Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05550675
Enrollment
150
Registered
2022-09-22
Start date
2022-06-08
Completion date
2030-07-31
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Double Incontinence, Faecal Incontinence, Urinary Incontinence

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.

Interventions

OTHERQuestionnaires

Disease specific questionnaires

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
compose a database of patients suffering from faecal or double incontinenceduring inclusion visita database will be created

Secondary

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

Countries

Belgium

Contacts

Primary ContactMagali Surmont
magali.surmont@uzbrussel.be+32 2 477 60 11
Backup ContactVirgini Van Buggenhout
virgini.vanbuggenhout@uzbrussel.be+32 2 477 60 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026