Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced External Counterpulsation | Experimental | Men with benign prostatic hyperplasia receive 35- 36 hours Enhanced External Counterpulsation treatment |
|
| Control | No Intervention | Men with benign prostatic hyperplasia without Enhanced External Counterpulsation treatment as control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary flow rate | Change from baseline in urinary flow rate | 7 weeks |
| Endothelial function | Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yadong Zhang, M. D. | Contact | 862087755766 | 8373 | zhyadong@mail.sysu.edu.cn |
| Zi Wan, M. D. | Contact | 862087755766 | 8227 | zi_wan2012@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Zhang, M. D. | First Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yat- sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D011470 | Prostatic Hyperplasia |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
Not provided
Not provided
Patients with benign prostatic hyperplasia are assigned to two groups in parallel for the duration of the study
Not provided
Not provided
Not provided
Not provided
|
|
| 7 weeks |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |