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Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

The approvals are supported by findings from the phase 3 CheckMate-67T trial.

Subcutaneous nivolumab approved in EU, Canada for solid tumors

These data are intended to support a new drug application to the FDA in the second half of 2025.

Phase 3 trial of tebipenem HBr for cUTI stopped early for efficacy

The single-use test can deliver diagnostic results for chlamydia and gonorrhea in approximately 30 minutes. 

Application submitted to FDA for 510(k) clearance of Men’s Sexual Health Test

However, the data did not show any benefit of a docetaxel doublet vs an ARPI doublet.

Combination therapy linked to longer OS vs ADT in veterans with mHSPC

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Clinical Focus

Leonard G. Gomella, MD, FACS; Maha Hussain, MD, FACP, FASCO; Daniel P. Petrylak, MD

18th Annual Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Malignancies

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

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

, on the recent amendment to the American Urological Association (AUA)/American Society for Reproductive Medicine (ASRM) guideline on male infertility.

 Brannigan is the vice chair of clinical urology and the chief of male reproductive medicine and men’s health at Northwestern University in Chicago, Illinois, as well as one of the Guideline Amendment Chairs for the AUA male infertility guideline. Andino is an assistant professor of urology at the University of California, Los Angeles (UCLA) Health.

This discussion originally took place during a live X (formerly Twitter) Spaces event held by 

During the discussion, Brannigan and Andino highlight 3 key changes to the male infertility guideline, which include:

The recommendation for lower the sperm concentration threshold to perform Y chromosome microdeletion testing (statement 13)

The recommendation to add pelvic MRI imaging an option for men with suspected ejaculatory duct obstruction. Formerly, the main option was TRUS/Seminal Vesicle aspiration (statement 23)

The recommendation to add use of testicular sperm as an option in the setting of men with elevated sperm DNA fragmentation testing and infertility (statement 32)

Other key changes addressed throughout the discussion include the additional situations in which a male should be evaluated even if the semen analysis is normal; the avoidance of exogenous therapy if a patient is interested in current or near future fertility; and the situations where a scrotal ultrasound may be useful, give that is not needed as a routine test. Brannigan and Andino also touch on the potential role for seminal vesiculoscopy, which is not included in the guidelines, and the ASRM’s broadened definition of infertility.

, or anywhere that podcasts are available.

1. Brannigan RE, Hermanson L, Kaczmarek J, Kim SK, Kirkby E, Tanrikut C. Updates to male infertility: AUA/ASRM guideline (2024). 

. August 15, 2024. Accessed September 23, 2024. doi:10.1097/JU.0000000000004180

In this episode, Robert E. Brannigan, MD, and Juan J. Andino, MD, MBA, discuss the recent amendment to the AUA/ASRM guideline on male infertility. 

Key updates from the AUA/ASRM male infertility guideline amendment

® Assistant Editor Janelle Hart spoke with 

. She discusses why the misconceptions of sexually transmitted diseases and infections are hindering patients from seeking appropriate care, and how urologists can help to rid of these misconceptions. Winter is a urologist at Kaiser Permanente in Portland, Oregon.

“We need to just approach STIs as the medical conditions they are because until we do, and until we take those stigmas away, people will truly have resistance to discussing it, hesitance to discussing it, and resistance to diagnosis and intervention,” says Ashley Winter, MD.

Destigmatizing Urology: Dr. Winter discusses STDs/STIs

 He discusses the common misconceptions associated with interstitial cystitis, specifically from the mindset of the patient. Furthermore, he gives an overview of the MAPP study, which has helped to destigmatize the condition in major ways. Clemens is an Edward J. McGuire professor of urology, an associate chair for research, and fellowship director of female pelvic medicine and reconstructive surgery at the University of Michigan in Ann Arbor.

“I think people can feel like they're all alone, or they have something that's uncommon, and it may not be,” says J. Quentin Clemens, MD, FACS, MSCI.

Destigmatizing Urology: Dr. Clemens discusses interstitial cystitis

article, Treatment of urethral stricture disease in women: A multi‐institutional collaborative project from the SUFU research network, for which she served as a study author. Lane is a fellow in female pelvic medicine and reconstructive surgery at the University of Michigan, Ann Arbor.

On the latest episode of the Speaking of Urology podcast, Dr. Giulia Lane discusses her recent study evaluating treatment of urethral stricture disease in women.

Dr. Giulia Lane discusses urethral stricture disease in women

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

FDA updates in urology: April 2025

The method involves local delivery of the antibiotic gentamicin directly into the bladder tissue. 

Novel drug delivery approach shows promise for UTI 

Check out the key regulatory decisions set to happen early this year.

