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Ashish Kamat: Hello, and welcome to UroToday's Bladder Cancer Center of Excellence. I'm Ashish Kamat, Professor of Urology and Cancer Research at MD Anderson Cancer Center. And it's my distinct pleasure to introduce and welcome today, Dr. Svetlana Avulova from the Mayo Clinic who is joining us today to talk about the award that she received from BCAN on sexual function in women undergoing radical cystectomy. So, first off I want to congratulate her and not just on this award, but on her journey from her residency at Vanderbilt to her current fellowship and for the next phase in her career, which is an academic position in Albany, New York. So Svetlana, congratulations, welcome, and the stage is yours.

Svetlana Avulova: Thank you, Dr. Kamat. I appreciate that kind introduction. And I want to thank tremendously BCAN for this award. This study is very personal to me and I'm looking forward to introducing it to everybody. The journey in this study started with a chapter that I actually co-authored with Dr. Sam Chang, which was titled, the organ-sparing radical cystectomy. And this was for The Urologic Clinics of North America in 2018. And we were looking at both men and women and trying to figure out how to best counsel folks about how to appropriately select patients for organ-sparing cystectomy, who qualifies, who does not. And what I found during this time is actually that there were a lot more studies in men than there were in women, and that the functional outcomes that were reported really were not equal at all.

And what I had realized then, this is a summary of all the studies that focused on organ-sparing cystectomy for men. So when they say organ-sparing cystectomy for men, they mean prostate-sparing, seminal vesicle-sparing, et cetera. And so when they were looking at functional outcomes, I realized that there were a lot of lessons that carried over from our prostatectomy literature and a lot of the questionnaires that were used to ask for functional outcomes. again, carried over from the prostatectomy literature. However, in women, a lot of this information really was missing and it was missing because it was unclear to me whether it was not reported because we just didn't have the appropriate tools to ask women this. Or we just didn't ask them.

Fast forward to 2019. And I attended a bladder cancer symposium that was hosted graciously by the AUA, and the Hopkins Greenberg Bladder Cancer Institute, where they were focusing on topics in particular specific to women. And there was actually one talk that was given by Dr. Daniela Wittmann, on women's sexual function and intimacy after bladder cancer. And this was eye-opening because again, this lack of information sort of crept into the background of my mind and was buttressed by patient advocates that were at the symposium, who also said that when they were counseled, sexual function really was rarely brought up. A lot of them did not know about organ-sparing approaches and wish that they were counseled about it. And so this really started the wheels turning in my head.

At this point, I had graduated from Vanderbilt residency and I was fortunate enough to start my urologic oncology fellowship at the Mayo Clinic. And I took a deep dive trying to understand why is it that we did not have enough of this information for women? So, first of all, a lot more men are diagnosed with bladder cancer than women. Most patients that are diagnosed are older, both men and women. And for women, a lot of them are post-menopausal as a result of age, and a lot of them either naturally or surgically. And then the third important point was that there was a common assumption that was made that perhaps they are not sexually active anyway. So we are assuming that they may not care about this as much as men may.

And so this study by Dr. Lindau, what it showed was that women by age group, at least up to 50% were still sexually active. And furthermore, there was another study out of Johns Hopkins led by Natasha Gupta and Dr. Bivalacqua, who looked at, they surveyed urologic oncologists to see whether the counseling was similar for their male and female patients. And what they found was that there was a significant difference in the percentage of providers who were routinely counseling, and the differences in how they were counseling both men and women. And up to 21% actually routinely did not ask female patients about their sexual activity preoperatively compared to men.

And I want to emphasize that none of this obviously would have been possible without the tremendous mentorship that I was fortunate enough to receive from the folks at Vanderbilt, Sam Chang, you see there, Dr. David Penson and Dr. Daniel Barocas who were instrumental in my interest and patient-reported outcomes and the studies I've done with them on prostate cancer. And then Dr. Steve Boorjian at The Mayo Clinic, who is the bladder cancer expert and who I went to with this question, and how can we study this? And what can I do to study this?

