Efficacy and Safety of Tadalafil, Tamsulosin, and Their Combinations in Treating Lower Urinary Tract Symptoms in BPH Patients With Prostate Volumes ≤ 40 ml: A Prospective Comparative Study

Summary

Abstract: Objective: To examine the influence of tadalafil and tamsulosin versus their combinations in the treatment of lower urinary tract symptoms in mildly enlarged prostates below 40 ml in volume. Materials and methods: A prospective randomized study was done at Fayoum and Beni-Suef University Hospitals in Egypt from December 2022 to August 2023. A total of 95 male participants aged over 45 years, all presenting with mild to intense lower urinary tract symptoms, were enrolled. Participants were randomized into three groups: Group A was administered Tamsulosin (0.4 mg per day), Group B was administered tadalafil (5 mg per day), and Group C was administered a mixture of both medications. The study assessed multiple parameters, the primary endpoint parameter was the International Prostate Symptom Score (IPSS) and the other secondary parameters were the five-item International Index of Erectile Function (IIEF-5), maximum urinary flow rate (Q-max), post-void residual urine (PVR), and the quality of life (QoL). At baseline, these parameters were assessed, followed by evaluations at 1, 3, and 6 months after treatment. Key words. Tamsulosin, tadalafil, BPH and LUTS.

Timeline

Start

2023-04-20

Primary completion

2024-05-20

Completion

2024-08-30

Publications

• Results Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
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• Results Morton A, Williams M, Perera M, Teloken PE, Donato P, Ranasinghe S, Chung E, Bolton D, Yaxley J, Roberts MJ. Management of benign prostatic hyperplasia in the 21st century: temporal trends in Australian population-based data. BJU Int. 2020 Sep;126 Suppl 1:18-26. doi: 10.1111/bju.15098. Epub 2020 Jun 17.
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