Bowel Urgency in Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

— URGENT-1  

Official title:

Bowel Urgency in Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06069167
• Other study ID #: PIBDC-2023-01
• Status: Completed
• Start date: October 12, 2023
• Est. completion date: March 22, 2024

Study information

• Verified date: March 2024
• Source: Paris IBD Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
France	Institut des MICI	Neuilly-sur-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Paris IBD Center

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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