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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

ClinicalTrials.gov · COMPLETED, 2024

95 participants

Abstract

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.

Conditions: BPH With Other Lower Urinary Tract Symptoms.

Primary outcome: IPSS (International Prostate Symptom Score).

Enrollment: 95 participants.

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: 95 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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