Digital therapeutics: A potential new care pathway for patients with OAB

In this interview, David Sheyn, MD, discusses the recent study, “Use of a digital conversational agent for the management of overactive bladder,”¹ for which he served as the lead author. Sheyn is the Division Chief of Female Pelvic Medicine at University Hospitals and an assistant professor of urology and reproductive biology at Case Western Reserve University in Cleveland, Ohio.

This transcription has been edited for clarity.

David Sheyn, MD

Could you highlight the background/rationale for this study?

I think everybody knows that overactive bladder [OAB] is a very common and bothersome condition affecting tens of millions of people in the United States, and maybe up to half a billion in the world. The main issue with OAB, like other pelvic floor disorders, is the intimate nature of these conditions. Patients may not want to talk about it with their doctors. They may not even know that this is something abnormal that can be treated, so we're probably only getting to a fraction of people that are affected by this condition. Potentially, 1 way to get to more patients and improve access to care is to have something that they can get at home that provides validated information by pelvic floor therapists, nurses, and physicians, especially urogynecologists, that the patients can then use to help themselves get better.

Could you go more in depth with the methodology and design of this study?

I'll just back up a little bit and tell you about Renalis, the company that created CeCe. This is a Cleveland-based company that created this digital therapeutic. They named it CeCe, just for patient comfort and to anthropomorphize this device. It is a digital conversational agent. It's based on artificial intelligence algorithms, so it can interact with patients and make it seem a little more human. The device contains information about pelvic floor exercises, which it then guides patients through. This has been validated by both urogynecologists and pelvic floor therapists. Patients do this for 5 to 10 minutes a day as often as they want, for as long as they want, theoretically. For the study, we did this for 8 weeks. We selected this number because a lot of the major pelvic floor therapy trials have been done over 8 weeks to see an improvement. Since this was a pilot and proof of concept, that's what we decided on.

The device also has a voiding dairy, which is very easy to use, even easier than the paper-and-pencil one. They made it a little fun to put things in there; it tracks their bladder irritant intake, their fluid intake, how much is coming out, and then their number of voiding events, so frequency, urgency, incontinence, and getting up at night. For the study, we thought that we would look at a single group of people and use them as their own controls. The primary outcome was the International Consultation on Incontinence—Overactive Bladder Quality-of-Life Questionnaire (ICIQ-OAB-QoL). This has been validated to measure quality of life and quality of life improvement. The main outcome was a 20% reduction, which was considered the minimally important difference in patient outcomes. We followed these patients for 8 weeks. We did baseline questionnaires, baseline voiding diary, and then we checked again at 4 weeks, and then again at 8 weeks in the trial. At 8 weeks, we also looked at the usability, because this is a digital device requiring a smartphone. A lot of our patients are older, so we wanted to make sure that this is accessible to them and that they can use it.

For homogeneity, we excluded patients who might have prolapse that's symptomatic, who had recent surgery, or if there was any evidence of neurologic issues or urinary tract infections.

What were the key findings from the study?

We looked at a total of 57 patients, and of those, 32 agreed to participate. Then, 29 [patients] completed all research activities. The median age was around 61. Patients had an average BMI of almost 30, which is roughly reflective of the country. What we basically found was that all patients reported improvement in their symptoms. At baseline, the OAB quality of life score was 62, and that decreased to 32. This was the median score. So, this is way more than 20%. And 30% of patients reported that they were very much better, 14% that they were much better, and 6% indicated that they were a little better.

In addition, we looked at quality of life using the 36-item Short-Form Health Survey and their level of anxiety [using the Generalized Anxiety Disorder Questionnaire]. Their quality of life and their overall health perception improved from baseline to week 8. Their anxiety levels dropped from baseline to week 8.

Also, the majority of patients reported that this was very usable. They had a usability score of 92.5; anything in the 90 to 100 range is considered universally usable.

You mentioned that this might help to increase access to care. Could you expand on this potential implication?

