Efficacy and safety of mirabegron, a β3-adrenoceptor agonist, for treating neurogenic bladder in pediatric patients with spina bifida: a retrospective pilot study
Antimuscarinics are the first pharmacological treatment option for neurogenic bladder in children with spina bifida but side effects limit their use. Mirabegron, a new β-3 adrenoceptor agonist with a distinct mechanism of action, is a potential agent for the treatment of neurogenic bladder; however, it has yet to be studied in the pediatric population. This study evaluated the efficacy and safety of mirabegron for treating neurogenic bladder in children with spina bifida.
Materials and methods
Clinical and urodynamic parameters were retrospectively studied in 66 children (under 18 years of age) with spina bifida who were treated for neurogenic bladder with mirabegron at Severance Children’s Hospital between July 2015 and December 2017. Pediatric patients received 50 mg mirabegron daily for at least 6 weeks either in addition to or instead of antimuscarinic therapy. Urodynamic parameters, including compliance, involuntary detrusor contraction, and maximum cystometric capacity, as well as patient-reported efficacy and adverse events, were measured.
In both groups post-treatment, incontinence significantly improved. In addition, maximum cystometric capacity and compliance significantly increased post-treatment. Six patients reported side effects (constipation, 4.5%; headache, 3.0%; and hypertension, 1.5%) and three patients discontinued treatment.
We evaluated the efficacy and safety of mirabegron for treating neurogenic bladder in pediatric patients with spina bifida. All clinical and urodynamic parameters improved with treatment. Prospective, placebo-controlled studies are necessary to confirm these findings.
KeywordsMirabegron β3-Adrenoceptor agonist Spina bifida Neurogenic detrusor overactivity
PJS: protocol/project development, data collection or management, data analysis, manuscript writing/editing. LYS: protocol/project development, manuscript editing. LCN: data collection or management. KSH: data collection or management. KSW: protocol/project development, manuscript editing. HSW: protocol/project development, manuscript editing.
Compliance with ethical standards
Conflict of interest
All authors declare that they have no conflicts of interest pertaining to this study.
All procedures performed in the studies involving human participants were in accordance with the ethical standards of the institutional or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
The Institutional Review Board of Yonsei University College of Medicine waived the requirement of obtaining informed consent because this study retrospectively reviewed anonymous patient data and did not involve a patient intervention or the use of human tissue samples.
- 8.Wada N, Okazaki S, Kobayashi S et al (2015) Efficacy of combination therapy with mirabegron for anticholinergic-resistant neurogenic bladder: videourodynamic evaluation. Hinyokika Kiyo 61:7–11Google Scholar
- 17.Leon LA, Hoffman BE, Gardner SD et al (2008) Effects of the beta 3-adrenergic receptor agonist disodium 5-[(2R)-2-[[(2R)-2-(3-chlorophenyl)-2-hydroxyethyl]amino]propyl]-1,3-benzodioxole-2,2-dicarboxylate (CL-316243) on bladder micturition reflex in spontaneously hypertensive rats. J Pharmacol Exp Ther 326:178–185CrossRefGoogle Scholar
- 18.Tyagi P, Tyagi V (2010) Mirabegron, a β3-adrenoceptor agonist for the potential treatment of urinary frequency, urinary incontinence or urgency associated with overactive bladder. IDrugs 13:713–722Google Scholar
- 26.Nitti VW, Chapple CR, Walters C et al (2014) Safety and tolerability of the β3-adrenoceptor agonist mirabegron, for the treatment of overactive bladder: results of a prospective pooled analysis of three 12-week randomised phase III trials and of a 1-year randomized phase III trial. Int J Clin Pract 68:972–985CrossRefGoogle Scholar