Clinical trial NCT05773742: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Fecal Incontinence
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 11-point Likert scale
timeFrame: 6 weeks
Secondary outcomes:
measure: 11-point Likert scale
timeFrame: 3 months, 6 months, 12 months
measure: 11-point Likert scale
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: 11-point Likert scale
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: 11-point Likert scale
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: 11-point Likert scale
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: The St. Mark's fecal incontinence score
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: The Fecal Incontinence Quality of Life Scale
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: PAC-SYM score
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: The Patients Assessment of Constipation Quality of life
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: The 5-level EQ-5D (EQ-5D-5L) index score
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Discontinuation rates
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Correlation for the primary outcome
timeFrame: 6 weeks
measure: Correlation for SMIS and PAC-SYM
timeFrame: 6 weeks
measure: Practicalities and adverse effects
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Mira Mekhael, MD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Rogini Balachandran, MD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Therese Juul, PhD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Klaus Krogh, DMSc, Phd
role: STUDY_CHAIR
affiliation: Queen Mary University of London/Amsterdam University
name: Paul Vollebregt, PhD, MD
role: STUDY_CHAIR
References: