Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Wexner overall score
研究概览
简要总结
A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.
详细描述
A prospective randomized study to assess the use of Bulkamid for anal incontinence using three different transanal injection techniques .
Patients with anal incontinence severity Wexner score >7. Standardised injection treatment at baseline. Clinical status and subjective symptom evaluation (Wexner score and FIQL) at baseline, 2 months, 6 months and 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •informed consent, anal incontinence with Wexner score >10
排除标准
- •ino additional pregnancies, schedule for pelvic organ surgery within 1 year of treatment, current or previous pelvic organ cancer, insulin treated diabetes, inflammatory bowel disease
研究组 & 干预措施
Bulkamid injection treatment group 1
Injection at four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide
干预措施: Transanal submucosal injection group 1 (Procedure)
Bulkamid injection treatment group 2
injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide
干预措施: Transanal submucosal injection group 2 (Procedure)
Bulkamid injection treatment group 3
injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide
干预措施: Transanal submucosal injection group 3 (Procedure)
结局指标
主要结局
Wexner overall score
时间窗: 1 year
次要结局
- FIQL overall score(1 year)
- Adverse events(1 year)
研究者
Daniel Altman
Associate professor
Karolinska Institutet