Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chonnam National University Hospital | OTHER |
| Kangdong Sacred Heart Hospital | OTHER |
| Yeungnam University Hospital | OTHER |
| Pusan National University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week treatment of patients with severe urinary disorders associated with benign prostatic hyperplasia (BPH).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silodosin | Experimental | Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silodosin | Drug | Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total International prostate symptom score(IPSS) score before and after treatment | Assess the improvement of lower urinary tract symptoms with change in total IPSS score before and after treatment. | For 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life(QoL) score before and after treatment | Assess the improvement of lower urinary tract symptoms with change in QoL score before and after treatment. | For 12 weeks |
| Maximal urinary flow rate(Qmax) before and after treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| G.S. Park, Prof | Chonnam National Univ. | Study Chair |
| D.Y. Yang, Prof | Kangdong Sacred Heart | Principal Investigator |
| K.H. Moon, Prof | Yeongnam Univ. Medical | Principal Investigator |
| N.C. Park | Pusan National Univ. Hospital | Principal Investigator |
| S.W. Kim, Prof | Seoul National Univ. Hospital | Principal Investigator |
| S.W. Lee, Prof | Samsung Medical Center | Principal Investigator |
| S.W. Kim, Prof | Seoul St. Mary's Hospital | Principal Investigator |
| D.G. Moon, Prof | Korea Univ. Guro Hospital | Principal Investigator |
| J.K. Park, Prof | Chunbuk National Univ. Hospital | Principal Investigator |
| T.Y. Ahn, Prof | Asan Medical Center |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university hospital | Seoul | South Korea |
Not provided
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C095285 | silodosin |
Not provided
Not provided
Not provided
| OTHER |
| Seoul National University Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Seoul St. Mary's Hospital | OTHER |
| Korea University Guro Hospital | OTHER |
| Chonbuk National University Hospital | OTHER |
| Asan Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Assess the improvement of lower urinary tract symptoms with change in Qmax before and after treatment.
| For 12 weeks |
| Voiding score of IPSS before and after treatment | Assess the improvement of lower urinary tract symptoms with change in voiding scores before and after treatment. | For 12 weeks |
| Storage scores of IPSS before and after treatment | Assess the improvement of lower urinary tract symptoms with change in storage scores before and after treatment. | For 12 weeks |
| Post void residual urine volume(PVR) before and after treatment | Assess the improvement of lower urinary tract symptoms with change in post void residual urine volume(PRV) before and after treatment. | For 12 weeks |
| Principal Investigator |
| D052801 |
| Male Urogenital Diseases |