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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

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Clinical Focus

2025 GU Satellite Symposia in San Francisco

Case-by-Case: Application of HIF-PHIs for the Treatment of Anemia in Patients with CKD

Jason Hafron, MD; Aaron D. Berger, MD; Arpeet Shah, MD

Medical Crossfire® in Adjunctive Testing: Charting a New Course in Prostate Cancer Risk Assessment

® Assistant Managing Editor Ben Saylor spoke with Dr. Michael Lutz. He discusses common myths and misconceptions surrounding men’s health and the urologist’s role in dispelling them. Lutz is a partner in the Michigan Institute of Urology and president of the MIU Men’s Health Foundation.

“I think it's really important to understand the role of prevention and early detection,” says Michael Lutz, MD.

The urologist's role in dispelling men's health myths

® Assistant Editor Janelle Hart spoke with 

 He discusses why clinicians and patients are reluctant to incorporate holistic medicine into their health management, and how he believes this will change in the future. Espinosa is a holistic clinician and clinical assistant professor of urology at NYU Langone Health in New York City, New York.

“I think that the audience should know that there is a movement going on,” says Geo Espinosa, ND.

Destigmatizing Urology: Dr. Espinosa discusses lifestyle changes

 He discusses perceived masculinity as a major barrier for men who need care for testosterone deficiency. He also discusses how urologists can create a more supportive environment for this reluctant population of patients. Dubin is an andrology fellow at Northwestern University in Chicago, Illinois.

“We need to create this safe, comfortable, welcoming environment for men to talk about the things that they need to talk about,” says Justin Dubin, MD.

Destigmatizing Urology: Dr. Justin Dubin discusses testosterone deficiency

 paper, “Male Infertility Websites: What are Our Patients Reading?” for which she served as senior author. Samplaski is an associate professor of clinical urology at Keck School of Medicine of USC, Los Angeles.

“The available information [on] male infertility websites right now is not of good quality,” Samplaski says.

Dr. Mary Samplaski discusses online resources regarding male infertility

This episode's guest is Ranjith Ramasamy, MD. He discusses findings from the recent Journal of Urology paper, Effect of Natesto on Reproductive Hormones, Semen Parameters, and Hypogonadal Symptoms: A Single Center, Open Label, Single Arm Trial. Ramasamy is director of male reproductive medicine and surgery and associate professor of urology at the University of Miami Miller School of Medicine.

Dr. Finkelstein discusses telemedicine for pediatric post-op visits

How to get started with HIFU for prostate cancer

What patients undergoing HIFU should expect postoperatively

Ramasamy talks about the findings of a recent study published in the Journal of Urology.

Speaking of Urology: Dr. Ranjith Ramasamy discusses nasal testosterone gel and sperm parameters

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

FDA Updates in Urology: January 2025

"The biggest thing that I took away from using the device is that it allowed me to do the procedure by myself, without an assistant," says Matthew J. Mutter, MD. 

FDA market clearance sought for Separo sealing system for vasectomy 

The test can provide results in 48 minutes for diagnostic insights for conditions such as hypogonadism, impotence, polycystic ovarian syndrome, and other androgenital syndromes. 

FDA clears chemiluminescence-based immunoassay for free testosterone

New research better defines the link between cardiovascular disease risk and prevalence of ED per serum ceramide levels.

Men with severe ED more than twice likely to have high ceramide levels

Data from a new SMSNA 2024 abstract show an association between significantly high BMI and risk of azoospermia and oligospermia.

Severe obesity linked to high risk of low sperm count

Bradley Roth, MS4, and Scott D. Lundy, MD, PhD, HCLD, consider some of the reasons that fertility restoration was found to have higher pregnancy success rates compared with sperm cryopreservation in a recent study.

Experts consider efficacy of fertility restoration vs sperm cryopreservation

, consider some of the reasons that fertility restoration was found to have higher pregnancy success rates compared with sperm cryopreservation in the study, “Routine Sperm Cryopreservation before Vasectomy Is Not Cost-Effective and Does Not Increase Live Birth Rates Compared to Surgical Sperm Retrieval or Vasectomy Reversal.”

Roth is a fourth-year medical student at the University of California, Irvine Medical Center, and Lundy is the section head of reproductive urology as well as a surgeon scientist at the Cleveland Clinic in Cleveland, Ohio.

 I'll let Dr. Lundy speak most on this because he actually performs these procedures, but I think a lot of it is the fact that urologists have gotten very good at vasectomy reversals, so the success rate from a surgical standpoint is very good. While there is a surgery that's involved in it vs just banking sperm, it tends to portend very good outcomes for these patients in terms of restoring fertility. The other thing that has to be kept in mind is that patients who are cryopreserving sperm, whatever theoretical future female partner they may have will have to undergo IUI or IVF or some sort of assistive technology, so that may be contributed to the discrepancy in success rates. But I'll let Dr Lundy expand upon that.

