NCT00200005已完成4 期
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 9
- 主要终点
- FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying
研究概览
简要总结
Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fecal incontinence (defined as incontinence to solid or liquid stool > 1 / week);
- •Failed biofeedback or medical therapy;
- •Groups 1 - 5 patients with:
- •Group 1) Circumferentially intact external anal sphincter, no previous surgery;
- •Group 2) Circumferentially intact external anal sphincter after surgical repair;
- •Group 3) Rectal prolapse repaired with a rectopexy;
- •Group 4) Spinal injury including disc prolapse;
- •Group 5) Sigmoid or partial rectal resection with colorectal or coloanal anastomosis
- •Constipation groups:
- •Main Inclusion Criteria:
- •Chronic constipation (defined as </= 2 weekly bowel movements; and/or >25% of bowel movements required straining; and/or >25% of bowel movements patient did not feel empty afterwards) with symptoms more than 1 year
- •Failed biofeedback or medical therapy;
- •Groups 6 - 7 patients with:
- •Group 6) Idiopathic slow transit constipation as proven on colonic transit studies;
- •Group 7) Normal colonic transit studies but chronic constipation due to either pelvic floor dysfunction or disordered defecation.
排除标准
- 未提供
结局指标
主要结局
FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying
时间窗: Annually
次要结局
- FI-number of days with staining/week;urgency with continent bowel movements; Improvement in QOL;* Improvement in anal canal pressure. Constipation - Improvement in Wexner constipation score; QOL.(Annually)
研究者
研究点 (9)
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