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

NCT05550675 | Recruiting

• 1 other identifier: ProDIM
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Faecal Incontinence; Urinary Incontinence; Double Incontinence

Outcome Measures

Primary Outcomes (1)

• compose a database of patients suffering from faecal or double incontinence

  a database will be created

  during inclusion visit

Secondary Outcomes (13)

• Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence

  during inclusion visit

• Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence

  during inclusion visit

• Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence

  during inclusion visit

• Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence

  during inclusion visit

• Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence

  during inclusion visit

Study Arms (3)

Double incontinence

Other: Questionnaires

faecal incontinence

Other: Questionnaires

controls

Other: Questionnaires

Interventions

Questionnaires OTHER

Disease specific questionnaires

Double incontinence; controls; faecal incontinence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Encopresis; Urinary Incontinence

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Magali Surmont

CONTACT

+32 2 477 60 11; magali.surmont@uzbrussel.be

Virgini Van Buggenhout

CONTACT

+32 2 477 60 11; virgini.vanbuggenhout@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: September 22, 2022
• Study Start: June 8, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)