The Effect of Enhanced External Counterpulsation Treatment to Lower Urinary Tract Symptoms

This study is not yet open for participant recruitment.
Verified March 2013 by 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: March 21, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to see if enhanced external counterpulsation treatment can improve lower tract symptoms.


Condition Intervention
Lower Urinary Tract Symptoms
Device: Enhanced external counterpulsation(EECP)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


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

Primary Outcome Measures:
  • evaluated lower urinary tract symptoms by International Prostate Symptom Score [ Time Frame: four weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary flow rate [ Time Frame: four weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: April 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
lower urinary tract symptoms
Men with lower urinary tract symptoms included for evaluating the lower urinary tract symptoms before and after the Enhanced external counterpulsation treatment
Device: Enhanced external counterpulsation(EECP)
Enhanced external counterpulsation(EECP) is used in cardiovascular and cerebrovascular diseases,which has the ability to improve the microcirculation

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Men complaining lower urinary tract symptoms were enrolled

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;

Exclusion Criteria:

  1. a 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;
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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: March 21, 2013
Health Authority: China: Ethics Committee

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
Men

ClinicalTrials.gov processed this record on April 17, 2014