Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 41
- 主要终点
- Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
研究概览
简要总结
This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.
详细描述
Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
- •Inadequate response to anticholinergic medication used to treat overactive bladder.
- •Neurological respiratory impairment and abnormal pulmonary function test results
排除标准
- •History or evidence of pelvic or urologic abnormality
- •Previous or current diagnosis of bladder or prostate cancer
- •Symptomatic or untreated urinary tract infection at time of enrollment
研究组 & 干预措施
botulinum toxin Type A 200U
Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
干预措施: botulinum toxin Type A (Biological)
botulinum toxin Type A 300U
Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
干预措施: botulinum toxin Type A (Biological)
Placebo/botulinum toxin Type A 200U
Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
干预措施: botulinum toxin Type A (Biological)
Placebo/botulinum toxin Type A 200U
Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
干预措施: Normal Saline (Placebo) (Drug)
Placebo/botulinum toxin Type A 300U
Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 300U injection (200U after discontinuation of 300U) after a minimum of 12 weeks (if applicable).
干预措施: botulinum toxin Type A (Biological)
Placebo/botulinum toxin Type A 300U
Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 300U injection (200U after discontinuation of 300U) after a minimum of 12 weeks (if applicable).
干预措施: Normal Saline (Placebo) (Drug)
结局指标
主要结局
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
时间窗: Baseline, Week 6
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.
Change From Baseline in Forced Vital Capacity (FVC)
时间窗: Baseline, Week 6
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.
Change From Baseline in FEV1/FVC Ratio
时间窗: Baseline, Week 6
The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.
次要结局
- Change From Baseline in the Number of Urinary Incontinence Episodes(Baseline, Week 6)
- Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)(Baseline, Week 6)
- Change From Baseline in Maximum Cystometric Capacity (MCC)(Baseline, Week 6)