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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00876447 | A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis | PHASE3 | COMPLETED | 397 | — | — | Jan 1, 2009 | Sep 4, 2013 | May 1, 2019 | 22 | United States, Australia +20 |
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
| Arm | Type | Description |
|---|---|---|
| Botulinum Toxin Type A 300U | EXPERIMENTAL | Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
| Botulinum Toxin Type A 200U | EXPERIMENTAL | Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
| Name | Type | Description |
|---|---|---|
| Botulinum Toxin Type A 300U | BIOLOGICAL | Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
| Botulinum Toxin Type A 200U | BIOLOGICAL | Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
Inclusion Criteria: * Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled: * Patient completed at least 52 weeks in the preceding study. * No longer than 6 months has elapsed since completion of the preceding study * Patient has not received any pr...