Marla Dubinsky, MD, on Bowel Urgency Among Patients With Ulcerative Colitis

Dr Dubinsky discusses the importance of addressing bowel urgency with patients who have ulcerative colitis.

Marla Dubinsky, MD, is codirector of the Susan and Leonard Feinstein IBD Clinical Center at the Icahn School of Medicine at Mt. Sinai in New York City.

TRANSCRIPT:

Dr. Marla Dubinsky:  I'm Dr. Marla Dubinsky from the Icahn School of Medicine at Mount Sinai, in New York. I'm delighted to share with you an important topic that was really brought to center stage at this year's Digestive Disease Week. That is the topic of urgency.

When we look at what are symptoms that most impact patients' quality of life and how they rate their disease overall, it's interesting, urgency rises to the top.

What's also similarly interesting is that we don't often talk about it. We talk about as we measure the impact of IBD, particularly ulcerative colitis, on patients' quality of life, or the way we gauge the effectiveness of our therapies, or any of the disease activity indices used even for drug approval.

We focus on rectal bleeding and number of bowel movements or stool frequency, for example. The fact that a topic that patients repeatedly tell us, 1 of 2 very important topics they want to talk about at their visit, one is abdominal pain and the other one is urgency.

We know that no matter what cohort study that has been published, including a recent publication from Japan, that patients note that one of the most embarrassing topics to talk about with their physicians is urgency, particularly if there's also bowel incontinence.

We know that patients seek alternative ways to find out information on this topic, because, again, it's difficult maybe to talk about. There could also be some embarrassing life events that are tied to or were related to having an episode of urgency. For example, after eating in a restaurant, at social activities, in an intimate moment with their loved ones or partners.

The idea being that I was excited that this year, we spent a whole hour focusing on urgency. And it wasn't just me and Dr. Ghosh talking about how important it is to talk about urgency, to bring it to the forefront, to ask, flat out, patients whether this is a symptom that they're experiencing, but also, we asked a patient. We had a lovely patient named Emily, who was thrilled to be able to tell us how important this topic was for her, that it was going to be discussed in a forum such as Digestive Disease Week.

We know that when you ask even different caregivers, which is very interesting, because symptom perception in ulcerative colitis does differ between patients, physicians, and even nurses, so within providers versus patients. When we actually look to identify who is noting that urgency is a big problem for our patients, patients note it rises to the top. Physicians note it rises to the top. And nurses actually rate it as one of the most important symptoms that they like to talk about, or do believe impacts our patients, or what we call the most bothersome symptom.

As I noted, when you ask patients, what do they wish we talked about or the attributes of a therapy, for example, as I noted, urgency rises again to the top as to a symptom that they want completely resolved.

We also know when I talk about attributes relative to what makes a therapy effective or what patients agree to think, "That's why I would want this medication," obviously, efficacy of a therapy — meaning, resolution of my symptoms, particularly pain — but bowel urgency and fatigue rises to the top.

So we know that patients, from their perspective, when they're looking for a treatment, they're not asking for a mucosal healing, or for us to achieve complete histologic remission, all the things that we're searching for as targets, particularly now, even in clinical trials and the advent of adding maybe histologic outcomes as being an important aspect of UC therapies.

Patients are talking about their symptoms. So I think we cannot disassociate symptoms from an objective finding, such as a biomarker or a colonoscopy finding. We have to find a way to somehow integrate those, such that in the short term, we know we want your symptoms to get better.

And urgency and number of bowel movements are not necessarily correlatory. A patient could have one bowel movement, but if that one bowel movement is tied to urgency or bowel incontinence, it doesn't matter how many bowel movements an individual is having.

So that's why the idea that we need to listen to our patients short term, "This is what I want," be able to say, as an interim, maybe we want to get an objective marker, like a lab test, which is a fecal marker like calprotectin or maybe a reduction in an inflammatory mediator.

Then, inch our way towards having improved quality of life and associating a change in symptoms or improvement in symptoms with our objective findings, such endoscopic remission or histologic remission, and use those to say that, "As we heal your insides, urgency may in fact improve, and we see that."

However, what we don't discuss enough also is that there are other reasons why patients may have urgency, from longstanding unhealed or uncontrolled inflammation in the pelvis and you lose that compliance, potentially, of the rectum. So we do know that even patients who have a completely normal mucosa or a completely normal histologic findings, that there is still urgency.

It's really important for us to understand that there's urgency tied to active inflammation, but there's also urgency tied to just anorectal dysfunction or lack of compliance of the rectum such that it can't hold it, or they may not sense as much that they need to go, and possibly aren't able to distinguish even liquid from gas.

Our ability as clinicians and any providers that are managing IBD patients, I think we really need to address this issue with our patients. There's a lot of anxiety around, "I can't leave the house for fear of having urgency. If I don't know where the bathroom is, I won't be able to travel on, for example, public transportation for a long period of time." And that really results in this loss of mental resiliency over time that your life is not going to be the way that you imagined it to be.

I think us being able to approach urgency and flat-out just asking patients about it, and having some help for them to be able to manage the anxiety often tied to urgency, or manage the fear of having an accident, and connecting them with behavioral health specialists would be important.

We forget also that there's pelvic floor dysfunction in chronic inflammation or in anyone who's had a weakened pelvic floor. For example, women who may have had multiple pregnancies or complicated vaginal deliveries. We must be open to asking this question and not assuming that it's related to the number of bowel movements, and stop thinking that the patient will disclose independently without us asking.

Why urgency matters is, it is a marker of disease severity. It's typically missing from clinical trial disease activity measures. What started a lot of this, and my personal interest is, Eli Lilly asked me to be involved in this important initiative, starting with their Phase 2 trial for mirikizumab, which is an IL-23 for ulcerative colitis, which we're now in Phase 3 with. We evaluated how much urgency changed and how patients did, based on their urgency scores or absence and/or severity of their urgency. It was the first time we started asking it as part of a clinical trial patient-reported outcome.

We know patients want therapies to address the urgency. We know it's associated with quality of life. We know that it could be a surrogate for improved disease activity. We also know there are other factors that need to be considered. And most of all, this is a very important and difficult and often embarrassing topic for our patients to discuss.

So I think, just like when we're asking, "How are you doing? How many stools above normal? Do you have rectal bleeding? Are you having cramping? Do you have urgency? Have you had accidents? Are you able to differentiate liquid from gas?" for example, we need to start embracing this as the way we ask classic ulcerative colitis symptoms.

Just by asking, I know that our patients will be most grateful. I'm excited to see what happens next with the future studies that are incorporating urgency as part of an important patient-reported outcome in the daily management of ulcerative colitis patients. Thank you.