Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition

Phase 4

Completed

• Conditions: Detrusor Hyperreflexia
• Interventions: Drug: Oxybutynin

• Registration Number: NCT00224016
• Lead Sponsor: Watson Pharmaceuticals

Brief 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.

Detailed Description

This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2007-04
• Study Completion: 2008-09
• Results First Submitted: 2009-11-13
• Results First Submitted QC: 2009-11-13
• Results First Posted: 2009-12-23
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-07
• Last Update Posted: 2012-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxybutynin Transdermal System	Oxybutynin	Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day
Oral oxybutynin	Oxybutynin	5 to 15 mg/day immediate release or extended release tablets, or syrup

Primary Outcome Measures

Name	Time	Method
Average Catheterization Urine Volume	14 weeks	Change from baseline in average volume of urine collected by catheterization

Secondary Outcome Measures

Name	Time	Method
Catheterizations Without Leakage	14 weeks	Percentage of catherizations without leakage
Urine Volume After First Awakening	14 weeks	Change from baseline in average volume of urine collected after first morning awakening

Trial Locations

Locations (1)

Watson Investigational Site; 🇺🇸 Salt Lake City, Utah, United States