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

2026年4月30日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 台湾
    • Taiwan
      • Kaohsiung、Taiwan、台湾、807
        • 招聘中
        • Kaohsiung Medical University
        • 接触：
        • 接触：
        • 副研究员：
          • Jiun-Hung Geng, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：LiESWT Group
Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region.
设备：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.
假比较器：Sham Control Group
Participants receive a sham procedure that mimics LiESWT without delivering therapeutic energy.
设备：Sham Shock Wave Therapy
The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Overactive Bladder Symptom Score (OABSS)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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)
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Incidence of treatment-related adverse events
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

KMUHIRB-F(I)-20230051

调查人员

  • 首席研究员：Yung-Chin Lee, MD,PHD、Kaohsiung Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月10日

初级完成 (估计的)

2026年6月30日

研究完成 (估计的)

2026年6月30日

研究注册日期

首次提交

2026年4月23日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年5月4日

上次提交的符合 QC 标准的更新

2026年4月30日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • KMUHIRB-F(I)-20230051
  • KMUH-LiESWT-OAB-2023 (其他标识符：Kaohsiung Medical University Hospital)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Data available upon reasonable request

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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