Sexual Medicine Society of North America (SMSNA)/American Urological Association (AUA) telemedicine and men's health white paper.

PURPOSE: The purpose of this white paper is to educate health care professionals about the evolution of telemedicine (TM) and to propose a hybrid model that leverages the strengths of traditional in-person medicine as well as virtual medicine while maximizing the safety and quality of men's sexual health care. LITERATURE SEARCH STRATEGY: A literature search focused on the use of TM in urology and men's health was performed through PubMed/MEDLINE, Embase, and Web of Science (January 1, 2012-April 26, 2022). Keywords included all known permutations of the terminology used to refer to virtual health, care as well as the terminology used to refer to urologic diseases, issues specific to men's health, and men's sexual health concerns. Publications that emerged after the literature search that met this criterion also were incorporated. Opinion pieces, letters to the editor, meeting abstracts, and conference proceedings were excluded. Additional resources were retrieved, such as governmental technical reports, legislative updates and reviews, and blogs. This search strategy yielded 1684 records across databases after removal of duplicates. Abstracts from the retrieved records were reviewed for relevance. Relevant publications were defined as those that reported data on any aspect of TM use specific to urology, men's health, and/or men's sexual health. If relevance was unclear from the abstract, then the full text of the article was retrieved for a more detailed review. In addition, the published evidence-based practice guidelines relevant to care for erectile dysfunction, Peyronie's disease, ejaculatory dysfunction, and hypogonadism were retrieved. The most common reasons for article exclusions were a focus on TM use in disciplines other than urology and the absence of data (ie, opinion pieces). After exclusions, a total of 91 publications remained and constituted the evidence base for this paper.

Comparative assessment of outcomes and adverse effects using two different intramuscular testosterone therapy regimens: 100 mg IM weekly or 200 mg IM biweekly.

This study aimed to compare the change in levels of several laboratory values and the development of adverse events using two commonly used intramuscular testosterone therapy regimens. Men were included if they were 18 years or older and received one of the following testosterone therapy regimens: 100 mg intramuscular once weekly or 200 mg intramuscular once every other week. Primary outcomes were relative changes in total testosterone, free testosterone, estradiol, prostate-specific antigen, and hematocrit at 6 months after initiation of testosterone therapy. Secondary outcomes were any significant rises in estradiol, hematocrit, prostate-specific antigen, and any other treatment-related adverse events requiring cessation of testosterone therapy. A total of 263 men were enrolled. In a subanalysis of men who had a baseline hematocrit below 54% before intramuscular testosterone therapy initiation, we found the following: men who received 100 mg weekly injections were significantly less likely to have hematocrit levels rising above 54% (1/102 (1%) vs. 4/51 (8%); p = 0.023). No significant differences were recorded in the increase in total testosterone, free testosterone, prostate-specific antigen, and estradiol levels between both groups. A higher average serum testosterone over the dosing interval seen with the 200 mg regimen appears to be associated with a higher risk of erythrocytosis.

Current State of Advanced Practice Providers in Urological Practice.

INTRODUCTION: This document provides an update to the 2015 consensus statement with new content on inpatient utilization, procedural data, and compensation. The full document is available on the American Urological Association (AUA) website (https://www.auanet.org/guidelines/guidelines/current-state-of-advanced-practice-providers-in-urologic-practice). This document was created by an ad-hoc group of urological providers formed by the AUA board of directors. METHODS: A workforce shortage of 65,000 physicians is projected by the year 2025. In 2018, there were 3.89 urologists per capita, which is amongst the most severe specialty shortages. Urology has the second oldest surgical subspecialty workforce with an average age of 52.5 years. According to the 2018 census, 72.5% of urologists used an advanced practice provider (APP) in their practice, and APPs accounted for 41% of a medical doctor/doctor of osteopathy full-time equivalent. The AUA endorses the use of APPs in the care of patients through a formally defined, supervised role with a board certified urologist under the auspices of applicable state law. This physician-led, team-based approach provides the highest quality urological care. RESULTS: Urologists work with APPs frequently, but many may not know the most efficient way to incorporate them into their practice. This document examines APP integration from a regulatory and practice management approach, as well as provides information on inpatient utilization, procedural data, and compensation. CONCLUSIONS: This document supports the AUA's policy statement that in a team-based approach with a board certified urologist in a supervisory role, APPs contribute to the care of the patient with genitourinary disease and, therefore, encourages the proper use of APPs.

