The Value of Enhanced External Counterpulsation on Erectile Dysfunction (EECPED)

April 2, 2017 updated by: Chen Sheng Fu,MD, First Affiliated Hospital, Sun Yat-Sen University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • First Affiliated Hospital, Sun Yat-Sen University
        • Contact:
          • Deng Chun Hua, M. D.
          • Phone Number: 0086-13501519349
          • Email: dch0313@163.com
        • Principal Investigator:
          • Chen Shen Fu, M. D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced External Counterpulsation
Men with erectile dysfunction receive Enhanced External Counterpulsation treatment
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.
Other Names:
  • EECP
No Intervention: Control
Men with erectile dysfunction without Enhanced External Counterpulsation treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial function
Time Frame: 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
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

March 16, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 2, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EECPED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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