Hannah Clarke

This year has placed a long-overdue spotlight on women’s health.

 and sexual medicine specialists have been tireless champions of women’s health needs, it is only recently that these issues have started to gain substantial traction within national guidelines and federal policy. The lack of recognition can be in part attributed to outdated data and subsequent stigma that have pushed women’s health to the sidelines.

Rachel Pope, MD, MPH
Credit: University Hospitals

“While men have medication that's very well covered for erectile dysfunction, women have fewer options, not because there's not medication. We do have medications, but coverage is lacking, and access is lacking,” explained Rachel Pope, MD, MPH, an obstetrician/gynecologist in the department of urology at University Hospitals Cleveland Medical Center in Cleveland, Ohio.

In 2025, these issues began to take center stage. Notably, we saw 2 pivotal advancements in this space: the development of the first-ever guideline on genitourinary syndrome of menopause (GSM) as well as the removal of the black box warning label on hormone replacement therapy (HRT) for menopause.

GSM guideline offers evidence-based guidance for the first time

In April 2025, at the American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada, the AUA released their first-ever guideline on GSM. This milestone both recognized GSM as a priority in urologic care and equipped urologists with the tools to manage it, thus enhancing care for women across the country.

The term GSM was introduced in 2014, and according to the AUA, “describes the spectrum of symptoms and physical changes resulting from declining estrogen and androgen concentrations in the genitourinary tract during perimenopause and after menopause.”

 This condition affects millions of postmenopausal women, impacting urinary, sexual, and vaginal health, yet it has remained historically under-addressed in urology.

Rachel Rubin, MD 
Credit: RachelRubinMD.com

Until the release of the GSM guideline in 2025, there had been no consensus regarding the number or type of symptoms needed to diagnose GSM nor a requirement for identifying concurrent physical signs. Thus, the guideline statements—26 in total—offer evidence-based guidance on care for these patients for the first time.

“It will truly save lives,” said Rachel Rubin, MD, in an episode of Pearls & Perspectives at the AUA Annual Meeting. “There's a paper at this meeting that looks at the reduction in sepsis, mortality, [and] hospitalizations in the patients who took vaginal estrogen. This document gives permission to clinicians of every specialty, to say, ‘This is not just a little vaginal dryness that's uncomfortable. This is sepsis, death, decrease in sexual health, urinary overactivity, urinary tract infections.’ This is urology. By giving women vaginal hormones, not just estrogen, we will save lives.”

Updated warning labels on HRT overturn misguided data

Women’s health became a topic of conversation again in November 2025 when the FDA convened an expert panel to discuss the labeling on HRT for menopause.

During the discussion, the experts outlined what they called outdated data surrounding HRT, namely from the Women’s Health Initiative (WHI) study, which found a statistically nonsignificant increase in the risk of breast cancer among patients receiving estrogen plus progestin. These data led to the inclusion of a black box warning label on all estrogen-containing products—a move which many physicians argued was too broad.

Since the findings were released in 2002, advocates for HRT have emphasized the differences between the context of the WHI study and the use of HRT in routine practice. Particularly, the study used conjugated equine estrogens, which is a hormone formulation that is not commonly used in clinical practice today.

 Clinicians have argued that risks associated with this formulation cannot be generalized to all forms of hormonal therapies, noting a clear difference between systemic products and local vaginal estrogen. Further, the average age of participants in the WHI study was 63 years, which is over a decade past the average age of women experiencing menopause.

Ignoring these nuances has led to decades of fear and misinformation surrounding HRT. The warning label both discouraged physicians from prescribing vaginal estrogen and prevented women from adhering to life-changing care.

There have been a multitude of studies that have confirmed the safety and efficacy of local vaginal estrogen. Specifically, data have shown that women who initiate HRT within 10 years of the onset of menopause have reduced all-cause mortality, as well as a 50% reduction in the risk of cardiovascular disease,

 a 35% reduction in the risk of Alzheimer’s disease,

 and a 50% to 60% reduction in the risk of bone fractures.

Ramzy T. Burns, MD
Credit: Indiana University

Based on these data and expert advocacy, in November 2025, the FDA issued a correction to their decision 2 decades prior, announcing plans to remove the broad box warning labels on HRT for women experiencing menopause.

