Peristeen Light for bowel control and management
An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light
This test will see if using the Peristeen Light trans-anal irrigation device for 12 weeks helps adults with fecal incontinence or chronic constipation improve their bowel function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Coloplast A/S Industry-sponsored |
| Locations | 2 sites (Aarhus, Gotland and 1 other locations) |
| Trial ID | NCT07126327 on ClinicalTrials.gov |
What this trial studies
Adults with fecal incontinence or functional constipation will use the Peristeen Light trans-anal irrigation system during a 12-week test period. The main outcome is a patient-reported change in bowel function measured on a 10 cm visual analog scale at baseline and at the end of the period. Participants must be able to use a smartphone and give informed consent, and investigators will record adherence and any adverse events. The investigation aims to determine whether this device can simplify or speed up bowel management compared with each participant's prior routine.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic functional constipation and/or fecal incontinence who experience time-consuming bowel management, can use a smartphone, and can give informed consent are the intended candidates.
Not a fit: Patients whose bowel problems stem from other causes or who cannot use the device or a smartphone may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, Peristeen Light could reduce incontinence episodes and shorten time spent on bowel care, improving patients' daily functioning and quality of life.
How similar studies have performed: Previous studies of trans-anal irrigation systems, including earlier Peristeen devices, have shown benefits for certain patients with neurogenic bowel, refractory constipation, and fecal incontinence.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Aarhus, Gotland and 1 other locations
- Århus University Hospital — Aarhus, Gotland, Denmark (Recruiting)
- Montecatone Rehabillitation Institute S.p.A — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Michel Briand de Crevecoeur
- Email: dkmibc@coloplast.com
- Phone: +4549111272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.