Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)
Not Applicable
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Registration Number
- NCT01404637
- Lead Sponsor
- Samsung Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 150
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tamsulosin 0.4mg Tamsulosin 0.4mg - tamsulosin 0.2mg Tamsulosin 0.2mg -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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