Overactive Bladder
Conditions
Keywords
OAB, anticholineric, oxybutynin, urge urinary incontinence
Brief summary
A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.
Interventions
DRUGOxybutynin topical gel
1 application daily to skin for 12 weeks
OTHERPlacebo topical gel
1 application daily to skin for 12 weeks
Sponsors
Watson Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females and males, 18 years of older with overactive bladder symptoms
Exclusion criteria
* Treatable conditions that may cause urinary incontinence * Medical conditions in which it would be unsafe to use an anti-cholinergic agent. * The use of concomitant drugs that would confound the efficacy evaluation. * The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Average Number of Daily Incontinence Episodes | Baseline | Average number of daily incontinence episodes at baseline |
| Change From Baseline in Average Daily Number of Incontinence Episodes | Baseline to Week 12 | Change from Baseline to Week 12 in average daily number of incontinence episodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Average Daily Urinary Frequency | Baseline | Number of daily urinary voids |
| Change From Baseline in Average Daily Urinary Frequency | Baseline to 12 weeks | Change from baseline in average daily urinary frequency |
| Baseline Average Urine Void Volume | Baseline | Baseline average urine void volume |
| Change From Baseline in Average Urine Void Volume | Change from Baseline to Week 12 | Change from baseline to Week 12 in average urine void volume |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxybutynin Topical Gel 1 g Oxybutynin topical gel | 389 |
| Placebo Topical Gel 1 g placebo topical gel | 400 |
| Total | 789 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 19 | 13 |
| Overall Study | Lost to Follow-up | 9 | 8 |
| Overall Study | Other | 1 | 2 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 13 | 17 |
Baseline characteristics
| Characteristic | Placebo Topical Gel | Oxybutynin Topical Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 140 Participants | 143 Participants | 283 Participants |
| Age, Categorical Between 18 and 65 years | 260 Participants | 246 Participants | 506 Participants |
| Age Continuous | 59.3 years STANDARD_DEVIATION 12.17 | 59.5 years STANDARD_DEVIATION 12.5 | 59.4 years STANDARD_DEVIATION 12.17 |
| Region of Enrollment United States | 400 participants | 389 participants | 789 participants |
| Sex: Female, Male Female | 352 Participants | 352 Participants | 704 Participants |
| Sex: Female, Male Male | 48 Participants | 37 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 176 / 389 | 145 / 400 |
| serious Total, serious adverse events | 7 / 389 | 10 / 400 |
Outcome results
Primary
Baseline Average Number of Daily Incontinence Episodes
Average number of daily incontinence episodes at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxybutynin Topical Gel | Baseline Average Number of Daily Incontinence Episodes | 5.4 Number of episodes | Standard Deviation 3.26 |
| Placebo Topical Gel | Baseline Average Number of Daily Incontinence Episodes | 5.4 Number of episodes | Standard Deviation 3.28 |
Primary
Change From Baseline in Average Daily Number of Incontinence Episodes
Change from Baseline to Week 12 in average daily number of incontinence episodes
Time frame: Baseline to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxybutynin Topical Gel | Change From Baseline in Average Daily Number of Incontinence Episodes | -3.0 Number of episodes | Standard Deviation 2.73 |
| Placebo Topical Gel | Change From Baseline in Average Daily Number of Incontinence Episodes | -2.5 Number of episodes | Standard Deviation 3.06 |
Secondary
Baseline Average Daily Urinary Frequency
Number of daily urinary voids
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxybutynin Topical Gel | Baseline Average Daily Urinary Frequency | 12.4 Number of urinary episodes | Standard Deviation 3.34 |
| Placebo Topical Gel | Baseline Average Daily Urinary Frequency | 12.2 Number of urinary episodes | Standard Deviation 3.32 |
Secondary
Baseline Average Urine Void Volume
Baseline average urine void volume
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxybutynin Topical Gel | Baseline Average Urine Void Volume | 163.4 mL | Standard Deviation 65.85 |
| Placebo Topical Gel | Baseline Average Urine Void Volume | 167.9 mL | Standard Deviation 68.4 |
Secondary
Change From Baseline in Average Daily Urinary Frequency
Change from baseline in average daily urinary frequency
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxybutynin Topical Gel | Change From Baseline in Average Daily Urinary Frequency | -2.7 Number of urinary episodes | Standard Deviation 3.21 |
| Placebo Topical Gel | Change From Baseline in Average Daily Urinary Frequency | -2.0 Number of urinary episodes | Standard Deviation 2.82 |
Secondary
Change From Baseline in Average Urine Void Volume
Change from baseline to Week 12 in average urine void volume
Time frame: Change from Baseline to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxybutynin Topical Gel | Change From Baseline in Average Urine Void Volume | 21.0 mL | Standard Deviation 65.33 |
| Placebo Topical Gel | Change From Baseline in Average Urine Void Volume | 3.8 mL | Standard Deviation 53.79 |