One size does not fit all: variations by ethnicity in demographic characteristics of men seeking fertility treatment across North America.

OBJECTIVE: To compare racial differences in male fertility history and treatment. DESIGN: Retrospective review of prospectively collected data. SETTING: North American reproductive urology centers. PATIENT(S): Males undergoing urologist fertility evaluation. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Demographic and reproductive Andrology Research Consortium data. RESULT(S): The racial breakdown of 6,462 men was: 51% White, 20% Asian/Indo-Canadian/Indo-American, 6% Black, 1% Indian/Native, <1% Native Hawaiian/Other Pacific Islander, and 21% "Other". White males sought evaluation sooner (3.5 ± 4.7 vs. 3.8 ± 4.2 years), had older partners (33.3 ± 4.9 vs. 32.9 ± 5.2 years), and more had undergone vasectomy (8.4% vs. 2.9%) vs. all other races. Black males were older (38.0 ± 8.1 vs. 36.5 ± 7.4 years), sought fertility evaluation later (4.8 ± 5.1 vs. 3.6 ± 4.4 years), fewer had undergone vasectomy (3.3% vs. 5.9%), and fewer had partners who underwent intrauterine insemination (8.2% vs. 12.6%) compared with all other races. Asian/Indo-Canadian/Indo-American patients were younger (36.1 ± 7.2 vs. 36.7 ± 7.6 years), fewer had undergone vasectomy (1.2% vs. 6.9%), and more had partners who underwent intrauterine insemination (14.2% vs. 11.9%). Indian/Native males sought evaluation later (5.1 ± 6.8 vs. 3.6 ± 4.4 years) and more had undergone vasectomy (13.4% vs. 5.7%). CONCLUSION(S): Racial differences exist for males undergoing fertility evaluation by a reproductive urologist. Better understanding of these differences in history in conjunction with societal and biologic factors can guide personalized care, as well as help to better understand and address disparities in access to fertility evaluation and treatment.

Telemedicine in Urology: The Socioeconomic Impact.

The emergence of the COVID-19 pandemic and subsequent public health emergency (PHE) have propelled telemedicine several years into the future. With the rapid adoption of this technology came socioeconomic inequities as minority communities disproportionately have yet to adopt telemedicine. Telemedicine offers solutions to patient access issues that have plagued urology, helping address physician shortages in rural areas and expanding the reach of urologists. The Centers for Medicare & Medicaid Services have adopted changes to expand coverage for telemedicine services. The expectation is that telemedicine will continue to be a mainstay in the health care system with gradual expansion in utilization.

Vasculogenic Erectile Dysfunction: The Impact of Diet and Lifestyle.

Vasculogenic erectile dysfunction has been aptly called the "canary in the coal mine" for cardiovascular disease because it almost always precedes other manifestations of atherosclerotic cardiovascular disease, including myocardial infarction and stroke. It is common, associated with the presence of modifiable cardiovascular risk factors, and impacted by diet and lifestyle choices. This concise review provides an update on the use of dietary and other lifestyle interventions to improve vasculogenic erectile dysfunction and atherosclerotic cardiovascular disease.

A review of the evolving landscape between the consumer Internet and men's health.

Internet adoption continues to increase as broadband access and mobile connectivity penetrate developing global markets. Alongside increasing adoption, the Internet continues to evolve and usher in new modes of user interaction. Social media and search engines have facilitated the emergence of the participatory web, in which users are able to contribute content, form online communities, and disseminate information. This participatory web is reshaping the patient-physician relationship as patients are able to search for medical information, directly engage with healthcare practitioners through social media, and make therapeutic decisions via online marketplaces. The ability for patients to self-diagnose and self-treat is highly relevant to andrology, given that men have a baseline reluctance to visit healthcare providers. Furthermore, men's health issues such as erectile dysfunction and male infertility are stigmatized, with men turning to the Internet for guidance. The focus of this review is to survey the academic literature that evaluates the quality of online content for four common men's health conditions: hypogonadism, male infertility, erectile dysfunction, and Peyronie's disease.