 This decision was met with excitement by experts across urology and sexual medicine, who emphasized that these changes would allow for the destigmatization of HRT and equip physicians with confidence in prescribing it.

“This is a huge step forward for women’s health,” said Ramzy T. Burns, MD, an assistant professor of urology and adjunct assistant professor of obstetrics and gynecology at Indiana University School of Medicine. “It finally reflects what the evidence has shown for years and allows us to have more open, accurate conversations about hormone therapy with our patients.”

Many experts also reflected on the significance of recognizing women’s health on a national scale, albeit following a misguided recommendation.

Pope noted, “While I do think the changes are hugely overdue and some of these things could have been prevented, I'm so glad that the whole nation has now moved attention towards women's health.”

FDA decisions move the needle toward individualized care

Sameena A. Rahman, MD
Credit: Northwestern Medicine

The decision to remove the warning labels on HRT for menopause not only affirms the safety and efficacy of this therapy for women, but also allows clinicians to provide care on an individual basis. Rather than having a blanket warning for everyone, physicians can have a discussion with patients to determine who might be best suited for this treatment option.

“My counseling is now going to shift from a place of fear to a place of clarity,” said Sameena A. Rahman, MD, a clinical assistant professor at Northwestern Feinberg School of Medicine in Chicago, Illinois. “Instead of starting out the discussion with, ‘I know that you’ve heard about the fear around using hormones,’ now I’m going to start with, ‘Is this the right option for you?’”

For many, the hope is that these changes not only impact the current delivery of care but also the way that future generations of urologists are trained on GSM and vaginal estrogen. In the current system, education surrounding women’s health needs is lacking.

“One of the things that I presented at The Menopause Society this past year was a survey I did on 150 [physician assistants] PAs, asking them what their menopause training looked like in their PA programs,” said Aleece Fosnight, MSPAS, PA-C, CSC-S, CSE, IF, MSCP, HAES, founder of the Fosnight Center for Sexual Health and a medical advisor for Aeroflow Urology. “Only 3% of them said that they felt like they had adequate training in menopause in their programs.

 That's awful. We need to do better, and that needs to start at the education level. I'm hopeful that the media surrounding this box warning [update] will open up the eyes of our medical schools, our PA programs, and our nursing programs to say this is something that we need to implement sooner than later.”

Recent women’s health wins reflect the power of advocacy

Aleece Fosnight, MSPAS, PA-C
Credit: Fosnight Center

It’s important to emphasize that these changes did not happen overnight. Both the GSM guideline and the label update for HRT are the result of years of advocacy from urologists and sexual medicine specialists across the country. It is the product of many physicians who looked at the current state of care for women and said, “This system is not working, and our patients deserve better.”

“This has been over a decade in the making,” Rahman added. “I think this proves the power of advocacy. A lot of people say they don't want to get political, they don't want to get involved. But look, this push happened because people got involved, because people said, ‘You know what? We are speaking for the voiceless.’ As clinicians, we have authority in this area, we have knowledge, we have science, and we have research that promotes this. We need to get out there and just get loud about it, because change can happen.”

American Urological Association Releases New Guideline on Genitourinary Syndrome of Menopause. News release. American Urological Association. April 28, 2025. Accessed December 22, 2025. 

https://www.auanet.org/about-us/media-center/press-center/american-urological-association-releases-new-guideline-on-genitourinary-syndrome-of-menopause

HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. News release. US Food & Drug Administration. November 10, 2025. Accessed December 22, 2025. 

https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy

Connor EB, Bush TL. Estrogen and coronary heart disease in women. 

Paganini-Hill A, Henderson VW. Estrogen replacement therapy and risk of Alzheimer disease. 

Weiss NS, Ure CL, Ballard JH, Williams AR, Daling JR. Decreased Risk of Fractures of the Hip and Lower Forearm with Postmenopausal Use of Estrogen. 

