A Study Evaluating the Safety, Effectiveness, and Pharmacokinetics of Transdermal Oxybutynin in Treating Overactive Bladder Associated With a Neurological Condition
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.
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 Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Detrusor Hyperreflexia
Intervention
Oxybutynin, Oxybutynin
Location
Little Rock
Arkansas
United States
Status
Completed
Source
Watson Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00224016
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Urinary Incontinence, Urge
Involuntary discharge of URINE that is associated with an abrupt and strong desire to void. It is usually related to the involuntary contractions of the detrusor muscle of the bladder (detrusor hyperreflexia or detrusor instability).
Eclampsia
Onset of HYPERREFLEXIA; SEIZURES; or COMA in a previously diagnosed pre-eclamptic patient (PRE-ECLAMPSIA).
Urinary Bladder, Overactive
Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.
Urinary Incontinence, Stress
Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.
Pantothenate Kinase-associated Neurodegeneration
A rare autosomal recessive degenerative disorder which usually presents in late childhood or adolescence. Clinical manifestations include progressive MUSCLE SPASTICITY; hyperreflexia; MUSCLE RIGIDITY; DYSTONIA; DYSARTHRIA; and intellectual deterioration which progresses to severe dementia over several years. (From Adams et al., Principles of Neurology, 6th ed, p972; Davis & Robertson, Textbook of Neuropathology, 2nd ed, pp972-929)
Clinical Trials
This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.
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A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence
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PubMed Articles
INTRODUCTION AND HYPOTHESIS: The aim of this study was to evaluate the protective effect of intravesical oxybutynin on the bladder wall of rabbits with detrusor overactivity and partial bladder outlet...
Comparative adherence to oxybutynin or tolterodine among older patients.
PURPOSE: To compare persistence of oxybutynin or tolterodine therapy among older patients newly prescribed one of these drugs. METHODS: We conducted a retrospective cohort study of Ontarians aged 66 y...
Oxybutynin and trospium are substrates of the human organic cation transporters.
The muscarinic antagonists oxybutynin and trospium are used as spasmolytic agents for the treatment of overactive urinary bladder disease. Recently, it has been shown that trospium, but not oxybutynin...
Hyperthermia in spina bifida patients treated with oxybutynin.
Paraplegic spina bifida patients often suffer from disturbed sweat secretion in the paretic regions. A diminished sweat production of caudal parts of the body is compensated by an increased secretion...
Oxybutynin: past, present, and future.
Oxybutynin chloride is primarily indicated for the treatment of overactive bladder syndrome (OAB). It remains the most widely prescribed compound for OAB in the world. OAB is defined as the presence o...