Reproductive endocrinologists are the gatekeepers for male infertility care in North America: results of a North American survey on the referral patterns and characteristics of men presenting to male infertility specialists for infertility investigations.

OBJECTIVE: To characterize the referral patterns and characteristics of men presenting for infertility evaluation using data obtained from the Andrology Research Consortium. DESIGN: Standardized male infertility questionnaire. SETTING: Male infertility centers. PATIENT(S): Men presenting for fertility evaluation. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Demographic, infertility history, and referral data. RESULT(S): The questionnaires were completed by 4,287 men, with a mean male age of 40 years ± 7.4 years and female partners age of 37 years ± 4.9 years. Most were Caucasian (54%) with other races being less commonly represented (Asian 18.6%, and African American 5.5%). The majority (59.7%) were referred by a reproductive gynecologist, 19.4% were referred by their primary care physician, 4.2% were self-referred, and 621 (14.5%) were referred by "other." Before the male infertility investigation, 12.1% of couples had undergone intrauterine insemination, and 4.9% of couples had undergone in vitro fertilization (up to six cycles). Among the male participants, 0.9% reported using finasteride (5α-reductase inhibitor) at a dose used for androgenic alopecia, and 1.6% reported exogenous testosterone use. CONCLUSION(S): This broad North American patient survey shows that reproductive gynecologists are the de facto gateway for most male infertility referrals, with most men being assessed in the male infertility service being referred by reproductive endocrinologists. Some of the couples with apparent male factor infertility are treated with assisted reproductive technologies before a male factor investigation. The survey also identified potentially reversible causes for the male infertility including lifestyle factors such as testosterone and 5α-reductase inhibitor use.

The Current State of Telemedicine in Urology.

Telemedicine use in urology is an evolving practice. In this article, the authors review the early experience of telemedicine specifically as it relates to urologic practice and discuss the future implications and the utility of telemedicine as it applies to other fields.

Intramuscular depot formulations of leuprolide acetate suppress testosterone levels below a 20 ng/dL threshold: a retrospective analysis of two Phase III studies.

INTRODUCTION: Androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) analogs is a standard treatment for advanced prostate cancer. GnRH analog therapy can reduce testosterone to "castrate" levels, historically defined as <50 ng/dL. With the advent of newer assays, a lower threshold of <20 ng/dL has recently been proposed. We report the results of a retrospective analysis of two Phase III trials of 4- and 6-month depot microsphere formulations of leuprolide acetate (LA), a GnRH agonist that has previously demonstrated efficacy in testosterone suppression to <50 ng/dL in patients on ADT. This analysis investigates the ability of these LA formulations to suppress to ≤20 ng/dL levels. METHODS: In two of five AbbVie/Abbott clinical trials of microsphere formulations of LA for ADT, analytic technology permitting testosterone detection as low as 3 ng/dL was used and thus was selected for this analysis. Both trials were open-label, fixed-dose studies in prostate cancer patients, naïve to ADT. Patients received either 30 mg (4-month formulation; n=49) or 45 mg (6-month formulation; n=151) depot injections of LA microspheres. Treatment duration was up to 32 weeks for the 4-month formulation and 48 weeks for the 6-month formulation. The proportion of patients achieving the 20 ng/dL threshold was determined every 4 weeks. RESULTS: Pooled analysis showed that 152 of 193 (79%) of patients achieved serum testosterone levels of ≤20 ng/dL at 4 weeks, and sustained the improvement at week 24 (169/189, 89%). Additionally, in the 6-month study, 127/135 (94.1%) patients were suppressed to ≤20 ng/dL at 48 weeks. CONCLUSION: Both 4- and 6-month intramuscular depot formulations of LA achieved and maintained mean serum testosterone levels ≤20 ng/dL in the vast majority of patients as early as 4 weeks following treatment initiation. Additional research on the clinical relevance of this lower testosterone threshold is warranted.

Use of Advanced Practice Providers as Part of the Urologic Healthcare Team.

