Treatment of Anal Incontinence Using Intersphincteric Implants (SphinKeeper)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Region Skane
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Severity of anal incontinence
研究概览
简要总结
The purpose of this study is to determine whether treatment with intersphincteric implants is an effective and safe treatment option for patients with anal incontinence
详细描述
Treatment of anal incontinence (AI) remains a challenge - although conservative treatment can reduce the severity of many patients' AI, many continue to experience symptoms that severly affect their quality of life and ability to function properly both socially and professionally.
The level of AI is measured with the St Marks score (ranging from 0-24 where zero is complete continence).
Some patients with AI are shown to have defects in the anal sphincters (i.e. traumatic lesions post partum) and can be helped with reconstructive surgery. These procedures are effective but carry substantial risk for postoperative infection, and the healing process is painful.
One of the main treatment options for anal incontinence today is Sacral Nerve Stimulation (SNS), which is an effective but invasive and expensive treatment with a rather high level of infection. It is normally performed in two separate sessions and require life-long follow up and new surgical procedures every 6-7 years.
Historically artificial anal sphincters have been studied and shown to be effective but with high rates of infections leading to removal of the device. In more recent years studies have instead focused on "bulking agents" (injection of i.e. silicone in the submucosal space with the aim to increase the resting pressure of the anal canal), but the effect seems to be limited and the agents injected are rapidly resorbed by the body.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
- •Subject must be at least 18 years of age
- •Subject must have a St Marks score of at least 11
- •Subject must be able to comply with study and study follow-up requirements.
排除标准
- •Subjects with Crohn's disease or Ulcerative colitis
- •Subject has (a history of) malignancy in the rectum or anal canal
- •Subject has an ongoing treatment with chemotherapy (all indications)
- •Subject has verified active anal fistula(e)
- •Subject is unable or unwilling to provide informed consent.
研究组 & 干预措施
Intersphincteric implants
Treatment with intersphincteric implants in the anal sphincter using Sphinkeeper
干预措施: Sphinkeeper (Device)
结局指标
主要结局
Severity of anal incontinence
时间窗: 12 months
Reduction in St Marks score
次要结局
- Postoperative infection(12 months)
- Change from baseline in pain scores on the VAS at 3 and 12 months.(Baseline, 3 months and 12 months)