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NCT Number: NCT05773742

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

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).

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Key information

Conditions

Constipation Digestive System Diseases Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery

Aarhus, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-volume irrigation

Device

Qufora IrriSedo MiniGo

Primary outcomes

  1. 11-point Likert scale

    Time frame: 6 weeks

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

Secondary outcomes

  1. 11-point Likert scale

    Time frame: 3 months, 6 months, 12 months

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

  2. 11-point Likert scale

    Time frame: 6 weeks, 3 months, 6 months, 12 months

    Assessment of the present bowel function (0: no bowel dysfunction, 10: severe bowel dysfunction)

  3. 11-point Likert scale

    Time frame: 6 weeks, 3 months, 6 months, 12 months

    The present bowel functions impact on overall QoL (0: no influence, 10: maximum influence)

  4. 11-point Likert scale

    Time frame: 6 weeks, 3 months, 6 months, 12 months

    General satisfaction with present bowel function (0: perfect satisfaction, 10: total dissatisfaction)

  5. 11-point Likert scale

    Time frame: 6 weeks, 3 months, 6 months, 12 months

    General satisfaction with current treatment (0: perfect satisfaction, 10: total dissatisfaction)

  6. The St. Mark's fecal incontinence score

    Time frame: 6 weeks

    Participants suffering from fecal incontinence

  7. The Fecal Incontinence Quality of Life Scale

    Time frame: 6 weeks

    Participants suffering from fecal incontinence

  8. PAC-SYM score

    Time frame: 6 weeks

    Participants suffering from constipation

  9. The Patients Assessment of Constipation Quality of life

    Time frame: 6 weeks

    Participants suffering from constipation

  10. The 5-level EQ-5D (EQ-5D-5L) index score

    Time frame: 6 weeks

    For all patients

  11. Five-point ordinal scale

    Time frame: 6 weeks

    Self-rated change in bowel function measured on a five-point ordinal scale (much worse, a little worse, unchanged, a little better, much better).

  12. Discontinuation rates

    Time frame: 6 weeks, 3 months, 6 months, 12 months

    Time until discontinuation and reasons for discontinuation.

  13. Correlation for the primary outcome

    Time frame: 6 weeks

    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

  14. Correlation for SMIS and PAC-SYM

    Time frame: 6 weeks

    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

  15. Practicalities and adverse effects

    Time frame: 6 weeks, 3 months, 6 months, 12 months

    Descriptive analyses of volume and duration of irrigation, efficacy of irrigation with regards to evacuation, practical challenges and adverse effects.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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