Long-Term Tolerability of Tolterodine Extended Release in Children 5-11 Years of Age: Results from a 12-Month, Open-Label Study
Friday, 20 July 2007 - Children with urinary symptoms such as urinary incontinence, often have low self-esteem, and childhood incontinence is associated with adult urgent urinary incontinence (UUI). Initial treatment for children with UUI typically includes a timed schedule of drinking and voiding, pelvic floor muscle relaxation techniques, biofeedback, and pharmacotherapy as stand-alone therapies or in combination. However, a recent systematic review of randomized controlled trials of treatments for daytime urinary incontinence in children was ‘‘unable to identify proof of any intervention that is safe and effective’’. More recent studies have demonstrated that the antimuscarinic agents oxybutynin, trospium, and tolterodine benefit some children with incontinence. Nijman et al. (2005) examined in a 12-week study the efficacy of tolterodine extended release in children between 5 and 10 year of age with UUI. Recently, Nijman et al. (2007) evaluated the long-term tolerability of tolterodine extended release in children (aged 5-11 year) with UUI.
This was a multicenter, open-label extension of a 12-week, double-blind, placebo-controlled study of tolterodine ER. Patients had UUI suggestive of detrusor overactivity (≥1 diurnal incontinence episode per 24h for ≥5 of 7 d) and ≥6 voids per 24h at baseline and had completed the 12-week double-blind study. Patients received tolterodine ER (2mg once daily) for 12 months. The primary end points were the incidence and severity of adverse events (AEs) and the incidence and reasons for withdrawals. Visits were scheduled at 3, 6, 9, and 12 months, and investigators were instructed to report all AEs. At 6 and 12 months, vital signs were recorded and a physical examination was performed.
A total of 318 patients were enrolled (double-blind tolterodine ER, n=221; placebo, n=97). The majority of patients were white (90%), meanSD age was 7.61.5 year, and 54% were boys. Forty-nine percent of patients reported ≥1 AE during the study, similar to that observed in the preceding 12-week study (42%). The most frequent AEs were urinary tract infection (7%), nasopharyngitis (5%), headache (5%), and abdominal pain (4%); 111 (35%) patients withdrew. The most common reasons for withdrawal were lack of efficacy (12%), symptom improvement (8%), and withdrawn consent (6%). Ten patients (3%) withdrew because of AEs.
The authors concluded that long-term treatment with tolterodine ER is well tolerated in children with UUI.
Nijman, R. J., Borgstein, N. G., Ellsworth, P., & Siggaard, C. (2007). Long-Term Tolerability of Tolterodine Extended Release in Children 5-11 Years of Age: Results from a 12-Month, Open-Label Study. European Urology, doi:10.1016/j.eururo.2007.05.002.
