Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773742
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-05
First Post:
2023-02-27
Brief Title:
Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation
Sponsor:
Aarhus University Hospital
Organization:
University of Aarhus
Study Overview
Official Title:
Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation - Qufora IrriSedo MiniGo
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence andor 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 andor CC of heterogenous origin Further the aim is to investigate if low volume irrigation can change the negative impact that symptoms of FI andor 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 andor 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
This study is an interventional study Patients with FI andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None