Let's say a patient gets to me, which is hard from the get-go—there's not a ton of urogynecologists or even urologists or gynecologists. So, it might take an average of 3 to 6 months to get to a doctor from the referral. The average time from onset of symptoms to getting treatment is 4 to 7 years. Even if I saw the patient, and I said, "Hey, this is what you have, let's try some conservative therapy, let's head to physical therapy," then you have to find a pelvic floor therapist, [which are even more] rare than urogynecologists. Often, you have a months long wait. They might not be available in the location that the patient is at. Patients have kids, they have jobs, they have spouses, so they can't go as often. This [agent is] potentially a nice adjunct to what they can do.

[Patients] also might just find this app [by] just scrolling through the App Store. I've looked and there's not a ton for pelvic floor apps, and this is a really high-quality digital app. So, they might say, "Hey, maybe I'll give this a shot." Maybe even if they don't get better, then the next step, may be, "You know what, I tried. This is bothersome. Let me go talk to a doctor about it." So, I think it'll improve awareness about these conditions.

We just submitted a small grant to the NIH [National Institutes of Health] looking at a purely virtual care pathway for OAB. So, that would incorporate telehealth. Basically, patients, on their new patient visit before they see anyone, they'll get randomized to a virtual visit vs an in-person visit. If they're in the virtual group, they'll see us. Assuming there's no red flags, we'll just sign them up for CeCe, and then follow them for 6 months. If they go to the in-person group, we will see them in person, do our analysis and evaluation, and then send them to pelvic floor therapy in person like we would usually do. The outcome is going to be at 6 months, how good are you doing? We're not going to wait for them to start physical therapy. One of the criticisms might be we're not giving a fair comparison, but we're measuring access. We're not measuring whether one is better than the other; just overall, how does this perform compared to standard in-person care, especially in an area that doesn't have a lot of doctors and doesn't have a lot of physical therapists? Funnily enough, in the county that we're looking at, there's a fair number of pelvic floor therapists, which is great. But there are a lot of communities that are health care deserts. So, I think it will greatly help with that.

I also think for this specific application, there's a lot of utility for interfacing with the medical record system, where [we can track if the patient] is on medication. We can track them and see how they're doing with voiding diaries. The app can say, "Hey, it doesn't look like you're getting any better based on these voiding diaries. Do you want us to make a referral to a urogynecologist to talk about other therapies?" It would really automate things and make things easier for us.

[Then we have the] EMPOWER trial, which is looking at incontinence in primary care and having a nurse navigator vs CeCe. A human person is great, but you don't always have access to it. There's a health care worker shortage. We're in the process of analyzing the data, but the obvious answer is that this is better than what we currently have, which is nothing, to guide patients into the health care system to help them improve their quality of life.

So, I mentioned the small NIH grant. We have the EMPOWER grant. I definitely think [we’re] now looking at doing a randomized control trial, which the NIH is, but maybe in a larger population and comparing it to either a sham app or in-person care, and maybe looking at other locations with barriers to care. Not necessarily rural areas, but maybe urban areas where people also have similar obstacles to getting in-person care, like kids, transportation, whatever.

I think digital therapeutics and virtual care are going to expand access. It's never going to be as good in my mind as an in-person visit, just because of the warmth—not every visit is great for people, but a lot of times [patients] like that human interaction. That's why I'm not really worried about AI replacing doctors. This will be a very useful adjunct. Especially once we've established care, I don't need to see somebody all the time. This is a nice way to keep people engaged. [It's] almost like a glucose monitor for diabetics, but for pee.

[We could] maybe even expand this to other things. We could do it for menstrual pain, we could do it for infertility. The origin of CeCe was actually for looking at menstrual disorders in adolescent girls. They had tracking for pads for heavy bleeding, and it worked well for that and actually helped their parents. So, you could do something like that. You could even incorporate UTI symptoms into this, because I know UTIs are a big issue for people. The sky's the limit. I think this is the future.

Is there anything else you wanted to add?

I'm excited to see what the EMPOWER data is going to show. I'm really excited to keep working with Renalis. I think they've been great partners. The CEO is a former patient and the CMO is a urogynecologist, so they have the street cred to push this technology. I'm excited to continue working with them.

Reference

1. Sheyn D, Chakraborty N, Chen YB, Mahajan ST, Hijaz A. Use of a digital conversational agent for the management of overactive bladder. Urogynecology (Phila). 2024;30(6):536-544. doi:10.1097/SPV.0000000000001428