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

Spinal cord injury (SCI) impairs motor, sensory, and autonomic functions, including gastrointestinal motility, leading to neurogenic bowel dysfunction and chronic constipation that adversely affects quality of life. Up to 80% of SCI individuals experience chronic constipation, with complications such as incontinence, fecal impaction, and hemorrhoids. Current management follows a stepwise approach (lifestyle measures, pharmacologic agents) but exercise can be challenging for SCI patients and medications show limited efficacy; invasive options (enemas, transanal irrigation, surgery) are often last resort. Manual colon-specific massage is effective but requires daily professional administration, limiting feasibility at home. MOWOOT, an automated intermittent colonic exoperistalsis (ICE) device, simulates colonic peristalsis and has demonstrated safety and efficacy for chronic constipation in a multicenter trial, yet data specifically in SCI individuals and in home-use settings are lacking. This study aimed to assess long-term effectiveness, tolerability, and satisfaction with home-based ICE therapy in SCI patients with chronic constipation.

The introduction references existing guidelines that advocate a sequential management of chronic constipation, beginning with lifestyle modifications (hydration, fiber, activity) and progressing to pharmacologic treatments (laxatives, suppositories), with invasive measures (enemas, transanal irrigation, surgical options) as later steps. It highlights limited efficacy and feasibility of standard measures for SCI populations. Prior evidence supports manual colon-specific massage as an effective non-invasive therapy but with poor home feasibility due to the need for daily professional administration. An earlier multicenter clinical trial demonstrated safety, adherence, and efficacy of the ICE device in chronic constipation of mixed etiologies, including reduced symptoms and evacuation aids and increased complete bowel movements. However, targeted data in SCI individuals and real-world home settings remained insufficient, motivating the present survey.

Design: Structured, anonymous patient feedback survey of real-world home use of the MOWOOT ICE device. Setting and recruitment: Four specialized SCI hospitals in Germany; recruitment from February 2019 to September 2020. Participants: Eleven SCI individuals with chronic constipation and slow intestinal transit, diagnosed during routine follow-up based on self-reported symptoms consistent with chronic constipation for at least the prior three months; no additional selection criteria. Intervention/use: Participants were provided the MOWOOT-II system (CE class IIa; pneumatic desktop unit plus exoperistaltic belt providing sequential inflation-deflation along the colon) and instructed to use it 10–20 minutes daily at home. They could adapt device settings (massage duration and level) and continue usual bowel regimens (laxatives, suppositories) and dietary habits, with general advice to maintain a moderately active lifestyle and adequate fiber and fluid intake. Data collection: A self-administered questionnaire captured demographics, device use (sessions/day, minutes/session, minutes/day, adherence), bowel function (frequency, time per evacuation, failed and incomplete attempts, stool consistency via Bristol scale), symptoms (difficulty/strain, abdominal pain, bloating, cramps, spasms, vertigo, rectal bleeding), concomitant use of laxatives and evacuation aids (suppositories, enemas/irrigation, digital stimulation/evacuation), and satisfaction with bowel function and management. Timing: Feedback 1 (F1) reflected the bowel situation before treatment; Feedback 2 (F2) was collected after at least 10 months of ICE use. Because questionnaires were sent simultaneously, the evaluated use period varied per participant. Additional F2 evaluations included tolerability, overall efficacy, ease of use, and general satisfaction with the device. Device description: MOWOOT-II delivers automated intermittent colonic exoperistalsis via a belt with four pneumatic elements that inflate/deflate sequentially over ascending to descending colon in a clockwise pattern. Statistical analysis: Quantitative variables compared by Student’s t-test; semi-quantitative variables by Wilcoxon matched-pairs test; categorical comparisons (e.g., symptom presence, use of aids, satisfaction categories) by Chi-squared or Fisher’s exact test.

- Participants: N = 11; 63.6% male; age distribution: 40–49 (n=3), 50–59 (n=1), 60–69 (n=2), ≥70 (n=5). Mean (SD) ICE use duration 13.27 (4.03) months (range 10–24). Mean sessions/day 1.29 (0.58); mean minutes/session 19.09 (4.37); mean minutes/day 24.54 (12.41); mean adherence 123% (SD 62%). - Bowel function: From F1 to F2, mean time per evacuation decreased by 24.5 minutes (p = 0.0076). Failed attempts to evacuate per week decreased by 1.05 (p = 0.0354). There were trends toward increased bowel movements/week and higher Bristol stool scores (softer stools), and fewer incomplete bowel movements. - Symptoms: Significant reductions reported in difficulty/strain (p = 0.0055), abdominal pain (p = 0.0230), bloating (p = 0.0010), abdominal cramps (p = 0.0019), and spasms (p = 0.0198). Vertigo and rectal bleeding showed no significant changes. - Concomitant treatments: No significant changes in use of laxatives, suppositories, enemas/irrigation, or digital stimulation/evacuation across the study period. - Satisfaction: Satisfaction with bowel function and management improved significantly (mean score improvement p = 0.0095), with a higher proportion of participants very satisfied/satisfied at F2 (p = 0.0300). - Device appraisal at F2: Most participants rated tolerability, efficacy, and ease of use as very good/good across both <12-month and ≥12-month user groups.

The survey’s findings support that long-term, home-based use of an ICE device (MOWOOT) in SCI individuals with chronic constipation improves bowel function efficiency (shorter evacuation time, fewer failed attempts) and alleviates multiple constipation-related symptoms without necessitating increased use of laxatives or evacuation aids. Improved satisfaction with bowel management suggests enhanced quality of life and acceptability. The results address the study objective by demonstrating effectiveness, good tolerability, and user-perceived ease of use in a real-world setting, underscoring the feasibility of autonomous, non-invasive bowel management for SCI patients.

Long-term in-home intermittent colonic exoperistalsis therapy improved bowel function and reduced chronic constipation symptoms in spinal cord-injured individuals, with high tolerability and user satisfaction, indicating meaningful clinical benefits for this population.