Faecal IncontinenceNCT04741893
Anal Canal Functional Assessment Using EndoFLIP
A study testing EndoFLIP in people with Faecal Incontinence and Asymptomatic Condition, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Faecal incontinence (FI) is characterized by involuntary loss of rectal content through the anal canal. FI is psychologically and socially debilitating problem that can dramatically affect patient's quality of life, often in otherwise healthy individual. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Faecal Incontinence, Asymptomatic Condition
- What is being tested?
- EndoFLIP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Aug 2017to 27 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
For Asymptomatic Group:
Inclusion Criteria: adults over 30 with no history of faecal incontinence, who are able to give consent.
Exclusion Criteria: Patients with history of gastrointestinal disease on medication or neurological disorder with bowel symptoms, anorectal surgery or previous bowel resection. Patients who are not willing to undergo the specified tests in this study. Pregnant women.
For Faecally Incontinent Group:
Inclusion Criteria: Adults over 30 with history of faecal incontinence for over 3months, who are able to give consent.
Exclusion Criteria: Patients who are not willing to undergo the specified tests in this study. Pregnant women and patients who has had anorectal surgery or bowel resection.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Surgery, Chinese University of Hong Kong
Shatin, New Territories
About this study
Official title: Assessment of the Effect of Ageing on Anal Sphincter Distensibility in Hong Kong Using EndoFLIP
Faecal incontinence (FI) is characterized by involuntary loss of rectal content through the anal canal. FI is psychologically and socially debilitating problem that can dramatically affect patient's quality of life, often in otherwise healthy individual. FI can occur as a result of obstetric sphincter injury, surgery, irradiation, anorectal malformations as well as neurological, connective tissue or endocrine disorders. Currently management options for these patients are limited, partly due to the fact that control of defaecation and continence is multifactorial but also due to the fact that FI is difficult to identify the exact cause of patients' incontinence.
Current assessment of patients with FI include endoscopic assessment to rule out intraluminal organic cause for patients' symptoms, endoanal ultrasound scan / MRI to assess their pelvic floor anatomy and anorectal manometry to assess anorectal function. Anorectal manometry is a simple test to perform but Anorectal manometry is susceptible to measurement artifacts, with a high inter-individual variation with significant overlap between healthy asymptomatic and symptomatic patients with FI. Harris et al in 1966 suggested that the anal sphincter's resistance to distension that may be of importance for sphincter competence, not how tight anal sphincter can squeeze.
Endoluminal Functional Lumen Imaging Probe (EndoFLIP©) is a novel technology used to measure the dimensions and function of a hollow organ. Limited publication so far has shown that EndoFLIP© provides a new way of assessing anal sphincter competence. The study is to assess the use of EndoFLIP© to assess anal sphincter function in Hong Kong population. Firstly to evaluate whether age has an effect on the distensibility of the anal sphincter and its function and secondly to compare between symptomatic patients with faecal incontinence and asymptomatic healthy subjects.
- Conditions
- Faecal Incontinence, Asymptomatic Condition
- Being tested
- EndoFLIP
- Keywords
- Faecal incontinence, Functional Lumen Imaging Probe, Anal distensibility
- Medical subject headings
- Encopresis, Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoFLIPDevice
Use of Endoluminal Functional Lumen Imaging Probe to assess anal canal function
| Study group | Role | What they receive |
|---|---|---|
| faecally incontinent patients | Experimental | faecally incontinent patients are all assessed using EndoFLIP as well as anorectal manometry and endoanal ultrasound Receives: Device: EndoFLIP |
| Asymptomatic individuals | Experimental | asymptomatic individuals are all assessed using EndoFLIP as well as anorectal manometry and endoanal ultrasound Receives: Device: EndoFLIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anal distensibility with age in asymptomatic individuals assessed with EndoFLIP
Comparison of anal distensibility in between different age groups in asymptomatic individuals
Measured: 1 day
Abnormal anal distensibility in faecally incontinent group
Comparison of anal distensibility between faecally incontinent patients and asymptomatic individuals using EndoFLIP
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start14 Aug 2017
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaori Futaba, Chinese University of Hong Kong
- Investigators
- Kaori Futaba, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741893
- Sponsor's protocol ID
- CREC2017.125
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2018
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harris LD, Winans CS, Pope CE 2nd. Determination of yield pressures: a method for measuring anal sphincter competence. Gastroenterology. 1966 Jun;50(6):754-60.
PubMed 5212375Sorensen G, Liao D, Lundby L, Fynne L, Buntzen S, Gregersen H, Laurberg S, Krogh K. Distensibility of the anal canal in patients with idiopathic fecal incontinence: a study with the Functional Lumen Imaging Probe. Neurogastroenterol Motil. 2014 Feb;26(2):255-63. doi: 10.1111/nmo.12258. Epub 2013 Nov 29.