. 1980 Nov 20;303(21):1195-8. doi:10.1056/NEJM198011203032102

Fosnight A. The Alarming Unmet Educational Needs in Menopause Care for Physician Associates: Revealing the Systemic Gaps in PA Training and the Urgent Call to Integrate Menopause into Clinical Education. Presented at: The Menopause Society’s 2025 Annual Meeting. Orlando, Florida. October 21-25, 2025. Poster 53. 

https://tms.scientificposters.com/epsAbstractTMS.cfm?id=1

Articles

Recent advancements in women's health have emerged, notably the introduction of the first guideline on genitourinary syndrome of menopause (GSM) and the removal of the black box warning on hormone replacement therapy (HRT) for menopause. These changes address historical neglect and stigma, providing evidence-based guidance and affirming HRT's safety. The updates enable individualized care and reflect the power of advocacy in transforming healthcare practices. The focus on women's health is expected to influence future medical education and improve care delivery for women experiencing menopause.

2025 featured multiple advancements in women's health aimed at enhancing treatment options and awareness.

From GSM guidance to HRT reform: A landmark year for women’s health

The May 19, 2025, announcement of former President Joe Biden’s prostate cancer diagnosis placed renewed attention on screening, detection, and treatment of a disease that remains a leading cause of cancer-related death among US men. In the days and weeks that followed, urologists across the country began to notice subtle but meaningful changes in patient behavior and clinical conversations.

 surveyed urologists and advanced practice providers about the real-world impact of the news. Responses suggest an increase in patient questions about PSA testing, heightened anxiety among older men, and growing interest in baseline or continued screening later in life. At the same time, the findings raise important questions about patient understanding of modern diagnostic pathways and the ongoing controversy surrounding prostate cancer screening guidelines.

Together, these insights highlight how a high-profile diagnosis can influence awareness and decision-making in clinical practice. 

 to explore what providers are seeing, what patients are asking, and how this moment may shape future conversations around prostate cancer care.

• Open the survey by clicking the image or link above. It will open the interactive publication in a new browser window.

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• For now, the survey link performs better for desktop/laptop viewing. You can view on mobile, but some interactive experiences may not be available. 

• Questions? Problems? Feedback? Please reach out to Assistant Managing Editor Ben Saylor.

• Developed by Urology Times Co–Editor in Chief Michael S. Cookson, MD, MMHC, FACS, the survey polled urologists for their perceptions related to former President Joe Biden's diagnosis of metastatic hormone-sensitive prostate cancer

• In the article accompanying the results, Cookson provides insights on the survey data.

• Also included is an exclusive video with Cookson in which he discusses data from a forthcoming study indicating that prostate cancer–related searches climbed sharply and stayed elevated after former President Biden’s prostate cancer diagnosis.

The announcement of former President Joe Biden's prostate cancer diagnosis has sparked increased interest in prostate cancer screening and detection among patients and healthcare providers. Urologists have observed a rise in patient inquiries about PSA testing and heightened anxiety, particularly among older men. This situation underscores the influence of high-profile diagnoses on public awareness and clinical decision-making. The ongoing debate over prostate cancer screening guidelines is also highlighted, emphasizing the need for improved patient understanding of modern diagnostic pathways and the implications for future prostate cancer care discussions.

Results of an exclusive Urology Times survey indicate heightened concern among older men about prostate cancer screening.

Prostate Cancer Screening After Biden’s Diagnosis: What Urologists Are Seeing in Practice

A shift in the management of BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) has been the inevitable culmination of over a decade’s worth of work.

Traditional approaches to the management of NMIBC were limited to intravesical immunotherapy or chemotherapy––relying primarily on BCG, with the only other approved alternative being valrubicin. With the BCG shortage taking hold in 2012, urologists found themselves grappling with an even more constrained set of options. Considering this reality, pharmaceutical companies, investigators, and the FDA itself recognized the need for new therapeutics in this space, thus beginning the arm’s race for novel innovations.

In recent years, the fruits of this effort have become apparent, with 3 new approvals in the NMIBC realm and many more agents in phase 3 development.

However, even after the BCG shortage resolves, the need for agents in the BCG-unresponsive setting will remain.

