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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.
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 catheterization (CIC) frequency remained constant throughout the Dose Titration Period. The dose was adjusted every two weeks during the Dose Titration Period by increasing one dose level, at the investigator's discretion, based on the patient's symptoms. If a patient achieved complete continence and reported tolerable or absence of side effects, the patient was continued at that dose for the duration of the 8-week Titration Period. If a patient reported unacceptable side effects, the dose was reduced by one level. This reduced dose was considered the maximum tolerable dose for the patient and the patient continued at that dose for the duration of the 8-week Titration Period. The dose levels evaluated were 3.9 mg/day, 7.8 mg/day, 9.1 mg/day, and 11.7 mg/day. Of the 22 subjects in the modified intent-to-treat population evaluated for efficacy, 0 were in the 3.9 mg/day dose group, 3 were in the 7.8 mg/day dose group, 8 were in the 9.1 mg/day dose group, and 11 were in the 11.7 mg/day dose group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin transdermal system | Experimental | Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin transdermal system | Drug | 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Catheterizations Without Leaking Per Day | Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patch Adhesion | 8 weeks | |
| Urodynamic Measurements | 8 weeks | |
| Urinary Leakage and Catheterization Data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Hoel, RPh, PhD | Watson Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta | Georgia | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19628264 | Result | Kennelly MJ, Lemack GE, Foote JE, Trop CS. Efficacy and safety of oxybutynin transdermal system in spinal cord injury patients with neurogenic detrusor overactivity and incontinence: an open-label, dose-titration study. Urology. 2009 Oct;74(4):741-5. doi: 10.1016/j.urology.2009.05.008. Epub 2009 Jul 22. |
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washout of previous anticholinergic therapy during the screening period
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxybutynin Transdermal System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 8 weeks |
| The Bronx |
| New York |
| United States |
| Chapel Hill | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxybutynin Transdermal System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Number of Catheterizations Without Leaking Per Day | Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary. | The number of participants for analysis is determined by Last Observation Carried Forward (LOCF. | Posted | Mean | Standard Deviation | Number of Dry Catheterizations per Day | 8 weeks |
|
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| Secondary | Patch Adhesion | Not Posted | 8 weeks | ||||||||||||||||||||||||||||||||||||||||
| Secondary | Urodynamic Measurements | Not Posted | 8 weeks | ||||||||||||||||||||||||||||||||||||||||
| Secondary | Urinary Leakage and Catheterization Data | Not Posted | 8 weeks |
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxybutynin Transdermal System | 0 | 24 | 11 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Headache | General disorders | COSTART | Non-systematic Assessment |
| |
| Infection urinary tract | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Sweat | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Vision abnormal | Eye disorders | COSTART | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh, PhD, Executive Director of Clinical Research | Watson Laboratories, Inc. | 801-588-6641 | gary.hoel@watson.com |
| ID | Term |
|---|---|
| C005419 | oxybutynin |
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