A Randomized, Double-Blind, Sham-Controlled Trial of Low-Energy Extracorporeal Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Overactive Bladder Symptom Score (OABSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants, care providers, and investigators are blinded to group allocation. The sham procedure mimics the active treatment without delivering therapeutic energy.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
LiESWT Group
Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region.
干预措施: Low-Energy Extracorporeal Shock Wave Therapy (LiESWT) (Device)
Sham Control Group
Participants receive a sham procedure that mimics LiESWT without delivering therapeutic energy.
干预措施: Sham Shock Wave Therapy (Device)
结局指标
主要结局
Change in Overactive Bladder Symptom Score (OABSS)
时间窗: 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.
次要结局
- 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)
- Change in total daily urine volume assessed by 3-day voiding diary(Baseline to 24 weeks)
- change in Incontinence Impact Questionnaire short version (IIQ-7)(Baseline to 24 weeks)
研究者
KMUHIRB-F(I)-20230051
Principal Investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital