UZ Brussel
Brussels, Brussels Capital, 1090, Belgium
Location status: Recruiting
Location contact
Marijke De Wolf
CONTACT
Virgini Van Buggenhout
CONTACT
NCT Number: NCT05550675
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Brussels, Brussels Capital, 1090, Belgium
Location status: Recruiting
Marijke De Wolf
CONTACT
Virgini Van Buggenhout
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Disease specific questionnaires
Time frame: during inclusion visit
a database will be created
Time frame: during inclusion visit
this outcome will be assessed using jorge and wexner score
Time frame: during inclusion visit
this outcome will be assessed using vaizey score
Time frame: during inclusion visit
this outcome will be assessed using International consultation on incontinence questionnaire
Time frame: during inclusion visit
this outcome will be assessed using clinical frailty score
Time frame: during inclusion visit
this outcome will be assessed using bristol stool scale
Time frame: during inclusion visit
this outcome will be assessed using bristol stool scale
Time frame: during inclusion visit
this outcome will be assessed using clinical frailty score
Time frame: during inclusion visit
this outcome will be assessed using jorge and wexner score
Time frame: during inclusion visit
this outcome will be assessed using vaizey score
Time frame: during inclusion visit
this outcome will be assessed using International consultation on incontinence questionnaire
Time frame: during inclusion visit
this outcome will be assessed using HARM
Time frame: during inclusion visit
this outcome will be assessed using HARM
Time frame: during inclusion visit
this outcome will be assessed using the Quality of Life questionnaire (faecal incontinence Quality of Life scale)
Contact information is provided by the study sponsor or research team.
Magali Surmont
CONTACT
Virgini Van Buggenhout
CONTACT
Universitair Ziekenhuis Brussel
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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