Author informationGI_FI

1 Cedar, Cardiff and Vale University Health Board, Cardiff, UK. Megan.Dale@wales.nhs.uk.

2 Cedar, Cardiff University, Cardiff, UK.

3 National Institute for Health and Care Excellence, Manchester, UK.

4 Cedar, Cardiff and Vale University Health Board, Cardiff, UK.

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