title: Efficacy, tolerability, and safety of oxybutynin chloride in pediatric neurogenic bladder with spinal dysraphism: a retrospective, multicenter, observational study.
abstract: OBJECTIVE
  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).
  
  
  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.
authors.affiliation: Department of Urology, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Jung Hoon
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Urology, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Kyoung Rok
authors.initials: KR
authors.lastname: Kim
authors.affiliation: Department of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Yong Seung
authors.initials: YS
authors.lastname: Lee
authors.affiliation: Department of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Sang Won
authors.initials: SW
authors.lastname: Han
authors.affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Kun Suk
authors.initials: KS
authors.lastname: Kim
authors.affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Song
authors.affiliation: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Minki
authors.initials: M
authors.lastname: Baek
authors.affiliation: Division of Pediatric Urology, Department of Urology, Seoul National University Childrens' Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Kwanjin
authors.initials: K
authors.lastname: Park
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004341:Drug Evaluation / Q000379:methods; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008333:Mandelic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D016135:Spinal Dysraphism / Q000150:complications*; D016896:Treatment Outcome; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D064804:Urological Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D008333:Mandelic Acids; D018727:Muscarinic Antagonists; D064804:Urological Agents; C005419:oxybutynin
keywords: Child; Neurogenic urinary bladder; Oxybutynin