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临床试验/NCT01815697
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

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

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Sheng Fu,MD

Principal Investigator

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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