A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition
Completed · Phase 4
Conditions studied: Detrusor Hyperreflexia
In brief
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.
Key facts
- Study ID
- NCT00224029
- Run by
- Watson Pharmaceuticals
- People needed
- 24
- Starts
- 2004-12-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2010-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Atlanta, Georgia, United States
- Study site — The Bronx, New York, United States
- Study site — Chapel Hill, North Carolina, United States
- Study site — Charlotte, North Carolina, United States
- Study site — Dallas, Texas, United States
- Study site — Houston, Texas, United States
Full record on ClinicalTrials.gov
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