Bowel Urgency in Inflammatory Bowel Disease (URGENT-1)

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 Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Other: Collection of data related to bowel urgency

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Neuilly-sur-Seine, France, 92200
    • Institut des MICI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Inflammatory bowel disease patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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
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
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	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	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)	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	Through study completion, an average of 12 months

Collaborators and Investigators

• Sponsor: Paris IBD Center

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: October 1, 2023
• First Submitted That Met QC Criteria: October 1, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: IBD; Bowel urgency; URGENT index; UNRS (Urgency Numeric Rating Scale); GVE (Global Visual Evaluation)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: PIBDC-2023-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No