Clinical trial NCT04666155: MOWOOT Device Treatment for Adults with Chronic Constipation
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constipation - Functional
Constipation-predominant Irritable Bowel Syndrome
Constipation Chronic Idiopathic
Constipation; Neurogenic
Constipation
Lead sponsor: usMIMA S.L.
Sponsor class: INDUSTRY
Collaborators: name: County Durham and Darlington NHS Foundation Trust
name: University of York
First posted: 2020-12-14
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 exclusion criteria:

1. Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation and diarrhoea (IBSmix): (not due to laxative use)
2. Inflammatory Bowel Disease (IBD)

   Device-related exclusion criteria:
3. Abdominal perimeter ≤65cm or ≥130cm
4. Unable to independently use the MOWOOT or TAI technology, unless a carer is available daily to assist

   Other medical conditions, medications and contraindications:
5. Previous large bowel resection
6. The presence of a stoma
7. External rectal prolapse
8. Active anorexia or bulimia
9. Active abdominal cancer
10. Large inguinal or umbilical hernia
11. Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable
12. Pregnancy or attempt to become pregnant in the next 6 months
13. Use of strong opioids\*
14. Use of antidepressants, bladder stabilisers or any other medication inducing, or treating, constipation unless used at a stable dose for at least 4 weeks before Screening Visit (this excludes laxatives which may be used as required up to three days before the screening visit)
15. Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 months
16. Participation in another parallel interventional clinical trial or less than 2 months from participation in a previous interventional clinical trial
17. Planned surgery for constipation if it might be within trial dates

Primary outcomes:
measure: Changes in quality of life (PAC-QoL)
timeFrame: End of treatment (week 14, last week of treatment) - Baseline (before treatment)
Secondary outcomes:
measure: Frequency of use of TAI
timeFrame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
measure: Frequency of use of ICE
timeFrame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
measure: Changes in Constipation symptoms (PAC-SYM)
timeFrame: 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)
measure: Changes in quality of life according to Euroqol ED5D5L
timeFrame: 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)
measure: Changes in the number of days evacuation felt complete
timeFrame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
measure: Changes in the maximum number of consecutive days without complete bowel movements
timeFrame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
measure: Changes in the number of days with a normal stool
timeFrame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
measure: Changes in the mean time spent in bowel management
timeFrame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
measure: Changes in the mean time spent per evacuation
timeFrame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
measure: Changes in the number of days with fecal incontinence
timeFrame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
measure: Changes in laxative use
timeFrame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
measure: Changes in the use of SoC TAI (HE outcome)
timeFrame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
measure: Number of visits to GP and specialists (HE outcome)
timeFrame: 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)
measure: Number of visits to Accident & Emergency room (HE outcome)
timeFrame: 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)
measure: Continence Service consultations (HE outcome)
timeFrame: 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)
measure: Number of hospital admissions (HE outcome)
timeFrame: 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)
measure: Days spent at hospital (HE outcome)
timeFrame: 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)
measure: Use of relevant medications (HE outcome)
timeFrame: 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)
measure: Use of relevant supplies (HE outcome)
timeFrame: 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)
measure: Incremental cost/effectiveness ratio (ICER) and Quality-Adjusted Life years (QALYS) (HE outcome)
timeFrame: 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)
measure: Adverse events and Serious adverse events
timeFrame: Evrey day during all the follow-up, from recruitment (visit 0, day 0) to the end of study (visit 3, day 154)
Other outcomes:
Locations:
city: Durham
country: United Kingdom
facility: University Hospital of North Durham, NHS Foundation Trust
state: County Durham and Darlington
Study officials:
affiliation: usMIMA S.L.
name: Immaculada Herrero, PhD
role: STUDY_CHAIR
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