Background: Benign prostatic hyperplasia (BPH) is a non-malignant hyperplasia of prostatic cells.Most of patients with BPH present with lower urinary tract symptoms (LUTS). LUTS and BPH are highly prevalent entities in aging men.
Objectives: To assess the efficacy and safety of fixed-dose combination therapy of Tamsulosin 0.4 mg plus Tadalafil 5mg versus Tamsulosin 0.4mg, plus placebo once daily in the treatment of patients with LUTS related to BPH whose were refractory to tamsulosin monotherapy.
Patients and Methods: In this randomized controlled clinical study, carried out at Al-Azhar University Hospitals, 80 patients complaining of LUTS related to BPH were randomly divided into two equal groups. Fortypatients received fixed-dose combinations therapy of Tamsulosin 0.4mg/day and tadalafil 5mg /day for 6 months (group A), and forty patients received Tamsulosin 0.4mg plus placebo/day for 6 months (group B). The International Prostate Symptom Score (IPSS), Qmax, Post void residual urine (PVRU) and International Index of Erectile Function (IIEF-5) score used at baseline before starting treatment, at 3 months and 6 months to assess the efficacy in both groups.
Results: With combination therapy group, there was significant improvement in IPSS score P value (<0.001), significant increase in Qmax P value (<0.001), and significant decrease in PVRU P value (<0.001) compared with placepo group. IIEF- 5 score changes showed no statistically significant difference between bothgroups (P value) (0.102) in tadalafil group.
Conclusion: The fixed-dose combination of Tamsulosin 0.4 mg/day and Tadalafil 5 mg/day are significantly superior to Tamsulosin 0.4 mg/day plus placebo for the treatment of LUTS related to BPH whose were refractory to tamsulosin, supporting favorable benefit-risk balance of the fixed-dose combinations therapy for the treatment of LUTS related to BPH because of its synergistic effects, well toleration and safety.