NCT00971269Unknown1 期
A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in fecal incontinence episodes
研究概览
简要总结
The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fecal incontinence with at least 2 episodes/week
- •Symptom duration at least one year
- •Failed attempt of conservative therapy
- •Written informed consent
- •Available for follow-up
- •Fully compliant with protocol
排除标准
- •Active inflammatory bowel disease
- •Total external sphincter defect at ultrasound and clinical examination
- •Bleeding diathesis or anticoagulant therapy
- •Rectal prolapse or intussusceptions
- •Present anal sepsis
- •Anorectal implants
- •Recent anorectal surgery (within 6 months)
- •Rectal anastomosis
- •Pregnancy, postpartum (one year) or breast feeding
结局指标
主要结局
Change in fecal incontinence episodes
时间窗: Follow up during a four week period and after 6 and 12 months
次要结局
- Side effects related to treatment(12 months)
研究者
研究点 (1)
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