Arthur L. Burnett, II, MD, MBA

Editorial Council, is professor of urology at Johns Hopkins University School of Medicine, Baltimore, Maryland.

The reports of clinical trial results for 2 novel oral testosterone undeconoate agents for use as testosterone replacement therapy bring forward a major advance in the management of testosterone deficiency. The introduction of these agents represents a paradigm shift in this clinical space for sexual medicine practice (see articles, pages 6-7).

Historically, an oral option for testosterone replacement therapy was unavailable because of risks of liver toxicity, including cholestasis and jaundice, associated with earlier developed 17-alpha-alkylated oral analogues. A host of testosterone delivery routes including transdermal (gels, creams, or patches), buccal, intranasal, intramuscular, and subcutaneous options have been in use, but each preparation has potential limitations and all are more onerous to administer than the simple mode of oral treatment.

These novel oral agents offer a new entry to the testosterone replacement therapy armamentarium by addressing the liver toxicity issue. They feature specialized formulations that avoid adverse hepatic effects. In clinical trials, both oral agents were found to produce no significant adverse effects on liver function tests. Rather, there is evidence reportedly of improved markers of liver disease.

The rigorous study and promising clinical availability of oral therapy for testosterone deficiency are flash points in the current era, in which the utility of testosterone therapy is under critical review. Recent concern regarding the proper indications for testosterone replacement therapy has prompted regulatory agency requirements and medical society recommendations to assist practitioners in clinical practice. A simpler oral treatment for testosterone deficiency presents another variable to be fully defined in exercising its appropriate prescription and use.

These trials provide early reassurance of safety, although ongoing studies may further elucidate safety aspects across cardiovascular, hematologic, and genitourinary systems of regular clinical concern associated with testosterone replacement therapy. It will also be valuable to investigate further the efficacy of oral therapies across conditions of testosterone deficiency, including adult-onset hypogonadism-related diabetes mellitus, testicular dysfunction as a complication of prior radiation or chemotherapy, HIV infection status, and other conditions characterized by low testosterone function.

The new oral therapies are a welcome advance for managing testosterone deficiency and will certainly prompt thorough review and positioning in process-of-care therapeutic algorithms. Assuredly, current guidance for evaluation and monitoring schemes for testosterone replacement therapy will remain operable. Recommendations for lifestyle modifications to improve health outcomes, which may then modify the role for testosterone interventions, should remain in force.

An ongoing limitation of exogenous testosterone therapy having potential adverse effects on normal spermatogenesis that compromises fertility remains relevant with use of oral therapies. This latter concern underscores the purpose of ongoing studies in men’s health to foster interventions that normalize male andrologic function and optimize natural wellness.

Articles

"The rigorous study and promising clinical availability of oral therapy for testosterone deficiency are flash points in the current era, in which the utility of testosterone therapy is under critical review," writes Arthur L. Burnett II, MD, MBA.

Oral testosterone agents mark important paradigm shift

 Editorial Council, is professor of urology at Johns Hopkins School of Medicine, Baltimore.

The current COVID-19 viral pandemic has upended all of our lives, both personally and professionally. Because of it, we are enduring a sobering new reality with its threat to health and life.

I suspect the communications from many of my colleagues on the 

editorial board will echo similar sentiments of a constructive call to action, messages of collective sacrifice, and unity of purpose. Given that our medical profession as urologists is not commonly centered on emergent or intensive care matters, unlike that of so many of our clinician colleagues, we recognize that much of our craft is not as urgent in these times as for others. Our responsibility has been to participate rightly in medical triage efforts, therefore deferring “non-essential” surgeries and clinical activities.

Urology APPs: Making an impact during the COVID-19 pandemic

Willing as we are to prioritize the management of urologic conditions that truly rate as having urgency or high mortality risk, this new reality has nonetheless impacted our professional practices organizationally and economically. As for all business concerns at this time, the economic slowdown affects the livelihood of health care providers, urologists included. The American Medical Association has acknowledged that the pandemic has harmed the practices of health care providers universally, and the crisis presents costs of treating COVID-19-positive patients as well as sustaining revenue losses with costs for payroll and overhead. As urologists, we will have to adjust in terms of what we clinically manage but also how we will do it and how we will finance it.

Undoubtedly, we will be challenged by the circumstances of this pandemic. Our response may well be to adapt to fill positions that are unfamiliar and possibly unappealing. For many of us, we will repurpose in new enterprises, new business models, and new opportunities for work productivity and life utility. We will be resilient.

Some areas of urology will be impacted considerably more than others. In these times of resource conservation, benign and quality of life conditions, and subspecialty concerns in urology may be perceived to be less serious or life threatening than malignancies or conditions risking loss of an organ. Such non-urgent conditions would aptly be relegated for management sometime in the future.

Sexual medicine conditions are predictably included in the category of conditions whose management may well be deferred. These conditions include erectile dysfunction, Peyronie’s disease, and testosterone deficiency. Penile prosthesis surgery, surgical reconstruction of the genitalia, and other surgical procedures in sexual medicine conceivably are deemed “non-essential” and are being rescheduled.

