Faecal IncontinenceORBIT-1NCT07473622
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
A study testing Transanal irrigation in people with Faecal Incontinence and Chronic Constipation, run by Qufora A/S at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Faecal Incontinence, Chronic Constipation
- What is being tested?
- Transanal irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton
Southampton
About this study
Official title: 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.
- Conditions
- Faecal Incontinence, Chronic Constipation
- Being tested
- Transanal irrigation
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal irrigationDevice
Transanal irrigation by use of irrigation devices
| Study group | Role | What they receive |
|---|---|---|
| Qufora QNova | Experimental | Not described Receives: Device: Transanal irrigation |
| Qufora Irrisedo Klick | Active comparator | Not described Receives: Device: Transanal irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale
Participant experience with device (0: strongly disagree, 4: strongly agree)
Measured: Week 4, 10, 26, and 52
Secondary outcomes (5)
Patient Diary
Bowel irrigation frequency (times per week)
Measured: Week 10, 26, and 52
Patient Diary
Bowel irrigation volume (in ml)
Measured: Week 10, 26, and 52
Cleveland Clinic Constipation Score (CCCS)
Constipation severity (Higher scores indicate worse constipation symptoms; score range: 0-30)
Measured: 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)
Measured: 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)
Measured: Week 0, 4, 10, 26, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start9 Oct 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Post-market, exploratory, randomised, parallel, open-label
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qufora A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473622
- Sponsor's protocol ID
- QF008
- Acronym
- ORBIT-1
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07473622
- Acronym / sponsor ID
- ORBIT-1 / QF008
- Conditions
- Faecal Incontinence, Chronic Constipation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Qufora A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Post-market, exploratory, randomised, parallel, open-label
| Arm | Type | Receives |
|---|---|---|
| Qufora QNova | Experimental | Device: Transanal irrigation |
| Qufora Irrisedo Klick | Active comparator | Device: Transanal irrigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transanal irrigationTransanal irrigation by use of irrigation devices | Device | Qufora Irrisedo Klick, Qufora QNova |
Primary outcome
Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale
Time frame: Week 4, 10, 26, and 52
Participant experience with device (0: strongly disagree, 4: strongly agree)
5 secondary outcomes
Patient Diary
Time frame: Week 10, 26, and 52
Patient Diary
Time frame: Week 10, 26, and 52
Cleveland Clinic Constipation Score (CCCS)
Time frame: Week 0, 4, 10, 26, and 52
St Mark's Incontinence Score (SMIS
Time frame: Week 0, 4, 10, 26, and 52
The 5-level EQ-5D (EQ-5D-5L) index score
Time frame: Week 0, 4, 10, 26, and 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal irrigation in people with Faecal Incontinence and Chronic Constipation, run by Qufora A/S at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haya N.H. Pedersen (+45 31394941, hap@qufora.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale (time frame: Week 4, 10, 26, and 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.