The Value of Enhanced External Counterpulsation on Erectile Dysfunction

Erectile Dysfunction Clinical Trial

— EECPED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01815593
• Other study ID #: EECPED
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2013
• Last updated: April 2, 2017
• Start date: April 2013
• Est. completion date: April 2018

Study information

• Verified date: April 2017
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Yadong Zhang, M. D.
• Phone: 862087755766
• Email: zhyadong[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Enhanced external counterpulsation
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.

Locations

Country	Name	City	State
China	First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

El-Sakka A, Morsy A, Fagih B. Enhanced external counterpulsation in patients with coronary artery disease-associated erectile dysfunction. Part I: effects of risk factors. J Sex Med. 2007 May;4(3):771-9. Epub 2007 Apr 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile function evaluated by International Index of Erectile Function-5 questionnaire		7 weeks
Secondary	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