Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms

Not Applicable

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Device: Enhanced External Counterpulsation

• Registration Number: NCT01815697
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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

Study Timeline

• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-21
• Study Start: 2013-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04
• Primary Completion: 2018-04
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score	7 weeks

Secondary Outcome Measures

Name	Time	Method
Endothelial function	7 weeks	Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system
Urinary flow rate	7 weeks	Change from baseline in urinary flow rate

Trial Locations

Locations (1)

The First Affiliated Hospital, Sun Yat- sen University; 🇨🇳 Guangzhou, Guangdong, China