Hypothesis / aims of study
Trans anal irrigation (TAI) is a well-established bowel management therapy for patients with neurogenic bowel dysfunction (NBD). Recent studies have also shown good results in patients with functional constipation and fecal incontinence. Navina™ Systems is a relatively new medical device for TAI therapy, available in the EU since 2016. In the UK, Navina is supplied via a medical device home delivery system from the manufacturer (Wellspect, Sweden). The aim of this study was to retrospectively investigate which indications that are prescribed Navina in the UK, the adherence of patients of Navina in the Wellspect (Select) home delivery system and reasons for discontinuing therapy.
Study design, materials and methods
The Wellspect home delivery system has a standardised approach for customer follow-up via phone once a medical device arrives to the home. All users are registered on the service by their HCP. If the patient has decided to stop the therapy s/he is asked about the reason. Also, last delivery date is tracked in the system.
Results
The distribution of patients being prescribed Navina were 51% functional bowel (constipation and/or fecal incontinence), 23% multiple sclerosis (MS), 14% spinal cord injured (SCI), 7% cauda equina, spina bifida, diabetes, Parkinson’s disease, stroke and cancer, and 5% of the patients have unknown indications. An overwhelming majority were prescribed Navina Smart (86%) compared with Navina Classic.
After a median time of 7,8 months (range 0-19 months), 86% of the patients are still using Navina, and there are no differences in adherence between different indications (Graph 1).
In those cases where reason for stop using the therapy were given the main reason was changing bowel management (37%), did not start (25%), advised by healthcare professional (15%), change to another product (8%), and other (15%).
Interpretation of results
The majority of studies on the effect of TAI is done in a cohort of patients with NBD. It is therefore interesting to note that the main indication for prescribing Navina is functional bowel (functional constipation and functional fecal incontinence). To our knowledge there are no indications in the literature of how TAI-device prescription is divided between indications. The results from this study may be a good indication that prescribers consider Navina suitable for patients with several kinds of bowel dysfunction and not only NBD.
At a median follow-up time of 7,8 months we show an adherence of 86%. This is somewhat higher than what have been shown before; expected adherence at 8 months for patients with NBD is around 75% (1). Also we see no difference in adherence between the indications groups which does not agree with previous publications that show a significant difference in adherence between the different indication groups (2). Possible reasons behind this finding include 1) shorter follow-up time in our material, introduction of a different TAI device which is electronically operated (Navina Smart), or 3) that the patients are monitored through the Wellspect home-delivery system. Further studies are ongoing to elucidate the reason for the higher adherence at 8 months with Navina Systems.