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Articles

A recap of the FDA submissions and regulatory decisions in urology from February 2025. 

FDA updates in urology: February 2025

Overall, 84.2% of patients achieved a 50% or greater reduction in urgent leaks.

Pivotal study data show efficacy of percutaneous SNM device for UUI 

The updates emphasize a risk-stratified approach to the management of microhematuria.

AUA, SUFU release amendment to microhematuria guideline

 is compliance officer and medical director of coding and reimbursement, United Urology Group and Chesapeake Urology, in Towson, Maryland.

"For telephone-only (audio only) visits, Medicare has officially stated that such a visit would be considered the same as an in-person visit, with a few qualifications," write Jonathan Rubenstein, MD, and Mark Painter.

How to bill for telephone-only urology visits

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Clinical Focus

2025 GU Satellite Symposia in San Francisco

® Assistant Editor Janelle Hart spoke with 

. He discusses the stigmas related to penile cancer from both the patient and physician perspectives. In addition, he highlights major developments in the space that are helping to effectively treat and normalize this disease. Pettaway is a professor of urology at the University of Texas MD Anderson Cancer Center in Houston.

“When you compound the patient delay and…the physician delay, then you really get a delay in diagnosis,” says Curtis A. Pettaway, MD.

Destigmatizing Urology: Dr. Pettaway discusses penile cancer

 paper, “Tobacco screening and treatment during outpatient urologic office visits in the United States,” for which he served as a study author. Matulewicz is a clinical instructor in urology at NYU Grossman School of Medicine.

“Because so many disease processes that we deal with are related to tobacco use and smoking specifically… I think this is absolutely our domain,” says Richard S. Matulewicz, MD, of tobacco cessation counseling and treatment.

Dr. Richard Matulewicz discusses smoking cessation counseling and treatment among urologists

A list of facts and trends to know about the current landscape of urologic cancer management and research in the US.

Urologic Cancer Facts and Updates for World Cancer Day 2025

"This brief review captures the evolving role of miRNAs, focusing on their clinical relevance and implications as well as future directions for more effective targeted therapeutic interventions," write the authors.

The evolving role of microRNAs in testicular cancer management

The approval is supported by data from the phase 3 CheckMate-67T trial.

FDA approves subcutaneous nivolumab for solid tumors, including RCC

The study showed significant reductions in both anxiety and depressive symptoms following the intervention. 

Behavioral intervention may improve psychological distress after testicular cancer 

"RPLND is an attractive option for those who prefer to avoid chemotherapy," write Jiping Zeng, MD; Timothy A. Masterson, MD; and Clint Cary, MD, MPH, MBA. 

The role of surgery continues to evolve in seminoma

Martin G. Sanda, MD, shares his thoughts on key areas for future advancements in urology. 

Martin Sanda, MD, considers potential future advancements in urology

, highlights key areas of future advancements in urology. Sanda is a professor of urology and the outgoing chair of the department of urology at Emory University School of Medicine, as well as the director of the prostate cancer center at Emory’s Winship Cancer Institute in Atlanta, Georgia.

There's a lot of exciting things happening in urology. In the cancer space, there's a tremendous opportunity around using gene sequencing and RNA sequencing to better profile severity of patient cancers and to guide appropriate treatment plans. That's true for cancers across the board, and certainly true for the big 3 urology cancers, if you will––prostate cancer, bladder cancer, renal cancer––as well as other urological tumors. That's certainly an area where there's tremendous opportunity and a lot of dynamic changes ongoing. We've been very fortunate to be able to be involved in some of that work.

And I think the key progress in this arena is oftentimes not just 1 institution or 1 investigator, but it's really about collaboration, both within the institution as well as between different institutions. We've had partnerships with University of Michigan; University of Washington; University of Alabama, Birmingham; University of Texas, Southwestern; and a variety of other institutions across the country. Those are key to making the best progress.

Another area where Emory urology is very much involved and also very much a multidisciplinary [effort] is imaging. In particular, around [the] deployment of artificial intelligence in imaging and in the interpretation of imaging data, such as MRI, for example, MRI for prostate cancer, kidney cancer, other tumors, and other aspects of artificial intelligence, [such as] interpretation of genomic data with AI. I think those are some of the really exciting areas that are going to change the way we practice in the coming years.

This transcript was AI generated and edited by human editors for clarity.

Videos

According to Sanda, future advancements may involve gene and RNA sequencing, the use of AI in imaging, and multidisciplinary collaboration. 

