Actively Recruiting
Prospective Database of Factors Associated With Faecal vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry
Led by Universitair Ziekenhuis Brussel · Updated on 2025-12-18
150
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with faecal incontinence (FI), double incontinence (DI), and controls to better understand factors linked to these conditions. The study focuses on comparing neurological disorders, past surgeries, diarrhoea, and other factors, while assessing abnormalities using 3D high resolution anorectal manometry (HARM). It also evaluates the presence and severity of faecal and urinary incontinence through disease-specific questionnaires, aiming to measure how these conditions impact quality of life. Participants will undergo high resolution 3D anorectal manometry to identify abnormalities and will complete specialized questionnaires to assess the severity of their incontinence and its effect on quality of life. The study establishes a prospective database to compare findings between those with FI, DI, and control subjects, verifying previous retrospective study results. During the study visit, participants will provide information through questionnaires, and manometry data will be collected to analyze disease factors. Researchers will measure outcomes like the prevalence of double incontinence, the role of diarrhoea, and the impact of urinary incontinence on quality of life. The study includes adults aged 18 years and older and allows healthy volunteers. Total participation involves a single inclusion visit for data collection and assessment.
CONDITIONS
Brief Title
Prospective Database of Factors Associated With Faecal vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Self-reported faecal incontinence
You will not qualify if you...
- Unable to perform anorectal manometry due to pain, stenosis, or organic disease
- Active peri-rectal inflammation, including abscess
- Pregnancy
- Unable to cooperate during anorectal manometry
- Unable to perform high resolution anorectal manometry (HARM) due to pain, stenosis, or organic disease
- Unable to complete the questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit during inclusion
Participants complete disease specific questionnaires and undergo high resolution anorectal manometry (HARM) to collect detailed data on faecal and double incontinence.
1 visit (in-person)
Duration - Up to 3 years
Participants are observed to verify factors associated with faecal and double incontinence based on collected data.
Periodic assessments as determined by the study team
Trial Site Locations
Total: 1 location
1
UZ Brussel
Brussels, Brussels Capital, Belgium, 1090
Actively Recruiting
Research Team
M
Magali Surmont
V
Virgini Van Buggenhout
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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