Hypothesis / aims of study
Transanal irrigation (TAI) is an established therapy for patients with both neurogenic and idiopathic bowel dysfunction. Adherence to the therapy is a challenge and varies between conditions from 45-75% at 3 years, with most groups having significant drop off in the early stages of training. The reasons for this loss of adherence or failure to respond are not known, but are thought to be likely to relate to multiple factors such as, lack of training, inability to handle the device, patient factors connected to the disease. Personalised data correlated with objective aspects of irrigation may help address this. The Navina™ Smart app collects anonymous data from both user and Smart device. Here we present a sample of the data presented in a web portal connected to the Navina Smart data.
Study design, materials and methods
Navina Systems is a device for transanal irrigation containing Navina Smart, with an electronic pump and the Navina Smart app, an application for smartphones. After the irrigation with Navina Smart, data such as irrigation volume, speed, balloon size can be transferred to the Navina Smart app. In the Navina Smart app the user enters demographics such as year of birth, diagnosis, gender and also rate each irrigation and answer questions about the irrigation and current bowel function (not mandatory). The user can only rate the latest irrigation. The data is managed through Microsoft SQL Server (database), Microsoft Power BI Embedded and R (statistical package). Access is given by request.
Results
In March 2018 the Bowel portal contains over 18000 individual irrigations, there is about a 30% response rate to follow-up questions and rating of irrigations, there are continuously new data being added. The data can be sorted by, amongst other categories, diagnosis, age and country. To date the most common diagnosis is spinal cord injury, with most irrigations reported from the United Kingdom and demographically in men in the age group 18-50. The majority irrigate every day with an irrigation volume <750 ml. Over ¾ irrigate only once at each irrigation and 70% of the patients were satisfied or very satisfied with their bowel management with Navina Smart. Over 95% felt that Navina-based TAI was better than previous bowel management and >95 % would recommend TAI. There is a significant increase of satisfaction with TAI over time (graph 1). Only 16% of the app users reported issues during irrigation, most frequently leakage of water. 9% reported issues between irrigations, mainly abdominal bloating and pain.
Interpretation of results
Users of the Navina Smart app are generally satisfied with their irrigations using the associated device, correlating well with what previously has been seen (1). As has been shown before, there is a learning curve associated with TAI therapy. Unlike other descriptions of reduced adherence with time, we have identified greater satisfaction with time. The images on the bowel portal may be fed back to the patient to encourage the patients to persist even though it may be perceived as difficult in the beginning.
The Navina app data displayed on the Bowel portal gives a first view of the average user of the Navina Smart, what kind of settings and with which irrigation frequency is actually being used. This has not previously been shown to our knowledge. This may be used to give an indication of how irrigation is performed in a real-life setting in the community, especially in the early stages whilst initially adjusting to Navina TAI therapy. In clinical practice it may be used as feedback to the individual patient, and used by the HCP to help modify therapy by correlating patient-reported subjective outcomes to objective identification of the TAI parameters used.