Tadalafil vs Tamsulosin for the Management of Lower Urinary Tract Symptoms in Men with Benign Prostatic Hyperplasia: A Randomised Clinical Trial

Abstract

Introduction: Tadalafil and tamsulosin have both been approved for use in the management of Lower Urinary Tract Symptoms (LUTS). Limited studies have shown the efficacy of tadalafil in terms of maximum urinary output flow (Qmax) and post-void residual (PVR). Aim: To compare the efficacy of tadalafil 5 mg and tamsulosin 0.4 mg in patients with Benign Prostatic Hyperplasia (BPH). Materials and Methods: A prospective, open-label, Randomised clinical study was conducted in the Department of Urology at Kurnool Medical College, Kurnool, Andhra Pradesh, India. The study duration was one year and five months, from February 2015 to July 2016. A total of 83 patients clinically diagnosed with BPH were included, but 23 patients were excluded from the analysis due to lost follow-up. The remaining 60 patients were randomly assigned to two groups: one receiving tadalafil 5 mg (n=30) and the other receiving tamsulosin 0.4 mg (n=30) for 12 weeks. Demographic characteristics, total International Prostate Symptom Score (IPSS), individual IPSS, Quality of Life (QoL) score, Qmax, PVR, and differences in symptoms were analysed. Data were analysed using the Wilcoxon signed-rank test and Mann-Whitney U test. A p-value<0.05 was considered statistically significant. Results: The mean age for group I (tadalafil 5 mg) and Group II (tamsulosin 0.4 mg) was 62.7 and 61.0 years, respectively (p=0.147). Patients who received tadalafil showed significantly higher efficacy in all measures from baseline to 12 weeks, including increased Qmax (12.0 mL/sec vs 15.1 mL/sec), reduced QoL scores (4.2 vs 3.7), and PVR (26.5 mL vs 15.8 mL), compared to tamsulosin where the increase in Qmax was 11.6 mL/sec vs 13.6 mL/sec, reduction in QoL scores was 4.1 vs 2.4, and PVR was 24.0 mL vs 16.2 mL, between baseline and 12 weeks. Conclusion: Tadalafil 5 mg is a recent drug option available for the treatment of LUTS-BPH. The efficacy and safety of tadalafil 5 mg and tamsulosin 0.4 mg are comparable.