Detrusor Hyperreflexia
Conditions
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 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.
Interventions
DRUGOxybutynin transdermal system
3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration
Sponsors
Watson Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Catheterizations Without Leaking Per Day | 8 weeks | Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary. |
Secondary
| Measure | Time frame |
|---|---|
| Patch Adhesion | 8 weeks |
| Urodynamic Measurements | 8 weeks |
| Urinary Leakage and Catheterization Data | 8 weeks |
Countries
United States
Participant flow
Pre-assignment details
washout of previous anticholinergic therapy during the screening period
Participants by arm
| Arm | Count |
|---|---|
| Oxybutynin Transdermal System | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Oxybutynin Transdermal System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age Continuous | 41.9 years STANDARD_DEVIATION 10.35 |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
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.
Time frame: 8 weeks
Population: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxybutynin Transdermal System | Average Number of Catheterizations Without Leaking Per Day | Baseline at Week 0 | 2.4 Number of Dry Catheterizations per Day | Standard Deviation 1.8 |
| Oxybutynin Transdermal System | Average Number of Catheterizations Without Leaking Per Day | Change from baseline at Week 8 | 1.5 Number of Dry Catheterizations per Day | Standard Deviation 2.2 |
Secondary
Patch Adhesion
Time frame: 8 weeks
Secondary
Urinary Leakage and Catheterization Data
Time frame: 8 weeks
Secondary
Urodynamic Measurements
Time frame: 8 weeks