Comparative Efficacy of Tamsulosin Versus Tamsulosin Plus Finasteride in Patients with Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hypertrophy, a Randomized Open Label Parallel Group Study

Abstract

Background: Benign prostatic hypertrophy (BPH) is a common entity among elderly men and is responsible for significant disability. Medical treatment for BPH has played a major role in improving the symptoms associated with bladder outlet obstruction. Recent guidelines recommend the combination of an alpha-1 blocker and a 5-ARI as first-line treatment of men with moderate-to-severe LUTS. There is limited study data to support which is the effective therapy for BPH/LUTS in a tertiary care hospital in India. Methods: A randomized, open labelled, double blind, active control parallel group study comparing the safety and efficacy of tamsulosin versus tamsulosin+finasteride in subjects with lower urinary tract symptoms secondary to benign prostatic hypertrophy. The subjects were randomized after obtaining written informed consent. The subjects were recruited from the patient population that was attending the Out-Patient department of Urology, Sri Ramachandra Medical College & Research Institute, Sri Ramachandra University. Results: A total sample of 60 subjects, 30 into each group was enrolled. In the tamsulosin group, according to IPSS score, 11 patients who had moderate symptoms (36.7%) became mild, and among 19 patients who had severe symptoms (63.3%), 12 patients became mild (40%) and 7 patients became moderate (23.3%) with a p value of 0.021 which is statistically significant. In the tamsulosin+ finasteride group, according to IPSS score, 10 patients who had moderate symptoms (33.3%) became mild, and among 20 patients who had severe symptoms (66.7%), 12 patients became mild (40%) and 8 patients became moderate (26.7%) with a p value of 0.020 which is statistically significant. When comparing between the two groups, 76.7% attained mild symptoms in group 1 and 73.3% patients attained mild symptoms in group 2 with a p value of 0.766 which is statistically not significant. Conclusion: To conclude tamsulosin 0.4mg is as effective as the combination therapy of tamsulosin 0.4mg and finasteride 5mg in the treatment of lower urinary tract symptoms secondary to Benign prostatic hypertrophy.