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

NCT05773742 | Active Not Recruiting

• 1 other identifier: 222222
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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).

Conditions

Fecal Incontinence; Constipation

Outcome Measures

Primary Outcomes (1)

• 11-point Likert scale

  The present bowel functions impact on daily activities (0: no, 10: maximum influence)

  6 weeks

Secondary Outcomes (15)

• 11-point Likert scale

  3 months, 6 months, 12 months

• 11-point Likert scale

  6 weeks, 3 months, 6 months, 12 months

• 11-point Likert scale

  6 weeks, 3 months, 6 months, 12 months

• 11-point Likert scale

  6 weeks, 3 months, 6 months, 12 months

• 11-point Likert scale

  6 weeks, 3 months, 6 months, 12 months

Study Arms (1)

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.

Device: Low-volume irrigation

Interventions

Low-volume irrigation DEVICE

Qufora IrriSedo MiniGo

Low-volume irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years.
• Ability to understand written and spoken Danish (due to questionnaire validity).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Department of Surgery

Aarhus, Denmark

Location

MeSH Terms

Conditions

Constipation; Fecal Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 17, 2023
• Study Start: April 17, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2025-08

Locations

DK (1)