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New device aims to ease bathroom troubles for millions

NCT ID NCT05773742

Symptom relief Sponsor: Aarhus University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a low-volume irrigation device (Qufora IrriSedo MiniGo) in 92 adults with fecal incontinence, chronic constipation, or both. Participants used the device at home to see if it improved bowel function and daily life. The goal was to find a simple, non-drug option for managing these common but distressing conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Qufora IrriSedo MiniGo (low-volume irrigation device)
What this could lead to
If it works, this could offer a simple, at-home option to manage bowel symptoms and improve daily life for people with fecal incontinence or chronic constipation.
What could go wrong
This is a small, completed study without a control group, so results may not apply to everyone. The device may not work for all types of bowel problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

92 people

The number who actually took part.

Started

Apr 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with FI, CC or co-existing FI and CC of heterogenous origin. * Positive Rome IV criteria for constipation and/or positive Rome IV criteria for fecal incontinence. * Patients with Bristol stool type 1-5 as their primary stool consistency. * 18 years. * Ability to understand written and spoken Danish (due to questionnaire validity). Exclusion Criteria: * Prior use of transanal irrigation or mini enema. * Patients with chronic diarrhea (Bristol stool type 6-7). * Patients with neurogenic bowel dysfunction. * Participation in research conflicting with the current study. * Diseases treated with rectal or anal surgery (except minor rectal or anal surgery). * Physical disability that affects the ability to use QuforaÒ IrriSedo MiniGo. * Major psychiatric diagnoses. * Patients with constipation with a chronic opioid use or other medications inducing constipation. * Pregnancy or plans to become pregnant.

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Conditions

The condition(s) this trial relates to.

constipation disorder Fecal Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Constipation Fecal incontinence

Contacts and locations

Locations

  • Department of Surgery

    Aarhus, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.