A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition
Detrusor Hyperreflexia
About this trial
This is an interventional treatment trial for Detrusor Hyperreflexia
Eligibility Criteria
Inclusion Criteria: At least 18 years of age at day of consent; Is a male, or is a non-pregnant non-lactating female who is either of non-child-bearing potential, or is using adequate means of birth control; Has a h/o of urinary incontinence from neurogenic bladder of spinal cord injury etiology; Has impairment based on the American Spinal Injury Association (ASIA); Use clean intermittent catheterization; Has urinary incontinence between scheduled catheterization; Capable of understanding and complying with the protocol. 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; History of major lower urinary tract surgery, procedures; Has an active skin disorder, affecting TDS application site areas; Hypersensitivity to the investigational drug; Has participated in any study involving administration of an investigational compound within 30 days before this study.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Oxybutynin transdermal system
Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing