Prospective Database of Factors Associated with Faecal Vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry.

Recruiting

• Conditions: Urinary Incontinence; Double Incontinence; Faecal Incontinence
• Interventions: Other: Questionnaires

• Registration Number: NCT05550675
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

This study aims to verify the results from our previous retrospective cohort analysis by establishing a database of well-characterised patients prospectively. The different prevalence of neurological disorders, abdominal, urological and obstetrical surgery, diarrhoea and other potential associated factors as well as the importance of abnormalities identified by 3D high resolution anorectal manometry (HARM) will be compared between subjects with feacal incontinence (FI), double incontinence (DI) and controls. Presence and severity of both FI and urinary incontinence (UI) will be evaluated by disease specific questionnaires. Measuring both disease severity and Quality of Life (QoL) is needed to determine the true impact of incontinence. Finally, the impact on quality of life will be compared between both groups.

Detailed Description

Double incontinence (DI) is the concomitant incontinence for urine and stool. A 3 - 5 % prevalence among adults has been reported, while 7 - 18 % of community-dwelling adults suffer from faecal incontinence (FI), irrespective of gender. Risk factors for FI include structural anomalies of the anorectal region, disturbed rectal compliance, disturbed anorectal sensation and presence of diarrhoea. Age, body mass index (BMI), obstetrical history (especially parity), anal penetrative intercourse and chronic illness have also been implicated. In contrast, little is known about the pathophysiology of DI. Factors like older age, multiparity, neurological disease and medical comorbidities have been proposed based on analysis from the Nurse's health study. According to our recent retrospective cohort analysis (accepted for publication Acta Gastro-Enterologica Belgica), diarrhoea, neurological disease and previous urological interventions characterise patients suffering from DI. Males most frequently suffer from an underlying neurologic disorder, while anatomical anomalies and urological surgery was more frequently observed in women. There was a trend toward more frequent diarrhoea in both genders. Anorectal manometry parameters could not differentiate between FI alone or DI. However, this result could have been hampered by the use of conventional manometry in contrast to high-resolution 3D manometry.

This study aims to verify the results from our previous retrospective cohort analysis by establishing a database of well-characterised patients prospectively. The different prevalence of neurological disorders, abdominal, urological and obstetrical surgery, diarrhoea and other potential associated factors as well as the importance of abnormalities identified by 3D high resolution anorectal manometry (HARM) will be compared between subjects with FI, DI and controls. Presence and severity of both FI and UI will be evaluated by disease specific questionnaires.

Study Timeline

• Study Start: 2022-06-08
• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2027-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age > 18 years;
• Self-reported faecal incontinence.

Exclusion Criteria

• Impossibility to perform the anorectal manometry because of pain, stenosis or organic disease;
• Active (peri)rectal inflammation, including abscess;
• Pregnancy;
• Inability to cooperate during the anorectal manometry
• Impossibility to perform HARM due to pain, stenosis or organic disease;
• Inability to complete the questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Double incontinence	Questionnaires	-
controls	Questionnaires	-
faecal incontinence	Questionnaires	-

Primary Outcome Measures

Name	Time	Method
compose a database of patients suffering from faecal or double incontinence	during inclusion visit	a database will be created

Secondary Outcome Measures

Name	Time	Method
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence	during inclusion visit	this outcome will be assessed using bristol stool scale
Identify other factors associated with DI vs. FI ,	during inclusion visit	this outcome will be assessed using International consultation on incontinence questionnaire
Compare manometric data from HARM in DI vs. FI alone;	during inclusion visit	this outcome will be assessed using HARM
Assess the prevalence of DI in women and men with FI presenting for HARM;	during inclusion visit	this outcome will be assessed using HARM
Investigate the impact of UI on the quality of life in DI vs. FI alone.	during inclusion visit	this outcome will be assessed using the Quality of Life questionnaire (faecal incontinence Quality of Life scale)

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussels, Belgium