 mmHg or higher or on antihypertensive treatment, fasting glucose 100 mg/dL or higher or diabetes treatment, triglycerides 150 mg/dL or higher or lipid-lowering treatment, HDL cholesterol less than 50 mg/dL
  • No pharmacological or injection treatment for overactive bladder within 3 months before enrollment
  • Able to understand and follow study procedures and questionnaires
  • Willing to give informed consent
Not Eligible

You will not qualify if you...

  • History of kidney or bladder stones
  • Urinary tract infection within 3 months before enrollment or recurrent urinary tract infections (3 or more episodes)
  • Lower urinary tract surgery within 6 months before enrollment
  • Known or suspected urinary tract cancer
  • Significant bladder outlet obstruction
  • Severe bleeding problems, liver failure, or kidney failure
  • Previous pelvic cancer or pelvic radiation therapy
  • Intravesical injection or electrical stimulation therapy in the past year
  • Drug or alcohol abuse in the past year
  • Chronic pelvic pain from other causes
  • Unable to complete study questionnaires or procedures

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Kaohsiung medical university

Kaohsiung, Taiwan, Taiwan, 807

Actively Recruiting

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Research Team

J

JIUNHUNG GENG, MD

CONTACT

Y

Yung-Chin Lee, MD, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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