Back to resultsThe Value of Enhanced External Counterpulsation on Erectile Dysfunction (EECPED)
Primary Purpose
Erectile Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Enhanced external counterpulsation
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Vascular Endothelium, Counterpulsation, External
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
Sites / Locations
- First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Enhanced External Counterpulsation
Control
Arm Description
Men with erectile dysfunction receive Enhanced External Counterpulsation treatment
Men with erectile dysfunction without Enhanced External Counterpulsation treatment
Outcomes
Primary Outcome Measures
Erectile function evaluated by International Index of Erectile Function-5 questionnaire
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01815593
First Posted
March 16, 2013
Last Updated
April 2, 2017
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT01815593
Brief Title
The Value of Enhanced External Counterpulsation on Erectile Dysfunction
Acronym
EECPED
Official Title
A Prospective, Randomized Study of Enhanced External Counterpulsation for Patients With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile Dysfunction, Vascular Endothelium, Counterpulsation, External
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with erectile dysfunction are assigned to two groups in parallel for the duration of the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enhanced External Counterpulsation
Arm Type
Experimental
Arm Description
Men with erectile dysfunction receive Enhanced External Counterpulsation treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
Men with erectile dysfunction without Enhanced External Counterpulsation treatment
Intervention Type
Device
Intervention Name(s)
Enhanced external counterpulsation
Other Intervention Name(s)
EECP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Erectile function evaluated by International Index of Erectile Function-5 questionnaire
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Endothelial function
Description
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
Time Frame
7 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yadong Zhang, M. D.
Phone
862087755766
Ext
8373
Email
zhyadong@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zi Wan, M. D.
Phone
862087755766
Ext
8227
Email
zi_wan2012@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhang, M. D.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiwei Zhang, PhD
Phone
8620-87334871
Email
zhweiw2@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Deng Chun Hua, M. D.
Phone
0086-13501519349
Email
dch0313@163.com
First Name & Middle Initial & Last Name & Degree
Chen Shen Fu, M. D.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17433083
Citation
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.
Results Reference
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The Value of Enhanced External Counterpulsation on Erectile Dysfunction
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