Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: Tamsulosin 0.4mg (Drug); Tamsulosin 0.2mg (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Samsung Medical Center

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.

Official title: The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment.

Changes of parameters in voiding diary after 4 and 12 weeks treatment.

Minimum age: 45 Years. Maximum age: 80 Years. Gender(s): Male.

Criteria:

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)

Starting date: July 2011
Last updated: July 30, 2011