NCT05550675 Prospective Database of Factors Associated With Faecal vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry.
| NCT ID | NCT05550675 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Double Incontinence |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-06-08 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-06-08 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05550675 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Double Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05550675 currently recruiting?
Yes, NCT05550675 is actively recruiting participants. Contact the research team at magali.surmont@uzbrussel.be for enrollment information.
Where is the NCT05550675 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT05550675 clinical trial?
NCT05550675 is sponsored by Universitair Ziekenhuis Brussel. The trial plans to enroll 150 participants.