Bowel Urgency in Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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. Caron et al. summarized data from 321 studies evaluating bowel urgency (Caron B et al. Clin Gastroenterol Hepatol. 2023). Only one third of these clinical studies clearly defined 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.

Official Title
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Bowel Urgency in Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Other: Collection of data related to bowel urgency


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Person unable to comply with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Collection of data related to bowel urgency|Data will be extracted from the patient's medical record and patients will be interviewed to collect data specific to the research|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the 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 | Through study completion, an average of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the 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 | Through study completion, an average of 12 months | 
| To estimate the 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 | Through study completion, an average of 12 months | 
| To develop 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 | 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) | Through study completion, an average of 12 months | 
| To evaluate 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 | Through study completion, an average of 12 months | 
| To evaluate 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) | Through study completion, an average of 12 months | 
| To determine the 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 | Through study completion, an average of 12 months |