Bowel dysfunction significantly impairs quality of life (QoL)(1).Transanal irrigation (TAI) has emerged as a therapeutic option, with both low-volume and high-volume systems (2). The aim of the study was to investigate the efficacy and safety of low-volume TAI using a new device (Navina™ Mini) in adults with fecal incontinence and chronic constipation.

This uncontrolled, prospective, multicenter study enrolled 40 female and male subjects aged 18+ eligible for TAI as assessed by the investigator. The primary outcome was patient satisfaction evaluated using a 5-graded assessment scale, WHC Questionnaire (3). The secondary outcomes were clinical benefit and ease of handling the device. The clinical benefit with the device was investigated using validated fecal incontinence questionnaires (i.e., Wexner FI Score, Renzi Score). The subjects completed questionnaires at recruitment with follow-up at 2 and 4 weeks after study start. The protocol, Informed Consent, and study questionnaires were approved by the National Ethical Committee.

Ninety-two (92%) of the study subjects were females, of whom 73% were in post-menopause age. All subjects had a medical history of bowel dysfunction, including both neurogenic and non-neurogenic causes leading to anal incontinence, outlet obstruction problems, or chronic constipation. The median time of bowel management prior to the study was 8 years.
A statistically significant reduction in accidental leakage (p=0.0027) and percentage of patients reporting excessive straining (p=0.0356) and a feeling of incomplete rectal evacuation (p=0.0229) was observed.
Handling of the device was assessed as easy or very easy. The patients considered the product to be hygienic (100%), discreet (73%), and convenient and intuitive to use. 
No serious adverse events were observed. Six (6) subjects (15%) reported seven (7) events, of which three (3) were device deficiencies and four (4) adverse events (AE). None of the AEs were related to the treatment or the device.

A significant improvement was observed for fecal leakage demonstrating the clinical efficiency of the device and low-volume TAI as a treatment method. For patients reporting they usually or sometimes felt incompletely emptied, there was no significant improvement. A slight tendency improvement was noted in the reduction of digital rectal assistance/perineal digital pressure and the need for wearing pads. The study showed that the majority (82%) of the subjects were satisfied or very satisfied with the treatment and handling of the device, with a relatively low proportion of unsatisfied (3%) or neither satisfied nor dissatisfied (15%).
The device was perceived as hygienic and easy to use, attributed to its ergonomic design and additional features such as an extension tube making it easier to use by patients of different ages and health states, without any assistance.  
The safety and efficacy of low-volume TAI were demonstrated by the absence of any adverse events due to therapy or device. Limitations of the study were the number of subjects and the relatively short observation period, which could explain the varying degrees of improvement of fecal leakage and perception of incomplete emptying.

Low-volume TAI is a safe and efficacious method for the treatment of fecal incontinence and chronic constipation of any etiology.

Byrne, C.M., A. Sharma, and K. Telford, Life & Times trans-anal irrigation should be offered to patients with severe bowel dysfunction. British Journal of General Practice, 2019. 69(680): p. 13
Emmanuel AV, Krogh K, Bazzocchi G, Leroi AM, Bremers A, Leder D, van Kuppevelt D, Mosiello G, Vogel M, Perrouin-Verbe B, Coggrave M, Christensen P; Members of working group on Trans Anal Irrigation from UK, Denmark, Italy, Germany, France and Netherlands. Consensus review of best practice of transanal irrigation in adults. Spinal Cord. 2013 Oct;51(10):732-8. doi: 10.1038/sc.2013.86. Epub 2013 Aug 20. PMID: 23958927.
Patient satisfaction questionnaire developed by Wellspect Healthcare.