ConstipationNCT05773742

Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation

A study testing Low-volume irrigation in people with Constipation and Fecal Incontinence, run by Aarhus University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Constipation, Fecal Incontinence
What is being tested?: Low-volume irrigation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteDenmark
Study dates: 17 Apr 2023to 1 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Show all 9Show fewer

Major psychiatric diagnoses.
Patients with constipation with a chronic opioid use or other medications inducing constipation.
Pregnancy or plans to become pregnant.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of Surgery
Aarhus

Other trials in Denmark

About this study

Official title: Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation - Qufora IrriSedo MiniGo

The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin).

Read the detailed description

The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with FI and/or CC (of heterogenous origin). Further, the aim is to investigate if low volume irrigation can change the negative impact that symptoms of FI and/or CC (of heterogenous origin) have on the patients' daily activities and QoL. Additionally, the aim is to investigate the short-term and long-term discontinuation rates in relation to treatment with low-volume irrigation. Finally, the aim is to investigate the daily time-consumption, the practical challenges and the side effects related to low-volume irrigation. The study period is six weeks and the participants will be instructed to irrigate once daily with Qufora IrriSedo MiniGo.

This study is an interventional study. Patients with FI and/or CC of heterogenous origin, seen in the Nurse-led Clinic for Bowel Dysfunction at the Pelvic Floor Unit, Aarhus University hospital, will be included. Patients will be offered transanal irrigation as a treatment option. Patients presenting with Bristol stool type 6-7 should be offered conservative treatment to optimize the stool consistency. If patients can be regulated to a Bristol stool type 1-5, they can be invited to participate in the study. If necessary, regulation of the stool consistency in patients presenting with Bristol stool type 1-2 is an option, before introducing transanal irrigation.

Conditions: Constipation, Fecal Incontinence
Being tested: Low-volume irrigation
Medical subject headings: Constipation, Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low-volume irrigationDevice
Qufora IrriSedo MiniGo

Study groups in NCT05773742
Study group	Role	What they receive
Low-volume irrigation	Experimental	The patients will be instructed to irrigate once daily at a fixed time for 6 weeks. The patients will be instructed to use the irrigation 30 min after breakfast, capitalizing on the gastrocolic response; however, should this not fit in with the individual's lifestyle, then an alternative time of the day may be used. Preferably shortly after a large meal. The patients should fill the pump with 180 milliliters (a full pump) and irrigate with a volume of 160 milliliters of water. Receives: Device: Low-volume irrigation

What is being measured

The primary outcome is the main question the study is designed to answer.

11-point Likert scale
The present bowel functions impact on daily activities (0: no, 10: maximum influence)
Measured: 6 weeks

Secondary outcomes (15)

11-point Likert scale
The present bowel functions impact on daily activities (0: no, 10: maximum influence)
Measured: 3 months, 6 months, 12 months
11-point Likert scale
Assessment of the present bowel function (0: no bowel dysfunction, 10: severe bowel dysfunction)
Measured: 6 weeks, 3 months, 6 months, 12 months
11-point Likert scale
The present bowel functions impact on overall QoL (0: no influence, 10: maximum influence)
Measured: 6 weeks, 3 months, 6 months, 12 months
11-point Likert scale
General satisfaction with present bowel function (0: perfect satisfaction, 10: total dissatisfaction)
Measured: 6 weeks, 3 months, 6 months, 12 months
11-point Likert scale
General satisfaction with current treatment (0: perfect satisfaction, 10: total dissatisfaction)
Measured: 6 weeks, 3 months, 6 months, 12 months
The St. Mark's fecal incontinence score
Participants suffering from fecal incontinence
Measured: 6 weeks
The Fecal Incontinence Quality of Life Scale
Participants suffering from fecal incontinence
Measured: 6 weeks
PAC-SYM score
Participants suffering from constipation
Measured: 6 weeks
The Patients Assessment of Constipation Quality of life
Participants suffering from constipation
Measured: 6 weeks
The 5-level EQ-5D (EQ-5D-5L) index score
For all patients
Measured: 6 weeks
Five-point ordinal scale
Self-rated change in bowel function measured on a five-point ordinal scale (much worse, a little worse, unchanged, a little better, much better).
Measured: 6 weeks
Discontinuation rates
Time until discontinuation and reasons for discontinuation.
Measured: 6 weeks, 3 months, 6 months, 12 months
Correlation for the primary outcome
Correlation between score change in primary outcome and the patients' subjective perception of present bowel function rated on a 11-point Likert scale (0: no bowel dysfunction, 10: severe bowel dysfunction) and the patients' evaluation of the efficacy of low-volume irrigation on bowel function rated on a scale from great improvement to great worsening
Measured: 6 weeks
Correlation for SMIS and PAC-SYM
Correlation between the SMIS or PAC-SYM and the patients' subjective perception of present bowel function rated on a 11-point Likert scale (0: no bowel dysfunction, 10: severe bowel dysfunction) and the patients' evaluation of the efficacy of low-volume irrigation on bowel function rated on a scale from great improvement to great worsening
Measured: 6 weeks
Practicalities and adverse effects
Descriptive analyses of volume and duration of irrigation, efficacy of irrigation with regards to evacuation, practical challenges and adverse effects.
Measured: 6 weeks, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 20231 Dec 2025