PubMed 24286561Gourcerol G, Granier S, Bridoux V, Menard JF, Ducrotte P, Leroi AM. Do endoflip assessments of anal sphincter distensibility provide more information on patients with fecal incontinence than high-resolution anal manometry? Neurogastroenterol Motil. 2016 Mar;28(3):399-409. doi: 10.1111/nmo.12740. Epub 2015 Dec 15.
PubMed 26670599
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Ageing on Anal Sphincter Distensibility in Hong Kong Using EndoFLIP
- ClinicalTrials.gov ID
- NCT04741893
- Acronym / sponsor ID
- CREC2017.125
- Conditions
- Faecal Incontinence, Asymptomatic Condition
- Keywords
- Faecal incontinence, Functional Lumen Imaging Probe, Anal distensibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 5 Feb 2021 (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.
Faecal incontinence (FI) is characterized by involuntary loss of rectal content through the anal canal. FI is psychologically and socially debilitating problem that can dramatically affect patient's quality of life, often in otherwise healthy individual. FI can occur as a result of obstetric sphincter injury, surgery, irradiation, anorectal malformations as well as neurological, connective tissue or endocrine disorders. Currently management options for these patients are limited, partly due to the fact that control of defaecation and continence is multifactorial but also due to the fact that FI is difficult to identify the exact cause of patients' incontinence.
Current assessment of patients with FI include endoscopic assessment to rule out intraluminal organic cause for patients' symptoms, endoanal ultrasound scan / MRI to assess their pelvic floor anatomy and anorectal manometry to assess anorectal function. Anorectal manometry is a simple test to perform but Anorectal manometry is susceptible to measurement artifacts, with a high inter-individual variation with significant overlap between healthy asymptomatic and symptomatic patients with FI. Harris et al in 1966 suggested that the anal sphincter's resistance to distension that may be of importance for sphincter competence, not how tight anal sphincter can squeeze.
Endoluminal Functional Lumen Imaging Probe (EndoFLIP©) is a novel technology used to measure the dimensions and function of a hollow organ. Limited publication so far has shown that EndoFLIP© provides a new way of assessing anal sphincter competence. The study is to assess the use of EndoFLIP© to assess anal sphincter function in Hong Kong population. Firstly to evaluate whether age has an effect on the distensibility of the anal sphincter and its function and secondly to compare between symptomatic patients with faecal incontinence and asymptomatic healthy subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| faecally incontinent patients | Experimental | Device: EndoFLIPfaecally incontinent patients are all assessed using EndoFLIP as well as anorectal manometry and endoanal ultrasound |
| Asymptomatic individuals | Experimental | Device: EndoFLIPasymptomatic individuals are all assessed using EndoFLIP as well as anorectal manometry and endoanal ultrasound |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| EndoFLIPUse of Endoluminal Functional Lumen Imaging Probe to assess anal canal function | Device | Asymptomatic individuals, faecally incontinent patients |
Primary outcome
Change in anal distensibility with age in asymptomatic individuals assessed with EndoFLIP
Time frame: 1 day
Comparison of anal distensibility in between different age groups in asymptomatic individuals
Abnormal anal distensibility in faecally incontinent group
Time frame: 1 day
Comparison of anal distensibility between faecally incontinent patients and asymptomatic individuals using EndoFLIP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Background: PubMed 5212375Harris LD, Winans CS, Pope CE 2nd. Determination of yield pressures: a method for measuring anal sphincter competence. Gastroenterology. 1966 Jun;50(6):754-60.
- Background: PubMed 24286561Sorensen G, Liao D, Lundby L, Fynne L, Buntzen S, Gregersen H, Laurberg S, Krogh K. Distensibility of the anal canal in patients with idiopathic fecal incontinence: a study with the Functional Lumen Imaging Probe. Neurogastroenterol Motil. 2014 Feb;26(2):255-63. doi: 10.1111/nmo.12258. Epub 2013 Nov 29.
- Background: PubMed 26670599Gourcerol G, Granier S, Bridoux V, Menard JF, Ducrotte P, Leroi AM. Do endoflip assessments of anal sphincter distensibility provide more information on patients with fecal incontinence than high-resolution anal manometry? Neurogastroenterol Motil. 2016 Mar;28(3):399-409. doi: 10.1111/nmo.12740. Epub 2015 Dec 15.
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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. This study is not recruiting at the moment.
Kaori Futaba principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoFLIP in people with Faecal Incontinence and Asymptomatic Condition, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 5 Feb 2021. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anal distensibility with age in asymptomatic individuals assessed with EndoFLIP (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04741893, which also lists 3 linked publications.
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 5 Feb 2021; AzTrials last refreshed its copy on 28 Oct 2026.