Benign Prostatic Hyperplasia
Conditions
Interventions
Silodosin 4 mg will be orally administered twice daily after breakfast and dinner for 12 weeks.
Tamsulosin hydrochloride 0.2 mg will be orally administered once daily after a meal for 12 weeks.
Sponsors
Kissei Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients with benign prostatic hyperplasia receiving combination therapy with tamsulosin hydrochloride and dutasteride who provide written consent to participate in the research. 1) Patients have received tamsulosin hydrochloride for at least 12 weeks prior to the start of treatment (Week 0) and dutasteride for at least 24 weeks prior to Week 0 according to fixed doses and modes of administration. 2) Patients meet the following conditions as confirmed through inspection and examination at Week 0. Total IPSS Score of 8 or higher QOL score of 3 or higher Residual urine volume of 150 mL or less 3) Patients are 50 years or older (at the time of consent).
Exclusion criteria
Exclusion criteria: 1) Patients have any of the contraindications listed in the package inserts for silodosin, tamsulosin hydrochloride, or dutasteride. 2) Patients have prostate cancer. 3) Patients have lower urinary tract symptoms possibly due to urinary tract infection or neurogenic bladder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total IPSS score before and after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in IPSS subscore before and after treatment 2) Percentage of subjects with an improvement of 25% or higher for total IPSS score 3) Change in QOL score before and after treatment 4) Change in OABSS score before and after treatment 5) Change in OABSS subscore before and after treatment 6) Changes in total IPSS score, QOL score, and OABSS score before and after treatment in the early stage of treatment (Weeks 1, 2, 3, 4) 7) Change in maximum urine flow rate before and after treatment 8) Change in mean urine flow rate before and after treatment 9) Change in residual urine volume before and after treatment 10) Acute urinary retention or surgery for benign prostatic hyperplasia 11) Subgroup analyses of primary/secondary endpoints by subject's baseline characteristic (age, BMI, duration of illness, OAB/renal disease/hepatic disease and other complications, treatment history, prostate volume, baseline data of each endpoint at the start of treatment [Week 0]) 12) Adverse events and adverse drug reactions | — |
Countries
Japan
Contacts
Public ContactKatsumi Watanabe
Mebix, Inc. Research Promotion Division
Outcome results
None listed