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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство Sham Shock Wave Therapy
  The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.

Первичные конечные точки

• Change in Overactive Bladder Symptom Score (OABSS) [Срок оценки: Baseline to 24 weeks]

Вторичные конечные точки (7)

• Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) [Срок оценки: Baseline to 24 weeks]
• Change in Urinary Distress Inventory (UDI-6) [Срок оценки: Baseline to 24 weeks]
• Change in maximum urinary flow rate measured by uroflowmetry (Qmax) [Срок оценки: Baseline to 24 weeks]
• Change in post-void residual volume measured by bladder ultrasound (PVR) [Срок оценки: Baseline to 24 weeks]
• Change in voided volume per micturition assessed by 3-day voiding diary [Срок оценки: Baseline to 24 weeks]
• Change in total daily urine volume assessed by 3-day voiding diary [Срок оценки: Baseline to 24 weeks]
• change in Incontinence Impact Questionnaire short version (IIQ-7) [Срок оценки: Baseline to 24 weeks]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Kaohsiung medical university — Kaohsiung

Идентификаторы

NCT: NCT07563764 · KMUHIRB-F(I)-20230051 · KMUH-LiESWT-OAB-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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