Benign Prostatic Hyperplasia
Conditions
Interventions
Silodosin 4 mg will be orally administered twice daily after breakfast and dinner for 8 weeks.
Tadalafil 5 mg will be orally administered once daily for 8 weeks. Subsequently, Tadalafil will be switc
Sponsors
Kissei Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients diagnosed with benign prostatic hyperplasia by digital rectal examination or ultrasonography who provide written consent to participate in the research. 1) Patients meet the following conditions as confirmed through inspection and examination at the start of treatment (Week 0): Total IPSS Score of 13 or higher QOL score of 3 or higher Prostate volume of 20 mL or higher Residual urine volume of 100 mL or less 2) Patients are 60 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 or tadalafil. 2) Patients have prostate cancer. 3) Patients have lower urinary tract symptoms possibly due to urinary tract infection or neurogenic bladder. 4) Patients have used silodosin or tadalafil within 12 weeks prior to Week 0.
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 (treatment period I, Weeks 1, 2, 3, 4: treatment period II, Weeks 9, 10, 11, 12) 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) Subgroup analyses of primary/secondary endpoints by subject's baseline characteristic (age, BMI, duration of illness, OAB/ED/renal disease/hepatic disease and other complications, treatment history, prostate volume, baseline data of each endpoint at the start of treatment [Week 0]) 11) Adverse events and adverse drug reactions | — |
Countries
Japan
Contacts
Public ContactKatsumi Watanabe
Mebix, Inc. Research Promotion Division
Outcome results
None listed