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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05773742
• Other study ID #: 222222
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2023
• Source: University of Aarhus
• Contact: Peter Christensen
• Phone: 004520375471
• Email: petchris[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Fecal Incontinence

Intervention

Device:
• Low-volume irrigation
Qufora IrriSedo MiniGo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	11-point Likert scale	The present bowel functions impact on daily activities (0: no, 10: maximum influence)	6 weeks
Secondary	11-point Likert scale	The present bowel functions impact on daily activities (0: no, 10: maximum influence)	3 months, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	11-point Likert scale	General satisfaction with present bowel function (0: perfect satisfaction, 10: total dissatisfaction)	6 weeks, 3 months, 6 months, 12 months
Secondary	11-point Likert scale	General satisfaction with current treatment (0: perfect satisfaction, 10: total dissatisfaction)	6 weeks, 3 months, 6 months, 12 months
Secondary	The St. Mark's fecal incontinence score	Participants suffering from fecal incontinence	6 weeks, 3 months, 6 months, 12 months
Secondary	The Fecal Incontinence Quality of Life Scale	Participants suffering from fecal incontinence	6 weeks, 3 months, 6 months, 12 months
Secondary	PAC-SYM score	Participants suffering from constipation	6 weeks, 3 months, 6 months, 12 months
Secondary	The Patients Assessment of Constipation Quality of life	Participants suffering from constipation	6 weeks, 3 months, 6 months, 12 months
Secondary	The 5-level EQ-5D (EQ-5D-5L) index score	For all patients	6 weeks, 3 months, 6 months, 12 months
Secondary	Discontinuation rates	Time until discontinuation and reasons for discontinuation.	6 weeks, 3 months, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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