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

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).

Study Overview

• Status: Completed
• Conditions: Constipation; Fecal Incontinence
• Intervention / Treatment: Device: Low-volume irrigation

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Low-volume irrigation; 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.

Device: Low-volume irrigation; Qufora IrriSedo MiniGo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discontinuation rates	Time until discontinuation and reasons for discontinuation.	6 weeks, 3 months, 6 months, 12 months
11-point Likert scale	The present bowel functions impact on daily activities (0: no, 10: maximum influence)	3 months, 6 months, 12 months
11-point Likert scale	Assessment of the present bowel function (0: no bowel dysfunction, 10: severe bowel dysfunction)	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)	6 weeks, 3 months, 6 months, 12 months
11-point Likert scale	General satisfaction with present bowel function (0: perfect satisfaction, 10: total dissatisfaction)	6 weeks, 3 months, 6 months, 12 months
11-point Likert scale	General satisfaction with current treatment (0: perfect satisfaction, 10: total dissatisfaction)	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	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	6 weeks
The St. Mark's fecal incontinence score	Participants suffering from fecal incontinence	6 weeks
The Fecal Incontinence Quality of Life Scale	Participants suffering from fecal incontinence	6 weeks
PAC-SYM score	Participants suffering from constipation	6 weeks
The Patients Assessment of Constipation Quality of life	Participants suffering from constipation	6 weeks
The 5-level EQ-5D (EQ-5D-5L) index score	For all patients	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).	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.	6 weeks, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Study Chair: Mira Mekhael, MD, Aarhus University Hospital; Study Chair: Therese Juul, PhD, Aarhus University Hospital; Study Chair: Klaus Krogh, DMSc, Phd, Aarhus University Hospital; Study Chair: Paul Vollebregt, PhD, MD, Queen Mary University of London/Amsterdam University; Study Chair: Louise Schmidt Grau, MD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): January 11, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation; Fecal Incontinence
• Other Study ID Numbers: 222222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No