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Completed

NCT Number: NCT06069167

Bowel Urgency in Inflammatory Bowel Disease

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut des MICI

Neuilly-sur-Seine, 92200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: Through study completion, an average of 12 months

    Inability to defer defecation for more than 15 minutes in patients with Crohn's disease

  2. Prevalence of bowel urgency in a cohort of ulcerative colitis patients

    Time frame: Through study completion, an average of 12 months

    Inability to defer defecation for more than 15 minutes in patients with ulcerative colitis

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

    Time frame: Through study completion, an average of 12 months

    Components of the index based on variables describing in systematic review Caron B et al. Clin Gastroenterol Hepatol. 2023 and IBD expert opinion

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

    Time frame: Through study completion, an average of 12 months

    Inability to defer defecation for more than 15 minutes and potentially predictive factors (i.e. baseline characteristics)

  5. Correlation between the URGENT index and the Urgency Numeric Rating Scale

    Time frame: Through study completion, an average of 12 months

    Relationships between changes in the URGENT index and changes in the Urgency Numeric Rating Scale

  6. Correlation between the URGENT index and a Global Visual Evaluation

    Time frame: Through study completion, an average of 12 months

    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)

  7. Most appropriate definition of bowel urgency for patients with IBD

    Time frame: Through study completion, an average of 12 months

    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

Sponsors and collaborators

Lead sponsor

Paris IBD Center

Other

Registry information

Acronym: URGENT-1

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2023
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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