 I think it's important to recognize that if you freeze sperm before your vasectomy, that sperm is only good enough for IVF or occasionally for intrauterine insemination, both of which are procedures that cost additional money and have variable success rates. On the other hand, a vasectomy reversal in particular allows for natural conception for these couples and avoiding any of the costs and challenges associated with IVF. A big benefit of pursuing this approach is to allow for a spontaneous pregnancy, and in many cases, multiple spontaneous pregnancies, as couples have more than 1 child down the road. It is important to know that the success rates are based upon the best available data, which admittedly is limited for this population. While I would hesitate to say that reversal is truly better in terms of efficacy, I think this data suggests that it's at least as good, with our 90 plus percent success rates with the surgery in terms of restoring sperm to the ejaculate. We then also have to consider the female factor and how old the female partner is and whether she's had children before in our decision-making as well.

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

Videos

“While I would hesitate to say that reversal is truly better in terms of efficacy, I think this data suggests that it's at least as good,” says Scott D. Lundy, MD, PhD, HCLD.

Matthew J. Mutter, MD, highlights safety and efficacy data from an investigational device exemption (IDE) trial on the Separo vessel sealing system for vasectomy procedures.

Matthew Mutter, MD, shares data on Separo vessel sealing system for vasectomy

, highlights safety and efficacy data from an investigational device exemption (IDE) trial on the Separo vessel sealing system for vasectomy procedures. Mutter is the principal investigator of the safety profile study for the device and a general urologist in New Orleans, Louisiana.

This was a single-arm trial. The end point was what it would be for a vasectomy, and that's to make a man azoospermic after the procedure. Our limited patients, our 8 patients that we did, all of them at 6 months either reached azoospermia or [had] rare, non-modal sperm, which is perfectly acceptable within the AUA guidelines for a successful vasectomy. So, our end point was reached.

I want to add that the safety profile was impeccable for this. No one experienced a [device-related] adverse event. As far as pain scores were recorded, there was only 1 pain score above a 0 throughout the duration of the study.

"I want to add that the safety profile was impeccable for this. No one experienced a [device-related] adverse event," says Matthew J. Mutter, MD. 

Bradley Roth, MS4, and Scott D. Lundy, MD, PhD, HCLD, highlight key findings from the study, “Routine Sperm Cryopreservation before Vasectomy Is Not Cost-Effective and Does Not Increase Live Birth Rates Compared to Surgical Sperm Retrieval or Vasectomy Reversal.” 

Fertility restoration may offer benefits in cost, efficacy vs sperm cryopreservation

, highlight key findings from the study, “Routine Sperm Cryopreservation before Vasectomy Is Not Cost-Effective and Does Not Increase Live Birth Rates Compared to Surgical Sperm Retrieval or Vasectomy Reversal.”

 We ran 3 types of models in the cost-effectiveness analysis, 1 being weighted in favor of cryopreservation—so, the weights that we entered into the actual mathematical model would more or less favor cryopreservation—a balanced model, which might be the most reflective of the real-world situation, and then a model that favors vasectomy reversal. In the balanced model and the vasectomy reversal model, vasectomy reversal was the more cost-effective finding, whereas the only situation in which sperm cryopreservation was more cost-effective was in the extreme situation in which the situation was weighed in favor of sperm cryopreservation, which likely is not reflective of what the real-life situation is. That, I think, is the key finding of this study. Whether or not it's surprising. I'm not sure, but I think it's a good finding to give patients more of an idea of the risks and benefits of both potential options prior to vasectomy. While sperm cryopreservation is very safe, there might be hidden costa that patients aren't aware of, both [in] the upfront costs of preserving the sperm and then the annual cost of maintaining it at a facility. I think that just shed some light on what might not be popularly known among patients.

 One of the key aspects of fertility preservation is that most of this is not covered by insurance. This is an out-of-pocket cost to anyone who decides to store their sperm, both upfront and then annually as well. The goal here is to understand whether that's worth it from a patient perspective, and secondarily, to understand whether the outcomes and the success rates are different for each approach. In this study, we found that it was more cost prohibitive to routinely bank sperm simply because very few people ultimately choose to restore fertility, and all those who don't are simply using their money for a frozen specimen that they'll never use. That costs quite a bit of money over time. What was surprising to me was that the success rates were actually higher in the group where we restored fertility, either through a vasectomy reversal or through collecting sperm to use for IVF with a minor procedure. In our models, this suggests that the outcomes, as far as success rates, are the same, if not slightly better, in the fertility restoration compared to the cryopreservation [group], which suggests that in both cost and in efficacy, the restoration might be a better choice.