On the other hand, sexual medicine issues remain active and can be readily met with newfound telehealth consultation practices. Whether the need for sexual interactions is heightened or reduced in these times in which social distancing is practiced remains an open question.

How to code for urologic care during the COVID-19 pandemic

Specialty organizations in sexual medicine are grappling with canceled professional meetings as much as institutions are wrestling with limited in-person training exercises. This reality is the same for all professional organizations and institutions currently. The value of new science and training in sexual medicine and elsewhere is recognized, and educational programing must continue.

Thankfully, we are in an age of remote electronic learning. Using various media to promote discovery and learning offers a new way of life. Look for “virtual” conferences and training sections focused on sexual medicine that will be vital for progress in our profession and service to our patients.

"For many of us, we will repurpose in new enterprises, new business models, and new opportunities for work productivity and life utility. We will be resilient," writes Arthur L. Burnett, II, MD, MBA.

Pandemic brings new challenges, opportunities-and resilience

 Editorial Council, is professor of urology at Johns Hopkins University School of Medicine, Baltimore.

The research by Gross et al provides important grounds for reconceptualizing infectious complications associated with penile prosthesis surgery (see 

"Data reveal timeline of post-IPP infections").

 The observations that penile prosthesis surgical infections occurring early are frequently associated with anaerobic bacterial organisms and that these infections overall comprise diverse pathogens including fungal organisms fundamentally alter conventional thinking related to this topic area.

Previous thinking considered primarily gram-positive bacterial organisms with antibiotic coverage directed accordingly. Prosthetic surgeons may wish to consider this new information strongly in applying revised antimicrobial protocols for penile prosthesis surgery.

Although prosthetic device infection is an infrequently occurring complication of prosthetic surgery in modern times, it is generally recognized that it represents the most serious complication risk of this surgery. Device loss (removal) and penile tissue damage are common sequelae of this complication. It is acknowledged that in the acute setting, salvage approaches such as the Mulcahy procedure have been used successfully under select indications.

In accordance with clinical guidelines, surgeons are advised to inform patients about the potential risk of device infection associated with this procedure. To mitigate this risk, good practice is to administer antibiotics perioperatively despite the rigor of deferring surgery in the presence of active clinical infection and performing the surgery with meticulous technique.

No consensus position exists as to the established antimicrobial regimen to be used for penile prosthetic surgery. Antibiotic regimens standardly feature a gram-positive-directed antimicrobial agent such as vancomycin or a cephalosporin, in combination with a gram-negative-directed antimicrobial agent such as an aminoglycoside. Expanded coverage to include agents directed toward anaerobic and fungal organisms warrants consideration given today’s paradigm shift.

It is accepted that this report may not represent a definitive organism profile registry, although the large multi-institutional effort here is commendable. It is acknowledged as well that only a rigorous comparative study of antimicrobial agents and regimens may affirm the optimal infectious disease approach. However, such a future study is unlikely to be probative given the low frequency of prosthetic device infection. Ongoing science of prosthetic infections including biofilm microbiology may also be advantageous to advance strategies to counteract infection risk.

"The observations that penile prosthesis surgical infections occurring early are frequently associated with anaerobic bacterial organisms and that these infections overall comprise diverse pathogens including fungal organisms fundamentally alter conventional thinking related to this topic area," writes Arthur L. Burnett, II, MD, MBA.

Post-prosthesis infection data alter conventional thinking

A new AUA clinical guideline on the diagnosis and treatment of erectile dysfunction is rigorous and evidence based while representing evolution of the field since the AUA last published a guideline on ED in 2005, says Arthur L. Burnett, II, MD, MBA, chair of the guideline development panel.

“We have actually decided to move forward with a new paradigm as well that allows us to move all the therapies forward in a way that we think is most useful and appropriate for patients,” said Dr. Burnett, of Johns Hopkins University School of Medicine in Baltimore.

In an interview at the AUA annual meeting, Dr. Burnett discusses some of the significant differences between the 2018 and 2005 AUA guidelines on ED, how the new guideline addresses novel treatments that are not currently FDA approved, and the shift from a process-of-care model to a shared decision-making model.

Dr. Burnett is a consultant/adviser to Astellas, Genomic Health, and Lilly, and conducts scientific studies/trials for Endo Pharmaceuticals, Pfizer, the National Institutes of Health, American Medical Systems/Boston Scientific, Coloplast, Reflexonic LLC, Medispec, Lilly, and Acorda Therapeutics.

Arthur L. Burnett, II, MD, MBA, discusses some of the significant differences between the 2018 and 2005 AUA guidelines on ED as well as how the new guideline addresses novel treatments that are not currently FDA approved.

Author | Arthur L. Burnett, II, MD, MBA

Articles

Oral testosterone agents mark important paradigm shift

Pandemic brings new challenges, opportunities-and resilience

Post-prosthesis infection data alter conventional thinking

New AUA ED guideline reflects paradigm change