Role of once-daily tadalafil in men with concomitant erectile dysfunction and symptomatic benign prostatic hyperplasia: A prospective randomized placebo-controlled study

Abstract

Background: Majority of men over age 50 are sexually active and sex is an important part of overall quality of life. Both benign prostatic hyperplasia (BPH) with lower urinary tract symptoms-BPH (BPH-LUTS) and erectile dysfunction (ED) are often found in this age group simultaneously. Pathophysiological mechanisms for both these diseases are almost common. All males presenting with LUTS should be assessed for sexual dysfunction and viceversa. The aim of this study is to evaluate the effects of once-daily tadalafil on erectile function in men with ED and benign prostatic hypertrophy with LUTS. One drug for treatment of both diseases and better patient's compliance are important issues for proper management. Materials and Methods: We did a study of 60 men. All patients were divided in two groups: 30 in group A who were given tadalafil 5 mg (megalis-5 mg of Macleods Pharmaceutical Company) and 30 patients in group B who were on placebo (plain sugar pills) for 12-week. This was a randomized, placebo-controlled study of once-daily tadalafil, which was carried out in men with BPH-LUTS in a rural Medical College of Northern India during June 2009 to November 2011. Results: International index of erectile function-erectile function (IIEF-EF) domain score improvements from baseline with 5 mg once-daily tadalafil were significantly greater throughout the study for tadalafil groups versus placebo (all P ≤ 0.001). International Prostate Symptom Score (IPSS) improvements from baseline to end point were significantly greater with 5 mg tadalafil dose versus placebo (all P Conclusion: There are encouraging results with tadalafil. It was used in 30 patients who were suffering with both ailments of BPH and LUTS simultaneously and is effective in both diseases.