And so what came out of this is, I would call a passion project, where I enlisted the experts at Mayo Clinic and the survey research, and again, asking Dr. Daniela Wittmann about her experience with prostatectomy, and what questionnaires we can ask women. And she pointed me to the PROMIS resource that was created by NIH. And this is the Patient-Reported Outcomes Measurement Information System, where they tested these questions at a population level to find out which questions tested highly specifically for women when it comes to sexual function and sexual dysfunction. And these are validated tools that are freely open to the public and that the NIH encourages researchers to use, to streamline studies, and so that studies can be compared across disease topics. But then also to focus on women, as their sexual function and questions we may ask women, vastly different than in men.

In addition, I enlisted the Patient Advocate Research Participants from BCAN to vet the survey questions and to see whether the questions that we were asking from the brief profile of the promise measures, whether were pertinent to the female bladder cancer patients. And in addition, whether we should be asking anything else, whether their timeline of questioning was appropriate. In addition, we wanted to see the surgeon's perspective as well. And as surgeons are routinely busy, we did not want them to be burdened with questions. So we created this very easy form for them to check off, to avoid the burden of chart abstraction, to ask the surgeon in real-time, what they did in terms of preoperative counseling and what type of pelvic organ-sparing they did, what type of vaginal closure if the vagina was resected at all, as well as the type of counseling they provided. And, if they did not provide counseling, the reasons for why they did not.

And these actual items came directly from the Gupta-Bivalacqua study at Hopkins. These were the most common testable answers that urologic oncologists provided. And so we wanted to align with that study to make sure we are asking appropriately and receiving appropriate responses. So currently, because bladder cancer is rarer in women than in men, a lot of the academic institutions at most will have 10 to 15 cystectomies a year that they do in women. And so, we decided that we needed to put our forces together and enlist other sites, clinical sites across North America. And so currently we have 46 women enrolled from the Mayo Clinic sites, as well as the eight external clinical sites. And we're definitely looking to add more. And so, the person of contact is our research coordinator who is also the project manager of the study. It's very easy to participate. We just need to have their IRB done and then the survey research center at Mayo Clinic takes care of the rest.

So again, I want to thank Dr. Kamat and BCAN for this award, and I'm excited to keep this going. Thank you.

Ashish Kamat: So that was great, Svetlana. And congratulations, once again on the award. This is a topic that it's interesting to see how you came about your interest in this, and it's a topic that not many people recognize as you alluded to the lack of information that we have. And then people also do not recognize the importance. I mean, our patients know this and we know this, but we sometimes get tied up in a busy clinic, and we're worried about obviously the morbidity and mortality of the actual procedure and obviously, cancer control's at the top of our minds. And in prostate cancer, obviously, there has been a lot more focus on us because a lot of the patients may be younger and able to concentrate on this. And we are seeing this age migration with bladder cancer as well to where this is really something that needs to be at the forefront of everybody's mind. So thank you very much for taking this on as your cause and your research interests.

Delving a little bit into the actual study design and what you expect to gain from it. Could you just, again, I know you would be hypothesizing and guesstimating, but what do you expect to see? What are you hoping to find?

Svetlana Avulova: Yeah. Dr. Kamat, thank you for those excellent points. So what we hope to find is, again, this study is very much exploratory in nature, as you said. And we're looking to hone in on things that we should study more. And this is just the first step in asking and figuring out how, which percentage of the population of these women are sexually active? We are assuming that based on Dr. Lindau's study, at least 40% to 50% of our patients will be. But at least from this study, we will have that denominator. In addition, we are trying to hone in whether there are any surgical techniques that perhaps were associated with better function. We know that counseling, in addition, preoperatively and setting patient expectations is of utmost importance of how recovery and convalescence go for these types of patients. And so we are trying to figure out whether they are factors we can control as surgeons, whether there is a type of pelvic organ-sparing, whether it is the preservation of neurovascular bundles or leaving the uterus and the anterior vagina and the ovaries, whether it's the robotic or open approach, whether it's neobladder or conduit, so types of urinary diversions.

