Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence: Results of Mid-term Follow-up. A Multicenter Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 主要终点
- Change in Number of Fecal Incontinence Episodes per Week
研究概览
简要总结
This study evaluated a treatment called Sphinkeeper™ implantation for people suffering from fecal incontinence, a condition where individuals are unable to control their bowel movements. The procedure involves placing small expandable devices into the anal sphincter area to help improve muscle function and prevent leakage.
Researchers from several European hospitals followed 111 patients over three years to assess how safe and effective this treatment is, and how it affects quality of life. Most patients had not improved with other treatments like diet, medications, or pelvic floor therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adults diagnosed with clinical fecal incontinence (FI), defined as experiencing at least one incontinence episode per week for a duration exceeding six months.
- •Refractory to all standard conservative treatments, including:
- •Pharmacologic therapy
- •Behavioral interventions
- •Pelvic floor rehabilitation
- •Endoanal ultrasonography indicating:
- •Intact internal and external anal sphincters, or
- •Internal, external, or combined sphincter defects involving no more than 120 degrees of the anal circumference.
排除标准
- •Presence of inflammatory bowel disease with anorectal involvement.
- •Diagnosis of anorectal cancer.
- •Evidence of perianal sepsis.
- •Endoanal ultrasound detection of sphincter defects extending over more than 120 degrees of the internal or external sphincter, or both.
- •Prior treatment with sacral neuromodulation.
结局指标
主要结局
Change in Number of Fecal Incontinence Episodes per Week
时间窗: 3 years
The mean change from baseline in the number of fecal incontinence episodes per week at 3-year follow-up. Unit of Measure: Episodes per week
Change in Number of Soiling Episodes per Week
时间窗: 3 years
The mean change from baseline in the number of soiling episodes per week at 3-year follow-up. Unit of Measure: Episodes per week
Change in Time to Postpone Defecation
时间窗: 3 years
The mean change from baseline in the maximum time participants are able to postpone defecation at 3-year follow-up. Unit of Measure: Minutes
Change in Cleveland Clinic Incontinence Score (CCIS)
时间窗: 3 years
The mean change from baseline in the CCIS at 3-year follow-up. Unit of Measure: Points on the CCIS scale (0-20)
Change in Vaizey Incontinence Score
时间窗: 3 years
The mean change from baseline in the Vaizey score at 3-year follow-up. Unit of Measure: Points on the Vaizey scale (0-24)
次要结局
- Change in Fecal Incontinence Quality of Life (FIQoL) Score(3 years)
研究者
Luigi Marano
Professor
Academy of Applied Medical and Social Sciences, Poland