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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 397
- 试验地点
- 22
- 主要终点
- Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •History or evidence of pelvic or urologic abnormality.
- •Previous or current diagnosis of bladder or prostate cancer.
结局指标
主要结局
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
时间窗: 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).
次要结局
- 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)