NCT05773742

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Constipation
• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	Low-volume irrigation	Qufora IrriSedo MiniGo

Timeline

• Start date: 2023-04-17
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-03-17
• Last updated: 2026-02-19

Locations

1 site across 1 country: Denmark