AnismusEndo-DCNCT04155307
Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?
A study testing Anal EndoFLIP®, Anal Manometry and Defecography in people with Anismus and Distal Constipation, run by University Hospital, Rouen at 1 site in France.
Trial summary
Terminal constipation affects 13 to 20% of the french population. Anismus is defined by an absence of relaxation or a paradoxical contraction of the striated anal sphincter muscle during defecation. Anismus is one of the main causes of terminal constipation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anismus, Distal Constipation
- What is being tested?
- Anal EndoFLIP®, Anal Manometry and Defecography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2020to 21 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient older than 18 years
- patient with distal constipation defined according to the Rome IV criteria, for at least 3 months and verified by a transit time study showing a predominant slowing of markers at the recto-sigmoid level.
- patient who read and signed the informed consent form
Who cannot join
- Patients with a predominant right of left colonic constipation;
- Pregnant woman or woman with no effective contraception and of childbearing age
- Patient with inflammatory bowel disease, ischemic colitis, history of colon or rectal cancer, infectious colitis or proctologic disease.
- Patient with anorectal malformation
- Patient with an history of pelvic floor radiotherapy
- Patient with a digestive stoma
Show all 11Show fewer
- Insertion of the probe impossible or painful
- Patient who has participated to a clinical trial within 30 days prior to the inclusion visit
- Patient not understanding or reading French
- Patients under guardianship, curatorship, safeguard of justice
- Patient without liberty by administrative or judicial decision
Trial locations and contacts
1 site in 1 country.
About this study
Terminal constipation affects 13 to 20% of the french population. Anismus is defined by an absence of relaxation or a paradoxical contraction of the striated anal sphincter muscle during defecation.
Anismus is one of the main causes of terminal constipation. Anismus diagnosis is retained if 2 out of 3 examinations (manometry, electromyogram, defecography) are positive.
Read more
EndoFLIP® is a new medical device developed to measure distensibility of a hollow organ. Anal EndoFLIP® l could be a more sensitive and specific tool for detecting anismus in patients with distal constipation.
60 patients suffering from distal constipation will be included in order to perform, in addition to the usual examinations, an anal EndoFlip in order to test the sensitivity and specificity of this method for the diagnosis of anismus.
- Conditions
- Anismus, Distal Constipation
- Being tested
- Anal EndoFLIP®, Anal Manometry, Defecography, Electromyogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal EndoFLIP®Device
Anal EndoFLIP® measure to evaluate anal compliance
Anal ManometryDiagnostic test
Anal Manometry done in standard care
DefecographyDiagnostic test
Defecographydone in standard care
ElectromyogramDiagnostic test
Electromyogram done in standard care
| Study group | Role | What they receive |
|---|---|---|
| Detection of anismus in patients with distal constipation | Experimental | Not described Receives: Device: Anal EndoFLIP®; Diagnostic Test: Anal Manometry; Diagnostic Test: Defecography; Diagnostic Test: Electromyogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
Measured: 30 min
Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start14 Jan 2020
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnismusStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura BRIL, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155307
- Sponsor's protocol ID
- 2018/0347/HP
- Acronym
- Endo-DC
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desprez C, Duflot T, Melchior C, Gourcerol G, Zifan A, Houivet E, Savoye-Collet C, Leroi AM. Diagnostic Value of the Anal Endoluminal Functional Luminal Imaging Probe for the Diagnosis of Anismus: An Exploratory Study. Neurogastroenterol Motil. 2026 Oct;38(10):e70452. doi: 10.1111/nmo.70452.
PubMed 42823906
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?
- ClinicalTrials.gov ID
- NCT04155307
- Acronym / sponsor ID
- Endo-DC / 2018/0347/HP
- Conditions
- Anismus, Distal Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 7 Nov 2019 (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.
Terminal constipation affects 13 to 20% of the french population. Anismus is defined by an absence of relaxation or a paradoxical contraction of the striated anal sphincter muscle during defecation.
Anismus is one of the main causes of terminal constipation. Anismus diagnosis is retained if 2 out of 3 examinations (manometry, electromyogram, defecography) are positive.
EndoFLIP® is a new medical device developed to measure distensibility of a hollow organ. Anal EndoFLIP® l could be a more sensitive and specific tool for detecting anismus in patients with distal constipation.
60 patients suffering from distal constipation will be included in order to perform, in addition to the usual examinations, an anal EndoFlip in order to test the sensitivity and specificity of this method for the diagnosis of anismus.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Detection of anismus in patients with distal constipation | Experimental | Device: Anal EndoFLIP®, Diagnostic Test: Anal Manometry, Diagnostic Test: Defecography, Diagnostic Test: Electromyogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient older than 18 years
- patient with distal constipation defined according to the Rome IV criteria, for at least 3 months and verified by a transit time study showing a predominant slowing of markers at the recto-sigmoid level.
- patient who read and signed the informed consent form
Key exclusion criteria (11 listed)
- Patients with a predominant right of left colonic constipation;
- Pregnant woman or woman with no effective contraception and of childbearing age
- Patient with inflammatory bowel disease, ischemic colitis, history of colon or rectal cancer, infectious colitis or proctologic disease.
- Patient with anorectal malformation
- Patient with an history of pelvic floor radiotherapy
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 |
|---|---|---|
| Anal EndoFLIP®Anal EndoFLIP® measure to evaluate anal compliance | Device | Detection of anismus in patients with distal constipation |
| Anal ManometryAnal Manometry done in standard care | Diagnostic test | Detection of anismus in patients with distal constipation |
| DefecographyDefecographydone in standard care | Diagnostic test | Detection of anismus in patients with distal constipation |
| ElectromyogramElectromyogram done in standard care | Diagnostic test | Detection of anismus in patients with distal constipation |
Primary outcome
Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
Time frame: 30 min
Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
Time frame: 30 min
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 13 Oct 2026.
- Results publication: PubMed 42823906Desprez C, Duflot T, Melchior C, Gourcerol G, Zifan A, Houivet E, Savoye-Collet C, Leroi AM. Diagnostic Value of the Anal Endoluminal Functional Luminal Imaging Probe for the Diagnosis of Anismus: An Exploratory Study. Neurogastroenterol Motil. 2026 Oct;38(10):e70452. doi: 10.1111/nmo.70452.
- Individual participant dataSharing planned: No
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.
Laura BRIL, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anal EndoFLIP®, Anal Manometry and Defecography in people with Anismus and Distal Constipation, run by University Hospital, Rouen at 1 site in France.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 13 Oct 2026. 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 France. 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?
Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus (time frame: 30 min). 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 NCT04155307, which also lists 1 linked publication.
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 13 Oct 2026.