Efficacy and safety of oxybutynin in children with detrusor hyperreflexia secondary to neurogenic bladder dysfunction.
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.
Franco
Israel
I
Pediatric Urology Associates, 19 Bradhurst Avenue, Hawthorne, NY 10532, USA. isfranco@optonline.net
Horowitz
Mark
M
Grady
Richard
R
Adams
Richard C
RC
de Jong
Tom P V M
TP
Lindert
Kelly
K
Albrecht
Detlef
D
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
D000892:Anti-Infective Agents, Urinary; D008333:Mandelic Acids; D013607:Tablets; C005419:oxybutynin