The Value of Enhanced External Counterpulsation on Erectile Dysfunction

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of Enhanced External Counterpulsation (EECP) in patients with erectile dysfunction

Detailed Description
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Patients with erectile dysfunction will be randomized into two groups: EECP intervention or not. Erectile function, hemodynamic parameters, vascular endothelial function will be measured and compared.

Official Title
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A Prospective, Randomized Study of Enhanced External Counterpulsation for Patients With Erectile Dysfunction

Conditions
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Erectile Dysfunction

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 erectile dysfunction agree not to use any other erectile dysfunction treatment at least one month; Exclusion Criteria: history of long drug abuse; pelvic, spine, brain trauma or surgery; endocrine, liver, lung, kidney disease, malignancies, hematological disorders; abnormal urogenital status, such as small testicle (<2cm), penile plaques;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 erectile dysfunction 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 erectile dysfunction receive Enhanced External Counterpulsation treatment | Device: Enhanced external counterpulsation<br>* Enhanced external counterpulsation 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 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 erectile dysfunction without Enhanced External Counterpulsation treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function evaluated by International Index of Erectile Function-5 questionnaire |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Flow-mediated dilation：In this method,brachial artery diameter is measured before and after an increase in shear stress that is induced by reactive hyperemia (FMD). Endothelial progenitor cells：Flow cytometry to detect changes in the number of endothelial progenitor cells | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Endothelium, Erectile Dysfunction, Counterpulsation, External