The Value of Enhanced External Counterpulsation on Erectile Dysfunction

NCT01815593 | Unknown DMC

• 1 other identifier: EECPED
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Vascular Endothelium; Counterpulsation, External

Outcome Measures

Primary Outcomes (1)

• Erectile function evaluated by International Index of Erectile Function-5 questionnaire

  7 weeks

Secondary Outcomes (1)

• Endothelial function

  7 weeks

Study Arms (2)

Enhanced External Counterpulsation

EXPERIMENTAL

Men with erectile dysfunction receive Enhanced External Counterpulsation treatment

Device: Enhanced external counterpulsation

Control

NO INTERVENTION

Men with erectile dysfunction without Enhanced External Counterpulsation treatment

Interventions

Enhanced external counterpulsation DEVICE

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.

Also known as: EECP

Enhanced External Counterpulsation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related 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):771-779. doi: 10.1111/j.1743-6109.2007.00458.x. Epub 2007 Apr 13.

  PMID: 17433083 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Yan Zhang, M. D.

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Yadong Zhang, M. D.

CONTACT

862087755766; zhyadong@mail.sysu.edu.cn

Zi Wan, M. D.

CONTACT

862087755766; zi_wan2012@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with erectile dysfunction are assigned to two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: March 16, 2013
• First Posted: March 21, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)