A pilot study of a digital ostomy leakage notification system: impact on worry and quality of life

Abstract

More than 90% of people with an ostomy worry about leakage, with associated high rates of psychological morbidity. To assess the performance of a novel digital ostomy leakage notification system in subjects with faecal stomas who experience and worry about leakage. A prospective, single-arm, pilot study (ClinicalTrials.gov: NCT04894084) with 25 subjects testing the product for 21 days. Subjects completed questionnaires at baseline and termination of study evaluating leakage episodes, leakage worry and quality of life (QoL). Mean age was 56 years, 60% had an ileostomy, and 40% were females. Mean episodes of leakage outside the baseplate decreased significantly from 2.8 to 0.5 episodes after 21 days' use of the test product (P<0.001), worry about leakage decreased significantly (P<0.001) and QoL improved. The findings indicate strong improvements to emotional health with the test product, driven by reductions in leakage incidents outside baseplate and in users' worry about leakage.