Benign Prostatic Hyperplasia
Conditions
Interventions
Silodosin 4 mg, once daily after breakfast
Tamsulosin 0.2 mg, once daily after breakfast
Sponsors
Matsushita Urology Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1)Subject must have urinary symptoms associated with benign prostatic hyperplasia. (2)Subject must give written informed consent. (3)Subject must satisfy the following conditions during screening conducted at the start of the treatment period (Day 0): * the total IPSS voiding symptom score is 8 or more, * the QOL score is 2 or more, * prostate volume is 20 mL or more, * maximum urinary flow rate (Qmax) is 15 mL/sec or less, and * residual urine volume is less than 100 mL. (4)Subject must not use prohibited concomitant drugs except at least 2 weeks before the start of the treatment period (Day 0), or the subject must be able to undergo a drug washout for at least 2 weeks before the start of the treatment period. (5)Subject must be an outpatient who can fill in the questionnaire. (6)Subject must be 65 years or older at the time of signing the informed consent.
Exclusion criteria
Exclusion criteria: (1)Subject is contraindicated to silodosin or tamsulosin according to the respective package insert. (2)Subject has received prostatic resection. (3)Subject has received radiotherapy to the pelvic region. (4)Subject has received hyperthermia or thermotherapy for prostatic hypertrophy. (5)Subject has or is suspected to have prostate cancer. (6)Subject has neurogenic overactive bladder, bladder neck contracture, urethral stricture, bladder stones, large bladder diverticulum, active urinary tract infection requiring treatment, or other complications that may affect urination. (7)Subject performs self-catheterization. (8)Subject has taken any of the following drugs within 12 months before the start of treatment period (Day 0): * silodosin or tamsulosin, * 5alpha-reductase inhibitors, or * antiandrogen drugs. (9)Subject has clinically important cardiovascular disturbances. (10)Subject has clinically important hepatorenal diseases. (11)Subject has a history of severe drug hypersensitivity. (12)Subject is scheduled to have cataract surgery in the study period. (13)Subject has or is suspected to have a complication of dementia. (14)Subject is considered inappropriate for participating in the study by the subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS voiding symptom score | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Efficacy; IPSS total score and subscores QOL score OABSS Urodynamic parameters (2) Safety; Blood pressure Adverse events and adverse drug reactions | — |
Countries
Japan
Contacts
Public ContactOrie Watanabe
Sogo Rinsho Médéfi Co., Ltd Business Promotion Department
Outcome results
None listed