Impact of a Digital Leakage Notification System on Leakage, Quality of Life, Healthcare Resource Utilisation, and Work Productivity: Interim Results from a Longitudinal Real-World Study in the UK

<b>Background:</b> Leakage is a major concern for individuals living with a stoma and may negatively impact quality of life (QoL). A digital leakage notification system (DLNS) recently launched in the UK provides timely notifications to users via their smartphone when faeces is detected underneath the baseplate. This provides predictability and enables users to take proactive measures to help avoid leakages outside the baseplate. <b>Methods:</b> A single-arm, observational, longitudinal study of the DLNS, including its associated support service, has been initiated to follow 300 users for a year in the UK to evaluate long-term health benefits of the DLNS and its implications for healthcare resource utilisation in a real-world setting. The DLNS is prescribed by healthcare professionals (HCPs), and all users were invited to participate in the study. Study participants complete questionnaires capturing data on QoL (using the Ostomy Leak Impact tool), number of leakages outside the baseplate, utilisation of ostomy products, interactions with HCPs, and work productivity (using the Work Productivity and Activity Impairment questionnaire) at baseline and then every third month for one year. Data from the planned interim analysis of the first 100 participants who had been in the study for 6 months is presented. <b>Results:</b> Use of the DLNS for 6 months together with the associated support service was associated with a 51% reduction in leakage episodes outside the baseplate (<i>p</i> < 0.001) and great improvements in QoL (<i>p</i> < 0.001). Use of the DLNS reduced the number of unplanned baseplate changes due to worry about leakage by 47% (<i>p</i> < 0.001) and overall was associated with a reduction in the number of baseplates used by 14% (<i>p</i> = 0.002). Total time spent with HCPs related to stoma care was reduced by 65% after 6 months compared with baseline (<i>p</i> < 0.001). Work absenteeism and presenteeism improved significantly with the use of the DLNS. <b>Conclusions:</b> The interim results of this prospective, longitudinal study provided first insights into the long-term benefits of the DLNS in a real-world setting. <b>ClinicalTrials.gov ID:</b> NCT06554015.