title: Efficacy and safety of oxybutynin in children with detrusor hyperreflexia secondary to neurogenic bladder dysfunction.
abstract: OBJECTIVE
  We evaluated the efficacy and safety of oxybutynin in children with detrusor hyperreflexia due to neurological conditions.
  
  
  METHODS
  Study 1--A prospective, open label trial of 3 formulations of oxybutynin (tablets, syrup and extended release tablets) was conducted for 24 weeks in children 6 to 15 years old with detrusor hyperreflexia who used oxybutynin and clean intermittent catheterization. The effect of treatment on average urine volume per catheterization and on secondary urodynamic outcomes was evaluated. Study 2--The efficacy and safety of oxybutynin syrup were evaluated urodynamically in an open label study of children 1 to 5 years old with detrusor hyperreflexia who used oxybutynin and clean intermittent catheterization.
  
  
  RESULTS
  Study 1--Mean urine volume per catheterization (+/- SEM) increased by 25.5 +/- 5.9 ml (p <0.001). Maximal cystometric capacity increased by 75.4 +/- 9.8 ml (p <0.001). Mean detrusor and intravesical pressures were significantly decreased by -9.2 +/- 2.3 (p < or =0.001) and -7.5 +/- 2.5 cm H2O (p <0.004), respectively, at week 24. Of 61 children with uninhibited detrusor contractions 15 cm H2O or greater at baseline 34 did not have them at week 24 (p <0.001). Improvements in bladder function were consistent across all oxybutynin formulations. Study 2--Mean maximal cystometric capacity increased significantly by 71.5 +/- 21.99 ml (p = 0.005). At study end only 12.5% of patients had uninhibited detrusor contractions 15 cm H2O or greater compared with 68.8% at baseline (p = 0.004). Oxybutynin was well tolerated in both studies. There were no serious treatment related adverse events.
  
  
  CONCLUSIONS
  All 3 formulations of oxybutynin are safe and effective in children with neurogenic bladder dysfunction.
authors.affiliation: Pediatric Urology Associates, 19 Bradhurst Avenue, Hawthorne, NY 10532, USA. isfranco@optonline.net
authors.forename: Israel
authors.initials: I
authors.lastname: Franco
authors.forename: Mark
authors.initials: M
authors.lastname: Horowitz
authors.forename: Richard
authors.initials: R
authors.lastname: Grady
authors.forename: Richard C
authors.initials: RC
authors.lastname: Adams
authors.forename: Tom P V M
authors.initials: TP
authors.lastname: de Jong
authors.forename: Kelly
authors.initials: K
authors.lastname: Lindert
authors.forename: Detlef
authors.initials: D
authors.lastname: Albrecht
mesh_terms: D000293:Adolescent; D000892:Anti-Infective Agents, Urinary / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D006801:Humans; D008333:Mandelic Acids / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D012021:Reflex, Abnormal / Q000187:drug effects*; D013607:Tablets; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy* / Q000503:physiopathology; D014563:Urodynamics
chemical_list: D000892:Anti-Infective Agents, Urinary; D008333:Mandelic Acids; D013607:Tablets; C005419:oxybutynin