Key FDA decisions urologists can expect in the first half of 2025

In a recent study of the RELIEF stent, 95% of patients showed no VUR following stent placement. 

FDA grants 510(k) clearance to RELIEF stent for vesicoureteral reflux

, Anna Myers, CNP, was asked about preventing urinary tract infections (UTIs), as well as the importance of antibiotic stewardship.

“We all have to be very good stewards of antibiotics. There have not been a lot of new antibiotics, and when any new medicines come out, they are so expensive, they are untouchable for many,” Myers said.

Because of this, Myers said, “It's very important to go to the basics. We can improve urinary tract infections considerably with behavioral modification. Let's say a person is not drinking at least a 1 and a half liters of fluids a day. And I'm talking about a person that's able to drink that…If we can increase those fluids to greater than 1 and a half liters, we can improve their symptoms by 90%. Drinking fluids pushes that bacteria out of the bladder that's coming up from the vagina,” Myers said.

Anna Myers, CNP, was asked about preventing urinary tract infections (UTIs), as well as the importance of antibiotic stewardship.

Anna Myers, CNP, discusses her approach to preventing UTIs

Myers also talked about changes in patients’ pH and its effect on the bladder.

“I use pH paper in the office, and I can see what their pH is, and then I can treat that, and then we can see if we've improved their urinary tract infections. [It] just takes a little bit of microtrauma. That tissue is real thin and fragile; that bacteria will get right up in there and cause them a urinary tract infection,” Myers said.

Videos

"We can improve urinary tract infections considerably with behavioral modification," says Anna Myers, CNP.

Vanita Gaglani, RPT, discusses her books on post-prostatectomy incontinence and prostatitis

Vanita Gaglani, RPT, discusses books on post-prostatectomy incontinence and prostatitis

discusses her books on post-prostatectomy incontinence and prostatitis. Gaglani is a registered physical therapist and owner of Vanita’s Rehab in Melbourne, Florida. She was interviewed at the 2025 Desai Sethi Urology Institute Urology on the Beach meeting in Miami Beach, Florida.

You have written books regarding post-prostatectomy incontinence as well as prostatitis. Could you provide a brief summary of these works?

[One of my books is about] radical prostatectomy and overcoming incontinence in several weeks. It encompasses everything. It shows all the exercises, but it also talks about how to increase your bladder capacity, why you should drink water, how drinking water does not make you leak more; it actually makes you leak less, how doing more exercises will actually make you leak more.

The reason that we focus on not doing a lot of exercises initially is because the pelvic floor is small, like your hand. Your hand muscles are small. If you keep squeezing your hand muscles, then what will happen is that at a point, you will not be able to hold anything. Similarly, if you do too many Kegels, it will create a problem that the pelvic floor won't have the strength to hold it. The second important thing in the book is how the bladder works. I encourage men to not have drinks or bladder aggravants, and to focus on alkaline or neutral foods to decrease bladder spasms. The reason that happens is,imagine if a person has had a cut on the hand and it is sutured, and then if you put lemon juice on it, it goes into a spasm. Similarly, when people drink soda after surgery, the bladder goes into a spasm, and then the urine will get pushed out, because the job of the kidneys is to remove toxic material, and soda is very toxic, along with several other bladder aggravants. The book focuses on a holistic approach, along with exercise, and it is focused on nutrition, hydration, behavior modification, and exercise. All 4 components are required for a man to get dry. You cannot just do Kegel exercise or only drink a lot of water or just do body mechanics. They all have to be combined together in a sequence, and that is what the book focuses on.

My second book is on pelvic pain or prostatitis. It is focused on a holistic approach and stretches and mindfulness exercises. It is more of a self-help book A person can sit at home and do all these stretches and exercises. It also requires following certain nutritional protocol and behavioral protocol, as well as body mechanics. Prostatitis is a very unique condition in men. It is not something men talk about very frequently, because it is something that is not talked about often in public. lt is very difficult for a man to go and say, "my rectum is hurting," or "my scrotum is hurting," or "I have got penile pain and I cannot sit for a long time," or "I cannot bike," or "I cannot stand for a long time." This book helps them to know that they are not the only ones having this problem. There are a lot of young men who have this problem, and it absolutely impinges on their social life, because they just kind of isolate themselves.

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

"My second book is on pelvic pain or prostatitis. It is focused on a holistic approach and stretches and mindfulness exercises," says Vanita Gaglani, RPT.

J. Quentin Clemens, MD, MSCI, discusses the role of diet and lifestyle modifications in the management of interstitial cystitis/bladder pain syndrome (IC/BPS). 

