Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms

Study Overview
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Brief Summary
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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
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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

Official Title
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A Prospective, Randomized Study of Enhanced External Counterpulsation in Patients With Lower Urinary Tract Symptoms

Conditions
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Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: Enhanced External Counterpulsation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with benign prostatic hyperplasia are assigned to two groups in parallel for the duration of the study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced External Counterpulsation<br>Men with benign prostatic hyperplasia receive 35- 36 hours Enhanced External Counterpulsation treatment | Device: Enhanced External Counterpulsation<br>* Enhanced external counterpulsation (EECP) is mainly used in cardiovascular and cerebrovascular diseases, which has been proven to be able to improve microcirculation and endothelial function. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. The systolic deflation/ Diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner. The patients will receive 35-36 hours EECP intervention, 1-hour session every day over a 7-week period.<br>* Other names: EECP;|
| No Intervention: Control<br>Men with benign prostatic hyperplasia without Enhanced External Counterpulsation treatment as control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary flow rate | Change from baseline in urinary flow rate | 7 weeks | 
| Endothelial function | Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Retention, Vascular Endothelium, Counterpulsation, External