Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms

Lower Urinary Tract Symptoms Clinical Trial

— EECPLUTS  

Official title:

A Prospective, Randomized Study of Enhanced External Counterpulsation in Patients With Lower Urinary Tract Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01815697
• Other study ID #: NSFC-81070488
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2013
• Last updated: April 3, 2017
• Start date: April 2013
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Yadong Zhang, M. D.
• Phone: 862087755766
• Email: zhyadong[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat- sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score		7 weeks
Secondary	Urinary flow rate	Change from baseline in urinary flow rate	7 weeks
Secondary	Endothelial function	Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system	7 weeks