Dr Carson on “Telehealth visit type and patient-reported outcomes among patients with cancer.” 

Dr. Daniel Carson on telehealth vs in-person urology visits

 discusses the background and notable findings from the 

 paper, “Telehealth visit type and patient-reported outcomes among patients with cancer.” Carson is a urology resident at the University of Washington in Seattle.

Please describe the background for this study.

The title of our study is "Telehealth visit type and patient-reported outcomes among patients with cancer," and the focus was really to evaluate patient satisfaction and appointment-related costs with telehealth or in-person visit stratified by new or established encounters. We know that telehealth as a health care delivery modality has numerous benefits, including its ability to overcome geographic barriers to care. Despite this, pre-COVID, there had been limited progress and broad implementation of these services. However, in response to the COVID-19 pandemic and the related emergency licensure waivers, we saw a dramatic rise in the use of telehealth by the end of 2020, but unfortunately, with the expiration of these emergency waivers, many of those pre-COVID legal restrictions on telehealth care resumed, and we've seen significant state-to-state variability in terms of its application, and several of those states that have incorporated licensure waivers beyond the COVID-19 pandemic have limited its use to establish patient visits only. As such, our study was meant to look at a prospective patient cohort and compare patient-reported outcomes between in-person and telehealth visits for both new and established visit encounters.

There were 2 main findings from our study. The first was that patient-reported satisfaction scores were high for both telehealth and inpatient visits for both new and established encounters. And second, we found that in-person visits incurred significantly higher costs and travel burden compared with telehealth visits for both new and established encounters. This was particularly magnified for our new-patient cohort. For example, the mean reported total cost related to new in-person visits was about $500 compared with about $25 for new telehealth visits. For new in-person visits, 27% of our patients required plane travel, and 41% required a hotel stay. That's compared with less than 1% or 3% for our new telehealth visits for those respective items. Finally, about half of our patients convening new in-person visits had to miss at least a half day at work, and that was compared to about 11% for our new telehealth visits. Intuitively, these results are not necessarily surprising to us, but data to this end are certainly important to share when we're advocating for policy change to broaden the application of telehealth services.

"Patient-reported satisfaction scores were high for both telehealth and inpatient visits for both new and established encounters," says Daniel Carson, MD, MS.  

Laura Bukavina, MD, MPH, MSc, touches on the need for improved mental health support for patients with urologic cancers, which was highlighted in the study, “Financial Distress in Genitourinary Cancer: Insights From CDC National Health Interview Survey.” 

Laura Bukavina, MD, on the need to integrate mental health support in GU cancer care

, touches on the need for improved mental health support for patients with urologic cancers, which was highlighted in the study, “Financial Distress in Genitourinary Cancer: Insights From CDC National Health Interview Survey.” Bukavina is an assistant professor of urologic oncology at Cleveland Clinic Glickman Urologic Institute and the translational science lead in GU oncology at Cleveland Clinic Lerner College of Medicine in Cleveland, Ohio.

For example, our bladder cancer patients, in terms of not only the chronicity of disease in non-muscle invasive bladder cancer, [but] when we're talking about muscle invasive cancer, there's a lot of self-image and coping mechanisms that patients have to be able to acquire when they start chemotherapy or surgery, or even being able to reflect on what their new identity looks like with a stoma, for example. All of it is a process. Unlike a lot of the societies within oncology, including ASCO or even NCCN, urology really does not do a good job at recommending mental health to our patients, whether it's prostate, kidney, or bladder. We don't really have it part of our guidelines. We don't really spend time, and a lot of people don't even have the resources to recommend it. But I think the more we talk about it and realize it's a real issue, the more these resources will become available within the institutions as well as to providers.

This transcription has been edited for clarity.

“Unlike a lot of the societies within oncology, including ASCO or even NCCN, urology really does not do a good job at recommending mental health to our patients,” says Laura Bukavina, MD, MPH, MSc.

In this interview, Laura Bukavina, MD, MPH, MSc, highlights the background and key findings from the study, “Financial Distress in Genitourinary Cancer: Insights From CDC National Health Interview Survey.” 

Study: GU cancer survivors report difficulty affording mental health, dental care

, highlights the background and key findings from the study, “Financial Distress in Genitourinary Cancer: Insights From CDC National Health Interview Survey.” Bukavina is an assistant professor of urologic oncology at Cleveland Clinic Glickman Urologic Institute and the translational science lead in GU oncology at Cleveland Clinic Lerner College of Medicine in Cleveland, Ohio.

Could you describe the background/rationale for this study?

