Clinical trial NCT05550675: Prospective Database of Factors Associated with Faecal Vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry.
Official title: Prospective Database of Factors Associated with Faecal Vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Double Incontinence
Faecal Incontinence
Urinary Incontinence
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred for HARM for FI are eligible to enroll in the database.

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.

Eligibility criteria: 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

Primary outcomes:
measure: compose a database of patients suffering from faecal or double incontinence
timeFrame: during inclusion visit
Secondary outcomes:
measure: Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
timeFrame: during inclusion visit
measure: Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
timeFrame: during inclusion visit
measure: Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
timeFrame: during inclusion visit
measure: Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
timeFrame: during inclusion visit
measure: Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
timeFrame: during inclusion visit
measure: Identify other factors associated with DI vs. FI ,
timeFrame: during inclusion visit
measure: Identify other factors associated with DI vs. FI ,
timeFrame: during inclusion visit
measure: Identify other factors associated with DI vs. FI ,
timeFrame: during inclusion visit
measure: Identify other factors associated with DI vs. FI ,
timeFrame: during inclusion visit
measure: Identify other factors associated with DI vs. FI ,
timeFrame: during inclusion visit
measure: Compare manometric data from HARM in DI vs. FI alone;
timeFrame: during inclusion visit
measure: Assess the prevalence of DI in women and men with FI presenting for HARM;
timeFrame: during inclusion visit
measure: Investigate the impact of UI on the quality of life in DI vs. FI alone.
timeFrame: during inclusion visit
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
Study officials:
References: