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

NCT ID: NCT05550675

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-08

Study Completion Date

2030-07-31

Brief Summary

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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

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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.

Conditions

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Double Incontinence Faecal Incontinence Urinary Incontinence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Double incontinence

Questionnaires

Intervention Type OTHER

Disease specific questionnaires

faecal incontinence

Questionnaires

Intervention Type OTHER

Disease specific questionnaires

controls

Questionnaires

Intervention Type OTHER

Disease specific questionnaires

Interventions

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Questionnaires

Disease specific questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Brussel

Brussels, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Magali Surmont

Role: CONTACT

Phone: +32 2 477 60 11

Email: [email protected]

Virgini Van Buggenhout

Role: CONTACT

Phone: +32 2 477 60 11

Email: [email protected]

Facility Contacts

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Virgini Van Buggenhout

Role: primary

Marijke De Wolf

Role: backup

Other Identifiers

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ProDIM

Identifier Type: -

Identifier Source: org_study_id