Double IncontinenceNCT05550675
Prospective Database of Factors Associated With Faecal vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry.
An observational study of Double Incontinence and Faecal Incontinence, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Double Incontinence, Faecal Incontinence, Urinary Incontinence
- What is being tested?
- Questionnaires
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jun 2022to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients referred for HARM for FI are eligible to enroll in the database.
Who may be able to join
- Age > 18 years;
- Self-reported faecal incontinence.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels, Brussels Capital, 1090
Virgini Van Buggenhout, +32 2 477 60 11, virgini.vanbuggenhout@uzburussel.be
Marijke De Wolf, +32 2 477 60 11, marijke.dewolf@uzbrussel.be
About this study
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.
Read the 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.
- Being tested
- Questionnaires
- Medical subject headings
- Encopresis, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Disease specific questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Double incontinence | Not described Receives: Other: Questionnaires | |
| faecal incontinence | Not described Receives: Other: Questionnaires | |
| controls | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
compose a database of patients suffering from faecal or double incontinence
a database will be created
Measured: during inclusion visit
Secondary outcomes (13)
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
Measured: during inclusion visit
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
this outcome will be assessed using vaizey score
Measured: during inclusion visit
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
Measured: during inclusion visit
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
this outcome will be assessed using clinical frailty score
Measured: during inclusion visit
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
this outcome will be assessed using bristol stool scale
Measured: during inclusion visit
Identify other factors associated with DI vs. FI ,
this outcome will be assessed using bristol stool scale
Measured: during inclusion visit
Identify other factors associated with DI vs. FI ,
this outcome will be assessed using clinical frailty score
Measured: during inclusion visit
Identify other factors associated with DI vs. FI ,
this outcome will be assessed using jorge and wexner score
Measured: during inclusion visit
Identify other factors associated with DI vs. FI ,
this outcome will be assessed using vaizey score
Measured: during inclusion visit
Identify other factors associated with DI vs. FI ,
this outcome will be assessed using International consultation on incontinence questionnaire
Measured: during inclusion visit
Compare manometric data from HARM in DI vs. FI alone;
this outcome will be assessed using HARM
Measured: during inclusion visit
Assess the prevalence of DI in women and men with FI presenting for HARM;
this outcome will be assessed using HARM
Measured: during inclusion visit
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)
Measured: during inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start8 Jun 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double IncontinenceStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550675
- Sponsor's protocol ID
- ProDIM
- Status last verified
- Dec 2025
- First submitted
- 12 Aug 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Database of Factors Associated With Faecal vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry.
- ClinicalTrials.gov ID
- NCT05550675
- Acronym / sponsor ID
- ProDIM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double incontinence | – | Other: Questionnaires |
| faecal incontinence | – | Other: Questionnaires |
| controls | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred for HARM for FI are eligible to enroll in the database.
Key inclusion criteria (2 listed)
- Age > 18 years;
- Self-reported faecal incontinence.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesDisease specific questionnaires | Other | Double incontinence, controls, faecal incontinence |
Primary outcome
compose a database of patients suffering from faecal or double incontinence
Time frame: during inclusion visit
a database will be created
13 secondary outcomes
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
Time frame: during inclusion visit
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
Time frame: during inclusion visit
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
Time frame: during inclusion visit
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
Time frame: during inclusion visit
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
Time frame: during inclusion visit
Identify other factors associated with DI vs. FI ,
Time frame: during inclusion visit
Identify other factors associated with DI vs. FI ,
Time frame: during inclusion visit
Identify other factors associated with DI vs. FI ,
Time frame: during inclusion visit
Identify other factors associated with DI vs. FI ,
Time frame: during inclusion visit
Identify other factors associated with DI vs. FI ,
Time frame: during inclusion visit
Compare manometric data from HARM in DI vs. FI alone;
Time frame: during inclusion visit
Assess the prevalence of DI in women and men with FI presenting for HARM;
Time frame: during inclusion visit
Investigate the impact of UI on the quality of life in DI vs. FI alone.
Time frame: during inclusion visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Double Incontinence and Faecal Incontinence, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali Surmont (+32 2 477 60 11, magali.surmont@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compose a database of patients suffering from faecal or double incontinence (time frame: during inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.