The Value of Enhanced External Counterpulsation on Erectile Dysfunction

Not Applicable

• Conditions: Erectile Dysfunction
• Interventions: Device: Enhanced external counterpulsation

• Registration Number: NCT01815593
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-03-16
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-21
• Study Start: 2013-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-02
• Last Update Posted: 2017-04-04
• Primary Completion: 2018-03
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

1. men over 18 years old;
2. provide signed informed consent;
3. existence of erectile dysfunction
4. agree not to use any other erectile dysfunction treatment at least one month;

Exclusion Criteria

1. history of long drug abuse;
2. pelvic, spine, brain trauma or surgery;
3. endocrine, liver, lung, kidney disease, malignancies, hematological disorders;
4. abnormal urogenital status, such as small testicle (<2cm), penile plaques;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced External Counterpulsation	Enhanced external counterpulsation	Men with erectile dysfunction receive Enhanced External Counterpulsation treatment

Primary Outcome Measures

Name	Time	Method
Erectile function evaluated by International Index of Erectile Function-5 questionnaire	7 weeks

Secondary Outcome Measures

Name	Time	Method
Endothelial function	7 weeks	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

Trial Locations

Locations (1)

First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China