A Randomised Controlled Trial to Evaluate Effectiveness and Cost-Effectiveness of Intermittent Colonic Exoperistalsis Treatment With MOWOOT Medical Device in Adults With Chronic Constipation Using Trans-Anal Irrigation.

usMIMA S.L.6 个研究点分布在 1 个国家目标入组 86 人2024年4月25日

适应症Constipation - Functional Constipation-predominant Irritable Bowel Syndrome Constipation Chronic Idiopathic Constipation; Neurogenic Constipation

干预措施Intermittent Colonic Exoperistalsis with MOWOOT device Standard of care with Trans-Anal Irrigation

概览

阶段: 不适用
干预措施: Intermittent Colonic Exoperistalsis with MOWOOT device
疾病 / 适应症: Constipation - Functional
发起方: usMIMA S.L.
入组人数: 86
试验地点: 6
主要终点: Changes in quality of life (PAC-QoL)
状态: 已完成
最后更新: 19天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The primary objective is to compare the effectiveness of the experimental Intermittent Colonic Exoperistalsis (ICE) treatment with MOWOOT, with the active control of trans-anal irrigation (TAI) as standard-of-care. The secondary objectives are to further compare the ICE treatment with MOWOOT to the TAI standard-of-care clinically and economically.

详细描述

The RCT will assess clinical effectiveness by means of quantitative and qualitative variables, and the cost effectiveness by means of economic outcomes.

注册库

clinicaltrials.gov

开始日期

2024年4月25日

结束日期

2026年4月2日

最后更新

19天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

usMIMA S.L.

责任方

Sponsor

入排标准

入选标准

•Any gender 18 years or older
•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
•PAC-QOL ≥1.8
•Using TAI for at least 3 months
•Able to undertake the treatment with TAI or with the device 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

•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)
•Device-related exclusion criteria:
•Abdominal perimeter ≤65cm or ≥130cm
•Unable to independently use the MOWOOT or TAI technology, unless a carer is available daily to assist
•Other medical conditions, medications and contraindications:
•Previous large bowel resection
•The presence of a stoma
•External rectal prolapse

研究组 & 干预措施

Intermittent Colon Exoperistalsis (ICE)

Intermittent Colon Exoperistalsis (ICE) Treatment with Mowoot device. 20min daily for 12 weeks

干预措施: Intermittent Colonic Exoperistalsis with MOWOOT device

Intermittent Colon Exoperistalsis (ICE)

Intermittent Colon Exoperistalsis (ICE) Treatment with Mowoot device. 20min daily for 12 weeks

干预措施: Standard of care with Trans-Anal Irrigation

Standard-of-care with Trans-anal Irrigation (Soc TAI)

Standard-of-care with Trans-anal Irrigation (Soc TAI) for chronic constipation for 12 weeks.

干预措施: Standard of care with Trans-Anal Irrigation

结局指标

主要结局

Changes in quality of life (PAC-QoL)

时间窗: End of treatment (week 14, last week of treatment) - Baseline (before treatment)

Semi-quantitative assessment of the changes in quality of life respect to chronic constipation, of patients using the ICE treatment with MOWOOT compared with patients under standard of care treatment. The measure is done according to PAC-QoL questionnaire.

次要结局

Changes in the number of days evacuation felt complete(Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.)
Changes in laxative use(Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.)
Frequency of use of ICE(Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.)
Changes in the maximum number of consecutive days without complete bowel movements(Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.)
Changes in the number of days with a normal stool(Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.)
Frequency of use of TAI(Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.)
Changes in the use of SoC TAI (HE outcome)(Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.)
Number of visits to GP and specialists (HE outcome)(3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment))
Number of hospital admissions (HE outcome)(3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment))
Days spent at hospital (HE outcome)(3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment))
Changes in Constipation symptoms (PAC-SYM)(3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment))
Changes in quality of life according to Euroqol ED5D5L(3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment))
Changes in the mean time spent in bowel management(Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.)
Changes in the mean time spent per evacuation(Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.)
Changes in the number of days with fecal incontinence(Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.)
Use of relevant supplies (HE outcome)(3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment))
Continence Service consultations (HE outcome)(3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment))
Number of visits to Accident & Emergency room (HE outcome)(3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment))
Use of relevant medications (HE outcome)(3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment))
Incremental cost/effectiveness ratio (ICER) and Quality-Adjusted Life years (QALYS) (HE outcome)(EQ-5D-5L3 answered 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment))
Adverse events and Serious adverse events(Evrey day during all the follow-up, from recruitment (visit 0, day 0) to the end of study (visit 3, day 154))