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.