Intermittent Colonic Exoperistalsis Treatment with MOWOOT Medical Device to Treat Chronic Constipation in Adult Patients Waiting for Using Trans-Anal Irrigation: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Satisfaction with Daily Quality of Life Related to Bowel Management
研究概览
简要总结
This prospective, open-labelled, longitudinal, controlled study aims to evaluate the suitability of Intermittent Colonic Exoperistalsis (ICE) treatment for adults with refractory chronic constipation who are awaiting trans-anal irrigation (TAI). The ICE treatment will be applied using the MOWOOT device (USMIMA). The study involves two treatment groups: an experimental group receiving daily ICE treatments and a control group following standard TAI care. Participants will serve as their own controls in pre- and post-treatment analyses to assess changes in bowel management satisfaction and other outcomes.
详细描述
This study is a prospective, open-labelled, longitudinal, controlled trial conducted at a single center. It aims to assess the suitability of Intermittent Colonic Exoperistalsis (ICE) treatment for bowel management in adults with refractory chronic constipation who are awaiting trans-anal irrigation (TAI). The ICE treatment will be applied using the MOWOOT device (USMIMA). The study includes two treatment groups:
Experimental ICE Group: Participants will receive one ICE treatment session lasting 20 minutes daily, at the same hour, for 12 weeks.
Control TAI Group: Participants will follow the usual TAI standard-of-care treatment for 12 weeks.
Participants will be given the option to choose between the ICE treatment and the TAI treatment after both options are explained to them. Healthcare professionals will recommend the most suitable treatment based on individual patient needs, but the final decision will rest with the patients.
The primary objective is to evaluate the change in satisfaction with daily quality of life related to bowel management, measured by a Likert scale (Bothersome scale). Secondary objectives include assessing the efficacy of the ICE treatment on chronic constipation, both qualitatively and quantitatively, and evaluating the economic impact from the hospital's perspective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study, meaning there is no masking. Both the participants and the researchers are aware of the treatment being administered. This approach is necessary due to the nature of the intervention, which makes blinding impractical.
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
- •Adult people (18 yo or older) of any gender
- •Attending their pre-scheduled on-site visit to the site (The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit | Central Middlesex Hospital) due to constipation (Symptoms meeting the American College of Gastroenterology definition of chronic constipation: unsatisfactory defaecation characterized by infrequent stool, difficult stool passage or both for at least previous 3 months.
- •Bothered by their constipation
- •Failed biofeedback (in absence of outlet problems)
- •In waiting list to use TAI
- •Able to undertake the treatment with the MOWOOT device or TAI themselves, or with a carer willing to do it
- •Able to understand the study requirements
- •Able to understand written and spoken English (due to questionnaire validity)
- •Able and willing to provide written informed consent to participate
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •Disease phenotype exclusion criteria:
- •Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation and diarrhoea (IBSmix): (not due to laxative use)
- •Inflammatory Bowel Disease (IBD)
- •Significant outlet problem
- •Trapping rectocele
- •Intra anal rectal intussusception
- •External rectal prolapse
- •Device-related exclusion criteria:
- •Abdominal perimeter ≤65cm or ≥130cm
- •Unable to independently use the MOWOOT technology, unless a carer is available daily to assist
- •Other medical conditions, medications and contraindications:
- •Pregnancy or attempt to become pregnant in the next 6 months.
- •Previous large bowel resection
- •Active anorexia or bulimia
- •Active abdominal cancer
- •Large inguinal or umbilical hernia
- •Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable
- •Any condition that contraindicates abdominal massage.
- •Significant abdominal pain
- •Participation in another parallel interventional clinical trial or less than 2 months from participation in a previous interventional clinical trial
- •Planned surgery* if it might be within trial dates (* minor surgery not affecting adherence to treatment is allowed)
研究组 & 干预措施
Experimental ICE Group
Each patient will receive 1 ICE treatment of 20 minutes at least once per day, every day at the same hour, during the intervention period of 12 weeks.
干预措施: ICE Treatment (Device)
Control TAI Group
Each patient will follow the usual TAI standard-of-care treatment for the intervention period of 12 weeks.
干预措施: TAI Standard-of-Care Treatment (Procedure)
结局指标
主要结局
Change in Satisfaction with Daily Quality of Life Related to Bowel Management
时间窗: 12 weeks
Assessed by the Bothersome Scale (a Likert scale) where 0 is 'not at all' and 10 is 'a great deal,' with higher scores indicating a worse outcome
次要结局
- Change in Number of Consultations to Primary Care (GP, Nurse)(12 weeks)
- Change in Time Spent in Bowel Management(12 weeks)
- Change in Time Spent in Evacuation(12 weeks)
- Change in Use of Other Treatments (e.g., Laxatives, Suppositories)(12 weeks)
- Changes in Quality of Life According to PAC-QOL Score(12 weeks)
- Changes in Constipation Symptoms According to PAC-SYM Score(12 weeks)
- Changes in Constipation Severity According to CCCS(12 weeks)