The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.
Even though it should be decided on patients cautiously under careful consideration about prostate volume, Prostate Specific Antigen(PSA) level, symptom score and maximum uroflow, recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been tried imprudently in Korea. As a result of several clinical trials which had conducted overseas for releasing the combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the combination therapy has been proved, however, plenty of patients still don't derive additional profit from it. Therefore, in this study, the investigators anticipate to meet with meaningful results on the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in Korean benign prostate hyperplasia patients, and provide guidelines of the combination therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
545
1 tablet(0.2mg) orally q.d.
1 tablet(5mg) orally q.d.
1 tablet(0.2mg) orally q.d.
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, South Korea
Hallym University Sacred Heart Hospital
Anyang, Gyeoggi, South Korea
Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Clinical Progression
One of below * Deterioration of the symptoms * Acute urinary retention * Renal failure * Recurrent urinary tract infection * Urinary incontinence * Surgical procedure related to benign prostate hyperplasia
Time frame: 1 & 2 months after baseline, and then every 3 months up to 4 years
International Prostate Symptom Score(IPSS)
Time frame: 1 & 2 months after baseline, and then every 3 months up to 4 years
International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form
Time frame: every 6 months up to 4 years
Uroflowmetry
including Qmax, voided volume and post-void residual volume(PVR)
Time frame: every 6 months up to 4 years
Prostate volume
Time frame: every 1 year up to 4 years
Global Response Assessment(GRA)
Time frame: every 1 year up to 4 years
PSA level
PSA level will be examined in the central laboratory and be reported to each center as an adjusted number. It is because PSA level tends to decrease to 50% of baseline after taking finasteride for 1\~4 years, so there is possibilities that the blindedness is broken with the actual result.
Time frame: every 1 year up to 4 years
Blood Chemistry
including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin
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Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Pusan National University Hospital
Busan, South Korea
Seoul National University Hospital
Seoul, South Korea
...and 1 more locations
Time frame: every 1 year up to 4 years
Adverse Events
Time frame: every visit up to 4 years
Physical examination
Digital Rectal Exam, Breast exam
Time frame: every 1 year up to 4 years
Male Sexual Health Questionnaire
Time frame: every 6 months up to 4 years