NCT01815697UnknownNot Applicable
A Prospective, Randomized Study of Enhanced External Counterpulsation in Patients With Lower Urinary Tract Symptoms
First Affiliated Hospital, Sun Yat-Sen University1 site in 1 country120 target enrollmentStarted: April 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score
Time Frame: 7 weeks
Secondary Outcomes
- Endothelial function(7 weeks)
- Urinary flow rate(7 weeks)
Investigators
Chen Sheng Fu,MD
Principal Investigator
First Affiliated Hospital, Sun Yat-Sen University
Study Sites (1)
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