Trials / Completed
CompletedNCT04666155
MOWOOT Device Treatment for Adults With Chronic Constipation
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- usMIMA S.L. · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Constipation - Functional
- Constipation-predominant Irritable Bowel Syndrome
- Constipation Chronic Idiopathic
- Constipation; Neurogenic
- Constipation
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intermittent 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. |
| DEVICE | Standard 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. |
Timeline
- Start date
- 2024-04-25
- Primary completion
- 2026-04-02
- Completion
- 2026-04-02
- First posted
- 2020-12-14
- Last updated
- 2026-04-13
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04666155. Inclusion in this directory is not an endorsement.