Benign Prostatic Hyperplasia
Conditions
Brief summary
The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic benign prostatic hyperplasia as a first line therapy.
Interventions
DRUGTamsulosin 0.4mg
Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.
DRUGTamsulosin 0.2mg
tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Severe LUTS : IPSS ≥ 20
Exclusion criteria
* Post voided residual urine ≥ 150mL * Patients performing catheterization * Urinary tract infection patients * Patients taking 5 alpha reductase inhibitor * Known hypersensitivity to tamsulosin * History of postural hypotension or syncope * Hypertension patients treated with other alpha1-blockers * Patients newly taking anticholinergic medication within 1 month * Hepatic insufficiency (AST/ALT ≥ 2 times of normal range) * Renal insufficiency (s-Cr ≥ 2mg/dL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T) | 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment. | 4 weeks and 12 weeks of treatment |
| Changes of parameters in voiding diary after 4 and 12 weeks treatment. | 4 weeks and 12 weeks of treatment |
Outcome results
None listed