International study of a continence device with 12-hour wear times.

This international, phase III, 215-day, open-label, non-randomized, multicentre study assessed the safety and efficacy of 12-hour wear times with a novel colostomy continence control device in participants with end colostomies. Study stages were usual pouching (21 days), wafer transition (14 days), device 'ramp-up' for 4, 6, and 8 hours (21 days), and 12-hour device wear (159 days). Of the 78 participants enrolled, 66 wore at least one device, and 45 completed treatment. Median device wear time was 11 hours per day during the final stage. Adverse events were reported by 12%, 7%, and 56% of participants during the usual pouching stage (0.01 events per participant per day), wafer transition stage, and device-wear stages (0.01 events per participant per day), respectively. No detrimental effects were seen on stoma vascularity or the normal gastrointestinal flora. The daily leakage-free rate was 0.89 for any leakage and 0.93 for type 2 leakage (e.g. not contained under the wafer). Most participants (87%) rated the ability of the device to restore continence as 'good' or 'very good'. Overall, the study showed that the continence control device was safe and effective for wear times up to 12 hours per day in colostomy patients.

Safety and efficacy of a novel continence device in colostomy patients.

PURPOSE: This study aimed to assess the safety and efficacy of a novel colostomy continence device. METHODS: This phase II, 142-day, open-label, nonrandomized, multicenter study enrolled patients who had end colostomies for ≥3 months. Study stages were usual pouching (21 days), wafer transition (14 days), and the device (107 days). During device wear, up to 8 hours per day, patients recorded the following outcomes in daily diaries: skin condition (if the wafer was changed); stoma color, moisture, and physical condition; and gastrointestinal symptoms. RESULTS: Of the 26 patients enrolled, 25 wore at least one device. The device was worn on 96% of study days and a mean of 6.8 hours per day. Adverse events were reported by 1 patient during the usual pouching 21-day period, by 5 patients during the wafer transition 14-day period, and by 15 patients during the device wear 107-day period. Stoma color and moisture were within normal range on all daily assessments. The device did not affect microbiology or vascularity. During device wear, patients had no unusual gastrointestinal symptoms or odor on >99% and 80% of days, respectively. The mean number of leaks per patient-month was 1.2 with usual pouching, 4.2 with the device overall, and 2.1 during the last 3 weeks with the device, suggesting a learning curve. Approximately 65% of patients preferred the device to usual pouching at the end of study. CONCLUSIONS: The novel continence device was safe and effective for up to 8 hours per day in colostomy patients.