New device aims to ease bowel troubles

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)