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 (mean age 62.2 years) completed the treatment, of whom 85.5% showed improvement in their urinary symptoms. Pre- and post-treatment differences in the IPSS, IPSS-QoL, and IIEF-5 scores were statistically significant at 4.4, 1, and 5.4 points, respectively (P < 0.0001). Tadalafil was well tolerated, and adverse events were mild, with a discontinuation rate of 1.6%. Conclusion According to study results, the use of tadalafil 5 mg once daily in a nonselected patient population with LUTS/BPH with or without ED led to improvements in terms of symptoms and quality of life and exhibited a safety profile similar to that obtained in controlled tadalafil clinical trials.

Predictors of Individual Response to Placebo or Tadalafil 5mg among Men with Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: An Integrated Clinical Data Mining Analysis

“…These findings have been confirmed in a prospective, naturalistic observational study (TadaLutsEd), which closely mirrors routine clinical practice. In this non-selective study, 86% of men aged 50 years and older with LUTS-BPH saw an improvement in urinary symptoms following 6 weeks treatment with tadalafil 5mg once daily [ 38 ].…”

Tadalafil Effect on Metabolic Syndrome-Associated Bladder Alterations: An Experimental Study in a Rabbit Model

“…The efficacy of PDE5 inhibitors in alleviating LUTS is well established [42][43][44][45][46][47][48]. However, their specific mechanism(s) of action has been only partially unraveled [4].…”

The role of phosphodiesterase-5 inhibitors in prostatic inflammation: a review

“…Several randomized, double-blind, placebo-controlled, multinational trials have investigated the efficacy and safety of tadalafil [ 79 – 87 ] or sildenafil [ 88 , 89 , 79 , 90 – 92 ] in the treatment of BPH-LUTS, as well as in the treatment of men with ED and with BPH-LUTS, leading to regulatory approval in the USA and Europe.…”