The multicenter clinical trial with 92 patients that confirms the safety and effectiveness of the medical device MOWOOT to treat patients with constipation of different origin has been recently published in the prestigious journal ‘Clinical and Translational Gastroenterology’ ‘ with the title “Safety and Efficacy of Intermittent Colonic Exoperistalsis device to treat Chronic Constipation”.
The 2-year clinical trial was led by Dr. Doreen McClurg from the Glasgow Caledonian University, a specialist in the field of neurogenic bowel dysfunction, in combination with 2 other European centers and with support of Dr. Immaculada Herrero-Fresneda, the Chief Scientific Officer of MOWOOT.
The aim of this clinical trial was to assess the safety and efficacy of the medical device MOWOOT, the first Intermittent Colonic Exoperistalsis (I.C.E.) on the market, to treat chronic constipation in patients with neurogenic bowel dysfunction (NBD), opioid-induced constipation (OIC) or idiopathic causes (CIC or FC), including patients with 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 the subgroups analyzed.
- Constipation symptoms improved in the overall population and in the subgroups analyzed
- The use of laxatives and/or suppositories was reduced.
- Both the Quality of life and patients’ Satisfaction with their bowel function were increased in the overall population and in a similar extent in the subgroups analyzed .
- The percentage of positive Responders was from >70% to 90%.
- Adherence to treatment was ≥95%.
- There were no serious adverse events.
Thus, considering safety, adherence, and efficacy being demonstrated, the results favor the use of MOWOOT to treat chronic constipation.
We are very proud to have shown that Intermittent Colonic Exoperistalsis has very good clinical results in patients with different root causes of chronic constipation” says Dr. Immaculada Herrero-Fresneda, “the feedback of the patients regarding the use and results of the MOWOOT device was very good and is reflected in the high adherence to treatment and positive responder rate. We are very pleased with the results of the clinical trial, which are in line with further studies that we are conducting in other European centres.
“The publication of our clinical trial in an international peer-reviewed scientific journal of such recognition is an important milestone for our company and will play a major role in our mission to make our solution available to as many patients as possible.” Dr. Markus Wilhelms, Chief Executive officer of MOWOOT“
In addition to the publication of this clinical trial, the company has been entering EU international markets recently and is currently preparing public healthcare reimbursement in Germany and the UK.
The complete clinical trial can be download at:
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
This clinical study has been funded by the European Union H2020, dedicated to promoting innovation and research in those companies with high growth potential and great social impact.