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Trial record 8 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Erectile Dysfunction"

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

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ClinicalTrials.gov Identifier: NCT01815593
Recruitment Status : Recruiting
First Posted : March 21, 2013
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Chen Sheng Fu,MD, 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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Enhanced external counterpulsation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with erectile dysfunction are assigned to two groups in parallel for the duration of the study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study of Enhanced External Counterpulsation for Patients With Erectile Dysfunction
Actual Study Start Date : April 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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 Name: EECP

No Intervention: Control
Men with erectile dysfunction without Enhanced External Counterpulsation treatment



Primary Outcome Measures :
  1. Erectile function evaluated by International Index of Erectile Function-5 questionnaire [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815593


Contacts
Contact: Yadong Zhang, M. D. 862087755766 ext 8373 zhyadong@mail.sysu.edu.cn
Contact: Zi Wan, M. D. 862087755766 ext 8227 zi_wan2012@163.com

Locations
China, Guangdong
First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Weiwei Zhang, PhD    8620-87334871    zhweiw2@mail.sysu.edu.cn   
Contact: Deng Chun Hua, M. D.    0086-13501519349    dch0313@163.com   
Principal Investigator: Chen Shen Fu, M. D.         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Director: Yan Zhang, M. D. First Affiliated Hospital, Sun Yat-Sen University

Publications:
Responsible Party: Chen Sheng Fu,MD, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01815593     History of Changes
Other Study ID Numbers: EECPED
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chen Sheng Fu,MD, First Affiliated Hospital, Sun Yat-Sen University:
Erectile Dysfunction
Vascular Endothelium
Counterpulsation, External

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders