Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients
Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients
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.
Inclusion Criteria:

 -  Male patients aged over 50

 -  Clinically diagnosed benign prostate hyperplasia(BPH)

 -  8 ≤ IPSS ≤ 30

 -  4 ml/sec ≤ Q max ≤ 15 ml/sec

 -  minimum voided volume ≥ 125 ml

 -  Post voided residual volume ≤ 250

 -  Volunteer who singed on informed consent documents

 Exclusion Criteria:

 -  Past history of surgical procedure experience related to BPH

 -  Past history of taking 5-alpha reductase inhibitor(5-ARI) within 6 months before
 screening, or for more than 12 months regardless of the point of time

 -  Past history of taking alpha blocker within 2 weeks before screening

 -  Past history of acute urinary retention within 3 months before screening

 -  Serum PSA ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ PSA < 10 ng/ml, the patients can
 be included only if prostate cancer is excluded by prostate biopsy)

 -  Anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis,
 bladder neck contracture)

 -  Clinical status that affects voiding other than BPH(neurogenic bladder, Chronic
 Prostatitis/Chronic Pelvic Pain Syndrome, urinary infection, etc.)

 -  Unstable and significant medical condition including below

 -  Unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6
 months before screening

 -  Past history of malignant tumor including skin basal cell carcinoma within 5
 years before screening

 -  Medically uncontrollable diabetes mellitus, peptic ulcer disease

 -  Severe hepatic diseases

 -  Past history of renal failure or renal disease (serum creatinine > 1.4mg/dl)

 -  Condition expected serious adverse event due to the investigational drug

 -  Other conditions considered not eligible for the trial upon investigator's judgement