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Published on: August 9, 2012
Efficacy, tolerability, and safety of oxybutynin chloride in pediatric neurogenic bladder with spinal dysraphism: a
Jung Hoon Lee1, Kyoung Rok Kim1, Yong Seung Lee2
1Department of Urology, Seoul National University College of Medicine, Seoul, Korea.
Insights
Oxybutynin chloride (OC) effectively treats neurogenic bladder in children with spinal dysraphism (SD), improving bladder capacity and reducing pressure. The medication is safe and well-tolerated in this pediatric population.
Area of Science:
- Pediatric Urology
- Neurogenic Bladder Management
- Pharmacological Interventions
Background:
- Anticholinergics are crucial for neurogenic detrusor overactivity.
- Limited pediatric data exist for oxybutynin chloride (OC), hindering its use in children.
- Spinal dysraphism (SD) frequently causes neurogenic bladder in pediatric patients.
Purpose of the Study:
- To evaluate the efficacy, tolerability, and safety of oxybutynin chloride (OC) in pediatric patients (0-15 years) with spinal dysraphism (SD).
- To provide essential data for the application of OC in treating pediatric neurogenic bladder.
- To assess the impact of OC on key urodynamic parameters in children with SD.
Main Methods:
- Retrospective analysis of 121 pediatric patient records from specialized urology clinics.
- Primary efficacy outcomes: maximal cystometric capacity (MCC) and end filling pressure (EFP).
- Evaluation of tolerability, compliance, and adverse events (AEs) associated with OC use.
Main Results:
- Significant improvement in MCC (approx. 8% increase) and reduction in EFP (from 33 to 21 cm H2O) were observed.
- High compliance (>70%) reported in over 80% of patients, with 50% using OC for over a year.
- Constipation and facial flushing were the most common AEs; no serious adverse events were reported.
Conclusions:
- Oxybutynin chloride (OC) demonstrates safety and efficacy in treating pediatric neurogenic bladder secondary to spinal dysraphism (SD).
- The drug is well-tolerated, suggesting age-specific dosage adjustments may not always be necessary.
- OC is a viable treatment option for improving bladder function in children with SD.
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.
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