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

ObjectiveWe evaluated long-term (≥12 months) efficacy and safety of tolterodine in children with neurogenic detrusor overactivity.Subjects and methodsSubjects 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 (4 months–4 years, tolterodine oral solution 0.2–2 mg twice daily; 5–10 years, tolterodine oral solution 0.5–4 mg twice daily; 11–16 years, tolterodine extended-release capsules 2, 4, or 6 mg once daily). Daily doses were individualized for each subject. Efficacy was evaluated urodynamically and using parent-completed 3-day bladder diaries.ResultsThirty subjects were enrolled. Functional bladder capacity (volume at first leakage, first sensation of bladder fullness or 40 cm H₂O pressure) increased by month 12 in the younger age groups but not in the oldest subjects. Volume to first detrusor contraction >10 cm H₂O pressure and detrusor leak point pressure did not change in any age group. The number of incontinence episodes per 24 h decreased in all subjects, as did the number of catheterizations per 24 h. Mean volume per catheterization increased in all subjects. Seven treatment-related adverse events were reported.ConclusionsBoth tolterodine formulations were effective and well tolerated in children with neurogenic detrusor overactivity.