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

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Astellas Pharma Korea, Inc.; Medical Research Collaborating Center, Seoul, Korea
• Treatments: Adrenergic alpha-Antagonists; Finasteride; Tamsulosin

Criteria

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