This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 Chen Sheng Fu,MD, First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Chen Sheng Fu,MD, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01815697
First received: March 19, 2013
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
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: None (Open Label)
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 Chen Sheng Fu,MD, 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
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01815697

Contacts
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

Locations
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
Investigators
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
ClinicalTrials.gov 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 (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

ClinicalTrials.gov processed this record on August 22, 2017