The efficacy of vardenafil and tamsulosin in treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: A randomised clinical trial

Abstract

Objectives: This randomised controlled trial (RCT) aimed to evaluate the efficacy of vardenafil monotherapy, tamsulosin monotherapy, and combination therapy of vardenafil and tamsulosin in treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Methods: This RCT involved 75 patients presenting with LUTS secondary to BPH. Patients were randomly allocated into three groups, receiving either vardenafil monotherapy, tamsulosin monotherapy, or a combination of both drugs. Assessments and follow-ups were conducted 1, 3, and 6 months after treatment initiation, focusing on improvements in LUTS, uroflowmetry measurements, and patients’ sexual performance. Data analysis was performed using Microsoft Office Excel 2007 and IBM SPSS statistics software version 22.0. Results: This study included 75 participants divided into three groups. No significant differences were found in terms of patients’ age (p = 0.504) or treatment duration (p = 0.680) between the groups. The combination of vardenafil/tamsulosin consistently showed the lowest International Prostate Symptom Score (IPSS) scores and grades, followed by the tamsulosin group (p < 0.001). Regarding Q-max and post-void residual urine (PVRU), significant differences were observed between the vardenafil group and the other two groups (p > 0.001), but no significant differences were found between the tamsulosin and vardenafil/tamsulosin groups. Conclusion: The combination therapy with vardenafil and tamsulosin is more effective in improving LUTS secondary to BPH than monotherapy. Tamsulosin monotherapy also appears to be more effective than vardenafil monotherapy. Combination therapy provides a viable treatment option for patients who do not respond adequately to monotherapy or experience adverse effects from either drug. Level of Evidence: Moderate