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

Primary Purpose

Constipation, Fecal Incontinence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-volume irrigation
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Low-volume irrigation

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    11-point Likert scale
    The present bowel functions impact on daily activities (0: no, 10: maximum influence)
    11-point Likert scale
    Assessment of the present bowel function (0: no bowel dysfunction, 10: severe bowel dysfunction)
    11-point Likert scale
    The present bowel functions impact on overall QoL (0: no influence, 10: maximum influence)
    11-point Likert scale
    General satisfaction with present bowel function (0: perfect satisfaction, 10: total dissatisfaction)
    11-point Likert scale
    General satisfaction with current treatment (0: perfect satisfaction, 10: total dissatisfaction)
    The St. Mark's fecal incontinence score
    Participants suffering from fecal incontinence
    The Fecal Incontinence Quality of Life Scale
    Participants suffering from fecal incontinence
    PAC-SYM score
    Participants suffering from constipation
    The Patients Assessment of Constipation Quality of life
    Participants suffering from constipation
    The 5-level EQ-5D (EQ-5D-5L) index score
    For all patients
    Discontinuation rates
    Time until discontinuation and reasons for discontinuation.
    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
    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
    Practicalities and adverse effects
    Descriptive analyses of volume and duration of irrigation, efficacy of irrigation with regards to evacuation, practical challenges and adverse effects.

    Full Information

    First Posted
    February 27, 2023
    Last Updated
    April 3, 2023
    Sponsor
    Aarhus University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05773742
    Brief Title
    Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation
    Official Title
    Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation - Qufora IrriSedo MiniGo
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 11, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2025 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Aarhus University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation, Fecal Incontinence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    92 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low-volume irrigation
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Low-volume irrigation
    Intervention Description
    Qufora IrriSedo MiniGo
    Primary Outcome Measure Information:
    Title
    11-point Likert scale
    Description
    The present bowel functions impact on daily activities (0: no, 10: maximum influence)
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    11-point Likert scale
    Description
    The present bowel functions impact on daily activities (0: no, 10: maximum influence)
    Time Frame
    3 months, 6 months, 12 months
    Title
    11-point Likert scale
    Description
    Assessment of the present bowel function (0: no bowel dysfunction, 10: severe bowel dysfunction)
    Time Frame
    6 weeks, 3 months, 6 months, 12 months
    Title
    11-point Likert scale
    Description
    The present bowel functions impact on overall QoL (0: no influence, 10: maximum influence)
    Time Frame
    6 weeks, 3 months, 6 months, 12 months
    Title
    11-point Likert scale
    Description
    General satisfaction with present bowel function (0: perfect satisfaction, 10: total dissatisfaction)
    Time Frame
    6 weeks, 3 months, 6 months, 12 months
    Title
    11-point Likert scale
    Description
    General satisfaction with current treatment (0: perfect satisfaction, 10: total dissatisfaction)
    Time Frame
    6 weeks, 3 months, 6 months, 12 months
    Title
    The St. Mark's fecal incontinence score
    Description
    Participants suffering from fecal incontinence
    Time Frame
    6 weeks, 3 months, 6 months, 12 months
    Title
    The Fecal Incontinence Quality of Life Scale
    Description
    Participants suffering from fecal incontinence
    Time Frame
    6 weeks, 3 months, 6 months, 12 months
    Title
    PAC-SYM score
    Description
    Participants suffering from constipation
    Time Frame
    6 weeks, 3 months, 6 months, 12 months
    Title
    The Patients Assessment of Constipation Quality of life
    Description
    Participants suffering from constipation
    Time Frame
    6 weeks, 3 months, 6 months, 12 months
    Title
    The 5-level EQ-5D (EQ-5D-5L) index score
    Description
    For all patients
    Time Frame
    6 weeks, 3 months, 6 months, 12 months
    Title
    Discontinuation rates
    Description
    Time until discontinuation and reasons for discontinuation.
    Time Frame
    6 weeks, 3 months, 6 months, 12 months
    Title
    Correlation for the primary outcome
    Description
    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
    Time Frame
    6 weeks
    Title
    Correlation for SMIS and PAC-SYM
    Description
    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
    Time Frame
    6 weeks
    Title
    Practicalities and adverse effects
    Description
    Descriptive analyses of volume and duration of irrigation, efficacy of irrigation with regards to evacuation, practical challenges and adverse effects.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peter Christensen
    Phone
    004520375471
    Email
    petchris@rm.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mira Mekhael, MD
    Organizational Affiliation
    Aarhus University Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Rogini Balachandran, MD
    Organizational Affiliation
    Aarhus University Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Therese Juul, PhD
    Organizational Affiliation
    Aarhus University Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Klaus Krogh, DMSc, Phd
    Organizational Affiliation
    Aarhus University Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Paul Vollebregt, PhD, MD
    Organizational Affiliation
    Queen Mary University of London/Amsterdam University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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