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

Last updated: November 21, 2024
Sponsor: Universitair Ziekenhuis Brussel
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fecal Incontinence

Urinary Incontinence

Enuresis

Treatment

Questionnaires

Clinical Study ID

NCT05550675
ProDIM
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years;

  • Self-reported faecal incontinence.

Exclusion

Exclusion Criteria:

  • Impossibility to perform the anorectal manometry because of pain, stenosis ororganic 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

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Questionnaires
Phase:
Study Start date:
June 08, 2022
Estimated Completion Date:
July 31, 2030

Study 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.

Connect with a study center

  • UZ Brussel

    Brussels, 1090
    Belgium

    Active - Recruiting

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