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

Primary Purpose

Lower Urinary Tract Symptoms

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Enhanced External Counterpulsation

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Retention, Vascular Endothelium, Counterpulsation, External

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

men over 18 years old;
provide signed informed consent;
existence of lower urinary tract symptoms
agree not to use any lower urinary tract symptoms treatment at least one month;
suitable for receiving EECP treatment

Exclusion Criteria:

history of long drug abuse;
pelvic, spine, brain trauma or surgery;
endocrine, liver, lung, kidney disease, malignancies, hematological disorders;
Severe infection without effective control；
lower limbs deep vein thrombosis；
Large area of ulcerative rash；
unsuitable for receiving EECP treatment

Sites / Locations

The First Affiliated Hospital, Sun Yat- sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced External Counterpulsation

Control

Arm Description

Men with benign prostatic hyperplasia receive 35- 36 hours Enhanced External Counterpulsation treatment

Men with benign prostatic hyperplasia without Enhanced External Counterpulsation treatment as control

Outcomes

Primary Outcome Measures

Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score

Secondary Outcome Measures

Urinary flow rate

Change from baseline in urinary flow rate

Endothelial function

Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system

Full Information

NCT ID

NCT01815697

First Posted

March 19, 2013

Last Updated

April 3, 2017

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT01815697

Brief Title

Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms

Acronym

EECPLUTS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 2013 (Actual)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lower Urinary Tract Symptoms

Keywords

Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Retention, Vascular Endothelium, Counterpulsation, External

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients with benign prostatic hyperplasia are assigned to two groups in parallel for the duration of the study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Enhanced External Counterpulsation

Arm Type

Experimental

Arm Description

Men with benign prostatic hyperplasia receive 35- 36 hours Enhanced External Counterpulsation treatment

Arm Title

Control

Arm Type

No Intervention

Arm Description

Men with benign prostatic hyperplasia without Enhanced External Counterpulsation treatment as control

Intervention Type

Device

Intervention Name(s)

Enhanced External Counterpulsation

Other Intervention Name(s)

EECP

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

Urinary flow rate

Description

Change from baseline in urinary flow rate

Time Frame

7 weeks

Title

Endothelial function

Description

Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system

Time Frame

7 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: men over 18 years old; provide signed informed consent; existence of lower urinary tract symptoms agree not to use any lower urinary tract symptoms treatment at least one month; suitable for receiving EECP treatment Exclusion Criteria: history of long drug abuse; pelvic, spine, brain trauma or surgery; endocrine, liver, lung, kidney disease, malignancies, hematological disorders; Severe infection without effective control； lower limbs deep vein thrombosis； Large area of ulcerative rash； unsuitable for receiving EECP treatment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yadong Zhang, M. D.

Phone

862087755766

Ext

8373

zhyadong@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zi Wan, M. D.

Phone

862087755766

Ext

8227

zi_wan2012@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan Zhang, M. D.

Organizational Affiliation

First Affiliated Hospital, Sun Yat-Sen University

Official's Role

Study Director

Facility Information:

Facility Name

The First Affiliated Hospital, Sun Yat- sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weiwei Zhang, PhD

Phone

8620-87334871

zhweiw2@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Chunhua Deng, M. D.

Phone

0086-13501519349

dch0313@163.com

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms

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