The overactive bladder in children: a potential future indication for tolterodine

• Published in: BJU international Vol. 87; no. 6; pp. 569 - 574
• Main Authors: Hjälmås, K., Hellström, A‐L., Mogren, K., Läckgren, G., Stenberg, A.
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01.04.2001; Blackwell
• Subjects: Administration; administration & dosage; Administration, Oral; adverse effects; antimuscarinic agents; Benzhydryl Compounds; Benzhydryl Compounds - administration & dosage; Benzhydryl Compounds - adverse effects; Benzhydryl Compounds - pharmacokinetics; Biological and medical sciences; Child; Child, Preschool; children; Cresols; Cresols - administration & dosage; Cresols - adverse effects; Cresols - pharmacokinetics; Dose-Response Relationship; Dose-Response Relationship, Drug; dose‐finding study; Drug; drug therapy; Farmaceutisk vetenskap; Female; Humans; Male; Medical sciences; Muscarinic Antagonists; Muscarinic Antagonists - administration & dosage; Muscarinic Antagonists - adverse effects; Muscarinic Antagonists - pharmacokinetics; Oral; Other Social Sciences not elsewhere specified; overactive bladder; Pharmaceutical Sciences; pharmacokinetics; Pharmacology. Drug treatments; Phenylpropanolamine; Preschool; tolterodine; Tolterodine Tartrate; Urinary Incontinence; Urinary Incontinence - drug therapy; Urinary system; Övrig annan samhällsvetenskap; Human; Urinary system disease; Tolterodine; Urinary tract disease; Urinary incontinence; Voiding dysfunction; Chemotherapy; Treatment; Bladder disease; Muscarinic receptor; Antagonist; Effective dose; Child
• ISSN: 1464-4096; 1464-410X
• DOI: 10.1046/j.1464-410X.2001.00084.x

Objective To determine the safety, efficacy and pharmacokinetics of tolterodine in children with an overactive bladder. Patients and methods Thirty‐three children (20 boys and 13 girls, aged 5–10 years) with an overactive bladder and symptoms of urgency, frequency and/or urge incontinence were enrolled in an open, dose‐escalation study. Patients were treated with oral tolterodine 0.5 mg (n = 11), 1 mg (n = 10) or 2 mg (n = 12) twice daily for 14 days. The primary safety endpoint was the change in residual urinary volume, as determined by ultrasonography. In addition, voiding diary variables (frequency and incontinence episodes) and pharmacokinetics were evaluated. Other safety endpoints included laboratory variables, electrocardiogram recordings and reported adverse events. Results There were no safety concerns in terms of the change in residual urinary volume for any of the three dosage groups; values were comparable with baseline after 2 weeks of treatment for all three dosages. Adverse events were reported by 20 patients (six on 0.5 mg, five on 1 mg, and nine on 2 mg). Most adverse events were not considered to be drug‐related; of the 13 possibly related events, 10 occurred in those taking 2 mg. Headache was the most commonly reported adverse event. No serious adverse events were reported and there were no general safety concerns. There was an improvement in voiding diary variables in all treatment groups after 2 weeks of treatment, although the efficacy was greatest in those taking 1 mg and 2 mg. Pharmacokinetic findings were consistent with dose linearity over the range 0.5–2 mg. Conclusion The results support the use of 1 mg twice daily as the optimal dose of tolterodine for treating children aged 5–10 years with an overactive bladder.