Open-label, Intermittent Dose, Prospective Study Evaluating the Effects of Tadalafil on Lower Urinary Tract Symptoms and Erectile Function in Patients with Benign Prostatic Hyperplasia: Continuation and Durability of Effects

Abstract

Purpose: Benign prostatic hyperplasia is often accompanied by age-related comorbidity, such as erectile dysfunction (ED). Recent data suggest an association between ED and lower urinary tract symptoms (LUTS), and increasing evidence indicates that the clinical use of phosphodiesterase type 5 (PDE5) inhibitors provides relief from LUTS. The aim of the present study was to investigate the effects of tadalafil (20 mg once every 3 days for 12 weeks, p.o.) in men with moderate-to-severe ED and LUTS and to investigate the duration of the effects of tadalafil beyond treatment cessation. Metrials and Methods: Men with an International Index of Erectile Function-5 (IIEF-5) score of less than 11 (representing "moderate-to-severe" ED status) and with an International Prostate Symptom Score (IPSS) of more than 8 (representing "moderate-to-severe" LUTS status) were enrolled. IPSS (total score, storage subscore, and voiding subscore) and IIEF-5 scores before treatment (baseline), during treatment (weeks 4 and 12 after treatment commencement), and after treatment (weeks 16 and 20after treatment commencement) were compared. Results: IPSS and IIEF-5 scores were significantly different between baseline and week 12 after treatment commencement. Furthermore, these scores were significantly different between baseline and week 20 after treatment commencement. However, except for IIEF-5 scores, no significant differences were observed between week 12 and week 20. Conclusions: Treatment with 20 mg tadalafil (once every 3 days) had beneficial effects on LUTS and ED beyond treatment cessation in patients with moderate-to-severe ED and LUTS.

BPH/LUTS and ED: Common Pharmacological Pathways for a Common Treatment

“…Tadalafil 5 mg administered daily for 1 year in men with LUTS secondary to BPH [44,46–51,54,55,57–59] was well tolerated. In open‐label extension study [48], few patients discontinued the study as a result of an adverse event, most of them were of mild or moderate intensity and the most commonly reported adverse effects (dyspepsia, back pain, and headache) are commonly associated with PDE5‐Is.…”

Effectiveness of the addition of tadalafil to tamsulosin in the treatment of acute urinary retention in patients with benign prostatic hyperplasia: A randomized clinical trial

“…1,2 BPH is usually characterized by enlargement of the prostate gland, narrowing of the urethra, and secondary to it, the appearance of lower urinary tract symptoms (LUTS). 3,4 Approximately 40% of men by the age of 50 years and 80% of them by 80 years will develop BPH. 5 The prevalence of erectile dysfunction (ED) increases with age, and the association between BPH and ED has already been confirmed by various studies.…”

“…1,2 BPH is usually characterized by enlargement of the prostate gland, narrowing of the urethra, and secondary to it, the appearance of lower urinary tract symptoms (LUTS). 3,4…”