Dual Therapy for Refractory Overactive Bladder in Children: A Prospective Open-Label Study

Abstract

No AccessJournal of UrologyPediatric Urology1 Apr 2017Dual Therapy for Refractory Overactive Bladder in Children: A Prospective Open-Label Study Fannie Morin, Anne-Sophie Blais, Geneviève Nadeau, Katherine Moore, Lucie Genois, and Stéphane Bolduc Fannie MorinFannie Morin , Anne-Sophie BlaisAnne-Sophie Blais , Geneviève NadeauGeneviève Nadeau , Katherine MooreKatherine Moore , Lucie GenoisLucie Genois , and Stéphane BolducStéphane Bolduc View All Author Informationhttps://doi.org/10.1016/j.juro.2016.11.101AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Mirabegron (β3 adrenoreceptor agonist) is a new molecule with a mechanism of action distinct from antimuscarinics. Combination therapy with solifenacin was recently studied in an adult population. We evaluated the efficacy and safety of mirabegron as add-on therapy to treat urinary incontinence in children with idiopathic overactive bladder refractory/intolerant to antimuscarinics. Materials and Methods: A prospective off-label study using add-on regimens of mirabegron was conducted in pediatric patients presenting with no symptom improvement while undergoing intensive behavioral and medical therapies and/or significant side effects while undergoing antimuscarinic dose escalation. Our primary outcome was better reported efficacy than with the use of prior antimuscarinic monotherapy. Secondary end points were tolerability, safety and satisfaction. Efficacy and tolerability were assessed based on voiding diaries, post-void residuals, urine cultures, electrocardiograms and vital signs. Families were questioned regarding continence, side effects and compliance. Wilcoxon signed-rank test was used for statistical analysis. Results: A total of 35 patients were recruited at a median age of 10.3 years and were administered add-on mirabegron for a median of 16.4 months. Median bladder capacity improved from 50% to 74% expected bladder capacity (p <0.001). Continence improved in all patients, with 12 being completely dry. Post-void residual was increased in 2 patients and 1 urinary tract infection was reported. Seven patients reported mild or moderate side effects, with 2 withdrawals because of side effects (1 patient) and post-void residual (1). Conclusions: Add-on mirabegron appears to be a safe alternative for children with refractory overactive bladder. Dual therapy is well tolerated and adjusted dose regimen appears safe in this first pediatric study. References 1 : Pediatric overactive bladder syndrome: pathophysiology and management. Paediatr Drugs2007; 9: 379. Google Scholar 2 : The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. 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Google Scholar © 2017 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byKim J, De Jesus M, Lee M, Dos Santos J, Dy J, Ming J, Rickard M, Lorenzo A and Chua M (2021) β3-Adrenoceptor Agonist for the Treatment of Bladder Dysfunction in Children: A Systematic Review and Meta-AnalysisJournal of Urology, VOL. 207, NO. 3, (524-533), Online publication date: 1-Mar-2022.Austin P (2017) The Current Status of Clinical Drug Trials in Pediatric UrologyJournal of Urology, VOL. 197, NO. 4, (975-976), Online publication date: 1-Apr-2017.Cain M (2017) This Month in Pediatric UrologyJournal of Urology, VOL. 197, NO. 4, (971-972), Online publication date: 1-Apr-2017. Volume 197Issue 4April 2017Page: 1158-1163Supplementary Materials Advertisement Copyright & Permissions© 2017 by American Urological Association Education and Research, Inc.Keywordsmirabegronoveractivecholinergic antagonistsurinary bladderMetricsAuthor Information Fannie Morin More articles by this author Anne-Sophie Blais More articles by this author Geneviève Nadeau Financial interest and/or other relationship with AMS, Astellas, Pfizer, Ferring, Allergan and Laborie. More articles by this author Katherine Moore Financial interest and/or other relationship with Pfizer Canada and Astellas Pharma. More articles by this author Lucie Genois More articles by this author Stéphane Bolduc Financial interest and/or other relationship with Pfizer Canada and Astellas Pharma. More articles by this author Expand All Advertisement PDF downloadLoading ...