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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Constipation, Fecal Incontinence

Intervention / Treatment
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* Device: Low-volume irrigation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-volume irrigation<br>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<br>* Qufora IrriSedo MiniGo<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| The St. Mark's fecal incontinence score | Participants suffering from fecal incontinence | 6 weeks, 3 months, 6 months, 12 months | 
| The Fecal Incontinence Quality of Life Scale | Participants suffering from fecal incontinence | 6 weeks, 3 months, 6 months, 12 months | 
| PAC-SYM score | Participants suffering from constipation | 6 weeks, 3 months, 6 months, 12 months | 
| The Patients Assessment of Constipation Quality of life | Participants suffering from constipation | 6 weeks, 3 months, 6 months, 12 months | 
| The 5-level EQ-5D (EQ-5D-5L) index score | For all patients | 6 weeks, 3 months, 6 months, 12 months | 
| Discontinuation rates | Time until discontinuation and reasons for discontinuation. | 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 | 
| 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 |