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

NCT ID: NCT05773742

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2026-01-11

Brief 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).

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low-volume irrigation

Intervention Type: DEVICE

Qufora IrriSedo MiniGo

Interventions

Low-volume irrigation

Qufora IrriSedo MiniGo

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mira Mekhael, MD

Role: STUDY_CHAIR

Aarhus University Hospital

Therese Juul, PhD

Role: STUDY_CHAIR

Aarhus University Hospital

Klaus Krogh, DMSc, Phd

Role: STUDY_CHAIR

Aarhus University Hospital

Paul Vollebregt, PhD, MD

Role: STUDY_CHAIR

Queen Mary University of London/Amsterdam University

Louise Schmidt Grau, MD

Role: STUDY_CHAIR

Aarhus University Hospital

Locations

Department of Surgery

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

222222

Identifier Type: -

Identifier Source: org_study_id