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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Chen Sheng Fu,MD, First Affiliated Hospital, Sun Yat-Sen University Identifier:
First received: March 19, 2013
Last updated: April 3, 2017
Last verified: April 2017
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 Intervention
Lower Urinary Tract Symptoms
Device: Enhanced External Counterpulsation

Study Type: Interventional
Study Design: 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: No masking
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study of Enhanced External Counterpulsation in Patients With Lower Urinary Tract Symptoms

Resource links provided by NLM:

Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

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

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

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

Estimated Enrollment: 120
Actual Study Start Date: April 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01815697

Contact: Yadong Zhang, M. D. 862087755766 ext 8373
Contact: Zi Wan, M. D. 862087755766 ext 8227

China, Guangdong
The First Affiliated Hospital, Sun Yat- sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Weiwei Zhang, PhD    8620-87334871   
Contact: Chunhua Deng, M. D.    0086-13501519349   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Study Director: Yan Zhang, M. D. First Affiliated Hospital, Sun Yat-Sen University
  More Information

Responsible Party: Chen Sheng Fu,MD, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University Identifier: NCT01815697     History of Changes
Other Study ID Numbers: NSFC-81070488
Study First Received: March 19, 2013
Last Updated: April 3, 2017
Individual Participant Data  
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 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 processed this record on April 28, 2017