Phase 4
N=24
A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition
Detrusor Hyperreflexia
Bottom Line
View on ClinicalTrials.gov: NCT00224029 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcome: Primary: Average Number of Catheterizations Without Leaking Per Day — 2.4; 1.5 Number of Dry Catheterizations per Day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxybutynin transdermal system (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Watson Pharmaceuticals
- Primary completion
- Dec 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of Catheterizations Without Leaking Per Day |
2.4; 1.5 | — |
| SECONDARY Patch Adhesion |
— | — |
| SECONDARY Urodynamic Measurements |
— | — |
| SECONDARY Urinary Leakage and Catheterization Data |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00224029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.