OBJECTIVETo compare the efficacy and safety of tolterodine and oxybutynin in the treatment of idiopathic overactive bladder in children.

METHODSA total of 204 children with idiopathic overactive bladder were randomly divided into three groups (n=68 each): placebo, tolterodine-treated and oxybutynin-treated. The efficacy and safety were evaluated two weeks after treatment.

RESULTSThe effective rate was 25% in the placebo group, 89% in the tolterodine-treated group, and 92% in the oxybutynin-treated group. The effective rate in the two treatment groups was significantly higher than that in the placebo group (P<0.05). There was a similar efficacy between the two treatment groups. The incidence of adverse events in the tolterodine-treated group (28%) was significantly lower than that in the oxybutnin-treated group (57%) (P<0.05).

CONCLUSIONSTolterodine has a similar efficacy to oxybutynin in the treatment of idiopathic overactive bladder in children, with better safety in pharmacotherapy.

Adolescent ; Benzhydryl Compounds ; adverse effects ; therapeutic use ; Child ; Child, Preschool ; Cresols ; adverse effects ; therapeutic use ; Female ; Humans ; Male ; Mandelic Acids ; adverse effects ; therapeutic use ; Muscarinic Antagonists ; therapeutic use ; Phenylpropanolamine ; adverse effects ; therapeutic use ; Tolterodine Tartrate ; Urinary Bladder, Overactive ; drug therapy

PURPOSE: Anticholinergics are a key element in treating neurogenic detrusor overactivity, but only limited data are available in the pediatric population, thus limiting the application to children even for oxybutynin chloride (OC), a prototype drug. This retrospective study was designed to provide data regarding the efficacy, tolerability, and safety of OC in the pediatric population (0-15 years old) with spinal dysraphism (SD). MATERIALS AND METHODS: Records relevant to OC use for neurogenic bladder were gathered and scrutinized from four specialized clinics for pediatric urology. The primary efficacy outcomes were maximal cystometric capacity (MCC) and end filling pressure (EFP). Data on tolerability, compliance, and adverse events (AEs) were also analyzed. RESULTS: Of the 121 patient records analyzed, 41 patients (34%) received OC at less than 5 years of age. The range of prescribed doses varied from 3 to 24 mg/d. The median treatment duration was 19 months (range, 0.3-111 months). Significant improvement of both primary efficacy outcomes was noted following OC treatment. MCC increased about 8% even after adjustment for age-related increases in MCC. Likewise, mean EFP was reduced from 33 to 21 cm H2O. More than 80% of patients showed compliance above 70%, and approximately 50% of patients used OC for more than 1 year. No serious AEs were reported; constipation and facial flushing consisted of the major AEs. CONCLUSIONS: OC is safe and efficacious in treating pediatric neurogenic bladder associated with SD. The drug is also tolerable and the safety profile suggests that adjustment of dosage for age may not be strictly observed.
Adolescent ; Child ; Child, Preschool ; Drug Evaluation/methods ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Mandelic Acids/adverse effects/*therapeutic use ; Muscarinic Antagonists/adverse effects/*therapeutic use ; Retrospective Studies ; Spinal Dysraphism/*complications ; Treatment Outcome ; Urinary Bladder, Neurogenic/*drug therapy/etiology/physiopathology ; Urological Agents/adverse effects/*therapeutic use