Diet and interstitial cystitis: A urologist’s view

discusses the role of diet and lifestyle modifications in the management of interstitial cystitis/bladder pain syndrome (IC/BPS). Clemens gave a talk at the 2025 Desai Sethi Urology Institute Urology on the Beach meeting titled “Tailoring IC Therapies for the Individual Patient.” He is the Edward J McGuire Professor of Urology, program director for the Urogynecology and Reconstructive Pelvic Surgery Fellowship, Urology, and associate chair for Research, Urology, at the University of Michigan, Ann Arbor.

What are your current perspectives on the role of diet and lifestyle modifications in the management of IC/BPS, and how do you advise patients on these aspects?

Most patients when they see me, already have identified that there may be some triggers, and so I certainly let them know that that's a common feature, and that if there are certain foods or beverages that flare up their symptoms, then that's something they obviously should consider avoiding. There are some very strict IC diets that have been published, and I've had a handful of patients who have really found that helpful. They kind of stumbled across that, if you will. I feel like having IC is miserable enough as it is without also telling patients that they can only eat pears and blueberries, for instance. That's pretty much what I tell them, in the sense that I think that for most treatments for IC, the data to support these very strict IC diets are not really there. To me, it's somewhere in the middle. One thing I like is the elimination diet approach, where sometimes you have patients stop certain things for a bit, and then if they don't see any change, then they can go back and take those so that's one way approach to consider.

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

"There are some very strict IC diets that have been published, and I've had a handful of patients who have really found them helpful," says J. Quentin Clemens, MD, MSCI.

J. Quentin Clemens, MD, MSCI, provides a summary of a talk he gave at the 2025 Desai Sethi Urology Institute Urology on the Beach meeting titled “Tailoring IC Therapies for the Individual Patient.” 

J. Quentin Clemens, MD, on individualized treatment of interstitial cystitis

 provides a summary of a talk he gave at the 2025 Desai Sethi Urology Institute Urology on the Beach meeting titled “Tailoring IC Therapies for the Individual Patient.” Clemens is the Edward J McGuire Professor of Urology, program director for the Urogynecology and Reconstructive Pelvic Surgery Fellowship, Urology, and associate chair for Research, Urology, at the University of Michigan, Ann Arbor.

I started by saying, unfortunately, there aren't many examples where we can do that. In other words, the approach is often to identify what treatments the patients have tried already, so we don't try those again, and then have a discussion about the pros and cons. However, there are a few examples. The first is patients with Hunner lesions, where it's very important to identify them, because that's a totally different treatment approach, where you target the lesions and can augment that with oral cyclosporine. So that's important. The second is, many patients will have pelvic muscle tenderness, and that's a feature of really, most pelvic pain conditions. But the point is that if they have that, and that contributes to their symptoms, so if they have tenderness, and they say, "yes, when you push there, it hurts, and that's part of the symptoms I have," those patients will benefit from pelvic floor physical therapy, and so they should be referred for that. And so those are 2 clear areas.

"The approach is often to identify what treatments the patients have tried already, so we don't try those again, and then have a discussion about the pros and cons," says J. Quentin Clemens, MD, MSCI.

J. Quentin Clemens, MD, on tailoring interstitial cystitis treatment

team conducted dozens of video interviews in 2024, comprising a variety of topics, ranging from erectile dysfunction to urinary tract infection. Here are the top-performing 

Dr. Dubin on trends in erectile dysfunction medication usage

, shares key findings from the study, “Beyond the prescription: trends and challenges in erectile dysfunction medications among young adult men,” for which he served as the senior author. Watch the video 

Olivia Paulsen on the association between BPH and erectile dysfunction

 gives an overview of the study “Benign Prostatic Enlargement Is Associated With Erectile Dysfunction in United States,” which she presented at the 25th Fall Scientific Meeting of the Sexual Medicine Society of North in Scottsdale, Arizona. Watch the video 

Dr. Bernie on testosterone therapy for men on active surveillance

, highlights the lack of long-term data on testosterone therapy for men on active surveillance for prostate cancer. Watch the video 

Urologist discusses Aquablation, rise in large prostates seen in his practice

 discusses Aquablation and shares an observation regarding an increase in large prostates. Watch the video 

Dr. Hougen on adding a coefficient for Black race to the 4Kscore

, shares the background and findings from the study, “Adding a Coefficient for Race to the 4Kscore Improves Calibration for Black Men.” Watch the video 

Dr. Dubin on the direct-to-consumer market for erectile dysfunction medications

 discusses the rationale for the study, “Beyond the prescription: trends and challenges in erectile dysfunction medications among young adult men.” Watch the video 

Dr. Soon-Shiong discusses the FDA approval of N-803 in NMIBC

In April 2024, the FDA approved N-803 (Anktiva, nogapendekin alfa inbakicept-pmln), a first-in-class IL-15 receptor agonist immunotherapy for use in combination with BCG for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. In this interview, 

 discusses the significance of the FDA approval for immunotherapy in NMIBC. Watch the video 

Steven A. Kaplan, MD, shares initial data on sildenafil oral spray vs tablets

 of ASP-001, an investigational oral formulation of sildenafil for patients with erectile dysfunction. Watch the video 

Dr. Meddings on catheterizing for urinary retention

 describes the background and notable findings from the 

 paper “Urinary Retention Evaluation and Catheterization Algorithm for Adult Inpatients.” Watch the video 

Dr. Varda on challenges in the diagnosis of urinary tract infection

 discusses the key take-home messages from the study, “Antibiotic Overtreatment of Presumed Urinary Tract Infection Among Children with Spina Bifida,” for which she served as the lead author. Watch the video 

As the year comes to a close, we revisit some of this year’s top video content from Urology Times.

Expert: Catheter reprocessing device has potential to be “game changer”

 further discusses the reusable intermittent urinary catheter system and reprocessing device evaluated in the 

study “Initial Antimicrobial Testing of a Novel Reusable Intermittent Urinary Catheter System and Catheter Reprocessing Device.” Flores-Mireles is the Janet C. and Jeffrey A. Hawk Collegiate Associate Professor in the Department of Biological Sciences at University of Notre Dame in Notre Dame, Indiana.

Do you see any need for patient or health care professional training for the Aurie system?

No, this is super easy. Of course, the first device was huge, and the feedback that we [received] was, "This is too much." There was a lot of communication with all the different [components], the scientific [component] [and] the company,...to try to make something small and simple...Even for us, when we were still doing all of that, it was really straightforward. So this is not going to require additional training by any staff or the patient.

I think that one of the major issues that we have...is that we have a lot of pathogens. They are becoming multi-drug resistant, to everything, to all the different drugs that we have. There are people that suffer [many] UTIs, and the quality of life is difficult. With this system, we're not involving the bacteria because we're killing it. We're washing everything. There is no way that they will survive that. It's not like an antimicrobial that will stop something [but there will be] a mutation, and they're going to be able to survive. So the fact that we can meet the incidence of UTIs in this patient population, that they are not healthy already, they're already going through all of this, that we can improve the quality of life. That's huge. Not only that, [but]...we have found that even 1 pathogen can affect your bladder completely and make you more susceptible to get more infections over time. So to have something like this [that is] so simple that you're washing the catheter...and it will improve your quality of life, I think, is a life-changing device. The idea that the company has to make it affordable speaks to the fact that they really want to improve the quality of life of these patients.

The idea is to keep improving these devices. I don't know if I'm going to work with them again, but the fact that we're going to have something that is FDA regulated is critical. None of these catheters that are available right now can [be reused], because the companies have not tested them. And again, we don't even have protocols for the patients to follow and clean their own catheters. There is lack of regulation, in many ways. To have a device that has been tested so many times that it proves it can clean the catheter. That is reproducibility. It's not you doing it, it's just put it right there and get it clean, and then you can re-use it safely and reduce the incidence of UTIs. Many patients end up having recurring UTIs from [their first] infection. So I think that that will be life changing because many of these patients use tons of antibiotics. Antibiotics will affect your gut microflora. Now, we know that your gut microflora is really important for you, not only for digestion, [but] even for mental health and metabolic disease. So the fact that we're going to improve quality of life by reducing the amount of antibiotics and reducing the waste by using single intermittent catheters, I think this, again, is a game changer.

"The idea is to keep improving these devices," says Ana Lidia Flores-Mireles, PhD.

A. Lenore Ackerman, MD, PhD, discusses sulopenem etzadroxil/probenecid (oral sulopenem) for the proposed indication of adult patients with uncomplicated urinary tract infection 

Dr. A. Lenore Ackerman on sulopenem and the UTI treatment landscape

 discusses sulopenem etzadroxil/probenecid (oral sulopenem) for the proposed indication of adult patients with uncomplicated urinary tract infection (UTI) caused by designated susceptible bacteria along with the UTI treatment landscape. Ackerman is an assistant professor in the department of surgery, division of urology at the University of California, Los Angeles. She is an advisor for GlaxoSmithKline.

