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

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Abstract

Purpose

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.

Results

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.

Conclusion

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.

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Authors and Affiliations

  1. Department of Urology and Urological Science Institute, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Republic of Korea

    Jee Soo Park, Yong Seung Lee, Sang Woon Kim & Sang Won Han

  2. Department of Pediatric Urology, Severance Children’s Hospital, Seoul, Republic of Korea

    Cho Nyeong Lee & Sung Hoon Kim

Authors
  1. Jee Soo Park
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  2. Yong Seung Lee
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  3. Cho Nyeong Lee
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  4. Sung Hoon Kim
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  5. Sang Woon Kim
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  6. Sang Won Han
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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.

Corresponding authors

Correspondence to Yong Seung Lee or Sang Won Han.

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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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Park, J.S., Lee, Y.S., Lee, C.N. et al. Efficacy and safety of mirabegron, a β3-adrenoceptor agonist, for treating neurogenic bladder in pediatric patients with spina bifida: a retrospective pilot study. World J Urol 37, 1665–1670 (2019). https://doi.org/10.1007/s00345-018-2576-0

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  • DOI: https://doi.org/10.1007/s00345-018-2576-0

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