Skip to main content
OpenTrials
Completed

NCT Number: NCT00224016

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Detrusor Hyperreflexia

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Watson Investigational Site, Little Rock, Arkansas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxybutynin

Drug

1.3, 2.6, 3.9 mg/day transdermal

Other names: Oxytrol

Primary outcomes

  1. Average Catheterization Urine Volume

    Time frame: 14 weeks

    Change from baseline in average volume of urine collected by catheterization

Secondary outcomes

  1. Catheterizations Without Leakage

    Time frame: 14 weeks

    Percentage of catherizations without leakage

  2. Urine Volume After First Awakening

    Time frame: 14 weeks

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

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

A Multi-Center, Open-Label (OL), Active-Controlled, Dose-Titration Study Evaluating the Safety, Efficacy and PK of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity in Pediatric Patients

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.