NCT01380132已完成1 期
Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Treatment response as measured by a 50% reduction in no of incontinence episodes.
研究概览
简要总结
The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.
详细描述
Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).
- •Age 18-80
- •Available for follow-up for the duration of the study
- •Written informed consent.
排除标准
- •Sphincter defect visible on anal ultrasound.
- •Pregnancy.
- •Rectal prolapse or inflammatory bowel disease.
- •Recent (within 6 months) anal surgery except for haemorrhoids.
- •Anorectal sepsis.
- •Anticoagulant medication or bleeding diathesis.
结局指标
主要结局
Treatment response as measured by a 50% reduction in no of incontinence episodes.
时间窗: One year posttreatment
次要结局
- Adverse events(Two years posttreatment)
- Global assessment(Two years posttreatment)
- Change in incontinence episodes(Two years posttreatment)
- Quality of life(Two years posttreatment)
- Treatment response as measured by a 50% reduction in no of incontinence episodes.(Two years posttreatment)
研究者
研究点 (1)
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