Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence (ORBIT-1)

Outcome Research in Bowel Irrigation Techniques: A Novel Self-retaining Catheter Compared With a Conventional Balloon Catheter for the Treatment of Chronic Constipation and/or Faecal Incontinence, a Real-world Randomised Explorative Investigation.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Constipation; Faecal Incontinence
• Intervention / Treatment: Device: Transanal irrigation

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haya N.H. Pedersen; Phone Number: +45 31394941; Email: hap@qufora.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 18 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Qufora QNova	Device: Transanal irrigation; Transanal irrigation by use of irrigation devices
Active Comparator: Qufora Irrisedo Klick	Device: Transanal irrigation; Transanal irrigation by use of irrigation devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Diary	Bowel irrigation frequency (times per week)	Week 10, 26, and 52
Patient Diary	Bowel irrigation volume (in ml)	Week 10, 26, and 52
Cleveland Clinic Constipation Score (CCCS)	Constipation severity (Higher scores indicate worse constipation symptoms; score range: 0-30)	Week 0, 4, 10, 26, and 52
St Mark's Incontinence Score (SMIS	Fecal incontinence severity (Higher scores indicate worse incontinence symptoms; score range: 0-24)	Week 0, 4, 10, 26, and 52
The 5-level EQ-5D (EQ-5D-5L) index score	General health-related quality of life (measure across five dimensions; higher levels indicate greater health impairment)	Week 0, 4, 10, 26, and 52

Collaborators and Investigators

• Sponsor: Qufora A/S

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Behavioral Symptoms; Elimination Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Encopresis
• Other Study ID Numbers: QF008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No