Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial (CONFIDEnCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Change in FI severity
研究概览
简要总结
The purpose of this study is to assess the cost-effectiveness and improvement in quality of life of using a novel anal insert (navina)
详细描述
After being informed about the study including the potential pros and cons, patients will be given a minimum of 7 days to think about whether they would like to participate in the study. If they would like to participate, and informed consent form will need to be signed, after which the patients will undergo a screening to ensure they meet the inclusion criteria. A 2 week run-in period will take place to let patients get used to filling in an electronic daily diary. Prior to this period, patients will be asked to fill out several questionnaires. After this period, randomisation into either (1) the anal insert group or (2) the care as usual group. Group 1 will then have an 'accommodation' week in which they can try out two different sizes of the anal insert to see which size they would prefer for the treatment period. The treatment period will consist of 8 weeks In which the (1) anal insert group is expected to use the anal inserts and the (2) care as usual group is asked to continue with their treatment as usual. During the treatment period, patients will fill out an electronic daily diary as well as weekly questionnaires.At the end of the 8 week treatment period, patients will fill out additional questionnaires. The follow-up consists of 4 weeks, after which patients will be asked again to fill out several questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For run in period
- •Patients with FI according to Rome IV criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months)
- •Aged between 16-90 years
- •For randomisation and treatment period
- •Patients with FI according to Rome IV criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months)
- •Aged between 16-90 years
- •patients who experience at least 1 episode of accidental bowel leakage during the 2 week run-in period will be eligible for randomisation.
排除标准
- •Insufficient cognitive skills to fill in patient-reported questionnaires, inability to present to hospital for screening visit and inclusion, neurological/psychiatric or physical inability to comply with the study protocol (including diary assessments) at the investigator's discretion, or insufficient command of the Dutch language.
- •Anatomic abnormalities: known communication between the anal and vaginal tracts, prior diagnosis of congenital anorectal malformations, previous rectal surgery, radiotherapy to a pelvic organ (uterus, prostate, rectum).
- •Prior diagnosis of inflammatory bowel disease.
- •Pregnancy or intention to become pregnant during the study period.
研究组 & 干预措施
Anal insert
This group will be asked to use anal inserts to help manage their faecal incontinence during the treatment period
干预措施: Navina anal insert (Device)
Care as usual
This group will be asked to continue with their care as usual (e.g. incontinence pads)
干预措施: Care as usual (Other)
结局指标
主要结局
Change in FI severity
时间窗: 8 weeks
Measured using the St. Marks/vaizey incontinence score. This scale ranges from 0 (complete continence = best score) to 24 (complete incontinence= worst score). We are particularly interested in whether a clinically meaningful decrease of ≥3 points will occur in the intervention group compared to the control group.
次要结局
- Frequency and severity of adverse events(8 weeks)
- Cost effectiveness (Costs due to loss of productivity)(8 weeks)
- Mental health (anxiety)(8 weeks)
- Mental health (depression)(8 weeks)
- Adherence to therapy(8 weeks)
- Cost effectiveness (direct medical costs)(8 weeks)
- Quality of life (QoL) (general QoL)(8 weeks)
- Quality of life (QoL) (disease specific QoL)(8 weeks)
- Wellbeing(8 weeks)