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Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms (EECPLUTS)

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ClinicalTrials.gov Identifier: NCT01815697
Recruitment Status : Recruiting
First Posted : March 21, 2013
Last Update Posted : April 4, 2017
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 access the effects of Enhanced External Counterpulsation treatment on lower urinary tract symptoms in patients with benign prostatic hyperplasia.

Condition or disease Intervention/treatment
Lower Urinary Tract Symptoms Device: Enhanced External Counterpulsation

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with benign prostatic hyperplasia 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 in Patients With Lower Urinary Tract Symptoms
Actual Study Start Date : April 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Enhanced External Counterpulsation
Men with benign prostatic hyperplasia receive 35- 36 hours Enhanced External Counterpulsation treatment
Device: 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.
Other Name: EECP
No Intervention: Control
Men with benign prostatic hyperplasia without Enhanced External Counterpulsation treatment as control

Primary Outcome Measures :
  1. Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Urinary flow rate [ Time Frame: 7 weeks ]
    Change from baseline in urinary flow rate

  2. Endothelial function [ Time Frame: 7 weeks ]
    Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

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): NCT01815697

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

China, Guangdong
The First Affiliated Hospital, Sun Yat- sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Weiwei Zhang, PhD    8620-87334871    zhweiw2@mail.sysu.edu.cn   
Contact: Chunhua Deng, M. D.    0086-13501519349    dch0313@163.com   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Study Director: Yan Zhang, M. D. First Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Chen Sheng Fu,MD, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01815697     History of Changes
Other Study ID Numbers: NSFC-81070488
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:
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Urinary Retention
Vascular Endothelium
Counterpulsation, External

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms