Patient-Reported Bowel Urgency Burden in IBD Underscores Need for Assessment in Clinical Settings

Despite the use of biologic and conventional therapies in inflammatory bowel disease (IBD), findings from a recent study highlight the significant burden of bowel urgency and bowel urgency-related accidents as reported by patients with ulcerative colitis (UC) and Crohn disease (CD).¹

The study, published in Inflammatory Bowel Diseases, qualitatively explored which aspects of bowel urgency and related accidents patients considered most bothersome and meaningful to improve, highlighting the need for the development of novel treatment strategies to reduce these experiences as well as patient-reported outcome (PRO) measures to assess bowel urgency in clinical settings.¹

“Bowel urgency is often ignored during patient–healthcare provider interactions due to the embarrassment associated with it; therefore, patients’ individual concerns may remain unaddressed,” lead investigator Vipul Jairath, MBChB, DPhil, John and Susan McDonald Endowed Chair in Inflammatory Bowel Disease Clinical Research at Western University and chief medical officer at Alimentiv, and colleagues wrote.¹ “In this context, patient-reported outcome measures are valuable tools for quantifying the patient perspectives of bowel urgency.”

Despite being a pivotal symptom influencing patient health-related quality of life, bowel urgency is not frequently included in clinical assessments or clinical trial endpoints in IBD. However, recent US Food and Drug Administration guidelines encourage the exploration of bowel urgency in UC and CD, highlighting the need for a more comprehensive understanding of patient experiences.^2,3

To explore bowel urgency and bowel urgency-related accidents and further identify the concepts most important to patients, investigators conducted concept elicitation interviews via telephone or Web-enabled teleconference with adult participants ≥18 years of age who were diagnosed with moderate-to-severe UC or CD for ≥6 months and had experienced bowel urgency in the past 6 months.¹

Researchers trained in qualitative interviewing techniques from Adelphi Values conducted semi-structured interviews with a total of 30 patients from September 27, 2021, to December 8, 2021. Participants were asked to describe the experiences and impacts of bowel urgency and bowel urgency-related accidents as well as the aspects of bowel urgency experience that are most bothersome and how they define meaningful improvement in bowel urgency.¹

Among the interviewees enrolled in the study, 15 had UC and 15 had CD. Both cohorts were predominantly female (53.3%), although patients with UC were slightly older (51.6, ± 19.8 years vs 50.0, ± 16.8 years) and more frequently reported experiencing bowel urgency in the past week (60% vs 53.3%). However, investigators noted more patients with CD were reported by their clinicians to have severe disease (46.7%) compared to patients with UC (26.7%).¹

The majority of participants in both groups were receiving biologic and/or conventional therapy (80% for UC and 87% for CD). Despite this, investigators noted most participants with UC (87%) and all with CD (100%) reported experiencing bowel urgency-related accidents.¹

Abdominal pain or abdominal cramps and frequency of bowel urgency were reported as the most bothersome aspects of bowel urgency in patients with UC. The urgent need to use or be near the bathroom, uncertainty of the condition, fear of experiencing an accident, and all aspects of bowel urgency were found to be the most bothersome in patients with CD.¹

Patients with UC most frequently reported adaptive behaviors (100%), emotional functioning (86.7%), and social functioning (66.7%) as impact domains, while the most frequently reported impact concepts were dietary changes (73.3%), inability to participate in social activities (66.7%), and difficulty running errands (60.0%). Similarly, investigators pointed out patients with CD frequently reported adaptive behaviors (100%), emotional functioning (86.7%), and social functioning (66.7%) as impact domains, additionally citing household chores (66.7%), recreational/leisure activities (66.7%), and travel (53.3%). Dietary changes (80.0%), embarrassment (60.0%), and social isolation (53.3%) were the most frequently reported impacts.¹

Patients with UC described decreased frequency of bowel urgency, abdominal pain, decrease in the severity of bowel urgency, and improved control as the aspects of bowel urgency that were meaningful to improve. Patients with CD cited bowel urgency frequency, complete resolution/reduced bathroom visits due to bowel urgency, abdominal pain, and having more time to get to the bathroom as the aspects of bowel urgency that were meaningful to improve.¹

“Assessment of bowel urgency and bowel urgency-related accidents must be considered in clinical trials and by healthcare providers in routine clinical examinations,” investigators concluded.¹ “Our findings may facilitate the development of appropriate PRO measures to assess and discuss bowel urgency in clinical practice and clinical trials, manage symptoms, and disseminate the impacts of treatments on disease activity and severity.”

References:

1. ^{Jairath V, Hunter Gibble T, Potts Bleakman A, et al. Patient Perspectives of Bowel Urgency and Bowel Urgency-Related Accidents in Ulcerative Colitis and Crohn’s Disease, Inflammatory Bowel Diseases, 2024;, izae044, https://doi.org/10.1093/ibd/izae044}
2. ^{US Food and Drug Administration. Crohn’s Disease: Developing Drugs for Treatment Guidance for Industry. April 2022. Accessed March 28, 2024. https://www.fda.gov/media/158001/download}
3. ^{US Food and Drug Administration. Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry. April 2022. Accessed March 28, 2024. https://www.fda.gov/media/158016/download}