We wanted to look at the financial distress in GU cancers by utilizing what's called the CDC National Health Interview Survey, which is a great database that evaluates patients who've had bladder cancer, or who've had any kind of cancer, including bladder cancer, or healthy individuals, and it's able to follow them through a couple of years. They ask multiple survey questions that relate to financial distress, including are you able to pay for medications? Are you not seeing a physician, including specialists such as your eye doctors or your dentist? Are you able to afford mental health [care]? A lot of the questions are aimed not only for care, but also for being able to establish even primary care, not just a specialist care. So, it's a great resource to gauge our ability to see how our treatments are affecting people's ability to afford further care, food, travel, specialist care after their cancer is cured, which is all part of toxicity that many, many of our cancer patients and our chronic illness patients are suffering even after their cancer has been cured from the oncology standpoint.

What were the key findings from the analysis?

We were going in expecting that we were going to find people have trouble affording medications and affording being able to see their primary care doctor or splitting medications. But surprisingly, we did not see that. We even looked at patients less than 65 and over 65 because of Medicare coverage, which changes a lot of your ability for medication coverage. But what we found, which is really interesting, is that mental health is incredibly ignored, and not a lot of patients, especially our bladder and kidney cancer [patients], were not able to afford mental health [care]. That is anywhere from between 15% to 25% of those patients were not able to get specialized mental health treatment. We all know that bladder cancer particularly is such a long disease, including our non–muscle-invasive bladder cancer patients. Those patients have the burden of being under oncology care for sometimes even a decade. We know that many of those patients are just not able to get the care that they need with their diagnosis.

The second thing we found that was really interesting is dental care. No one really talks about dental care, but it's also incredibly important. Not only is that important because of infection risk and self-image, but because a lot of the medications we give, including medications in prostate cancer, dental health is vital to make sure that these things don't happen. What we found is our patients are just not able to afford dental health, and really it has to do with the insurance coverage. While the medications might be covered, while the surgical treatment might be covered, we all know that mental health and dental care are one of those things where people have large copays, long delays to care, and it is very clear to see that from our study.

“While the medications might be covered, while the surgical treatment might be covered, we all know that mental health and dental care are one of those things where people have large copays, long delays to care, and it is very clear to see that from our study,” says Laura Bukavina, MD, MPH, MSc. 

Clint Cary, MD, MPH, MBA, describes the history of Indiana University’s testicular cancer program. 

Dr. Cary details the history of IU’s testicular cancer program

, describes the history of Indiana University’s testicular cancer program. Cary is an associate professor of urology and the director of the germ cell tumor program at Indiana University Health in Indianapolis.

It's hard to talk about the program without giving a little bit of the historical background of it. So, [Dr.] John Donohue was a previous chairman here, and he really, in the 60s, began pioneering the surgical approach for metastatic testicular cancer. As he was doing this, there really was no chemotherapeutic option for the disease, so he was offering men, at the time, one of the highest cure rates just by surgery alone for metastatic cancer. That grew our volume here as patients came to see him and seek the potential for cure. Then once Dr. [Lawrence] Larry Einhorn came on staff in the medical oncology space and had ideas about some chemotherapy options, they partnered and really set the standard for multidisciplinary care for oncology. Fortunately, the chemotherapy regimens that Dr. Einhorn put together in combination with the surgical approaches with Dr. Donohue really revolutionized the cure rates and the care for men with testicular cancer. That carried the 60s, 70s, and 80s [and] really revolutionized the care for those men.

We've been fortunate to continue that legacy through the last 50 years. That continues to be the program today. It's a big multidisciplinary effort. We work very closely with medical oncology. Still, we are, from a clinical volume standpoint, one of the largest, if not the largest, surgical programs for retroperitoneal lymph node dissection in the world. Patients come to see us from almost every continent, and we've treated patients from every state in the United States. That allows us to maintain a clinical database where we can answer important and relevant questions. It also pushes us as leaders to continue to find cutting edge treatments to further either improve the quality of life, or in certain subsets of the disease, improve survival rates.

“Fortunately, the chemotherapy regimens that Dr. Einhorn put together in combination with the surgical approaches with Dr. Donohue really revolutionized the cure rates and the care for men with testicular cancer,” says Clint Cary, MD, MPH, MBA.

 shares final thoughts on the publication, “Diagnosis, management, and follow-up of the incidentally discovered adrenal mass: CUA Guideline Endorsed by the AUA,” and highlights a course at the American Urological Association (AUA) Annual Meeting that touches on these topics. Rowe is an assistant professor at the University of Ottawa in Canada and a panel chair for the guideline by the Canadian Urological Association.