First posted17 Mar 2023
Study start17 Apr 2023
Primary completion11 Jan 2025
Study completion1 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ConstipationStudies of the same condition, open and under way.
More trials run by Aarhus University HospitalThe sponsor's other registered studies.
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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05773742
Sponsor's protocol ID: 222222
Status last verified: Aug 2025
First submitted: 27 Feb 2023
Last updated: 7 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
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RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation - Qufora IrriSedo MiniGo
ClinicalTrials.gov ID: NCT05773742
Acronym / sponsor ID: 222222
Conditions: Constipation, Fecal Incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Aarhus University HospitalUniversity, hospital or other
Study start: 17 Apr 2023 (actual)
Primary completion: 11 Jan 2025 (actual)
Study completion: 1 Dec 2025 (actual)
First posted: 17 Mar 2023 (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.

The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Low-volume irrigation	Experimental	Device: Low-volume irrigationThe patients will be instructed to irrigate once daily at a fixed time for 6 weeks. The patients will be instructed to use the irrigation 30 min after breakfast, capitalizing on the gastrocolic response; however, should this not fit in with the individual's lifestyle, then an alternative time of the day may be used. Preferably shortly after a large meal. The patients should fill the pump with 180 milliliters (a full pump) and irrigate with a volume of 160 milliliters of water.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (9 listed)

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).

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
Low-volume irrigationQufora IrriSedo MiniGo	Device	Low-volume irrigation

Primary outcome

11-point Likert scale
Time frame: 6 weeks
The present bowel functions impact on daily activities (0: no, 10: maximum influence)

15 secondary outcomes

11-point Likert scale
Time frame: 3 months, 6 months, 12 months
11-point Likert scale
Time frame: 6 weeks, 3 months, 6 months, 12 months
11-point Likert scale
Time frame: 6 weeks, 3 months, 6 months, 12 months
11-point Likert scale
Time frame: 6 weeks, 3 months, 6 months, 12 months
11-point Likert scale
Time frame: 6 weeks, 3 months, 6 months, 12 months
The St. Mark's fecal incontinence score
Time frame: 6 weeks
The Fecal Incontinence Quality of Life Scale
Time frame: 6 weeks
PAC-SYM score
Time frame: 6 weeks
The Patients Assessment of Constipation Quality of life
Time frame: 6 weeks
The 5-level EQ-5D (EQ-5D-5L) index score
Time frame: 6 weeks
Five-point ordinal scale
Time frame: 6 weeks
Discontinuation rates
Time frame: 6 weeks, 3 months, 6 months, 12 months
Correlation for the primary outcome
Time frame: 6 weeks
Correlation for SMIS and PAC-SYM
Time frame: 6 weeks
Practicalities and adverse effects
Time frame: 6 weeks, 3 months, 6 months, 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.

Related trials for Constipation

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

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. This study is not recruiting at the moment.

Mira Mekhael, MD study chair

Aarhus University Hospital

Therese Juul, PhD study chair

Aarhus University Hospital

Klaus Krogh, DMSc, Phd study chair

Aarhus University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low-volume irrigation in people with Constipation and Fecal Incontinence, run by Aarhus University Hospital at 1 site in Denmark.

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 9 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: finished, as of the sponsor's last update on 7 May 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 Denmark. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

11-point Likert scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05773742.

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 7 May 2026.