The Value of Enhanced External Counterpulsation on Erectile Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enhanced External Counterpulsation

Men with erectile dysfunction receive Enhanced External Counterpulsation treatment

Group Type EXPERIMENTAL

Enhanced external counterpulsation

Intervention Type 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.

Control

Men with erectile dysfunction without Enhanced External Counterpulsation treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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EECP

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No