Latest Mowoot’s clinical trial “Automated colon-specific massage with MOWOOT medical device to treat chronic constipation in adults” published at the prestigious Clinical and Translational Gastroenterology journal as original manuscript “Safety and Efficacy of Intermittent Colonic Exoperistalsis device to treat Chronic Constipation” has confirmed the safety and effectiveness of our medical device MOWOOT to treat chronic constipation.
The 2-year multicenter clinical study conducted by our CSO Dra. Immaculada Herrero-Fresneda, in collaboration with Dr. McClurg and L. Booth from the Glasgow Caledonian University has demonstrated the effectiveness and safety of the automatic colon-specific massage with MOWOOT medical device to treat chronic constipation. Ref. McClurg, D; Booth, L; Herrero-Fresneda, I. Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial. Clin Trans Gastroenterology 2020; 11(12):e00267
The aim of this clinical trial was to assess the safety and efficacy of the ICE device Mowoot to treat chronic constipation due to neurogenic bowel dysfunction (NBD) or idiopathic causes with high component of pelvic floor disorders. The ICE device was used daily for 20 min over 4 weeks. Each participant was followed for 9 consecutive weeks. The same outcome measures (primary: complete bowel movements per week; secondary: KESS score for constipation symptoms, and PAC-QoL for quality of life, among others) were assessed at baseline, intervention, and post-treatment.
Participants of the study, male and female subjects of 18 years old or older, were confirmed with a chronic constipation diagnosis according to the criteria established in Roma III.
The results of the MOWOOT performance after 4 weeks of use by the subjects with chronic constipation can be summarized as follows:
- The number of complete bowel movements increased in the overall population and in a similar extent in NBD and idiopathic subgroups analyzed.
- Constipation symptoms improved in the overall population
- The use of laxatives and/or suppositories was reduced.
- The use of enemas and/or digitations does not change significantly.
- Quality of life and Subjects’ satisfaction with their bowel function were increased in the overall population
- The percentage of Responders (those with better results after intervention respect to baseline) was from >70% to 81%
- Adherence to treatment (quantity of treatment received) was ≥95%
- There were no serious adverse events and only 1% of moderate to mild adverse events possibly related with the Mowoot device
Thus, considering safety, adherence, and efficacy being demonstrated, the results favor the use of MOWOOT to treat chronic constipation.