Lower Urinary Tract Symptoms
Conditions
Keywords
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Retention, Vascular Endothelium, Counterpulsation, External
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
Interventions
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.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with benign prostatic hyperplasia are assigned to two groups in parallel for the duration of the study
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score | 7 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary flow rate | 7 weeks | Change from baseline in urinary flow rate |
| Endothelial function | 7 weeks | Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system |
Countries
China
Contacts
Primary ContactYadong Zhang, M. D.
Backup ContactZi Wan, M. D.
Outcome results
None listed