Benign Prostatic Hyperplasia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet all the following criteria will be enrolled. 1 Age >= 50 yrs 2 IPSS >= 8 3 IPSS QOL >= 3 4 Prostate volume >= 25mL measured by abdominal ultarsonograpy 5 Qmax < 15mL/sec
Exclusion criteria
Exclusion criteria: Subjects who apply to any of the following criteria will not be enrolled. 1 Use of any alpha-blocker within 4 weeks 2 Previous use of 5ARIs or antiandrogens 3 History of prostate cancer 4 History of acute urinary retention (AUR) within 3 months 5 Previous prostatic surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in PFS parameter | — |
Secondary
| Measure | Time frame |
|---|---|
| IPSS OABSS Urinary flow Post voided residual volume Safety | — |
Countries
Japan
Contacts
Nagoya University Graduate School of Medicine Department of Urology