Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00909181 | Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence | PHASE3 | COMPLETED | 626 | — | — | Mar 1, 2009 | Nov 1, 2010 | Jul 2, 2014 | 55 | United States |
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
| Arm | Type | Description |
|---|---|---|
| Oxybutynin Gel 56 mg/day | EXPERIMENTAL | - |
| Oxybutynin Gel 84 mg/day | EXPERIMENTAL | - |
| Placebo Gel | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Oxybutynin | DRUG | 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 |
| Placebo | DRUG | 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 |
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, o...