“While sperm cryopreservation is very safe, there might be hidden costs that patients aren't aware of, both [in] the upfront costs of preserving the sperm and then the annual cost of maintaining it at a facility,” says Bradley Roth, MS4. 

, Bradley Roth, MS4, and Scott D. Lundy, MD, PhD, HCLD, outline the background and rationale for the study, “Routine Sperm Cryopreservation before Vasectomy Is Not Cost-Effective and Does Not Increase Live Birth Rates Compared to Surgical Sperm Retrieval or Vasectomy Reversal.” 

Investigators discuss cost-effectiveness study of cryopreservation vs vasectomy reversal

, outline the background and rationale for the study, “Routine Sperm Cryopreservation before Vasectomy Is Not Cost-Effective and Does Not Increase Live Birth Rates Compared to Surgical Sperm Retrieval or Vasectomy Reversal.”

Roth is a fourth year medical student at the University of California, Irvine Medical Center, and Lundy is the section head of reproductive urology as well as a surgeon scientist at the Cleveland Clinic in Cleveland, Ohio.

 The inspiration for this study was that ever since sperm banks opened in the 60s, there's been a popular idea among men who are pursuing vasectomy to cryopreserve sperm, so that if they ever do want future fertility, they have the sperm saved. While this is a very safe procedure, there hasn't been a lot of literature on is how cost effectiveness is, especially given how far advancements have come in vasectomy reversal, particularly with urologist skill in the procedure. The idea of the study was to take a look and do a cost effectiveness analysis so patients can have a better idea which might be a better route for them if they are going to pursue vasectomy, be it vasectomy reversal or sperm cryopreservation.

 The genesis of this study was actually very much rooted in modern technology. A friend of mine, Dr. [Pietro] Bortoletto, who's a female fertility specialist in Boston, posed a question to me on a social media site publicly about the cost effectiveness of this approach. So, we thought we might as well make a research study out of it. As Dr. Roth said, the idea here is to determine, from an epidemiologic perspective, whether freezing sperm for many men before their vasectomy is cost-effective compared to whether we should simply avoid this routine practice and allow men to proceed with their vasectomy and then restore their fertility in the future. It's also important to state that for some men, freezing sperm is absolutely a good idea and is medically indicated. For those who are undergoing chemotherapy or radiation or other gonadotoxic therapies, they're really not the purpose of this study. This is for healthy men who are considering this more from a social perspective, rather than a medically indicated perspective.

"The idea here is to determine, from an epidemiologic perspective, whether freezing sperm for many men before their vasectomy is cost-effective compared to whether we should simply avoid this routine practice and allow men to proceed with their vasectomy and then restore their fertility in the future," says Scott D. Lundy, MD, PhD, HCLD.

Justin Dubin, MD, discusses the potential harms of SARMs and anabolic steroids

Justin Dubin, MD, on potential health effects of SARMs and anabolic steroids

 discusses the potential harms of SARMs and anabolic steroids. He is an author of the paper “Utilization Patterns of Testosterone Supplementation and Replacement in Young Adult Men,” which he presented at the 2024 Sexual Medicine Society of North America Fall Scientific Meeting. Dubin is a urologist with Memorial Healthcare System in Aventura, Florida.

This study revealed a concerning popularity of potentially harmful substances like anabolic steroids and SARMs among young men. What are the potential health consequences associated with these substances, and what can be done to reduce their usage?

The main motivating factor for this study was, like I said, a lot of young men were coming to me under the age of 40, either on testosterone replacement therapy or interested in testosterone replacement therapy, especially people who really were not eligible for it. Now, the long-term factor is that a lot of these things, especially testosterone replacement therapy, you can become dependent on. Not only can you be dependent on it for life, it can also cause infertility. When we're looking at men who are under the age of 40, fertility can be a big factor. We know that things like SARMs can potentially compromise your fertility. We know things like anabolic steroids, which was unfortunately seen to be in a large usage in a population of men that were using these interventions in our survey, these are things that can have long-term impacts. Anabolic steroids especially can have issues on bone health, liver health, kidney health; it depends on the steroid, but there are other health implications. And if we can at least educate men and let them understand that doing these things can have long-term impact. It's not just about looking good and feeling good now, especially when it comes to family planning and your overall health in general, I think it goes a long way, and we really need to make sure that, once again, we are meeting our patients where they are, whether it's online, whether it's in the community, we really need to do a better job of destigmatizing these conversations so guys are comfortable asking their providers and also educating them, so that they know the risks before they're doing any of these things.

