NCT01059370已完成不适用
Autonom Dysrefleksi Ved Rygmarvsskade
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Intervention induces 25 % raise in BP compared to baseline measurements.
研究概览
简要总结
Autonomic dysreflexia in high spinal cord-injured can be initiated by a full bladder or bowel, or when trying to empty either. This randomised study aims at evaluating whether irrigation procedure or digital stimulation or evacuation of the rectum is less provocative of autonomic dysreflexia. Participants have their bowels emptied on different days, in the morning fasting. Bladder filling with sterile saline water is evaluated on a third day as a control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •People with a spinal cord injury above th6 and with symptoms of autonomic dysreflexia.
- •At least one year post injury.
- •18 years or older.
- •Informed consent.
排除标准
- •Usage of prophylactic anti-autonomic dysreflexia medication.
- •Pregnant or breastfeeding.
- •People who is not able to follow the sudy protocol.
- •No former major surgery in the abdomen or pelvic region.
- •No former radiotherapy in the pelvic region.
结局指标
主要结局
Intervention induces 25 % raise in BP compared to baseline measurements.
时间窗: Outcome are monitored all through bowel or bladder-procedure at each of three study-days, and compaire to measurements at baseline.
次要结局
未报告次要终点
研究者
研究点 (2)
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