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CompletedNCT07126327Updated Sep 23, 2026

Peristeen Light Explorative Clinical Investigation

An interventional study of Peristeen Light - trans anal irrigation system in Faecal Incontinence and Constipation - Functional, sponsored by Coloplast A/S. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Coloplast A/S · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Faecal Incontinence
  • Constipation - Functional

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Keywords

  • trans anal irrigation
03

In context

Encopresis

35 studies on the registry are indexed under Encopresis; 13 are open to participants now.

This study's enrollment of 60 is close to the median of 66 across 27 interventional studies indexed under Encopresis.

Browse Encopresis studies →

Lead sponsor

Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Exploratory single-arm interventional investigation

    Prescription of Peristeen Light transanal irrigation system at enrolment to use for a 12 week test period

    Device: Peristeen Light - trans anal irrigation system

Interventions

  • DevicePeristeen Light - trans anal irrigation system

    Subjects naive to TAI will use Peristeen Light trans anal irrigation

06

What researchers measure

Primary outcomes

  1. Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7).

    0 cm = worst possible bowel function and 10 cm = best possible bowel function.

    Time frame: From enrollment to the end of treatment at week 12.

07

Study locations

2 sites
  • Århus University Hospital
    Aarhus, Gotland 8200, Denmark
  • Montecatone Rehabillitation Institute S.p.A
    Bologna, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07126327
Lead sponsor
Coloplast A/S
Responsible party
Sponsor
First posted
Aug 17, 2025
Start date
Nov 10, 2025
Primary completion
Sep 2, 2026
Completion
Sep 2, 2026
Last update
Sep 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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