Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial

Doreen McClurg, Lorna Booth, Immaculada Herrero-Fresneda, Doreen McClurg, Lorna Booth, Immaculada Herrero-Fresneda

Abstract

Introduction: Chronic constipation is associated with various comorbidities and reduced quality of life. Current solutions, either pharmacological or invasive, show limited efficacy. Manual colon-specific massage is a well-established intervention to treat chronic constipation, but it should be applied daily. MOWOOT automatically provides intermittent colonic exo-peristalsis (ICE) treatment like that in manual massage.

Methods: This study assessed the safety and effectiveness of the ICE device to treat chronic constipation due to neurogenic bowel dysfunction or idiopathic causes with high component of pelvic floor disorders. The ICE device was used daily for 20 minutes over 4 weeks. Each participant was followed for 9 consecutive weeks. The same outcome measures (primary: complete bowel movements per week; secondary: Knowles Eccersley Scott Symptom Score and Patient Assessment of Constipation Quality of Life among others) were assessed at baseline (V1), last intervention weeks (V2), and post-treatment (V3). Responders were defined for selected outcomes as better results at V2 respect to V1.

Results: N = 92 adult patients constituted the intention-to-treat population, with N = 65 as the per protocol population. Adherence (quantity of treatment received) was ≥95% in the intention-to-treat population. Adverse events related with the treatment were low (8.7%). Using the device significantly increased the number of complete bowel movements per week (V2 - V1 = 1.8 [2.7], P < 0.0001), reduced the symptoms of chronic constipation (Knowles Eccersley Scott Symptom Score V2 - V1 = -3.9 [5.0], P < 0.0001), improved quality of life (Patient Assessment of Constipation Quality of Life V2 - V1 = -0.7 [0.8], P < 0.0001), and facilitated a reduction in laxatives. Colon transit and fecal consistency were not modified. There was a high number of responders (>70%).

Discussion: Considering safety, adherence, and efficacy being demonstrated, the results favor the use of MOWOOT to treat chronic constipation (Visual abstract, Supplementary Digital Content 1, http://links.lww.com/CTG/A440).(Equation is included in full-text article.).

Trial registration: ClinicalTrials.gov NCT04262752.

Conflict of interest statement

Guarantor of the article: Immaculada Herrero-Fresneda, PhD.

Specific author contributions: D.M.: as lead principal investigator, designed and conducted the study; reviewed the statistical analysis plan, interpreted data, and wrote the manuscript. L.B.: as nurse investigator, conducted the study and collected the data. I.H.F.: as coordinator investigator, designed the study and the statistical analysis plan, interpreted the data, and wrote the manuscript.

Financial support: The MOW-01-2017 clinical trial was mainly funded through a Horizon 2020 SME-II instrument grant for Research and Innovation by the European Commission (ref. 756280) and partly funded by usMIMA S.L. IHF received a “Torres Quevedo” grant from the Science, Innovation and University Ministry of the Spanish Government (PTQ-15-07517).

Potential competing interests: I. Herrero-Fresneda is an employee (CSO) and shareholder of USMIMA S.L., the manufacturer of the ICE medical device.

Trial ID number: NCT04262752, ClinicalTrials.gov. This clinical trial was approved by the institutional ethics committees (North West—Greater Manchester South Research Ethics Committee, NHS Health Res. 17/NW/0593 November 7, 2017, Aut; and CEIM-Navarra, AEMPS). Written informed consent was obtained from all participants.

Figures

Figure 1.
Figure 1.
Intermittent colonic exo-peristalsis (ICE) device. The ICE device externally generates rhythmic, wave-like pressurizations on the abdomen following the colon's path, resembling the natural peristaltic contractions of a healthy colon. The actuators, positioned on the ascending and descending segments of the colon, inflate sequentially from 1 to 4 in clockwise direction. This cycle is continuously repeated for 20 minutes when the ICE device automatically stops the treatment.
Figure 2.
Figure 2.
Flow chart. All subjects who received a device were included in the “safety” population (SAF) for safety analysis. All subjects who received at least 1 ICE treatment were included in the “intention-to-treat” population (ITT). The patients who followed the protocol as described were included in the “per protocol” population (PP). All outcomes were analyzed for the ITT population. The primary outcome was also analyzed for the PP population. In addition, the ITT population was analyzed comparing people with neurogenic bowel dysfunction (NBD) vs people with idiopathic constipation from unknown origin (idiopathic no-NBD).

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