It's not super well defined, because...there hasn't been an oral option in the carbapenem family. So we don't really know how, if it was introduced to the greater population with uncomplicated UTIs, how that's going to impact multi-drug resistance? And I am a little nervous, because these are our big guns. These are the ones that we need to have available when people are coming in with complicated infections that are drug resistant, and so it's a little bit scary, but I think that there is kind of a clear hierarchy of how we should go through what order we should use [antibiotics] in. We've got our first-line antibiotics, and then you've got some second-line ones, and then you reserve your fluoroquinolones for when you've got no other options. And then probably after that, you're going to see your carbapenems orally, if that's available. And I think what that may end up doing for sort of the possibility of outpatient prescriptions, on the good side, I think there are those patients with those highly resistant infections who probably don't need hospitalization that you could now keep out of the hospital. That's a really, really big bonus. I think the hard part is knowing who those people are. I have to say, this is a little bit of a sideways move here, but one of the things I think that's really interesting is we're seeing the development of a lot of AI predictive models of who might progress to urosepsis and who might be at higher risk for progression of their infection to have greater health consequences. Maybe the combination of those tools with better diagnostic stewardship and a little bit better education of both physicians and patients about whether you really even need aggressive antibiotics for most infections can help us both use that to its greatest efficacy, but also prevent it from being used or overused in situations in which you don't need it...We don't really go into this very much with patients anymore, but what happens for most uncomplicated UTIs when they're not treated, they resolve spontaneously without antibiotics. You may be miserable for a couple days—and ask any woman who's had a UTI; it can be a very unpleasant couple of day—but there's, I think, this pervasive attitude, both among physicians and patients, that leaving a UTI untreated is going to kill somebody. And I think that the more we can get away from that as a concept and just treat it like, if you get the flu, most of the time we're not treating that with aggressive antiviral medications. Most people can recuperate and recover on their own. And there are some people who are higher risk for whom they need maybe more aggressive treatment. And if we could view UTI a little bit more like that, where we treat people for symptomatic resolution, we treat people to keep them more comfortable, and we reserve our big guns for thosepeople that are higher risk, I think that's going to be the most productive way to preserve our big-gun antibiotics for those situations in which they're really needed. So I think if there are AI models that can help us out, if there are better guidelines that can help us out, all these things will be really, really helpful moving forward.

"One of the things I think that's really interesting is we're seeing the development of a lot of AI predictive models of who might progress to urosepsis and who might be at higher risk for progression of their infection to have greater health consequences," says A. Lenore Ackerman, MD, PhD.

A. Lenore Ackerman, MD, PhD, discusses the potential usage of sulopenem etzadroxil/probenecid (oral sulopenem) 

Expert discusses sulopenem for uncomplicated UTI

 discusses the potential usage of sulopenem etzadroxil/probenecid (oral sulopenem) for the proposed indication of adult patients with uncomplicated urinary tract infection caused by designated susceptible bacteria. Ackerman is an assistant professor in the department of surgery, division of urology at the University of California, Los Angeles. She is an advisor for GlaxoSmithKline.

How does sulopenem compare to existing treatments for uncomplicated UTIs in terms of efficacy, safety, and potential for resistance development? What factors may influence a health care professional's decision to choose sulopenem over other options?

What probably should be happening is that we should be reserving these antibiotics only for those situations in which someone has a multi-drug-resistant infection for which there are options that are not available otherwise. And really, when we talk about these more advanced, broader spectrum antibiotics, I think it's kind of interesting to me that the choice was made to try to go after an indication for uncomplicated UTI. There are some reasons why in terms of how it did initially in treating complicated UTIs, but I really think there's a very, very narrow place for these antibiotics and uncomplicated community presentations of UTI just because we really shouldn't need this kind of "big gun" for a lot of those infections. But obviously, there are people coming in and there's this gray line, I think, between what's defined as an uncomplicated UTI in patients that are at high risk for progressive infections. And maybe there's a place for it in those patients who've got demonstrated multi-drug-resistant infections and a high possibility of progressing to more systemic infections. But I think in general, we really have to be careful about the use of those kinds of drugs in this population. And there are some, I think, societies that would classify highly drug-resistant infections as being kind of complicated to begin with. I think this antibiotic is going to have its role in that gray zone between high-risk, uncomplicated and complicated UTI. So you have your patient who maybe is on some kind of immunomodulatory medication, who is just coming in with seemingly localized symptoms and drug-resistant infections, maybe that's a place that you want to use it, but I would think that's going to be a very small sliver of your population for whom it would really be appropriate.

“What probably should be happening is that we should be reserving these antibiotics only for those situations in which someone has a multi-drug-resistant infection for which there are options that are not available otherwise,” says A. Lenore Ackerman, MD, PhD.

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