Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation - Qufora IrriSedo MiniGo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- 11-point Likert scale
研究概览
简要总结
The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin).
详细描述
The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with FI and/or CC (of heterogenous origin). Further, the aim is to investigate if low volume irrigation can change the negative impact that symptoms of FI and/or CC (of heterogenous origin) have on the patients' daily activities and QoL. Additionally, the aim is to investigate the short-term and long-term discontinuation rates in relation to treatment with low-volume irrigation. Finally, the aim is to investigate the daily time-consumption, the practical challenges and the side effects related to low-volume irrigation. The study period is six weeks and the participants will be instructed to irrigate once daily with Qufora IrriSedo MiniGo.
This study is an interventional study. Patients with FI and/or CC of heterogenous origin, seen in the Nurse-led Clinic for Bowel Dysfunction at the Pelvic Floor Unit, Aarhus University hospital, will be included. Patients will be offered transanal irrigation as a treatment option. Patients presenting with Bristol stool type 6-7 should be offered conservative treatment to optimize the stool consistency. If patients can be regulated to a Bristol stool type 1-5, they can be invited to participate in the study. If necessary, regulation of the stool consistency in patients presenting with Bristol stool type 1-2 is an option, before introducing transanal irrigation.
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
- 是
入选标准
- •Patients with FI, CC or co-existing FI and CC of heterogenous origin.
- •Positive Rome IV criteria for constipation and/or positive Rome IV criteria for fecal incontinence.
- •Patients with Bristol stool type 1-5 as their primary stool consistency.
- •18 years.
- •Ability to understand written and spoken Danish (due to questionnaire validity).
排除标准
- •Prior use of transanal irrigation or mini enema.
- •Patients with chronic diarrhea (Bristol stool type 6-7).
- •Patients with neurogenic bowel dysfunction.
- •Participation in research conflicting with the current study.
- •Diseases treated with rectal or anal surgery (except minor rectal or anal surgery).
- •Physical disability that affects the ability to use QuforaÒ IrriSedo MiniGo.
- •Major psychiatric diagnoses.
- •Patients with constipation with a chronic opioid use or other medications inducing constipation.
- •Pregnancy or plans to become pregnant.
研究组 & 干预措施
Low-volume irrigation
The patients will be instructed to irrigate once daily at a fixed time for 6 weeks. The patients will be instructed to use the irrigation 30 min after breakfast, capitalizing on the gastrocolic response; however, should this not fit in with the individual's lifestyle, then an alternative time of the day may be used. Preferably shortly after a large meal. The patients should fill the pump with 180 milliliters (a full pump) and irrigate with a volume of 160 milliliters of water.
干预措施: Low-volume irrigation (Device)
结局指标
主要结局
11-point Likert scale
时间窗: 6 weeks
The present bowel functions impact on daily activities (0: no, 10: maximum influence)
次要结局
- Discontinuation rates(6 weeks, 3 months, 6 months, 12 months)
- Correlation for the primary outcome(6 weeks)
- Correlation for SMIS and PAC-SYM(6 weeks)
- The Fecal Incontinence Quality of Life Scale(6 weeks)
- PAC-SYM score(6 weeks)
- The Patients Assessment of Constipation Quality of life(6 weeks)
- The 5-level EQ-5D (EQ-5D-5L) index score(6 weeks)
- 11-point Likert scale(3 months, 6 months, 12 months)
- The St. Mark's fecal incontinence score(6 weeks)
- 11-point Likert scale(6 weeks, 3 months, 6 months, 12 months)
- Five-point ordinal scale(6 weeks)
- Practicalities and adverse effects(6 weeks, 3 months, 6 months, 12 months)