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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Allergan
- Enrollment
- 397
- Primary Endpoint
- Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).
Detailed Description
Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the arm containing botulinum toxin Type A 300U will receive botulinum toxin Type A 200U moving forward. Also, the masking of the study is now open-label.
Investigators
Eligibility Criteria
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 prohibited medications during any intervening period between the preceding study and this long-term study.
Exclusion Criteria
- •History or evidence of pelvic or urologic abnormality.
- •Previous or current diagnosis of bladder or prostate cancer.
Outcomes
Primary Outcomes
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Time Frame: Study Baseline, Week 6 Treatment Cycle 5
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).
Secondary Outcomes
- Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score(Study Baseline, Week 6 Treatment Cycle 5)
- Change From Study Baseline in Volume Per Void(Study Baseline, Week 6 Treatment Cycle 5)