Constipation, Constipation Chronic Idiopathic, Constipation - Functional, Constipation; Neurogenic, Constipation-predominant Irritable Bowel Syndrome
Conditions
Brief summary
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.
Detailed description
The RCT will assess clinical effectiveness by means of quantitative and qualitative variables, and the cost effectiveness by means of economic outcomes.
Interventions
DEVICEIntermittent Colonic Exoperistalsis with MOWOOT device
Patients under the experimental arm of the study should place the belt of the Mowoot device on the abdomen and use it for 20 minutes every day for 12 weeks. They should continue with their individualized standard of care againts constipation for the first 4 weeks. During the following 8 weeks of the interventional period of 12weeks, their use of SocTAI will be considered "rescue intervention". The 8weeks following the 12weeks of intervention, they can keep on using ICE device.or SocTAI or both.
DEVICEStandard of care with Trans-Anal Irrigation
Patients under the active comparator arm of the study should continue with their individualized standard of care againts constipation for the 12weeks of intervention. The following 8 weeks they can keep on using SocTAI or ICE device or both.
Sponsors
usMIMA S.L.
County Durham and Darlington NHS Foundation Trust
University of York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Any gender 18 years or older 2. 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 3. Bothered by their constipation 4. PAC-QOL ≥1.8 5. Using TAI for at least 3 months 6. Able to undertake the treatment with TAI or with the device themselves or with a carer willing to do it 7. Able to understand the study requirements 8. Able to understand written and spoken English (due to questionnaire validity) 9. Able and willing to provide written informed consent to participate
Exclusion criteria
Disease phenotype
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in quality of life (PAC-QoL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | How many days per week the patient has used TAI |
| 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. | How many days per week the patient has used ICE |
| 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) | Semi-quantitative assessment of the changes in symptoms of constipation of patients using the ICE treatment with MOWOOT compared with patients under standard of care treatment. The measure is done according to PAC-SYM questionnaire. |
| 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) | Semi-quantitative assessment of the changes in self-perceived quality of life according to the EQ-5D-5L instrument |
| 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. | Quantitative assessment of the change in the number of days per week evacuation felt complete at the end of the day |
| 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. | Quantitative assessment of the change in the maximum number of consecutive days within the 2-week diary period without complete bowel movementscomplete at the end of the day |
| 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. | Quantitative assessment of the change in the number of days with a normal stool (Bristol Stool Scale 3-5) during the 2-week diary period |
| 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. | Quantitative assessment of the change in the mean time spent in bowel management per week |
| 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. | Quantitative assessment of the change in the mean time spent per evaquation |
| 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. | Quantitative assessment of the change in the number of days with fecal incontinence per week |
| 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. | Quantitative assessment of the change in the number of days per week taking laxatives |
| 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. | Quantitative assessment of the changes in number of people (%) who stop using TAI while using ICE with MOWOOT during the 12-week RCT period; and mean/median change in the use of TAI while using Mowoot during the 12-week 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) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of visits to GP and specialists (in primary care centres, hospitals, or visits received at home) over the previous 8 weeks |
| 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) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of visits to to Accident \& Emergency room (A\&E) over the previous 8 weeks * Number of visits to GP and specialists (in primary care centres, hospitals, or visits received at home) * Number of visits to Accident \& Emergency room (A\&E) * Continence Service consultations (face-to-face visits and/or phone calls) * Number of hospital admissions * Days spent at hospital * Use of relevant medications (including opioids, antidepressants, bladder stabilisers or any other medication inducing constipation) and supplies (diapers, protector sheets, suppositories and micro-enemas) during the 12-week RCT period; and mean/median change in the use of TAI while using Mowoot during the 12-week RCT period |
| 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) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of continence Service consultations (face-to-face visits and/or phone calls) over the previous 8 weeks |
| 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) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of hospital admissions over the previous 8 weeks |
| 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) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the days spent at hospital over the previous 8 weeks |
| 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) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the use of relevant medications, including opioids, antidepressants, bladder stabilisers or any other medication inducing constipation, over the previous 8 weeks |
| 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) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the use of relevant supplies (diapers, protector sheets, suppositories and micro-enemas), over the previous 8 weeks |
| 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) | Quantitative assessment of the of ICER and QALYS based on the health-related quality of life questionnaire EQ-5D-5L |
| 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) | Quantitative and qualitative assessment of adverse events (AEs) and serious adverse events (SAEs) |
Countries
United Kingdom
Contacts
STUDY_CHAIRImmaculada Herrero, PhD
usMIMA S.L.
Outcome results
None listed