MICA: Stomasense: A New Route to the Proactive Detection and Management of Leaks within Ostomy Pouches

The creation of a stoma is an invasive surgical procedure that requires significant physical and psychological adaptation particularly as bowel/bladder content is collected in a disposable pouch that adheres to the abdomen. Leakage, especially in public, is a constant worry resulting in decreased social interactions, increased anxiety and depression and can have a tremendous impact on family and work life. The extent of the problem was confirmed by the Ostomy Life Study (2015) which surveyed some 4000 ostomates from 11 different countries and found the majority (91%) of participants reported that leakage of the pouch was a concern with 69% confirming that it was their prime worry and greatly impacted on their quality of life.

The project seeks to develop and refine a smart device which can work alongside existing stoma pouch systems, providing an early warning alert to impending leaks that could enable the replacement of the appliance before failure of the adhesive flange. This could significantly improve ostomy management, improve patient confidence and minimise the distress that can accompany leak events. The research team have developed a prototype sensor which can be used with any pouch system and which will provide a discrete alert vibration the patient. The team aim to expand the capabilities of the device to incorporate wireless communications such that an alert can be sent directly to a carer or a nursing station. The team have demonstrated proof of principle for the basic operation of the system in a pilot study and seek to optimise it for everyday use by ostomates.

Every stoma patient will experience a leak from their disposable pouch and it can be almost impossible to predict when such events will occur. The possibility of leakage has long been recognised as a prime contributor to patient anxiety and, especially when occurring in public, can cause immense distress. The applicants have developed a sensing system that can detect the early onset of stoma pouch failure - providing an alert that allows the patient to replace the pouch before catastrophic seepage of bowel/bladder content. The applicants have demonstrated the proof of principle of the system and seek funding to refine the device - improving user accessibility/acceptability and demonstrate its capacity to significantly improve the confidence of the wearer to re-engage with everyday activities without fear of uncontrolled leakage. The applicants also seek to expand the capabilities of the device from a personal vibration alert to one which could exploit wireless connectivity for institutional use (care home/hospital) or by family members / community carers tending the immobile. A key strength is that the device has the potential to work as an accessory to existing pouch systems through the use of an innovative microwire/microneedle probe system. The pouch system is applied as normal without any change to the normal/established stoma practice and the microprobes applied thereafter to the adhesive seal. The disposable probes do not contact the skin but rather monitor the condition of the adhesive. Swelling of the latter is detected and, upon reaching a threshold, a discrete warning is sent to the wearer (or carer). The availability of the sensor could transform the confidence of those recovering from stoma surgery who will lack expertise in stoma management and inevitably suffer from more frequent leakage. It will also be invaluable for those seeking to re-engage with their social networks and those attempting to return to public facing occupations.