Inflammatory Bowel DiseasesURGENT-1NCT06069167
Bowel Urgency in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Paris IBD Center at 1 site in France.
Trial summary
Bowel urgency is commonly defined as the sudden need to rush to the bathroom to empty one's bowel. In the field of inflammatory bowel disease (IBD) (including Crohn's disease (CD) and ulcerative colitis (UC)), bowel urgency is part of the top five research priorities for future IBD nursing research, and it is a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Collection of data related to bowel urgency
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2023to 22 Mar 2024
- 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: Inflammatory bowel disease patients
Who may be able to join
- Male or female, aged at least 18 years old
- Diagnosis of inflammatory bowel disease according to the European Crohn´s and Colitis Organisation criteria for at least 3 months
- Person who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data
- Person affiliated to or beneficiary of a social security plan
Who cannot join
- Person unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Bowel urgency is commonly defined as the sudden need to rush to the bathroom to empty one's bowel. In the field of inflammatory bowel disease (IBD) (including Crohn's disease (CD) and ulcerative colitis (UC)), bowel urgency is part of the top five research priorities for future IBD nursing research, and it is a symptom that patients consider to be most important when prioritizing their disease control. Urgency is a patient-reported outcome associated with compromised quality of life and future risk of hospitalizations, corticosteroids, and colectomy in patients with UC.
A meta-analysis of 321 studies examining bowel urgency revealed that only one-third of these clinical studies clearly defined the concept of bowel urgency. Definition of bowel urgency was heterogeneous as 14 different definitions were identified. In most of these studies, non-validated questionnaires were used. They are based on subjective responses of the patients, and they could determine evaluation bias. These data emphasize the lack of standardization in bowel urgency assessment.
- Being tested
- Collection of data related to bowel urgency
- Keywords
- Bowel urgency, URGENT index, IBD, UNRS (Urgency Numeric Rating Scale), GVE (Global Visual Evaluation)
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of data related to bowel urgencyOther
Data will be extracted from the patient's medical record and patients will be interviewed to collect data specific to the research
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of bowel urgency in a cohort of patients with inflammatory bowel disease
Inability to defer defecation for more than 15 minutes in patients with inflammatory bowel disease
Measured: Through study completion, an average of 12 months
Secondary outcomes (7)
Prevalence of bowel urgency in a cohort of Crohn's disease patients
Inability to defer defecation for more than 15 minutes in patients with Crohn's disease
Measured: Through study completion, an average of 12 months
Prevalence of bowel urgency in a cohort of ulcerative colitis patients
Inability to defer defecation for more than 15 minutes in patients with ulcerative colitis
Measured: Through study completion, an average of 12 months
Development of the URGENT index (i.e. inflammatory bowel disease-specific bowel urgency index)
Components of the index based on variables describing in systematic review Caron B et al. Clin Gastroenterol Hepatol. 2023 and IBD expert opinion
Measured: Through study completion, an average of 12 months
To identify IBD-related risk factors associated with an increased risk of bowel urgency
Inability to defer defecation for more than 15 minutes and potentially predictive factors (i.e. baseline characteristics)
Measured: Through study completion, an average of 12 months
Correlation between the URGENT index and the Urgency Numeric Rating Scale
Relationships between changes in the URGENT index and changes in the Urgency Numeric Rating Scale
Measured: Through study completion, an average of 12 months
Correlation between the URGENT index and a Global Visual Evaluation
Relationship between changes in the URGENT index and changes in the Global Visual Evaluation on a 10-point visual analog scale ranging from 0 (minimal activity) to 10 (maximal activity)
Measured: Through study completion, an average of 12 months
Most appropriate definition of bowel urgency for patients with IBD
Urgent desire to defecate and/or extreme desire to defecate and/or immediate need to defecate and/or inability to defer defecation for more than 2 minutes and/or inability to defer defecation for more than 5 minutes and/or inability to defer defecation for more than 20 minutes and/or inability to defer defecation for more than 30 minutes and/or having to rush to the toilet and/or not making it to a toilet in time and/or having to stop whatever to have a bowel movement and/or difficult to withstand urge to open bowels and/or running to the bathroom and/or inability to delay bowel movements
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start12 Oct 2023
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris IBD Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069167
- Sponsor's protocol ID
- PIBDC-2023-01
- Acronym
- URGENT-1
- Status last verified
- Mar 2024
- First submitted
- 1 Oct 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Urgency in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06069167
- Acronym / sponsor ID
- URGENT-1 / PIBDC-2023-01
- Keywords
- Bowel urgency, URGENT index, IBD, UNRS (Urgency Numeric Rating Scale), GVE (Global Visual Evaluation)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Paris IBD CenterUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 5 Oct 2023 (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.
Bowel urgency is commonly defined as the sudden need to rush to the bathroom to empty one's bowel. In the field of inflammatory bowel disease (IBD) (including Crohn's disease (CD) and ulcerative colitis (UC)), bowel urgency is part of the top five research priorities for future IBD nursing research, and it is a symptom that patients consider to be most important when prioritizing their disease control. Urgency is a patient-reported outcome associated with compromised quality of life and future risk of hospitalizations, corticosteroids, and colectomy in patients with UC.
A meta-analysis of 321 studies examining bowel urgency revealed that only one-third of these clinical studies clearly defined the concept of bowel urgency. Definition of bowel urgency was heterogeneous as 14 different definitions were identified. In most of these studies, non-validated questionnaires were used. They are based on subjective responses of the patients, and they could determine evaluation bias. These data emphasize the lack of standardization in bowel urgency assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inflammatory bowel disease patients
Key inclusion criteria (4 listed)
- Male or female, aged at least 18 years old
- Diagnosis of inflammatory bowel disease according to the European Crohn´s and Colitis Organisation criteria for at least 3 months
- Person who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data
- Person affiliated to or beneficiary of a social security plan
Key exclusion criteria (1 listed)
- Person unable to comply with study procedures
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 |
|---|---|---|
| Collection of data related to bowel urgencyData will be extracted from the patient's medical record and patients will be interviewed to collect data specific to the research | Other | – |
Primary outcome
Prevalence of bowel urgency in a cohort of patients with inflammatory bowel disease
Time frame: Through study completion, an average of 12 months
Inability to defer defecation for more than 15 minutes in patients with inflammatory bowel disease
7 secondary outcomes
Prevalence of bowel urgency in a cohort of Crohn's disease patients
Time frame: Through study completion, an average of 12 months
Prevalence of bowel urgency in a cohort of ulcerative colitis patients
Time frame: Through study completion, an average of 12 months
Development of the URGENT index (i.e. inflammatory bowel disease-specific bowel urgency index)
Time frame: Through study completion, an average of 12 months
To identify IBD-related risk factors associated with an increased risk of bowel urgency
Time frame: Through study completion, an average of 12 months
Correlation between the URGENT index and the Urgency Numeric Rating Scale
Time frame: Through study completion, an average of 12 months
Correlation between the URGENT index and a Global Visual Evaluation
Time frame: Through study completion, an average of 12 months
Most appropriate definition of bowel urgency for patients with IBD
Time frame: Through study completion, an average of 12 months
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 26 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inflammatory Bowel Diseases and Crohn Disease, run by Paris IBD Center 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 4 inclusion and 1 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 26 Mar 2024. 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?
Prevalence of bowel urgency in a cohort of patients with inflammatory bowel disease (time frame: Through study completion, an average of 12 months). 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 26 Mar 2024.