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

Doreen McClurg, Lorna Booth, Immaculada Herrero-Fresneda

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Abstract

INTRODUCTION: Chronic constipation is associated with various comorbidities and reduced quality of life. Current solutions,eitherpharmacologicalorinvasive,showlimitedefficacy.Manualcolon-specificmassage 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 5 92 adult patients constituted the intention-to-treat population, with N 5 65 as the per protocol population.Adherence(quantityoftreatmentreceived)was‡95%intheintention-to-treatpopulation. Adverse events related with the treatment were low(8.7%).Using the device significantly increased the number of complete bowel movements per week (V2 2 V1 5 1.8 [2.7], P< 0.0001), reduced the symptoms of chronic constipation (Knowles Eccersley Scott Symptom Score V2 2 V1 523.9 [5.0], P< 0.0001), improved quality of life (Patient Assessment of Constipation Quality of Life V2 2 V1 5 20.7 [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: Consideringsafety,adherence,andefficacybeingdemonstrated,theresultsfavortheuseofMOWOOTtotreat chronic constipation
Original languageEnglish
Article numbere00267
JournalClinical and Translational Gastroenterology
Volume11
Issue number12
Early online date16 Nov 2020
DOIs
Publication statusE-pub ahead of print - 16 Nov 2020

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