EFFICACY AND SAFETY OF TAMSULOSIN (0.4 mg) ONCE DAILY FOR TREATING SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA

Objective: To evaluate the efficacy and safety of tamsulosin 0.4mg once daily compared with placebo in men with symptomatic benign prostatic hyperplasia. Patients and method: In this randomised, placebo-controlled study 69 patients were enrolled. Of these 51 were receive tamsulosin 0.4 mg and 18 patients were receive placebo once daily for 12 weeks. Study was designed to compare the efficacy safety and of tamsulosin verses placebo group. The primary outcome measures were; mean changes in total and /or individual I-PSS score, prostate volume and life style questionnaire, from baseline to 12 weeks of study. Result: Tamsulosin significantly improved lower urinary tract symptoms compared to placebo, with a mean change in I-PSS scores from baseline to end of the study was 16.7 VS 9.0 for placebo (P ≤0.0002). Improvement in symptoms was 85.74%. Compare to placebo. The life style questionnaire was significantly improved in tamsulosin group. Adverse events were similar to placebo, most common observed adverse event was dizziness (4.34%) similar to placebo ((7.14 %). While sexual disorder ((2.1% delayed ejaculation) was prominent in tamsulosin group. Conclusion: Once daily dosing of tamsulosin at bed time at a fix dose level (0.4mg) offers an efficient improvement in total and individual I-PSS score but have no effect on prostate volume, adverse events other than ejaculatory disorder were similar to placebo. Tamsulosin is safe and well tolerated and most effective for treatment of symptomatic BPH at a short term basis.