"UH is working on starting clinics throughout rural Northeast Ohio, and we're meeting to develop a FPMRS program, both virtual and in-person, so patients can have access to this point of care," says David Sheyn, MD.
In this interview, David Sheyn, MD, discusses the new studies and specialty clinics at University Hospitals (UH) in Cleveland, Ohio. Sheyn was just named the Division Chief of Female Pelvic Medicine at UH, and he is also an assistant professor of urology and reproductive biology at Case Western Reserve University in Cleveland, Ohio.
I assumed this position in the beginning of 2023 in January, and I took over for my partner and mentor Adonis Hijaz [,MD], who has done a great job. My mission is to grow our research program into the premier research program in FPMRS [female pelvic medicine and reconstructive surgery] in the country, to grow our division and increase our presence throughout Northeast Ohio, as well as to develop more niche practices for each of our partners and members of the division.
The EMPOWER study is funded by the Agency for Healthcare Research and Quality, and it's in partnership with the Primary Care Institute at University Hospitals. What we're doing is screening patients coming in for their primary care visits for incontinence, and then ones that are bothered by it, we are either randomizing to standard care and follow-up—which is what people are currently getting, sometimes that's medication, sometimes that's nothing–and to 2 other experimental arms. One arm is a nurse navigator that interacts with the patient at different intervals that are pre-specified by the study to help guide them through treatment, and if they're successful, to discharge them, or if they're not successful to increase their referral to urogynecology or female urology. The other arm is with one of our industry partners Renalis, which has a digital platform for urinary incontinence that is driven by the patient. So, the patient gets signed up for this app on their phone, and then they can interact with this device and it helps them manage their symptoms. If their symptoms are no better, then they also get referred to a urogynecologist.
The overarching goal is to both increase the identification of patients with urinary incontinence as well as shorten the time between diagnosis and appropriate treatment, either at the primary care level or at the specialist level. Currently, the average amount of time it takes is around 4 years from diagnosis to treatment. The bar is pretty low to improve. We will have some publishable results [on that study] within the next few years.
We have several both industry and publicly sponsored trials. We have an application with our urology colleagues to look at the risk of anticholinergics and dementia in patients with OAB. It's one of the hottest topics in our field, but all of the data are associative; they’re not causative. There's a lot of what we call protopathic bias, which is that the condition of OAB may be associated with dementia symptoms as much as the medication itself. We have no concrete evidence that these medications are necessarily so harmful that we should completely eradicate them from our treatment armament [because] they represent a giant chunk of what we can do for people.
This study is going to look at beta agonists, which are not supposed to have these kinds of effects, anticholinergics that have previously not been studied, and anticholinergics that have been associated with these risks, as well as a control group, who are not on any medications and without OAB. We're going to follow them over 2 years and see if they have any short- and intermediate- term outcomes with regard to their cognition. We're working with Dr. Charles Duffy, who is the head of the Memory Center at UH and is a very prominent memory loss researcher.
We have just completed another study with Renalis, which was a pilot to demonstrate that [their] device works. The results are currently in peer review. We basically found that having some kind of interactive device to facilitate bladder training and pelvic floor muscle therapy is very effective in the treatment of OAB. We believe that these kinds of digital therapeutics are going to increase access for patients, because they're not as expensive as seeing a physical therapist, and they're also more widely available. A pelvic floor physical therapist is extremely important to our practices, but they're not always around. Patients may not be able to get to them either because of work, childcare, or just transportation issues, so something like this can serve as a very useful adjunct.
We're also collaborating with OBGYN on identifying the mechanisms for postpartum stress incontinence. We're putting a grant together with them. We're focusing a lot on the genetic causes of various urologic conditions, including recurrent urinary tract infections and OAB. We're going to be doing more randomized trials with testing predictive models.
Then lastly, we were just funded by the National Institute of Aging for an R03 grant to look at the relationship between diet, demographics, genetics, and metabolic factors in the development of urinary urge incontinence. We're going to be using the Nurses’ Health Study, the first and second cohorts. It's over 40 years’ worth of data, and we'll be working with investigators at Brigham and Women's Hospital in Boston.
We started this clinic because I was seeing a lot of patients who were either cancer survivors or were having cancer, but they're not being referred by oncologists, they're being referred by their primary care doctors. For a lot of them, their conditions are very treatable, at least the pelvic floor conditions, either with medication or Botox or physical therapy. There are data that says if you compare people with the same exact medical condition, and then you add incontinence or OAB to it, their quality of life is 2½ times worse at least. They end up spending about 2 to 3 times more money on health care because of these issues.
I figured that the best way to get to these patients is to start a clinic within the cancer center so that we may be able to serve these patients better and quicker. It's a clinic where we have same-day appointments; patients can just walk in. We're also extending our services to not just cancer, but people with hematologic conditions, especially sickle cell. The role of pelvic floor disorders in sickle cell disease is extremely limited. We not only help take care of these patients, but to get a better understanding of how we can better take care of them and how sickle cell [affects] the urinary tract and the pelvic floor.
We are hoping to start a rural health clinic, because that's another big disparity. UH is working on starting clinics throughout rural Northeast Ohio, and we're meeting to develop a FPMRS program, both virtual and in-person, so patients can have access to this point of care.
I think there's going to be a rapid adoption of artificial intelligence platforms in our field. We saw that at the most recent Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction [SUFU] meeting. A lot of the research is in the development of these kinds of models, but very little is directed at proving that they're useful in the clinical setting. What I would like to see and what we're doing ourselves is we built models, and now we're doing randomized controlled trials, implementing these models in clinical practice to see if they're actually beneficial.
Last year, we developed a model to predict opioid use after urogynecologic surgery. The model was fairly predictive of how much narcotic to prescribe, and now we have a randomized controlled trial that's halfway done recruiting, where we're randomly assigning patients to either a surgeon deciding how much medication they get to go home with, or we're allowing the algorithm to decide. What we hope will happen is that A.) there will be no difference in pain control; that patients in either group will have low levels of pain, but B.) that this model can help substantially decrease the number of opioids prescribed.
One of the biggest issues with the opioid epidemic is not necessarily that the patients are developing dependence on these medications, it's that there's a lot of leftover medication and there's diversion of these pills and no good way of getting rid of them. So, if you prescribe 1 or 2 instead of 20, then we can maybe make a dent in this in the future. When we were actually building the model, even though we thought we were doing a good job and prescribing not very many, we found that we were overprescribing by 200% to 300% on average.
I sadly was not there, but my partners were and there was a great deal of attention paid to both artificial intelligence and to the risk of dementia and anticholinergics. Again, I think these 2 are going to be the hottest topics moving forward, maybe for the next decade or so, simply because they represent a lot of opportunities. I'm a little biased towards OAB, but I think there's a lot of opportunity in OAB because more than half the time, we don't know what OAB even is or what's causing it.
One of our goals here is to develop models that can help us phenotype OAB better, so that we can better identify which patients will be best served by which treatment. For instance, if somebody sat down in front of me, we would have an algorithm that matches with the electronic medical record, and I collect some data and everything gets inputted and at the end of the conversation, I have a chart that tells me which treatment is best suited for this patient. Instead of relying on the level of invasiveness, which is what the care pathway is based on now, we're going to rely on data and what the patient will be best treated with.