So trying to identify which factors we as surgeons can control and perhaps improve upon, as well as hone in on the counseling and setting the stage of expectations of what we are saying, what is being absorbed by our patients, perhaps improving that aspect of it. As you know, as somebody who treats women and patients with bladder cancer, there is a lot of information that these patients are trying to process. And perhaps we can improve upon that. Perhaps it's a surgical video or an instructional video that patients see before the clinic. And then clinic time, we spend addressing questions they may have. Or perhaps it's an improvement in other resources that we provide them. So I'm hoping that this study will open up the stage for these types of conversations, but also engage the patients themselves through BCAN to see how they can improve the care of other patients who are diagnosed with this terrible disease.

Ashish Kamat: Now, again, excellent points. If I were to put you on the spot a little bit, do you think that based on the publication from Natasha Gupta and some of the other folks that have been presenting this issue at our regional and national meetings, and of course, the whole patient advocacy group efforts, do you think you're going to find that that has improved and brought to the forefront, this topic in the minds of surgeons? Or do you, again, you're probably guessing, I know. But do you think that you are going to see the same numbers that were published in the Gupta paper?

Svetlana Avulova: That's an excellent point. And I think one comment that I received was, well, why are we asking whether they provided counseling? Of course, the surgeons will say that they did, but what I want to highlight is something we all know, but don't acknowledge is, we may do all these things and we may provide all this information, but if it's not landing in our patients' minds, then perhaps we're not doing a good enough job. So yes, I think I'm going to find similar numbers as in the Gupta paper. And I hope that this publication will bring this issue to the forefront of our minds. And then I hope it will inspire others to perhaps study this in the future and perhaps improve the care of others.

Ashish Kamat: Yeah. And one of the effects that you might end up having, which is a good positive outcome, of course, is just knowing that there's a survey like this out there, might stimulate more surgeons and their teams to actually talk to their patients about this. So it's an unintended benefit of just knowing that there is a study out there and that you are leading it, et cetera. So that's a good positive effect of having this. Now, let me ask you, have you, or are you collaborating with teams that are providing similar questionnaires on the patient side?

Svetlana Avulova: Yes. So I may have not been clear about the study design, but so we are asking patients questionnaires, and then we are asking the surgeons as well, so this is a dual effort.   We are asking the patients preoperatively before they have their cystectomy, then we are giving them the surveys at three months, six months, and twelve months after their surgery. And then we are collecting all of that information. And then we are trying to collect the surgeon factors as well at the time of the cystectomy. So, yes, to answer your question, we are asking both parties.

Ashish Kamat: Okay, great. Yeah, that wasn't as clear. I mean, I presume you were, based on your previous BCAN talk, but it wasn't clear today. So, that is part of the same study, it's not a separate study that you're collaborating with. As part of this study itself, the patients will be getting questionnaires as well. So you'll be able to assess the impact that the discussion had and get that baseline data too. Correct?

Svetlana Avulova: Absolutely. And I apologize if I wasn't clear, but yes, absolutely. Yes.

Ashish Kamat: Okay, great. Again, this has been a great discussion. In the interest of time, we will wrap it up now, but I want to hand the stage back to you and maybe, in the next 30 seconds to a minute,  what are some of the top-level items you want our audience to leave with after this discussion today?

Svetlana Avulova: Yes, absolutely. What I'd like the audience to leave with is, we are openly accruing patients. The Mayo Clinic is leading the efforts. However, if any of the academic institutions or clinical sites would like to participate, it is very easy. We would just ask you to complete an IRB and enroll the patients and give them the baseline questionnaires. And after the fact, our coordinators at Mayo Clinic, as well as the survey research center, will take care of the rest and distribute the questionnaires at three, six, and twelve months. We are hoping that this data will provide further ground for additional research into how we can improve sexual function for women who are having this life-altering surgery.

Ashish Kamat: Excellent. Once again, congratulations. And thank you for taking the time off to spend with our audience here. I'm sure we will be having you back to give us updates on what you're finding and looking forward to a lot of good things from you in your career. So thank you again and congratulations.

Svetlana Avulova: Thank you, Dr. Kamat. I appreciate it.