Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- JPRN-UMIN000011556
- Lead Sponsor
- Matsushita Urology Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 60
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method