Exploring the Benefits of Peristeen Light for Adults with Faecal Incontinence or Chronic Constipation Using a Transanal Irrigation System

What this Trial Is About

This research aims to understand the clinical benefits of using the Peristeen Light transanal irrigation system in adults who have faecal incontinence, chronic constipation, or require time-consuming bowel management. The study focuses on evaluating changes in bowel function over a 12-week period using this device. It is an exploratory clinical investigation designed to assess bowel function improvements in these patients. Participants will receive a prescription for the Peristeen Light transanal irrigation system at enrollment and will use it for a 12-week test period. This device is intended to help manage bowel function through low-volume transanal irrigation. The study involves a single treatment group where all participants use the device during the study period. During the study, participants will have their bowel function measured using a 10 cm Visual Analog Scale VAS at the beginning Baseline Visit and at the end of the 12-week treatment period End of Clinical Investigation Visit. Researchers will monitor adherence and collect data on bowel symptoms, with assessments supported by smartphone use. The total participation duration for each participant is approximately 12 weeks.

Peristeen Light Explorative Clinical Investigation