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

McClurg, Doreen; Booth, Lorna; Herrero‐Fresneda, Immaculada

doi:10.14309/ctg.0000000000000267

Cited by 8 publications

(7 citation statements)

References 56 publications

(20 reference statements)

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“…Enterosgel, an intestinal adsorbent approved for use in IBS-D and available over-the-counter in the UK is currently the subject of a multicentre RCT in IBS-D. 295 For IBS-C, there are ongoing trials of an exo-peristalsis device. 296 Future research priorities are outlined below.…”

Section: Other Treatments In Developmentmentioning

confidence: 99%

British Society of Gastroenterology guidelines on the management of irritable bowel syndrome

Vasant

Paine

Black

et al. 2021

Gut

266

334

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Irritable bowel syndrome (IBS) remains one of the most common gastrointestinal disorders seen by clinicians in both primary and secondary care. Since publication of the last British Society of Gastroenterology (BSG) guideline in 2007, substantial advances have been made in understanding its complex pathophysiology, resulting in its re-classification as a disorder of gut-brain interaction, rather than a functional gastrointestinal disorder. Moreover, there has been a considerable amount of new evidence published concerning the diagnosis, investigation and management of IBS. The primary aim of this guideline, commissioned by the BSG, is to review and summarise the current evidence to inform and guide clinical practice, by providing a practical framework for evidence-based management of patients. One of the strengths of this guideline is that the recommendations for treatment are based on evidence derived from a comprehensive search of the medical literature, which was used to inform an update of a series of trial-based and network meta-analyses assessing the efficacy of dietary, pharmacological and psychological therapies in treating IBS. Specific recommendations have been made according to the Grading of Recommendations Assessment, Development and Evaluation system, summarising both the strength of the recommendations and the overall quality of evidence. Finally, this guideline identifies novel treatments that are in development, as well as highlighting areas of unmet need for future research.

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Section: Other Treatments In Developmentmentioning

confidence: 99%

British Society of Gastroenterology guidelines on the management of irritable bowel syndrome

Vasant

Paine

Black

et al. 2021

Gut

266

334

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“…A recent clinical trial has reported the benefits of ICE treatment in patients with chronic constipation [ 13 ]. This trial showed reduced symptoms of discomfort and reduced use of evacuation aids, demonstrating the efficacy of a four-week intervention.…”

Section: Discussionmentioning

confidence: 99%

“…MOWOOT is an automated intermittent colonic exoperistalsis (ICE) treatment device simulating the natural peristaltic contractions of the colon. In a multicentric clinical trial, the ICE device has shown safety and efficacy in patients with chronic constipation due to several causes, reducing constipation symptoms and evacuation aids, with a concomitant increase in the number of complete bowel movements and excellent adherence [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

Intermittent colonic exoperistalsis for chronic constipation in spinal cord-injured individuals. A long-term structured patient feedback survey to evaluate home care use

Bremer,

König

et al. 2023

Spinal Cord Ser Cases

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Study design Structured patient feedback survey evaluating real-world home care use. Objectives To assess the long-term effectiveness, tolerability, and satisfaction with the intermittent colonic exoperistalsis (ICE) treatment device MOWOOT in spinal cord-injured (SCI) individuals with chronic constipation. Setting Four specialized German hospitals. Methods SCI individuals with chronic constipation were invited to use MOWOOT 10–20 min daily and answer a questionnaire about their bowel situation before treatment (feedback 1, F1) and after ≥10 months of use (feedback 2, F2). Collected variables were device use, bowel function effectiveness, chronic constipation symptoms, concomitant use of laxatives and evacuation aids, and satisfaction with bowel function and management, which were compared between time points. At F2, participants reported efficacy, tolerability/side effects, and ease of use. Results Eleven participants used the device for a mean (SD) of 13.27 (4.03) months. From F1 to F2, mean time per evacuation decreased by 24.5 min (p = 0.0076) and the number of failed attempts to evacuate/week, by 1.05 (p = 0.0354) with a tendency toward increased bowel movements and softer stool consistency, and decreased incomplete bowel movements. Participants experienced decreased difficulty/strain (p = 0.0055), abdominal pain (p = 0.0230), bloating (p = 0.0010), abdominal cramps (p = 0.0019), and spasms (p = 0.0198), without significant changes in the use of laxatives and evacuation aids. Satisfaction with bowel function and management improved (p = 0.0095) and more participants reported being very satisfied/satisfied (p = 0.0300). Most reported tolerability, efficacy, and ease of use as very good/good. Conclusion Long-term in-home ICE treatment improved bowel function and chronic constipation symptoms in SCI individuals, providing clinical benefits to this population. Sponsorship (MOWOOT devices lending) 4 M Medical GmbH, Norderstedt, Germany.

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“…This stimulation crosses two medium-frequency, out-of-phase currents from anterior and posterior abdominal locations to cross-sect to create a new modulated, low-frequency, intra-abdominal current, not generated by traditional TENS. Intermittent colonic exoperistalsis (ICE), a pneumatic abdominal massaging belt with four actuators providing rotating pressure, demonstrated improvement in CSBMs, reduced constipation symptoms, and decreased laxative use after 20-min daily sessions over 4 weeks in an open-label study of patients with neurogenic bowel and constipation [35].…”

Section: Nonpharmacological Treatmentsmentioning

confidence: 99%

Step on the accelerator: modern treatment of constipation

Staursky,

Shimoga,

Sharma

2023

Current Opinion in Gastroenterology

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Purpose of review This review aims to explore effective management of constipation, examine challenges in making a positive diagnosis, and highlights the significance of a positive patient-provider relationship and emerging treatments. Recent findings Less than one-fifth of patients feel satisfied with treatment of their constipation. Sixty percent of patients with functional dyspepsia and gastroparesis have severe to very severe constipation that correlates with their upper gastrointestinal symptom severity. Two gold kiwifruits are noninferior to 10 g of psyllium in the treatment of constipation. More than 40% of patients undergoing lumbar fusion continue to fill opioid prescriptions 90 days after surgery, contributing to 80 000 chronic opioid users annually. Most patients are using over-the-counter (OTC) treatments for constipation with greater than 60% dissatisfied. Pharmacologic management involves the use of GCC agonists and emerging drug classes such as bile acid transport inhibitors and sodium hydrogen exchanger isoform 3 (NHE3) inhibitors. Nonpharmacologic treatments, including neuromodulation and FDA-approved vibrating capsule, show promise in improving symptoms and quality of life. Summary Constipation significantly impacts patients’ quality of life and well being and the majority of patients are refractory to conservative measures and OTC treatments. Both pharmacologic and nonpharmacologic treatments hold promise for improving constipation and quality of life.

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

Cited by 8 publications

References 56 publications

British Society of Gastroenterology guidelines on the management of irritable bowel syndrome

British Society of Gastroenterology guidelines on the management of irritable bowel syndrome

Intermittent colonic exoperistalsis for chronic constipation in spinal cord-injured individuals. A long-term structured patient feedback survey to evaluate home care use

Step on the accelerator: modern treatment of constipation

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