Peristeen Transanal Irrigation System to Manage Bowel Dysfunction: A NICE Medical Technology Guidance

Abstract

The Peristeen transanal irrigation system is intended to allow people with bowel dysfunction to flush out the lower part of the bowel as part of their bowel management strategy. Peristeen was the subject of an evaluation by the National Institute for Health and Care Excellence, through its Medical Technologies Evaluation Programme, for the management of bowel dysfunction. The company, Coloplast, submitted a case for adoption of the technology, claiming that the technology improves the severity of chronic constipation or faecal incontinence and improves quality of life for people with bowel dysfunction. Other claimed benefits included reduced frequency of UTIs, stoma surgery and hospitalisation rates, as well as reduced costs. The submission was critiqued by Cedar. The clinical evidence assessed included one randomised controlled trial, and 12 observational studies for adults and 11 studies for children. Although there are limitations in the evidence, the assessed studies show some improvement in outcomes for patients who choose to continue using Peristeen. The committee heard from patient experts that Peristeen had improved their lives and allowed them increased independence. The submitted economic evidence had numerous flaws, however following Cedar’s changes to the model, and additional sensitivity analysis, the use of Peristeen was judged unlikely to be cost incurring compared with standard bowel care. The Peristeen transanal irrigation system received a positive recommendation in Medical Technologies Guidance 36.

Transanal Irrigation for Neurogenic Bowel Disease, Low Anterior Resection Syndrome, Faecal Incontinence and Chronic Constipation: A Systematic Review

“…Transanal irrigation (TAI) has received increasing attention as a treatment option in patients with bowel dysfunction as it has shown to improve faecal incontinence (FI) and chronic constipation (CC) [ 1 , 2 ]. With TAI, water is introduced into the bowel through the anus, facilitating emptying of the rectosigmoid and the left colon [ 3 ].…”

Use of a new transanal irrigation device for bowel disorder management by patients familiar with the irrigation technique: a prospective, interventional, multicenter pilot study

“…Perspectives for further research include confirmation of these results in a larger population, such as a European-wide study of efficacy and safety in different healthcare systems. Furthermore, the device's cost-effectiveness remains to be assessed, although this is also the case for established devices such as the Peristeen® [8].…”

“…However, the rectum and distal portion of the sigmoid colon can be emptied by introducing water into the anus (typically through a balloon catheter or a cone catheter). This transanal irrigation (TAI) procedure can enable a patient to schedule the regular evacuation of stools, and thus enhance his/her activities of daily living [5][6][7][8]. For example, it has been reported that TAI over a 6-month period led to a significant improvement in quality of life for patients with low anterior resection syndrome [9].…”

“…Various medical devices for TAI (based on gravitydriven instillation, hand pumps or electric pumps) are on the market [6]. A well-known device (the only one currently reimbursed by the French national health insurance system) is the Peristeen® Anal Irrigation System (Coloplast A/S, Humlebaek, Denmark) [8,18]. The aim of the present pilot study of patients familiar with TAI was to establish whether this procedure was feasible with a new, recently CE-marked pump system-the IryPump®R Set (B.Braun Melsungen AG Melsungen, Germany).…”

Advanced Management Protocol of Transanal Irrigation in Order to Improve the Outcome of Pediatric Patients with Fecal Incontinence

“…Among them, transanal irrigation (TAI) can be proposed as a different conservative treatment also in children with bowel dysfunction unresponsive to more conventional therapies such as enema or laxatives. TAI involves a large volume water irrigation of the rectum and the left colon, passing a catheter with a balloon as an anchor through the anus [ 5 , 6 ].…”