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NCT Number: NCT07473622

Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence

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.

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Key information

Conditions

Faecal Incontinence Behavior Behavioral Symptoms Chronic Constipation Elimination Disorders Encopresis Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transanal irrigation

Device

Transanal irrigation by use of irrigation devices

Primary outcomes

  1. 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)

Secondary outcomes

  1. Patient Diary

    Time frame: Week 10, 26, and 52

    Bowel irrigation frequency (times per week)

  2. Patient Diary

    Time frame: Week 10, 26, and 52

    Bowel irrigation volume (in ml)

  3. Cleveland Clinic Constipation Score (CCCS)

    Time frame: Week 0, 4, 10, 26, and 52

    Constipation severity (Higher scores indicate worse constipation symptoms; score range: 0-30)

  4. St Mark's Incontinence Score (SMIS

    Time frame: Week 0, 4, 10, 26, and 52

    Fecal incontinence severity (Higher scores indicate worse incontinence symptoms; score range: 0-24)

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

    Time frame: Week 0, 4, 10, 26, and 52

    General health-related quality of life (measure across five dimensions; higher levels indicate greater health impairment)

Study contacts

Contact information is provided by the study sponsor or research team.

Haya N.H. Pedersen

CONTACT

[email protected]

+45 31394941

Sponsors and collaborators

Lead sponsor

Qufora A/S

Industry

Registry information

Official study 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.

Acronym: ORBIT-1

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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