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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05550675
• Other study ID #: ProDIM
• Status: Recruiting
• Start date: June 8, 2022
• Est. completion date: July 2030

Study information

• Verified date: November 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Magali Surmont
• Phone: +32 2 477 60 11
• Email: magali.surmont[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2030
• Est. primary completion date: July 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Faecal Incontinence
• Fecal Incontinence
• Urinary Incontinence

Intervention

Other:
• Questionnaires
Disease specific questionnaires

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compose a database of patients suffering from faecal or double incontinence	a database will be created	during inclusion visit
Secondary	Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence	this outcome will be assessed using jorge and wexner score	during inclusion visit
Secondary	Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence	this outcome will be assessed using vaizey score	during inclusion visit
Secondary	Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence	this outcome will be assessed using International consultation on incontinence questionnaire	during inclusion visit
Secondary	Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence	this outcome will be assessed using clinical frailty score	during inclusion visit
Secondary	Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence	this outcome will be assessed using bristol stool scale	during inclusion visit
Secondary	Identify other factors associated with DI vs. FI ,	this outcome will be assessed using bristol stool scale	during inclusion visit
Secondary	Identify other factors associated with DI vs. FI ,	this outcome will be assessed using clinical frailty score	during inclusion visit
Secondary	Identify other factors associated with DI vs. FI ,	this outcome will be assessed using jorge and wexner score	during inclusion visit
Secondary	Identify other factors associated with DI vs. FI ,	this outcome will be assessed using vaizey score	during inclusion visit
Secondary	Identify other factors associated with DI vs. FI ,	this outcome will be assessed using International consultation on incontinence questionnaire	during inclusion visit
Secondary	Compare manometric data from HARM in DI vs. FI alone;	this outcome will be assessed using HARM	during inclusion visit
Secondary	Assess the prevalence of DI in women and men with FI presenting for HARM;	this outcome will be assessed using HARM	during inclusion visit
Secondary	Investigate the impact of UI on the quality of life in DI vs. FI alone.	this outcome will be assessed using the Quality of Life questionnaire (faecal incontinence Quality of Life scale)	during inclusion visit