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Not yet recruiting NCT07473622

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

No phase Interventional Faecal Incontinence Chronic Constipation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transanal irrigation.
Who it may be relevant to
Registry conditions: Faecal Incontinence, Chronic Constipation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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.

Interventions

  • Device Transanal irrigation
    Transanal irrigation by use of irrigation devices

Primary outcome measures

  • Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale [Time frame: Week 4, 10, 26, and 52]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07473622 · QF008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