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The Value of Enhanced External Counterpulsation on Erectile Dysfunction

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01815593
Acronym
EECPED
Enrollment
120
Registered
2013-03-21
Start date
2013-04-30
Completion date
2018-04-30
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction, Vascular Endothelium, Counterpulsation, External

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.

Interventions

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.

Sponsors

First Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frame
Erectile function evaluated by International Index of Erectile Function-5 questionnaire7 weeks

Secondary

MeasureTime frameDescription
Endothelial function7 weeksFlow-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

Countries

China

Contacts

Primary ContactYadong Zhang, M. D.
zhyadong@mail.sysu.edu.cn862087755766
Backup ContactZi Wan, M. D.
zi_wan2012@163.com862087755766

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026