An Open Label Multi-center Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Tengion
- 试验地点
- 2
- 主要终点
- Overall safety
研究概览
简要总结
Subjects with non-neurogenic over-active bladder will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will increase functional capacity and thereby reduce the number of micturition episodes per day in subjects with non-neurogenic over active bladder and urge predominant incontinence.
详细描述
Subjects with non-neurogenic over-active bladder and urge predominant incontinence who are intolerant to medical therapy or have persistence of symptoms despite medical therapy and require augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will increase functional capacity and thereby reduce the number of micturition episodes per day in subjects with non-neurogenic over active bladder and urge predominant incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •History of non-neurogenic overactive bladder for at least 12 months prior to study entry
- •Intolerance to medical therapy or persistence of symptoms despite medical therapy
排除标准
- •Subjects with stress incontinence or mixed incontinence where the predominant component is stress incontinence
- •Use of Botulinum Toxin A injections into the bladder within the previous 6 months
- •Presence of a neuromodulator
- •Using catheterization as a way to control incontinence
- •History of bladder cancer
研究组 & 干预措施
1
Receipt of autologous neo-bladder construct
干预措施: Autologous neobladder construct (Biological)
结局指标
主要结局
Overall safety
时间窗: 12 months
Mean number of micturitions per day
时间窗: 12 months
次要结局
- Mean voided volumes, mean number of incontinent episodes, mean number of micturitions, cystometric capacity, detrusor pressure, end filling pressure and complaince(periodically within first 12 months as well as during long term follow up out to 5 years)