Presentation Authors: GOPAL TAK*, ABHISHEK SINGH, ARVIND GANPULE, RAVINDRA SABNIS, MAHESH DESAI, NADIAD, India
Introduction: An important reason for lower urinary tract symptoms (LUTS) in elderly men is Benign Prostatic Hyperplasia (BPH). Erectile dysfunction (ED) also has a negative effect on quality of life (QoL) also a major problem at this age. Dutasteride decreases the size of the prostate but has sexual problems, impotence as an adverse effect. These may be nullified with Tadalafil which used in the treatment of impotence and erectile dysfunction. It also has a proven beneficial effect in BPH. Aim: To assess the efficacy of Tadalafil with Dutasteride and Tadalafil with placebo for LUTS secondary to BPHPrimary objective: To evaluate the effect of Tadalafil with Dutasteride combination therapy as compared to Tadalafil with placebo on patients with LUTS due to BPH, objectivelySecondary Objective: To assess the safety profile of Tadalafil with Dutasteride combination therapy as compared to Tadalafil with placebo on patients with LUTS due to BPH.
Methods: Study design: A prospective, double-blind, randomized, placebo-controlled study(n=30) patients enrolled in each group Sample size generated from Power and Sample size calculation program (Version 3.0) using with Statistical Power (1-Î²) = 0.85 and Level of Significance (Î±) = 0.05. Studentâ€™s t-test used. Period of study: February 2016 to December 2016Dose and duration of study drugs Tadalafil 5mg, Dutasteride 0.5mg, duration 6 months
Results: â€˜Dutasteride + Tadalafil armâ€™ (D+T) and â€˜Tadalafil+ placebo armâ€™ (P+T), for only two parameters (IPSS-24 and Uroflow at 24 weeks UFR-24), (D+T) group showed statistically significant improvement over the (P+T) group (p < 0.05).For the rest of all the parameters, there was a statistically insignificant difference.Adverse effects were comparable.
Conclusions: Based on our study, combination therapy with daily Tadalafil and Finasteride/ Dutasteride is ideally suited for men with moderate to severe BPH-LUTS and a prostate volume >30 g. In addition, men with coexisting ED will benefit from PDE5 inhibition