PEDIATRIC UROLOGY

Long-term tolerability of tolterodine extended release in children 5-11 years of age: results from a 12-month, open-label study
Nijman RJ, Borgstein NG, Ellsworth P, Siggaard C
University Medical Centre Groningen, Groningen, The Netherlands
Eur Urol. 2007; 52: 1511-6

• Objective: To evaluate the long-term tolerability of tolterodine extended release (ER) in children (aged 5-11 yr) with urgency urinary incontinence (UUI).
• Methods: This was a multicenter, open-label extension of a 12-wk, 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-wk double-blind study. Patients received tolterodine ER (2mg once daily) for 12 mo. 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 mo, and investigators were instructed to report all AEs. At 6 and 12 mo, vital signs were recorded and a physical examination was performed.
• Results: A total of 318 patients were enrolled (double-blind tolterodine ER, n = 221; placebo, n = 97). The majority of patients were white (90%), mean +/- SD age was 7.6 +/- 1.5 yr, and 54% were boys. Forty-nine percent of patients reported >/= 1 AE during the study, similar to that observed in the preceding 12-wk 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 The most common reasons for withdrawal were lack of efficacy (12%), symptom improvement (8%), and withdrawn consent (6%).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.
• Conclusion: Long-term treatment with tolterodine ER was well tolerated in children with UUI.
  
  
• Editorial Comment
  This is the first large-scale prospective study for long-term safety and tolerability of tolterodine extended release, showing mostly mild side effects and 65% of the patients completing the entire 12 month treatment period. Few long-term drug studies are performed in children, which makes this study more significant. My regret for the study is that they did not include an efficacy arm so that a practitioner could have all the information necessary to make wise treatment choices for their patients that may need long-term care.

Dr. Brent W. Snow
Division of Urology
University of Utah Health Sci Ctr
Salt Lake City, Utah, USA
E-mail: brent.snow@hsc.utah.edu