Phase 4
Completed N=55
Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
Detrusor Hyperreflexia
Source: ClinicalTrials.gov NCT00224016 ↗
Enrolled (actual)
55
Serious AEs
16.4%
Results posted
Dec 2009
Primary outcomePrimary: Average Catheterization Urine Volume — 95.3; 114.0; 30.0; 52.4 mL
Summary
This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Catheterization Urine Volume |
95.3; 114.0; 30.0; 52.4 | — |
| SECONDARY Catheterizations Without Leakage |
28.7; 38.1; 53.8; 72.6 | — |
| SECONDARY Urine Volume After First Awakening |
— | — |
Eligibility Criteria
Inclusion Criteria
- Pediatric patient with a diagnosis of detrusor overactivity associated with a neurological condition;
- Use clean intermittent catheterization
- On stable dose of oral oxybutynin before participation
Exclusion Criteria
- Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
- Have any medical condition that precludes their participation in the study or may confound the outcome of the study
Data sourced from ClinicalTrials.gov (NCT00224016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.