Efficacy, Tolerability, and Safety of Oxybutynin Chloride in Pediatric Neurogenic Bladder With Spinal Dysraphism: A Retrospective, Multicenter, Observational Study

다국어 초록 (Multilingual Abstract)

Purpose: Anticholinergics are a key element in treating neurogenic detrusor overactivity,but only limited data are available in the pediatric population, thus limitingthe application to children even for oxybutynin chloride (OC), a prototype drug. Thisretrospective study was designed to provide data regarding the efficacy, tolerability,and safety of OC in the pediatric population (0–15 years old) with spinal dysraphism(SD).
Materials and Methods: Records relevant to OC use for neurogenic bladder were gatheredand scrutinized from four specialized clinics for pediatric urology. The primaryefficacy outcomes were maximal cystometric capacity (MCC) and end filling pressure(EFP). Data on tolerability, compliance, and adverse events (AEs) were also analyzed.
Results: Of the 121 patient records analyzed, 41 patients (34%) received OC at less than5 years of age. The range of prescribed doses varied from 3 to 24 mg/d. The median treatmentduration was 19 months (range, 0.3–111 months). Significant improvement ofboth primary efficacy outcomes was noted following OC treatment. MCC increasedabout 8% even after adjustment for age-related increases in MCC. Likewise, mean EFPwas reduced from 33 to 21 cm H2O. More than 80% of patients showed compliance above70%, and approximately 50% of patients used OC for more than 1 year. No serious AEswere reported; constipation and facial flushing consisted of the major AEs.
Conclusions: OC is safe and efficacious in treating pediatric neurogenic bladder associatedwith SD. The drug is also tolerable and the safety profile suggests that adjustmentof dosage for age may not be strictly observed.

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