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 objective is to evaluate changes in bowel-function when using Peristeen Light. Participants will use Peristeen Light for 12 weeks test period.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…
What they're measuring
1
Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7).
Timeframe: From enrollment to the end of treatment at week 12.