Urge Urinary Incontinence, Urinary Frequency
Conditions
Brief summary
The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel. The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.
Interventions
DRUGOxybutynin
Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo
DRUGPlacebo
Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo
Sponsors
Antares Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge incontinence for at least 3 months * Have a history of at least 1 - 2 urge episodes and 8 or more voids per day
Exclusion criteria
* Incontinence that is predominantly stress, insensate, or overflow in nature, or incontinence related to chronic illness, anatomical weakness/abnormalities or concomitant medications * PVR volume \> 200 mL or relative PVR \> 50% of pre-void volume as determined by bladder ultrasound * History of urinary retention, gastric retention, or uncontrollable narrow-angle glaucoma, or patients who are at risk for these conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 | 12 weeks | Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline. |
Countries
United States
Participant flow
Recruitment details
Recruitment in clinical sites (urologists mainly) started in September 2007 and was terminated in February 2010.
Pre-assignment details
Baseline period was 1 week. Patients on OAB drugs had to wash out.
Participants by arm
| Arm | Count |
|---|---|
| Oxybutynin Gel 56 mg/Day | 210 |
| Oxybutynin Gel 84 mg/Day | 214 |
| Placebo Gel | 202 |
| Total | 626 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 39 | 18 | 33 |
Baseline characteristics
| Characteristic | Total | Oxybutynin Gel 56 mg/Day | Oxybutynin Gel 84 mg/Day | Placebo Gel |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 264 Participants | 90 Participants | 92 Participants | 82 Participants |
| Age, Categorical Between 18 and 65 years | 362 Participants | 120 Participants | 122 Participants | 120 Participants |
| Age, Continuous | 58.8 years STANDARD_DEVIATION 13.1 | 59.4 years STANDARD_DEVIATION 12.6 | 59.1 years STANDARD_DEVIATION 13.3 | 57.8 years STANDARD_DEVIATION 13.3 |
| Number of incontinent episodes at baseline | 46.5 Episodes STANDARD_DEVIATION 29.3 | 50.1 Episodes STANDARD_DEVIATION 32.5 | 43.6 Episodes STANDARD_DEVIATION 27.5 | 45.8 Episodes STANDARD_DEVIATION 28.9 |
| Region of Enrollment United States | 626 participants | 210 participants | 214 participants | 202 participants |
| Sex: Female, Male Female | 542 Participants | 182 Participants | 182 Participants | 178 Participants |
| Sex: Female, Male Male | 84 Participants | 28 Participants | 32 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 98 / 210 | 90 / 214 | 53 / 202 |
| serious Total, serious adverse events | 3 / 210 | 4 / 214 | 2 / 202 |
Outcome results
Primary
Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
Time frame: 12 weeks
Population: mITT (modified intended to treatment) per protocol Difference between Baseline and after 12 weeks treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxybutynin Gel 56 mg/Day | Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 | -24.8 Episodes | Standard Deviation 28.7 |
| Oxybutynin Gel 84 mg/Day | Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 | -21.9 Episodes | Standard Deviation 25.1 |
| Placebo Gel | Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 | -20.0 Episodes | Standard Deviation 27 |