Efficacy and safety of oxybutynin in children with detrusor hyperreflexia secondary to neurogenic bladder dysfunction.

Abstract

PURPOSE:

We evaluated the efficacy and safety of oxybutynin in children with detrusor hyperreflexia due to neurological conditions.

MATERIALS AND 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: Israel Franco, Mark Horowitz, Richard Grady, Richard C Adams, Tom P V M de Jong, Kelly Lindert, Detlef Albrecht
• Journal: The Journal of urology (J Urol) Vol. 173 Issue 1 Pg. 221-5 (Jan 2005) ISSN: 0022-5347 [Print] United States
• PMID: 15592080 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents, Urinary
• Mandelic Acids
• Tablets
• oxybutynin

Topics

• Adolescent
• Anti-Infective Agents, Urinary (administration & dosage, pharmacology, therapeutic use)
• Child
• Humans
• Mandelic Acids (administration & dosage, pharmacology, therapeutic use)
• Reflex, Abnormal (drug effects)
• Tablets
• Urinary Bladder, Neurogenic (drug therapy, physiopathology)
• Urodynamics