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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
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.

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

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

ClinicalTrials.gov processed this record on August 28, 2014