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

This study is currently recruiting participants.
Verified April 2017 by Chen Sheng Fu,MD, First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01815697
First Posted: March 21, 2013
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chen Sheng Fu,MD, First Affiliated Hospital, Sun Yat-Sen University
March 19, 2013
March 21, 2013
April 4, 2017
April 2013
April 2018   (Final data collection date for primary outcome measure)
Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score [ Time Frame: 7 weeks ]
evaluated lower urinary tract symptoms by International Prostate Symptom Score [ Time Frame: four weeks ]
Complete list of historical versions of study NCT01815697 on ClinicalTrials.gov Archive Site
  • 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
Urinary flow rate [ Time Frame: four weeks ]
Not Provided
Not Provided
 
Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms
A Prospective, Randomized Study of Enhanced External Counterpulsation in Patients With Lower Urinary Tract Symptoms
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.
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
Interventional
Not Provided
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
Lower Urinary Tract Symptoms
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
  • Experimental: Enhanced External Counterpulsation
    Men with benign prostatic hyperplasia receive 35- 36 hours Enhanced External Counterpulsation treatment
    Intervention: Device: Enhanced External Counterpulsation
  • No Intervention: Control
    Men with benign prostatic hyperplasia without Enhanced External Counterpulsation treatment as control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2018
April 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 90 Years   (Adult, Senior)
No
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
 
 
NCT01815697
NSFC-81070488
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Chen Sheng Fu,MD, First Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital, Sun Yat-Sen University
Not Provided
Study Director: Yan Zhang, M. D. First Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital, Sun Yat-Sen University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP