Effectiveness of tadalafil 5 mg once daily in the treatment of men with lower urinary tract symptoms suggestive to benign prostatic hyperplasia with or without erectile dysfunction: results from naturalistic observational TadaLutsEd study
Abstract
INTRODUCTION: Naturalistic clinical trials provide data on the effectiveness of drugs in nonexperimental and everyday situations and are extremely helpful for decision-making purposes and for confirming experimental findings in clinical trials. No data have been published from naturalistic studies performed in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) with or without erectile dysfunction (ED) and treated with phosphodiesterase type 5 inhibitors.
AIM: The aim of this study (TadaLutsEd Study) was to assess, in the context of medical practice, the effectiveness of tadalafil 5 mg once daily in patients with LUTS/BPH with or without erectile dysfunction.
METHODS: The study was a 6-week uncontrolled, prospective, open-label, multicentric, observational study. The patient population involved sexually active males aged ≥ 50 years, diagnosed with LUTS/BPH with or without concomitant ED, and treated with tadalafil 5 mg daily in accordance with standard urological practice.
MAIN OUTCOME MEASURES: Effectiveness was assessed through the self-administered International Prostate Symptom Score (IPSS) questionnaire; quality of life was evaluated through the IPSS quality of life section (IPSS-QoL). The patients were also evaluated with the International Index of Erectile Function (IIEF-5). Adverse events were recorded. Statistical analyses using paired data samples was applied (Wilcoxon signed-ranks test).
RESULTS: Sixty-two patients…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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