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This study is designed to investigate the comparison between alpha blocker monotherapy and 5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic hyperplasia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination group | Experimental | combination therapy of alpha blocker and 5-alpha-reductase inhibitor medication |
|
| alpha blocker group | Active Comparator | alpha blocker monotherapy |
|
| 5 ARI group | Active Comparator | 5 alpha-reductase inhibitor group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combination therapy | Drug | alpha blocker and 5-alpha-reductase inhibitor medication |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric change of IPS and Numeric change of IPSS total score | from baseline to 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS | from baseline to 12 months of treatment | |
| Changes in urodynamic parameters : maximal flow rate and PVR | from baseline to 12 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu-Sung Lee, Ph.D | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| alpha blocker monotherapy |
| Drug |
alpha blocker monotherapy group |
|
| 5 alpha reductase inhibitor monotherapy | Drug | 5 alpha reductase inhibitor monotherapy |
|
| change in finding of TRUS | from baseline to 12 months of treatment |
| Numeric Change and percent change in PSA | from baseline to 12 months of treatment |
| safety evaluation : incidence and severity of adverse events | 12 months of treatment |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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