At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A clinical study evaluating Intermittent Colonic Exoperistalsis with MOWOOT device and Standard of care with Trans-Anal Irrigation for Constipation - Functional and 4 related conditions. Completed, enrolled 86 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Intermittent Colon Exoperistalsis (ICE) Treatment with Mowoot device. 20min daily for 12 weeks
Standard-of-care with Trans-anal Irrigation (Soc TAI) for chronic constipation for 12 weeks.
Interventions
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.
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.