Prospective Database of Factors Associated With Faecal vs. Double Incontinence in Patients Referred for High Resolution Anorectal 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 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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Faecal Incontinence; Double Incontinence
• Intervention / Treatment: Other: Questionnaires

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Magali Surmont; Phone Number: +32 2 477 60 11; Email: magali.surmont@uzbrussel.be
• Study Contact Backup: Name: Virgini Van Buggenhout; Phone Number: +32 2 477 60 11; Email: virgini.vanbuggenhout@uzbrussel.be

Study Locations

• Belgium
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1090
      • Recruiting
      • UZ Brussel
      • Contact: Virgini Van Buggenhout; Phone Number: +32 2 477 60 11; Email: virgini.vanbuggenhout@uzburussel.be
      • Contact: Marijke De Wolf; Phone Number: +32 2 477 60 11; Email: marijke.dewolf@uzbrussel.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All patients referred for HARM for FI are eligible to enroll in the database.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
controls	Other: Questionnaires; Disease specific questionnaires
Double incontinence	Other: Questionnaires; Disease specific questionnaires
faecal incontinence	Other: Questionnaires; Disease specific questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compose a database of patients suffering from faecal or double incontinence	a database will be created	during inclusion visit

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Signs and Symptoms, Digestive; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Urinary Incontinence; Encopresis; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: ProDIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No