The study highlights the rising use of anabolic steroids and SARMs among young men, emphasizing the potential health risks, including dependency and infertility. These substances can adversely affect bone, liver, and kidney health. The research underscores the importance of educating young men about these risks, particularly concerning family planning and overall health. Effective communication and destigmatizing discussions about these substances are crucial. Healthcare providers should engage with patients in various settings to ensure they are informed about the long-term consequences before using these substances.

“We really need to do a better job of destigmatizing these conversations so guys are comfortable asking their providers [about sensitive health issues],” says Justin Dubin, MD.

Justin Dubin, MD, discusses the study “Utilization Patterns of Testosterone Supplementation and Replacement in Young Adult Men"

Study identifies trends in testosterone use in young adult men

 discusses the study “Utilization Patterns of Testosterone Supplementation and Replacement in Young Adult Men,” which he presented at the 2024 Sexual Medicine Society of North America Fall Scientific Meeting. Dubin is a urologist with Memorial Healthcare System in Aventura, Florida.

Given the significant differences in usage patterns observed across racial and insurance status groups, could you elaborate on the potential underlying factors that contribute to these disparities?

When we were looking at the people in our study, men under 40, we did see there was a large portion of African American younger men under the age of 40 who were taking testosterone replacement supplements or testosterone boosters. We also saw there was a large portion of uninsured people, and I think that really stands to show us how people are getting these things. A lot of the people we know are not getting it from urologists. They're getting it from friends, they're getting it from family. They're getting it from direct to consumer, which is often cash based. And so we really need to educate our patients, or men in general, about the risks and benefits of these therapies, so at least if they can't even come see us, we can at least give them the opportunity to know what they're getting into. Because when we know that a lot of men are doing things like SARMS, they're doing a lot of things like anabolic steroids, we know that they're probably not getting these things from a true health care provider. And if we can educate them on those risks of taking those things, we can hopefully motivate them to actually see the people that they should be seeing.

The study presented by Dr. Justin Dubin highlights the utilization patterns of testosterone supplementation among young adult men, particularly focusing on racial and insurance status disparities. A significant number of African American men and uninsured individuals under 40 are using testosterone supplements, often obtained outside traditional healthcare channels. This trend underscores the need for better patient education on the risks and benefits of such therapies. By informing men about potential dangers, there is hope to encourage them to seek guidance from qualified healthcare providers.

Kristy L. Mardis, NP, discusses ongoing work to increase and train advanced practice providers (APPs) in the field of sexual medicine.

Kristy L. Mardis, NP, on APP development initiatives in sexual medicine

, discusses ongoing work to increase and train advanced practice providers (APPs) in the field of sexual medicine. Mardis is a nurse practitioner at Indiana University Health in Indianapolis, Indiana.

One of our goals here with our program is to hopefully expand the APPs in the sexual medicine field. We are hoping to, at some point, we're working at creating a curriculum, and we'll hopefully have an APP fellowship here [at Indiana University.] I currently participate with the SMSNA and their APP committee. I've done some APP webinars on erectile dysfunction, and they have a new APP bootcamp. So, lots of exciting things happening in the APP world for sexual medicine, and we're hoping to contribute to that and hopefully teach some fellow APPs here in the future.

I'm also getting ready to start participating in a mentorship program with SMSNA where an APP will be paired with another new APP that's entering into sexual medicine to help mentor [them] and transition [them] into the field of sexual medicine. So, super excited to be a part of that and to help others as they enter this amazing field.

This transcription has been edited for clarity.

“One of our goals here with our program is to hopefully expand the APPs in the sexual medicine field,” says Kristy L. Mardis, NP. 

Catherine S. Nam, MD, discusses potential avenues for future work based on findings from the study, “Short-Term Changes in Vasectomy Consults and Procedures Following Dobbs v Jackson Women's Health Organization.” 

Dr. Nam on potential future research on vasectomy in the post-Dobbs era

, discusses potential avenues for future work based on findings from the study, “Short-Term Changes in Vasectomy Consults and Procedures Following 

Dobbs v Jackson Women's Health Organization

.” Nam is a clinical andrology fellow at Northwestern Medicine in Chicago, Illinois and a recent graduate of the University of Michigan residency program in Ann Arbor, Michigan.