I am hopeful that urologists and other clinicians will find these guidelines helpful. Given that these lesions are common, even if surgeons aren't treating adrenal tumors, they're certainly going to find some on imaging. Now we have a concise document that we hope will help clinicians work through these patients and participate in their evaluation and perhaps even their treatment. I will put a plug in that at the AUA annual meeting each year, we do have an instructional course on case-based management of adrenal tumors. We review some of the recommendations from the guideline, but we also go through some of the steps of surgical approach robotically and laparoscopically and clarify which patients benefit from surgery and which perhaps don't. So, if people are interested in that we certainly invite colleagues and trainees to join us for the course at the AUA this year.

"Given that these lesions are common, even if surgeons aren't treating adrenal tumors, they're certainly going to find some on imaging," says Neal E. Rowe, MD, FRCSC. 

Dr. Rowe highlights AUA course on the management of adrenal tumors

 discusses potential future work building off the publication, “Diagnosis, management, and follow-up of the incidentally discovered adrenal mass: CUA Guideline Endorsed by the AUA,” as well as general unmet needs in the management of adrenal tumors. Rowe is an assistant professor at the University of Ottawa in Canada and a panel chair for the guideline by the Canadian Urological Association.

I would say we covered the whole scope of the field in the guideline, but it was evident that a lot of the background information wasn't of high quality. There's not a lot of randomized trials in this space. Although these lesions are common and there are a lot of publications out there, a lot of the literature is of low quality. The recommendations are based on the current evidence, but the evidence is overall relatively weak. So, I think there's a lot of room for improvement. When patients are worked up through the guideline, I would say one of the areas of interest is in patients with what was historically known as subclinical Cushing's syndrome that we now call mild cortisol secretion excess. In those patients, it's really not clear to us who should be treated with surgery and who shouldn't. So, it's kind of a case-by-case approach, and that's what we stated in our guideline. I'm very hopeful that future clinical trials may address that question.

I think in the big picture for the whole field, at the end of the day, there's a lot of indeterminant adrenal lesions, and despite our current laboratory and imaging investigations, we really can't clarify whether some of these lesions are benign or malignant. So, I think many patients are still having surgery that may not be required. I think the future is going to go in 2 directions. One is better laboratory investigations. There have been some big studies, looking at urine steroid metabolomics, looking at compounds in the urine that may be present in malignant tumors that aren't there for benign tumors. I think that field is exciting, but it's still in infancy in terms of making a guideline recommendation. The other is with better quality imaging. PET scan, with certain marked biomarkers, can look at the adrenal glands at the molecular level [and] perhaps help us identify which patients could benefit from surgery and which perhaps don't need surgery. They're looking at a variety of compounds that can be radio labeled for PET scanning. Again, this is not primetime, and probably not in infancy, and we'll see that down the road, but I anticipate that's something we're going to see in the next 10 to 15 years.

“The recommendations are based on the current evidence, but the evidence is overall relatively weak. So, I think there's a lot of room for improvement,” says Neal E. Rowe, MD, FRCSC. 

Dr. Rowe on potential future work with incidental adrenal tumors

Albert Jang, MD, a 3rd-year internal resident physician at Tulane University, discusses progress and unmet needs with immunotherapy for the treatment of patients with genitourinary cancers.

There are still quite a few patients who still do not respond to immunotherapy, says Albert Jang, MD.

Dr. Jang on current state of immunotherapy in advanced GU cancers

, Moffitt Cancer Center, discusses the latest developments in the evolving treatment paradigm for patients with penile cancer.

Philippe Spiess, MD, Moffitt Cancer Center, discusses the latest developments in the evolving treatment paradigm for patients with penile cancer.

Developments in the penile cancer treatment paradigm

Philippe E. Spiess, MD, MS, FRCSC, FACS, 

discuss how and why clinicians can and should get involved in the new Global Society of Rare Genitourinary Tumors, for which they serve as President and Vice President. Spiess is a genitourinary oncologist and assistant chief of surgical services at the Moffitt Cancer Center in Tampa, Florida. Necchi is an associate professor at Vita-Salute Raffaele University and the head of genitourinary medical oncology at IRCCS San Raffaele Hospital and Scientific Institute in Milan, Italy.

“The important thing to know is that…we…aim to focus on the regions…that were not under the light of research education, in particular in the [genitourinary] space,” says Andrea Necchi, MD.

Genitourinary Cancers

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