Randomized Controlled Trial to Assess the Efficacy of the Combination Therapy of Alfuzosin and Tadalafil in Patients with Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. 
The purpose of our study was to evaluate the effect of alfuzosin and tadalafil as combination therapy compared with each monotherapy, in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).  Men over the age of 50 years with LUTS secondary to BPH and an International Prostate Symptom Score (IPSS) 8 or higher, were randomized to receive 10 mg alfuzosin (n = 25), 10 mg tadalafil (n = 25) or the combination of both the drugs (n = 25) once daily for 3 months.  Symptoms were assessed at baseline, 6 weeks and 3 months.  The primary endpoint was the change in IPSS from the baseline.  Secondary endpoints were changes in IPSS storage and voiding subscores, peak urinary flow rate, residual urine volume, IPSS quality of life score and erectile domain score.  There were significant improvements in all IPSS scores, peak urinary flow rate and IPSS quality of life score from baseline at both 6 weeks and 3 months in all the three groups (P < 0.003).  Combination therapy was better than monotherapy in improving IPSS scores and reducing post-void residual urine volume (P < 0.005).  Combination therapy was similar to alfuzosin regarding improvement in maximum urine flow rate (P = 0.22), similar to tadalafil in improvement on erectile function (P = 0.22) and better than each monotherapy in improving the IPSS quality of life (P ≤ 0.015).  Alfuzosin and tadalafil combination therapy provides greater symptomatic improvement as compared to either monotherapy in men with LUTS due to BPH.