An Open-Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Spina Bifida
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Tengion
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Responders as Assessed by Compliance
研究概览
简要总结
Subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.
详细描述
Subjects with neurogenic bladder secondary to spina bifida (myelodysplasia) that is refractory to medical treatment and require augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.
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
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with neurogenic bladders secondary to myleodysplasia
排除标准
- •prior augment procedures
- •recent urologic surgery
- •requires concomitant urologic intervention
结局指标
主要结局
Number of Responders as Assessed by Compliance
时间窗: 12 months
Efficacy of the autologous neo-bladder construct as assessed by a responder analysis (comparing each patient's baseline with 12 month data). Improvement in compliance (i.e. improved bladder pressure/volume relationship) was measured by urodynamics at predetermined bladder pressure points. This was coupled with an assessment of clinical benefit and used to determine responders versus non-responders
次要结局
- Overall Safety Profile - Number of Participants Experiencing an Adverse Event(periodically within first 12 months as well as during long term follow up out to 5 years)