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

Sun Yat-sen University

Status: Unknown

Conditions: Lower Urinary Tract Symptoms

Treatments: Device: Enhanced External Counterpulsation

Study type: Interventional

Funder types: Other

Identifiers

NCT01815697

NSFC-81070488

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Enhanced External Counterpulsation

Experimental group

Description:

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

Treatment:

Device: Enhanced External Counterpulsation

Control

No Intervention group

Description:

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