Comparing the Efficacy and Safety of Treatment with Fixed Dose of Tadalafil Monotherapy versus Its Combination with Silodosin in Patients with Benign Prostatic Hyperplasia and Erectile Dysfunction
Abstract
Background Benign prostate hyperplasia (BPH) is a histological diagnosis which is identified by non-malignant hyperplasia of prostatic tissue due to smooth muscle and epithelial cell proliferation in the prostatic transition zone. Aim of the Work To assess the efficacy and safety of fixed-dose of Tadalafil monotherapy versus its combination with Silodosin in treatment of BPH patient and erectile dysfunction (ED) by comparing IPSS score, PVR, Q max and The international Index of Erectile Function (IIEF questionnaire). Methodology This prospective randomized control clinical study was conducted at tertiary care hospital at Ain Shams University hospitals from June 2021 till January 2022 and performed on total 60 men patients which were 45 years old or older with a history of LUTS secondary to BPH of at least 6 months. Results Our study results revealed that there was no statistically significant difference found between the studied groups regarding IPSS and Q-max at baseline while there was statistically significant difference found in IPSS and Q-max at 1 month, 2 months and 3 months, with statistically significant decrease in IPSS and significant increase in Q-max through follow-up from baseline in each group. Conclusion This analysis suggested that the combination-therapy of tadalafil and Silodosin was more effective than tadalafil alone in improving subjective LUTS, but there was no significant improvement in sexual function.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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