Benign Prostatic Hyperplasia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) IPSS total score>8 points; 2) IPSS-QOL score>3 points; 3) prostate volume >20 mL as measured by transperitoneal or transrectal ultrasonography; 4) Qmax for urination of >100 mL <15 mL/second on uroflowmetry; 5) PVR <100 mL; and 6) patient age >50 years.
Exclusion criteria
Exclusion criteria: (1) undergoing oral treatment with alpha-antagonists, anticholinergic agents, antidepressants, antianxiety agents, or anti-androgens; (2) suspected of having prostate cancer; (3) with neurogenic bladder dysfunction, bladder calculus, or active urinary tract infection; (4) with serious cardiac complications; (5) with renal complications (serum-creatinine >2 mg/dL); and (6) with hepatic dysfunction (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) at least twofold higher than reference values).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The chnage of urodymamic parameters on storage and voiding functions before and after administration of silodosin | — |
Secondary
| Measure | Time frame |
|---|---|
| The chnage of subjective parameters (IPSS, OABSS) before and after administration of silodosin | — |
Countries
Japan
Contacts
Nagoya University Graduate School of Medicine Urology