Peristeen Light Explorative Clinical Investigation

The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and/or time-consuming bowel management procedures.

The primary endpoint is bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit and end of Clinical Investigation visit.

Participants will use Peristeen Light for 12 weeks test period.

Inclusion criteria

• Has given written informed consent
• Is at least 18 years old
• Has full legal capacity
• Is able (assessed by investigator) and willing to adhere to clinical investigational procedures during clinical investigation-al duration
• Has access to and is able to use a smartphone
• Has constipation and/or faecal incontinence based on one or more of the following symptoms during the last 3 month: Straining in more than 25% of defecations, lumpy stools (Bristol Stool Type 1 and 2) in more than 25% of defecations, sensation of incomplete evacuation in more than 25% of defecations, sensation of anorectal obstruction/blockage in more than 25% of defecations, need to use manual maneuvers to facilitate defecation in more than 25% of defecations, fewer than three spontaneous bowel movements per week, loose stools are rarely present without use of laxatives, recurrent uncontrolled passage of faecal material (other words to describe this could be: Soiling, leak-age, passive faecal incontinence of flatus, mucus and/or stool)
• Is assessed (by investigator) to have a need for low-volume TAI minimum every other day

Exclusion criteria

• Is participating in any other clinical investigation during this investigation
• Has previously completed this investigation
• Is former or current user of transanal irrigation (low- and high volume)
• Has known hypersensitivity towards the device used in the investigation
• Is pregnant
• Has known anal stenosis
• Has active/recurrent colorectal cancer
• Has had anastomotic colorectal surgery within the last 3 months
• Has ischaemic colitis
• Has active inflammatory bowel disease
• Has acute diverticulitis or diverticular abscess
• Has medicine induced constipation (e.g. due to opioids)
• Has chronic diarrhea
• Has bowel dysfunction due to neurogenic disorder(s)
• Is in need of high-volume TAI (as estimated by investigator)