We don't have any planned studies at this point, unfortunately, but I think there's a lot of different directions that we can go with from this study. It'd be really interesting to look at the vasectomy practice patterns, whether it's increasing consultation or procedures that differ by state, given that the abortion laws are dependent on a state level. For example, our findings were a little bit different than the findings that were found in Ohio. So, it'd be very interesting to see how that looks across the country depending on the political climate of the abortion law. We did this partially, but also across the country it would be interesting to see what's the conversion rate of a vasectomy consult to actual vasectomies that were performed. Part of the limitation is what I was alluding to earlier in terms of what kind of systematic changes do we need to make from each institution to be able to meet the demands of the patients. That doesn't happen overnight; typically, it takes weeks or months for that to be instituted. So, it'd be interesting to see what kind of a time lag existed and how are we actually able to meet the demands of patient care.

It would also be interesting to see if there is growing interest in male contraceptives with the increased interest in vasectomy, which is considered to be a permanent solution. For an oral contraceptive equivalent for men, is that something that is going to be more interesting to our patients? The other thing that I think would be interesting is there's the thought of vasectomy regret where because of the permanent nature, what proportion of patients have regret surrounding their decision? Especially in the post-Dobbs era, given the political nature of it, does that look different compared to our prior patient population that used to seek out vasectomy?

“The other thing that I think would be interesting is there's the thought of vasectomy regret where because of the permanent nature, what proportion of patients have regret surrounding their decision?” says Catherine S. Nam, MD.

Catherine S. Nam, MD, shares implications for urologists based on findings from the study, “Short-Term Changes in Vasectomy Consults and Procedures Following Dobbs v Jackson Women's Health Organization.” 

Dr. Nam on the increased interest in vasectomy amidst urologist shortages

, shares implications for urologists based on findings from the study, “Short-Term Changes in Vasectomy Consults and Procedures Following 

From the urologist perspective, I think in the immediate timeline, there's been a lot of discussion about how do we meet the current vasectomy demand from patients? There was a very sharp increase in both the consult demand as well as the procedure demand. Within our department at University of Michigan, there has been increased numbers of vasectomy procedure days to be able to meet the demand so that there's not a very long prolonged delay for our patients. The proportion of the new patient visits that were dedicated to vasectomy was definitely higher.

It'll be interesting to see how that plays out long-term, especially with the general increase in awareness and disputing of misconceptions that has taken place recently. It'll also be interesting to see how this plays out in the context of the urologic work force shortage. It's an AUA advocacy priority; we don't have enough urologists to be able to meet the demands of the population. Especially when vasectomy is one of the more commonly performed procedures across the country, how are we going to meet the demands of the patients that are potentially increasing with time to be able to make sure that we're able to provide timely care?

The other thing that's really interesting about the patient population that pertains specifically to vasectomy patients is a lot of them tend to be young. So, young men tend to pursue preventative care or have primary care doctors at a lower rate than our older patient population. It'll be really important for us to collaborate with primary care doctors, whether it's us referring our patients to primary care to make sure that they're able to participate in preventative health care throughout their lives, or for the primary care doctors to be able to provide some of the initial counseling before they come to the urologist's office to make sure that the patients are getting the care that they want.

“Within our department at University of Michigan, there has been increased numbers of vasectomy procedure days to be able to meet the demand so that there's not a very long prolonged delay for our patients,” says Catherine S. Nam, MD. 

Jacob Rust, MD, provides an overview of the recent Sexual Medicine Society of North America (SMSNA) Men’s Health Fellowship Bootcamp held in Minneapolis, Minnesota

Dr. Rust recaps the SMSNA Men’s Health Fellowship Bootcamp

, provides an overview of the recent Sexual Medicine Society of North America (SMSNA) Men’s Health Fellowship Bootcamp held in Minneapolis, Minnesota. Rust is the incoming andrology/male sexual and reproductive medicine fellow at Indiana University in Indianapolis.

The boot camp is designed for the incoming andrology and sexual medicine fellows. We get exposure and get an opportunity to work with experts in the field before we even start fellowship, so that we can develop a baseline of expertise in areas of Peyronie's disease, erectile dysfunction, infertility, and managing sexual medicine and fertility in men across the board. So, we had the opportunity to hear from several experts in the field teaching us about each of those topics, and also the opportunity to work with both of the device manufacturers, Boston [Scientific] and Coloplast, and tour their facilities and get a behind-the-scenes look at how inflatable penile prosthetics and other prosthetic devices are made. Then we also had the opportunity to work in a cadaver lab with those experts who were giving us lectures and learn their techniques, so that we come in with a broad range of experience that expands beyond our individual fellowship directors.

“We get exposure and get an opportunity to work with experts in the field before we even start fellowship, so that we can develop a baseline of expertise in areas of Peyronie's disease, erectile dysfunction, infertility, and managing sexual medicine and fertility in men across the board,” says Jacob Rust, MD.

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