Efficacy, Tolerability, and Safety of Oxybutynin Chloride in Pediatric Neurogenic Bladder With Spinal Dysraphism: A Retrospective, Multicenter, Observational Study
이정훈, 김경록, 이용승, 한상원, 김건석, 송상훈, 백민기, 박관진,
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이정훈 ( Lee Jung-Hoon )
Seoul National University College of Medicine Department of Urology
김경록 ( Kim Kyoung-Rok )
Seoul National University College of Medicine Department of Urology
이용승 ( Lee Yong-Seung )
Yonsei University College of Medicine Department of Urology
한상원 ( Han Sang-Won )
Yonsei University College of Medicine Department of Urology
김건석 ( Kim Kun-Suk )
University of Ulsan College of Medicine Asan Medical Center Department of Urology
송상훈 ( Song Sang-Hoon )
University of Ulsan College of Medicine Asan Medical Center Department of Urology
백민기 ( Baek Min-Ki )
Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology
박관진 ( Park Kwan-Jin )
Seoul National University College of Medicine Department of Urology
KMID : 0358320140550120828
Abstract
Purpose: Anticholinergics are a key element in treating neurogenic detrusor overactivity, but only limited data are available in the pediatric population, thus limiting the application to children even for oxybutynin chloride (OC), a prototype drug. This retrospective 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 gathered and scrutinized from four specialized clinics for pediatric urology. The primary efficacy 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 than 5 years of age. The range of prescribed doses varied from 3 to 24 mg/d. The median treatment duration was 19 months (range, 0.3-111 months). Significant improvement of both primary efficacy outcomes was noted following OC treatment. MCC increased about 8% even after adjustment for age-related increases in MCC. Likewise, mean EFP was reduced from 33 to 21 cm H2O. More than 80% of patients showed compliance above 70%, and approximately 50% of patients used OC for more than 1 year. No serious AEs were reported; constipation and facial flushing consisted of the major AEs.
Conclusions: OC is safe and efficacious in treating pediatric neurogenic bladder associated with SD. The drug is also tolerable and the safety profile suggests that adjustment of dosage for age may not be strictly observed.
키워드
Child; Neurogenic urinary bladder; Oxybutynin
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