A randomized, crossover trial comparing the efficacy and safety of fesoterodine and extended-release oxybutynin in children with overactive bladder with 12-month extension on fesoterodine: The FOXY study

Abstract

Introduction: We sought to assess and compare safety and efficacy of fesoterodine and oxybutynin extended-release in the treatment of pediatric overactive bladder (OAB). Methods: We conducted a non-inferiority, randomized, double-blind, crossover trial comparing fesoterodine 4–8 mg and oxybutynin 10–20 mg QD in children with OAB aged 5–14 years (2015–2018). Every child received the first medication for eight weeks, followed by crossover to the second antimuscarinic after a three-days washout. Dose up-titration was possible at mid-course. Patients could enter a fesoterodine 12-month extension. Endpoints were assessed through changes on voiding diaries, Patient’s Perception of Bladder Condition score (PPBC), adverse events, vital signs, electrocardiogram, post-void residual, urinalysis, and blood tests. The Wilcoxon rank sum and Wilcoxon signed rank tests were used for statistical analysis. Results: A total of 62 patients were randomized (two early dropouts). Expected class effects (dry mouth/constipation) were present but no significant difference was observed. There was a 10.1 beats/minute increase in heart rate with fesoterodine (p<0.01) (oxybutynin -1.9 beats/min; p=ns). No life-threatening or serious adverse events occurred. Efficacy was similar for both drugs. Bladder capacity improved over the 16 months of the study; baseline capacity of 125 mL (44.5% expected bladder capacity for age [%EBC]) to 171 mL (53.9%EBC) at the end of the extension phase. No clinical or statistical difference was shown between efficacy measures for fesoterodine or oxybutynin. Conclusions: The use of fesoterodine or oxybutynin appears as safe and effective for the treatment of OAB in children. Based on our study, long-term treatment to achieve the ultimate goal of urinary continence is needed in this population.