Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms

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

2018-12-31

Brief Summary

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The purpose of this study is to access the effects of Enhanced External Counterpulsation treatment on lower urinary tract symptoms in patients with benign prostatic hyperplasia.

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Detailed Description

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Patients with benign prostatic hyperplasia and will be randomized into two groups: EECP intervention or not. Lower urinary tract symptoms, hemodynamic parameters, vascular endothelial function will be measured and compared

Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with benign prostatic hyperplasia 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 benign prostatic hyperplasia receive 35- 36 hours Enhanced External Counterpulsation treatment

Group Type EXPERIMENTAL

Enhanced External Counterpulsation

Intervention Type DEVICE

Enhanced external counterpulsation (EECP) is mainly used in cardiovascular and cerebrovascular diseases, which has been proven to be able to improve microcirculation and endothelial function. EECP 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 will receive 35-36 hours EECP intervention, 1-hour session every day over a 7-week period.

Control

Men with benign prostatic hyperplasia without Enhanced External Counterpulsation treatment as control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced External Counterpulsation

Enhanced external counterpulsation (EECP) is mainly used in cardiovascular and cerebrovascular diseases, which has been proven to be able to improve microcirculation and endothelial function. EECP 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 will 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 lower urinary tract symptoms
4. agree not to use any lower urinary tract symptoms treatment at least one month;
5. suitable for receiving EECP treatment

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. Severe infection without effective control；
5. lower limbs deep vein thrombosis；
6. Large area of ulcerative rash；
7. unsuitable for receiving EECP treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No