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

Watson Pharmaceuticals57 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Detrusor Hyperreflexia

Interventions

OxybutyninDRUG

1.3, 2.6, 3.9 mg/day transdermal

OxybutyninDRUG

5 to 15 mg/day immediate release or extended release tablets, or syrup

Eligibility

Sex: ALLMin age: 6 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (23)

Watson Investigational Site

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Average Catheterization Urine Volume

Change from baseline in average volume of urine collected by catheterization

Time frame: 14 weeks

Secondary Outcomes

Catheterizations Without Leakage

Percentage of catherizations without leakage

Time frame: 14 weeks

Urine Volume After First Awakening

Change from baseline in average volume of urine collected after first morning awakening

Time frame: 14 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.