NCT07473622

Brief Summary

This clinical investigation is a post-market, exploratory, randomised, parallel, open-label investigation comparing two UKCA/CE-marked transanal irrigation products for the management of faecal incontinence and/or chronic constipation of heterogenous origin. The aim of this investigation is to assess outcomes in a real-world clinical setting, by following the typical clinical routine, with randomisation and more frequent visits/phone calls as the only difference from typical clinical procedure. During 4-week training period, participants will trained by nurse specialists on how to use the device to which they were randomised to and will be instructed to irrigate once per day. For the remainder of the investigation, participants will be advised to continue irrigation once daily (or a minimum of 3 times a week). Participants will be followed up via phone call or in-person visit up to 52 weeks.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 5, 2026

Last Update Submit

March 10, 2026

Conditions

Faecal IncontinenceChronic Constipation

Outcome Measures

Primary Outcomes (1)

  • Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale

    Participant experience with device (0: strongly disagree, 4: strongly agree)

    Week 4, 10, 26, and 52

Secondary Outcomes (5)

  • Patient Diary

    Week 10, 26, and 52

  • Patient Diary

    Week 10, 26, and 52

  • Cleveland Clinic Constipation Score (CCCS)

    Week 0, 4, 10, 26, and 52

  • St Mark's Incontinence Score (SMIS

    Week 0, 4, 10, 26, and 52

  • The 5-level EQ-5D (EQ-5D-5L) index score

    Week 0, 4, 10, 26, and 52

Study Arms (2)

Qufora QNova

EXPERIMENTAL
Device: Transanal irrigation

Qufora Irrisedo Klick

ACTIVE COMPARATOR
Device: Transanal irrigation

Interventions

Transanal irrigationDEVICE

Transanal irrigation by use of irrigation devices

Qufora Irrisedo KlickQufora QNova

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Faecal incontinence (FI), chronic constipation (CC) or co-existing FI/CC, all of heterogenous origin
  • Positive Rome IV criteria for functional constipation and/or positive Rome IV criteria for faecal incontinence
  • years or older
  • Ability to understand written and spoken English (due to questionnaire validity)
  • Ability to understand and provide written, informed consent prior to any investigation-specific procedures

You may not qualify if:

  • Prior use of transanal irrigation
  • Neurogenic bowel dysfunction
  • Low anterior resection syndrome (this group will be excluded due to the possibility of being randomised to a balloon catheter).
  • Previous rectal and/or anal surgery (except minor rectal or anal surgery such as haemorrhoid procedures, anal fissure surgery, drainage of a perianal/rectal abscess, or other rectal or anal surgeries deemed minor by the investigator)
  • Physical disability that affects the ability to independently use the irrigation device
  • Intermittent use of opioids inducing chronic constipation
  • Patulous anus
  • Participation in research conflicting with the current investigation
  • Physical or mental conditions affecting the ability to comply with the clinical investigation plan
  • Pregnancy or plans to become pregnant during the investigation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Central Study Contacts

Haya N.H. Pedersen

CONTACT

+45 31394941hap@qufora.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Post-market, exploratory, randomised, parallel, open-label
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 16, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03