Comparative Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil versus Tadalafil alone for BPH Patients with Lower Urinary Tract Symptoms and Erectile Dysfunction

Abstract Background benign prostatic hyperplasia (BPH) is a disorder histologically characterized as the nonmalignant hyperplasia of prostatic cells. Most of patients with benign prostate hyperplasia present with lower urinary tract symptoms (LUTS). Aim of the Study to assess the efficacy and safety of fixed-dose combinations therapy of Tamsulosin & Tadalafil versus Tadalafil alone in treatment for BPH patient with lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Patients and Methods this is a randomized controlled clinical study at Urology Department, Faculty of Medicine, Ain Shams University (El Demerdash Hospital) & Damanhour National Institute Hospital from 1-1-2018 till 1-9-2018. It concluded men of 45 years old or older with a history of LUTS secondary to BPH of at least 6 months were eligible for this study. Patients agreed not to use BPH medications during the research other than the study medications. Results the study showed that the fixed-dose combinations of Tamsulosin and Tadalafil significantly improve IPSS score and Qmax more than with Tadalafil 5 mg/day alone. Furthermore, PVRU significantly decreased with the fixed-dose combinations of Tamsulosin and Tadalafil more than with Tadalafil alone. Fixed-dose combinations of Tamsulosin 0.4 mg plus Tadalafil 5 mg were determined to be safe, efficacious, and well tolerated in the subjects investigated, which suggests the new fixed-dose combinations therapy can offer clinically relevant benefits for patients with LUTS complaints and desiring amelioration for comorbid ED complaints. Conclusion the study shows that the fixed- dose combination of Tamsulosin 0.4 mg/day and Tadalafil 5 mg/day are significantly superior to Tadalafil 5 mg/day alone for the treatment of BPH patients with LUTS and non-inferiority in treatment of ED Without showing any clinically significant safety issues, supporting favorable benefit-risk balance of the fixed-dose combinations of therapy for the treatment of BPH patients with LUTS and ED because of its synergistic effects, well toleration and its safety.