New catheter study aims to ease bathroom struggles for millions
NCT ID NCT07473622
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of catheters used for bowel irrigation to help people with chronic constipation and/or fecal incontinence. About 66 adults will be randomly assigned to use either a new self-retaining catheter or a standard balloon catheter. Participants will be trained by nurses and followed for up to 52 weeks to see which device is easier and more effective to use in everyday life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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