Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 829
- 试验地点
- 8
- 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 in treating patients with idiopathic overactive bladder with urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)
排除标准
- •Females who are pregnant, nursing or planning a pregnancy
- •Patient has any condition or situation which, in the Investigators opinion, would put the patient at risk from continuing treatment with botulinum toxin Type A
研究组 & 干预措施
botulinum toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
干预措施: botulinum toxin Type A (Biological)
botulinum toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
干预措施: botulinum toxin Type A (Biological)
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 12 Treatment Cycle 6
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 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Percentage of Patients With a Positive Response on the 4-Point TBS
时间窗: Week 12 Treatment Cycle 6
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)
时间窗: Week 12 Treatment Cycle 1
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
次要结局
- Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain(Study Baseline, Week 12 Treatment Cycle 1)
- Change From Study Baseline in Daily Frequency of Urgency Episodes(Study Baseline, Week 12 Treatment Cycle 6)
- Change From Study Baseline in the I-QOL Questionnaire Total Summary Score(Study Baseline, Week 12 Treatment Cycle 6)
- Change From Study Baseline in the Daily Average Number of Micturition Episodes(Study Baseline, Week 12 Treatment Cycle 6)
- Change From Study Baseline in the KHQ Role Limitations Domain(Study Baseline, Week 12 Treatment Cycle 6)
- Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score(Study Baseline, Week 12 Treatment Cycle 1)
- Change From Study Baseline in the KHQ Social Limitations Domain(Study Baseline, Week 12 Treatment Cycle 6)