NCT01815697Unknown不适用
A Prospective, Randomized Study of Enhanced External Counterpulsation in Patients With Lower Urinary Tract Symptoms
First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score
研究概览
简要总结
The purpose of this study is to access the effects of Enhanced External Counterpulsation treatment on lower urinary tract symptoms in patients with benign prostatic hyperplasia.
详细描述
Patients with benign prostatic hyperplasia and will be randomized into two groups: EECP intervention or not. Lower urinary tract symptoms, hemodynamic parameters, vascular endothelial function will be measured and compared
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men over 18 years old;
- •provide signed informed consent;
- •existence of lower urinary tract symptoms
- •agree not to use any lower urinary tract symptoms treatment at least one month;
- •suitable for receiving EECP treatment
排除标准
- •history of long drug abuse;
- •pelvic, spine, brain trauma or surgery;
- •endocrine, liver, lung, kidney disease, malignancies, hematological disorders;
- •Severe infection without effective control；
- •lower limbs deep vein thrombosis；
- •Large area of ulcerative rash；
- •unsuitable for receiving EECP treatment
结局指标
主要结局
Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score
时间窗: 7 weeks
次要结局
- Endothelial function(7 weeks)
- Urinary flow rate(7 weeks)
研究者
Chen Sheng Fu,MD
Principal Investigator
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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