Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms

NCT01815697 | Unknown DMC

• 1 other identifier: NSFC-81070488
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  7 weeks

Secondary Outcomes (2)

• Urinary flow rate

  7 weeks

• Endothelial function

  7 weeks

Study Arms (2)

Enhanced External Counterpulsation

EXPERIMENTAL

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

Device: Enhanced External Counterpulsation

Control

NO INTERVENTION

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

Interventions

Enhanced External Counterpulsation DEVICE

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.

Also known as: EECP

Enhanced External Counterpulsation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat- sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia; Urinary Retention

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Yan Zhang, M. D.

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Yadong Zhang, M. D.

CONTACT

862087755766; zhyadong@mail.sysu.edu.cn

Zi Wan, M. D.

CONTACT

862087755766; zi_wan2012@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)