Evaluation of a novel digital ostomy device on leakage incidents, quality of life, mental well-being, and patient self-care: an interventional, multicentre clinical trial

Abstract Background Most people with a stoma worry about leakage, and a quarter experience leakage of stomal effluent outside baseplate on a monthly basis. Leakage has additional physical and psychosocial consequences, for instance peristomal skin complications, feeling unable to cope and self-isolation. Method An interventional, single-arm, multi-centre, study was undertaken in United Kingdom, to evaluate a novel digital leakage notification system for ostomy care including a Support Service (=Test Product) for 12 weeks in patients with a recent stoma formation (≤9 months). Patients completed questionnaires at baseline and after 4, 6, 8, 10 and 12 weeks, evaluating leakage episodes, Ostomy Leak Impact (tool containing three domains) and patient self-management (by PAM-13). Additionally, mental well-being (by WHO-5) and quality of life (QoL) (by EQ-5D-5L) were assessed. Outcomes between baseline and final evaluation were compared by generalised linear- and linear mixed models. Results 92 patients (ITT population) were recruited with a mean age of 49.4-years (range 18-81 years). 80% had an ileostomy and 53% were female. After 12 weeks use of the Test Product, a significant decrease in mean episodes of leakage outside the baseplate (1.57 versus 0.93, P <0.046) was observed. Ostomy Leak Impact scores improved across all three domains ( P <0.001), indicating less embarrassment, increased engagement in social activities, and increased control. Patient self-management also improved significantly (PAM-13 score: Δ6.6, P <0.001), as did the WHO-5 well-being index (Δ8.0, P <0.001). Lastly, EQ-5D-5L-profile-scores tended to improve ( P =0.075). Conclusion A new digital leakage notification system demonstrated strong improvements to patients’ stoma self-care, mental well-being, and QoL. What does this paper add to the literature? Sensor technology embedded in supporting ostomy solutions can notify users about leakage seeping underneath the baseplate and thus secure a timely change of the baseplate before effluent may reach outside the baseplate soiling clothes or bedsheets. The technology showed potential in increasing quality of life for people with a stoma.