The Use of an "Anal-Tape" in Patients With Fecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
研究概览
简要总结
Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months and is a devastating disease. The negative impact on quality of life has been consistently demonstrated. The prevalence of FI is probably underestimated in most studies. Currently conservative treatment is only modestly effective and surgical treatment is complex and expensive with less than optimal efficacy.
The investigators developed an "anal tape" using a commercially available elastic band with a special adhesive that is approved for use in the skin. A special design of the tape can be applied to the skin surrounding the anus providing support and additional pressure forces to the anal sphincter.
This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and safety of this device in patients with FI. The primary endpoint will be improvement in quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •>18 years old
- •Fecal incontinence for more than 6 months
- •Willing to participate
- •Understand the study procedures
- •Is able to apply and remove the "anal tape" without significant assistance of others.
- •Have done sigmoidsocopy or colonoscopy and anal manometry within five year of screening visit
排除标准
- •Advanced full thickness rectal prolapse.
- •Injured, inflamed or any significant disease in the peri-anal skin.
- •Allergy to any component of the device, either known or developed during testing in the screening visit.
- •Moderate to severe proctitis of any etiology.
结局指标
主要结局
Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
时间窗: 2 weeks
The FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self-perception, and Embarrassment. Item 1, general health, is graded from 1 "excellent" to 5 "poor" and is reversely scored. Items 2 to 28 are graded on a 4-point Likert-scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 "extremely so" to 6 "not at all." The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated.
次要结局
- A 50% Reduction in the Number of Episodes of FI Per Week(4 weeks)
- Mean Wexner Score(2 weeks)
- Mean Redction in Wexner Scale Compared to Baseline(2 weeks)
- General Satisfaction(2 weeks)
- Willingness of the Patient to Continue Using the Anal Tape After the Study.(4 weeks)
研究者
Dan Livovsky
Dr. Dan M. Livovsky and Dr. Joseph Lysy
Shaare Zedek Medical Center