Efficacy and safety of mirabegron, a β3-adrenoceptor agonist, for treating neurogenic bladder in pediatric patients with spina bifida: a retrospective pilot study

  • Jee Soo Park
  • Yong Seung LeeEmail author
  • Cho Nyeong Lee
  • Sung Hoon Kim
  • Sang Woon Kim
  • Sang Won HanEmail author
Original Article



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.


Mirabegron β3-Adrenoceptor agonist Spina bifida Neurogenic detrusor overactivity 


Author contributions

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.

Ethical approval

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.

Informed consent

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.


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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Jee Soo Park
    • 1
  • Yong Seung Lee
    • 1
    Email author
  • Cho Nyeong Lee
    • 2
  • Sung Hoon Kim
    • 2
  • Sang Woon Kim
    • 1
  • Sang Won Han
    • 1
    Email author
  1. 1.Department of Urology and Urological Science InstituteYonsei University College of MedicineSeoulRepublic of Korea
  2. 2.Department of Pediatric UrologySeverance Children’s HospitalSeoulRepublic of Korea

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