“In the future, we are going to probably have other BCG strains, but this concept of BCG failure or BCG refractory disease is not going to go away,” said Siamak Daneshmand, MD, a professor of urology and director of clinical research at the University of Southern California, in an interview with 

®. “Not everybody responds to BCG. There's a global need for patients who don't respond to BCG, and then there's a small percentage of patients who don't tolerate BCG very well. We're so used to it because we've been using it for so long, but there are some patients who have a really difficult time with BCG.”

As 2024 comes to a close, the excitement for these new agents could not be more apparent. The BCG-unresponsive NMIBC space has gone from a dearth of options to a wave of new treatments, and now urologists are faced with an encouraging challenge: choosing the best one.

Siamak Daneshmand, MD
Credit: Keck School of Medicine of USC

The wave of new treatment options began in January 2020 with the approval of intravenous pembrolizumab (Keytruda), an anti-PD-1 therapy for patients with high-risk, BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Although this approval offered a new bladder-sparing option for patients, long-term outcomes showcased its downsides. Pembrolizumab was the first approved agent in the space with a 3-month complete response (CR) rate of 41%, but only 18.8% of the initial treatment cohort (n = 96) remained disease-free at 12 months.

Daneshmand noted, “Pembrolizumab has been around for several years now for [NMIBC], but the efficacy is not very high, especially when you start to look at 3 years. That safety-profile-to-benefit ratio is just not quite there.”

It wasn’t long before a new option rivaled the efficacy seen with pembrolizumab. In December 2022, the FDA approved nadofaragene firadenovec-vncg (Adstiladrin), an oncolytic adenovirus for patients with high-risk BCG-unresponsive NMIBC with CIS with or without papillary disease.

The approval was supported by data showing a 3-month CR rate of 53.4%.

 At 2 years following its initial approval, the therapeutic continues to demonstrate tolerability and safety in these patients, with promising cystectomy-free survival outcomes.

 The dosing schedule is also convenient for patients, as nadofaragene is dosed every 3 months as opposed to once per week like many of the other treatments that are available.

Vikram Narayan, MD
Credit: Emory University

However, this drug comes with its own set of challenges, primarily in its storing and handling. Nadofaragene arrives frozen and needs to be thawed before use, making it challenging for hospitals to manage in a busy environment.

Vikram Narayan, MD, an assistant professor of urology at Emory University in Atlanta, Georgia, explained, “The company has provided some additional guidance on how to make that piece easier, but I think in a lot of urology practices, being able to do that in an efficient way in a busy clinical practice remains a challenge.”

This year saw the approval of a third new agent––the interleukin-15 (IL-15) superagonist nogapendekin alfa inbakicept (N-803; Anktiva). Anktiva is indicated for use in combination with BCG for the treatment of patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors. The approval was based on data showing a CR rate of 55% at 3 months and 71% at any time point.

 However, real-world outcomes with this agent remain to be seen.

Although all 3 novel therapies have served as catalysts in bringing renewed hope to the BCG-unresponsive NMIBC space, there is optimism for further advancements in the near future.

Narayan noted, “I think it's fair to say that we haven't been as excited about the durability of a lot of these agents. So, we want to see better durability.”

Fortunately, it appears the wait for this progress will not be nearly as long as the decades leading up to these new options. Several agents already having demonstrated encouraging results in phase 2/3 studies, including TAR-200, cretostimogene grenadenorepvec, and TARA-002. Impressively, these agents boast CR rates at any time point of 83.5%,

Moving away from the BCG-unresponsive setting, there is even more potential with TAR-210, UGN-102, and combination regimens with BCG.

These agents are ushering in a new era of intravesical treatments, which appear to have comparable efficacy to systemic agents with less toxicity.

 Such treatments are anticipated to provide an additive impact to the profound progress that has already been seen in the BCG-unresponsive setting.

Sarah P. Psutka, MD, MSc
Credit: University of Washington

Thus, with a dizzying amount of activity in the management of NMIBC, urologists are now faced with new questions. The current treatment options were approved based on single-arm trials, so there are limited data on comparative efficacy. In the absence of head-to-head data, patient selection and treatment sequencing remain a challenge. As Sarah P. Psutka, MD, MSc, explains, these factors are a “black box,” and more data are needed to be able to make more informed decisions.

