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Faecal IncontinenceNCT04410822

Fecal Incontinence Type Assessment Scale

An observational study of Faecal Incontinence, run by Gérard Amarenco at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Urge faecal incontinence (FI) and passive FI are the two subgroups of FI described by the International Continence Society. Urge FI is described as "the inability to defer defecation once the urge is perceived for long enough to reach a toilet" and passive FI as "the involuntary leakage of faeces without forewarning". Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Faecal Incontinence
What is being tested?
Clinical tests
Type of treatment
Injection or infusion
How many people
150 participants
Where
1 siteFrance
Study dates
1 Dec 2019to 30 Jun 2020
Phase
Observational
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

Study population: Patients consulting in a tertiary center in neuro-urology

Who may be able to join

  • age older than 18 years old
  • symptoms of FI according to Rome IV criteria

Who cannot join

  • Anorectal fistula
  • Active inflammatory bowel disease
  • Anorectal malignant tumor not treated
  • Rectal or hemorrhoidal prolapses
  • Specific inability regarding the questionnaire (i.e. cognitive disorders, inability to read and to understand questions)

Trial locations and contacts

1 site in 1 country.

France1 site
  • Charlotte Desprez

    Paris, 75020

Other trials in France

About this study

Official title: Fecal Incontinence Type Assessment Scale (FITAS): a New Tool to Distinguish Among Subgroups of Fecal Incontinence

Urge faecal incontinence (FI) and passive FI are the two subgroups of FI described by the International Continence Society. Urge FI is described as "the inability to defer defecation once the urge is perceived for long enough to reach a toilet" and passive FI as "the involuntary leakage of faeces without forewarning". If several validated questionnaires are available for FI, all of these questionnaires were developed to assess FI severity. In literature, there is only a small number of studies that investigated clinical and paraclinical characteristics of the different phenotype of FI. Moreover, there is an heterogenicity in the definitions used for both urge and passive FI among these studies. Lastly, patients with mixed FI were commonly excluded from these studies. It can be established that there is a lack of validate tools to distinguish patients between subgroups of FI.

The aim of the present study was to develop and to validate a new tool in order to investigate and classify patients among the different subgroups of FI (active, passive and mixed) defined by Rome IV criteria.

Read more

A monocentric prospective study was conducted in the Neuro-urology Department of a University Hospital. All consecutive patients presenting in the Department with FI between December 2019 and June 2020 were screened for inclusion in the present study. Criteria of inclusion were an age older than 18 years old and symptoms of FI according to Rome IV criteria. Exclusion criteria were anorectal fistula, active inflammatory bowel disease, anorectal malignant tumor not treated, rectal or hemorrhoidal prolapses and specific inability regarding the questionnaire (i.e. cognitive disorders, inability to read and to understand questions).

Phase 1: review of literature and qualitative interviews: To determine the dimensions of the different subgroups of faecal incontinence, a literature review was performed using Pubmed without date limitation until February 2020. The key words used were "active faecal incontinence", "active fecal incontinence", "passive faecal incontinence", "passive fecal incontinence", "urge faecal incontinence", "urge fecal incontinence", "questionnaire", "scale", "score" and "tool". In parallel to this literature review, semi-structured interviews were performed on 20 patients from December 2019 to February 2020. During this phase, a panel expert of 9 neuro-urologists and gastroenterologists was composed. At the term of all interviews, dimensions that were both the most used by patients and the most discriminative among subgroups of FI were included in the questionnaire. Redaction of questions was then performed by the panel expert.

Phase 2: feasibility study: The feasibility study was conducted from February to April 2020 on 30 patients. Each patient was asked to rate each version of the 2 questions with a four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding acceptance and comprehension of the questions.

Phase 3: validation study: To investigate the psychometric properties of the questionnaire, a validation study was performed from April to June 2020 on 100 consecutive patients. In order to evaluate the FITAS' test reproducibility, patients were asked to answer a second time the questionnaire by mail with a second evaluation from 7 days to 10 days after the first one. The "intra-class correlation coefficient" (ICC) was used to determine if these evaluations could lead to similar results for each question. An ICC > 0.70 was necessary to define reproducibility.

Being tested
Clinical tests
Medical subject headings
Encopresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical testsOther

    Semi-qualitative interviews and questionnaire FITAS

Study groups in NCT04410822
Study groupRoleWhat they receive
Patients enrolledan age older than 18 years old and symptoms of FI according to Rome IV criteria.
Receives: Other: Clinical tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reproducibility of FITAS

    Patients were asked to answer a second time the questionnaire by mail with a second evaluation from 7 days to 10 days after the first one. The "intra-class correlation coefficient" (ICC) was used to determine if these evaluations could lead to similar results for each question. An ICC > 0.70 was necessary to define reproducibility.

    Measured: 1 day

  2. Acceptability of FITAS

    Each patient was asked to rate acceptability of FITAS with a four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding acceptance and comprehension of the questions.

    Measured: 1 day

  3. comprehension of FITAS

    Each patient was asked to rate comprehension of FITAS with a four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding acceptance and comprehension of the questions.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start1 Dec 2019
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

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
Cohort
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04410822
Sponsor's protocol ID
GREEN GRC01 FITAS
Status last verified
Feb 2022
First submitted
28 May 2020
Last updated
4 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Faecal Incontinence, run by Gérard Amarenco 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 2 inclusion and 5 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 4 Mar 2022. 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?

Reproducibility of FITAS (time frame: 1 day). The study lists 3 primary outcomes in all. 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 4 Mar 2022.

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