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. We present a data base, demonstrating the range of data that can be elicited from the TAI device Navina™ Systems and the associated technology. We speculate that this data may in turn produce clinical opportunities to more clearly help with start-up schedules for individual patients, outlining further clinical trials and indicate differences in usage between different indication groups.

Navina Systems is a device for transanal irrigation (TAI) 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, irrigation speed and 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 (such as Neurogenic bowel dysfunction (NBD) score). The user can only rate the latest irrigation, but evaluate the bowel symptoms at any time. The data is uploaded and stored anonymously to a cloud based system where it is available only to Wellspect.

In March 2018 the Bowel portal contains over 18000 individual irrigations; around 30% of the irrigations are rated and several hundred evaluations of the bowel symptoms has been transferred. New data is continuously added. The data can be used to investigate the actual user behavior of TAI users and how this is affected over time and correlates to diagnosis, NBD score or irrigation frequency.

With the data continuously collected and with new users being added, there is an opportunity to investigate what people actually are doing when they irrigate. The amount of water being used, how long it takes, which balloon sizes that the patients choose and how often the user irrigates etc. This allows comparison between groups to identify the optimal ranges for irrigation parameters (balloon volume, irrigation volume, infusion rate, etc) according to indication. This may give insights in to the pathophysiology of bowel dysfunction. It is also possible to compare how patients rate their satisfaction with what they are doing in their irrigation and thus identify any clinically relevant relationships for optimal irrigation parameters for different disorders, ages and gender. Figure 1 a, b and c, depicts a snap-shot image of what can be accumulated with the data.

Big data sets identifying irrigation parameters may allow better “prescribing” of irrgation regimes according to indication to start TAI. They allow the opportunity to better understand pathophysiology of bowel dysfunction, and to monitor therapy in future clinical trials.