Study of botulinum toxin A in neurogenic bladder due to spina bifida in children.

BACKGROUND

We report results of a pilot study investigating the safety and efficacy of Botulinum A toxin on urinary incontinence and bladder function in children with neurogenic bladder.

METHODS

This was a prospective, non-randomized clinical trial. Seven children with median age of 16 years with spina bifida who had high storage pressures, poor bladder compliance and had failed treatment with anticholinergic medications were offered a single intra-detrusor injection of Botulinum A toxin. All subjects were on clean intermittent catheterization before and during the study. Follow-up videourodynamic studies were performed at 1 month, between 3 and 6 months, and at 9 months. Data were collected on safety and on subjective outcomes through validated questionnaires filled out by patients at each visit.

RESULTS

In majority of the patients (5/7), the injection produced an increase in bladder compliance (P < 0.05) and an improvement in incontinence (P < 0.05) at 1-month follow-up. However, in two patients whose baseline bladder capacity was markedly reduced (<200 mL), the improvement was very minimal. The beneficial effects in bladder compliance and incontinence dissipated by 9 months. The changes in subjective outcomes (incontinence and satisfaction scores) did not parallel the changes in urodynamics through the study period. No side effects of Botulinum toxin were seen.

CONCLUSION

Botulinum A toxin injection produces beneficial urodynamics and clinical effects. These beneficial effects last for approximately 9 months. There is a poor correlation between improvement in the urodynamics and the subjective outcomes. Botulinum A toxin injection is a safe alternative treatment for patients with spina bifida and a neurogenic bladder.