“Real-world data hopefully will help us to start to be able to use a data-driven approach to intelligently guide patients towards the therapies that they are most likely to respond to, but we're obviously not there yet. In the absence of comparative trials, it's just really challenging to know,” said Psutka, an associate professor of urology at the University of Washington in Seattle.

Patients will also face some considerations of their own.

Mark D. Tyson, II, MD, MPH
Credit: Mayo Clinic

“My understanding of the data is that most of these agents are about the same in terms of their efficacy. So, I think what it's going to boil down to, for the most part with patients, is going to be tolerability,” said Mark D. Tyson, II, MD, MPH, a urologic oncologist at Mayo Clinic in Phoenix, Arizona. “I also think there's going to be some other drivers of utilization. I'm sure the payers going to have something to say about this when the costs––for all of these agents––come out into full view. For the most part, I think patients are going to look at convenience, administration methods, tolerability, those sorts of things.”

Despite all of these unknowns, one thing remains clear: the future for NMIBC is bright.

Undoubtedly, this shift––deciding which agent to choose from–– is a welcome challenge in consideration of the previous era where bladder-sparing options were limited. This year has been a marked reflection of the past decade’s worth of progress in this space, and 2025 is poised to provide even more practice-changing advancements.

Balar AV, Kamat AM, Kulkarni GS, et al. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. 

. 2021;22(7):919-930. doi:10.1016/S1470-2045(21)00147-9

Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. 

. 2021;22(1):107-117. doi:10.1016/S1470-2045(20)30540-4.

Narayan VM, Boorjian SA, Alemozaffar M, et al. Efficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin–Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial. 

. 2024;212(1):74-86. doi:10.1097/JU.0000000000004020

Chamie K, Chang SS, Kramolowsky E, et al. IL-15 Superagonist NAI in BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer. 

. 2023;2(1):EVIDoa2200167. doi:10.1056/EVIDoa2200167

Daneshmand S, Zainfeld D, Pieczonka C, et al. Safety and tolerability of TAR-200 monotherapy in patients with bacillus Calmette–Guérin (BCG)-unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) in SunRISe-1. Presented at: Society of Urologic Oncology 25th Annual Meeting. December 4-6, 2024. Dallas, Texas. Abstract 135. Accessed December 5, 2024. https://suo-abstracts.secure-platform.com/a/gallery/rounds/21/details/3800

Tyson M, Uchio E, Nam J-K, et al. Topline results from BOND-003: a phase-3 study of intravesical cretostimogene grenadenorepvec for the treatment of high-risk BCG-unresponsive NMIBC with CIS. Presented at: Society of Urologic Oncology 25th Annual Meeting. December 4-6, 2024. Dallas, Texas. Late-breaking abstract.

Mazzarella B, Jayram G, Shore S, et al. ADVANCED-2: phase 2 open-label study to evaluate safety and anti-tumor activity of intravesical instillation of TARA-002 in adults with high-grade non-muscle invasive bladder cancer. Presented at: Society of Urologic Oncology 25th Annual Meeting. December 4-6, 2024. Dallas, Texas. Abstract 119. Accessed December 5, 2024. https://suo-abstracts.secure-platform.com/a/gallery/rounds/21/details/3637

Guerrero-Ramos F, Boormans JL, Daneshmand A, et al. Novel Delivery Systems and Pharmacotherapeutic Approaches for the Treatment of Non-muscle-invasive Bladder Cancer. 

. 2024;7(6):1267-1279. doi:10.1016/j.euo.2024.05.012

The management of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) has evolved significantly due to a decade-long effort to develop new treatments. Traditional options were limited, but recent years have seen the approval of three new therapies: pembrolizumab, nadofaragene firadenovec, and nogapendekin alfa inbakicept. These advancements offer new hope, though challenges remain in terms of treatment durability, patient selection, and real-world efficacy. Future developments are promising, with several agents in advanced trials, potentially transforming the therapeutic landscape for NMIBC.

The BCG-unresponsive non-muscle invasive bladder cancer space has gone from a dearth of options to a wave of new treatments.