Outcome Research in Bowel Irrigation Techniques: A Novel Self-retaining Catheter Compared With a Conventional Balloon Catheter for the Treatment of Chronic Constipation and/or Faecal Incontinence, a Real-world Randomised Explorative Investigation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 主要终点
- Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale
研究概览
简要总结
This clinical investigation is a post-market, exploratory, randomised, parallel, open-label investigation comparing two UKCA/CE-marked transanal irrigation products for the management of faecal incontinence and/or chronic constipation of heterogenous origin. The aim of this investigation is to assess outcomes in a real-world clinical setting, by following the typical clinical routine, with randomisation and more frequent visits/phone calls as the only difference from typical clinical procedure.
During 4-week training period, participants will trained by nurse specialists on how to use the device to which they were randomised to and will be instructed to irrigate once per day. For the remainder of the investigation, participants will be advised to continue irrigation once daily (or a minimum of 3 times a week). Participants will be followed up via phone call or in-person visit up to 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Faecal incontinence (FI), chronic constipation (CC) or co-existing FI/CC, all of heterogenous origin
- •Positive Rome IV criteria for functional constipation and/or positive Rome IV criteria for faecal incontinence
- •18 years or older
- •Ability to understand written and spoken English (due to questionnaire validity)
- •Ability to understand and provide written, informed consent prior to any investigation-specific procedures
排除标准
- •Prior use of transanal irrigation
- •Neurogenic bowel dysfunction
- •Low anterior resection syndrome (this group will be excluded due to the possibility of being randomised to a balloon catheter).
- •Previous rectal and/or anal surgery (except minor rectal or anal surgery such as haemorrhoid procedures, anal fissure surgery, drainage of a perianal/rectal abscess, or other rectal or anal surgeries deemed minor by the investigator)
- •Physical disability that affects the ability to independently use the irrigation device
- •Intermittent use of opioids inducing chronic constipation
- •Patulous anus
- •Participation in research conflicting with the current investigation
- •Physical or mental conditions affecting the ability to comply with the clinical investigation plan
- •Pregnancy or plans to become pregnant during the investigation period
研究组 & 干预措施
Qufora QNova
干预措施: Transanal irrigation (Device)
Qufora Irrisedo Klick
干预措施: Transanal irrigation (Device)
结局指标
主要结局
Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale
时间窗: Week 4, 10, 26, and 52
Participant experience with device (0: strongly disagree, 4: strongly agree)
次要结局
- The 5-level EQ-5D (EQ-5D-5L) index score(Week 0, 4, 10, 26, and 52)
- Patient Diary(Week 10, 26, and 52)
- Cleveland Clinic Constipation Score (CCCS)(Week 0, 4, 10, 26, and 52)
- St Mark's Incontinence Score (SMIS(Week 0, 4, 10, 26, and 52)