An Open Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Tengion
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in Maximum Detrusor Pressure From Baseline to 12 Months
研究概览
简要总结
Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum detrusor pressure.
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
盲法说明
Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.
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
- •subjects with neurogenic bladders secondary to spinal cord injury
排除标准
- •prior augmentation procedures or urinary diversion
- •recent urologic or intraperitoneal surgery or device implantation
- •recent history of spinal cord injury of less than a year
- •recent neurologic surgery
- •requirement for concomitant urological surgical procedures
结局指标
主要结局
Change in Maximum Detrusor Pressure From Baseline to 12 Months
时间窗: baseline and 12 months
Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure.
Overall Safety Profile - Number of Participants Experiencing an Adverse Event
时间窗: through month 12
Clinical evaluation of adverse events experienced by patients enrolled in the trial.
次要结局
- Urodynamic Measurements and Long Term Safety(month 12 through month 60)