Status:
COMPLETED
A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Detrusor Hyperreflexia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
The Dose Titration Period began with a 3.9 mg/day or 7.8 mg/day as a starting dose after the completion of a 3-day diary for baseline evaluations, including urodynamic testing. The clean intermittent ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00224029
Start Date
December 1 2004
End Date
May 1 2008
Last Update
April 30 2010
Active Locations (6)
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1
Atlanta, Georgia, United States
2
The Bronx, New York, United States
3
Chapel Hill, North Carolina, United States
4
Charlotte, North Carolina, United States