Journal of pediatric urology · 2026
Clinical experience with mirabegron in pediatric patients with spina bifida under 3 years of age.
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Fugaru Ioana, VanderBrink Brian, Mueller Katie, Reddy Pramod, DeFoor William, Minevich Eugene, Strine Andrew, Daugherty Michael
Аннотация
INTRODUCTION: Mirabegron suspension, a beta-3-agonist [B3], has been approved in the United States for use in pediatric patients older than 3 years of age in 2021. We sought to evaluate the safety, tolerability and impact on urodynamic studies of the introduction of B3 in the management of neurogenic bladder for children younger than 3 years with spina bifida at our center.
METHODS: A retrospective study was performed at our institution with spina bifida patients younger than 3 years old treated with off label use of B3. Patients were stratified into three clinically distinct groups (primary, adjuvant, and alternative therapy). Patients were seen for the first outpatient urological visit at 3 months of age and subsequently underwent clinical and urologic evaluation at various timepoints. Patient demographics, clinical information and investigation results were extracted from the medical record.
RESULTS: 19 patients received B3 at a median age of 24 months (IQR 13-29 months). Four patients were primarily treated with B3, ten patients were switched to B3 due to intolerable adverse effects of antimuscarinics [AM] (AM to B3) and five patients received it as adjunct therapy (B3+AM). The measured bladder compliance was improved in all but one of the patients exposed to B3. Bladder capacity increased in patients on primary or adjuvant B3 and was preserved in patients on B3 as alternative to AM. All ten (10) patients who were on alternative B3 reported resolution of the AM adverse effects which motivated the pharmacological agent change. The medication was not discontinued in any patient due to adverse effects.
CONCLUSIONS: Spina bifida patients with neurogenic bladder younger than 3 years old may benefit from additional therapy with beta-3 agonist, particularly those experiencing intolerable adverse effects from antimuscarinics.
METHODS: A retrospective study was performed at our institution with spina bifida patients younger than 3 years old treated with off label use of B3. Patients were stratified into three clinically distinct groups (primary, adjuvant, and alternative therapy). Patients were seen for the first outpatient urological visit at 3 months of age and subsequently underwent clinical and urologic evaluation at various timepoints. Patient demographics, clinical information and investigation results were extracted from the medical record.
RESULTS: 19 patients received B3 at a median age of 24 months (IQR 13-29 months). Four patients were primarily treated with B3, ten patients were switched to B3 due to intolerable adverse effects of antimuscarinics [AM] (AM to B3) and five patients received it as adjunct therapy (B3+AM). The measured bladder compliance was improved in all but one of the patients exposed to B3. Bladder capacity increased in patients on primary or adjuvant B3 and was preserved in patients on B3 as alternative to AM. All ten (10) patients who were on alternative B3 reported resolution of the AM adverse effects which motivated the pharmacological agent change. The medication was not discontinued in any patient due to adverse effects.
CONCLUSIONS: Spina bifida patients with neurogenic bladder younger than 3 years old may benefit from additional therapy with beta-3 agonist, particularly those experiencing intolerable adverse effects from antimuscarinics.