Bowel Urgency in Inflammatory Bowel Disease

NCT06069167 | Completed

• 1 other identifier: PIBDC-2023-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

Bowel urgency; URGENT index; IBD; UNRS (Urgency Numeric Rating Scale); GVE (Global Visual Evaluation)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Prevalence of bowel urgency in a cohort of Crohn's disease patients

  Through study completion, an average of 12 months

• Prevalence of bowel urgency in a cohort of ulcerative colitis patients

  Through study completion, an average of 12 months

• Development of the URGENT index (i.e. inflammatory bowel disease-specific bowel urgency index)

  Through study completion, an average of 12 months

• To identify IBD-related risk factors associated with an increased risk of bowel urgency

  Through study completion, an average of 12 months

• Correlation between the URGENT index and the Urgency Numeric Rating Scale

  Through study completion, an average of 12 months

Interventions

Collection of data related to bowel urgency OTHER

Data will be extracted from the patient's medical record and patients will be interviewed to collect data specific to the research

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inflammatory bowel disease patients

You may qualify if:

• 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

You may not qualify if:

• Person unable to comply with study procedures

Sponsors & Collaborators

• Paris IBD Center: lead

Study Sites (1)

Institut des MICI

Neuilly-sur-Seine, 92200, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 5, 2023
• Study Start: October 12, 2023
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

FR (1)