Long-term efficacy and safety of tolterodine in children with neurogenic detrusor overactivity

Abstract 

Objective

We evaluated long-term (≥12months) efficacy and safety of tolterodine in children with neurogenic detrusor overactivity.

Subjects and methods

Subjects successfully completed one of three 12-week, open-label studies and had stable neurologic disease and urodynamic evidence of neurogenic detrusor overactivity requiring intermittent catheterization. Drug formulation and dosing were based on age (4months–4years, tolterodine oral solution 0.2–2mg twice daily; 5–10years, tolterodine oral solution 0.5–4mg twice daily; 11–16years, tolterodine extended-release capsules 2, 4, or 6mg once daily). Daily doses were individualized for each subject. Efficacy was evaluated urodynamically and using parent-completed 3-day bladder diaries.

Results

Thirty subjects were enrolled. Functional bladder capacity (volume at first leakage, first sensation of bladder fullness or 40cm H₂O pressure) increased by month 12 in the younger age groups but not in the oldest subjects. Volume to first detrusor contraction >10cm H₂O pressure and detrusor leak point pressure did not change in any age group. The number of incontinence episodes per 24h decreased in all subjects, as did the number of catheterizations per 24h. Mean volume per catheterization increased in all subjects. Seven treatment-related adverse events were reported.

Conclusions

Both tolterodine formulations were effective and well tolerated in children with neurogenic detrusor overactivity.

Keywords: Bladder, Neurogenic, Child, Muscarinic antagonists, Urinary incontinence