Advanced practice providers (APPs) are advanced practice nurses (APN)/nurse practitioners (NP) or physician assistants. Over half of urologists currently employ APPs to extend and enhance their practice. Because APPs can fulfill a variety of roles from surgical assisting to running their own subspecialty clinic, they have emerged as a vital solution to alleviating the looming workforce shortage in urology practice. About 40 % of practicing urologists have not yet incorporated APPs into their practices. Some may still be unfamiliar with the concept of utilizing advanced practice providers, some have concerns about liability or scope of practice, and some are just getting started. Recently, the American Urological Association (AUA) published a consensus statement on advanced practice providers that provides urologists a comprehensive review regarding the education, training, Medicare reimbursement policies, applicable state laws, liability concerns, and examples of utilization of advanced practice providers within a urology practice. The consensus statement represented one of the most comprehensive compendiums of information specific to advanced practice providers in a urologic practice. This review will touch on the AUA Consensus Statement on Advanced Practice Providers, background information that informed that statement, as well as recent responses to the publication.

The Evaluation and Treatment of Delayed Ejaculation.

INTRODUCTION: Delayed ejaculation is a small but important subsection of ejaculatory dysfunction, with prevalence estimated at 1-4%. It is most commonly defined by DSM-IV-TR criteria, as "a persistent delay in, or absence of, orgasm in a male following a normal sexual excitement phase during sexual activity that the clinician, taking into account the person's age, judges to be adequate in focus, intensity, and duration." The pathophysiology of delayed ejaculation is related to disruptions in ejaculatory apparatus, nervous transmission, hormonal or neurochemical ejaculatory control, or psychosocial factors. AIM: To update the clinician on the evaluation and treatment of delayed ejaculation. METHODS: The keywords "delayed ejaculation" and "retarded ejaculation" were utilized to search Pubmed for relevant publications. MAIN OUTCOME MEASURES: 319 results were generated from the search, and those publications judged relevant to the pathophysiology, epidemiology, evaluation, and treatment of delayed ejaculation were included in the review. RESULT: 110 articles were ultimately selected for inclusion in this review. CONCLUSION: The evaluation of this condition requires a focused history and physical, which includes a detailed sexual history, examination of the genitalia, and inquiry into the status of the partner. Laboratory tests are aimed at the detection of abnormalities in the blood count, glucose level, hormone levels, or kidney function. If a correctable etiology is discovered, treatment is directed towards the reversal of this condition. In some cases, the delayed ejaculation may be a lifelong problem. Also, in some cases the etiology of the delayed ejaculation may be irreversible, such as in the case of age-related sensation loss or diabetes-related neuropathy. In these instances treatment may require a combination of behavioral modification, sexual therapy, or perhaps pharmaceutical drugs. Participation of the partner in therapy may sometimes be necessary. Future investigations will continue to elucidate the complex biological and psychosocial factors which contribute to delayed ejaculation, leading to more effective treatments. Shin DH and Spitz A. The evaluation and treatment of delayed ejaculation. Sex Med Rev 2014;2:121-133.

Evaluation of the pharmacokinetics and pharmacodynamics of two leuprolide acetate 45 mg 6-month depot formulations in patients with prostate cancer.

The pharmacokinetics (PK) and pharmacodynamics of two leuprolide acetate (LA) 45 mg 6-month depot formulations were characterized in prostate cancer patients. Subjects (planned N = 150 in each cohort) received two intramuscular injections of LA Formulation-A or Formulation-B administered 24 weeks apart. Samples were collected for the measurement of testosterone, LH (all subjects) and leuprolide (in a subset of subjects approximately N = 24 in each cohort) at the same time points. Leuprolide PK profile showed an initial peak followed by a rapid decline over the first week post-dose, with mean leuprolide concentrations staying relatively constant through the end of 24-week period. Mean testosterone and LH serum concentrations showed initial increases above baseline values after the first dose and then decreased to 16.0 ng/dL and 0.6 mIU/mL by Week 4 for Formulation-A and were maintained at ≤14.3 ng/dL and 0.4 mIU/mL, thereafter, with negligible mean increases after the second dose. Formulation-A showed a lower initial peak and higher leuprolide concentration during the sustained release phase which may explain higher testosterone suppression rates for Formulation-A compared to Formulation-B. Differences in PK between LA depot formulations were reflected in pharmacodynamic responses, with a higher rate of testosterone suppression and less escapes and acute-on-chronic responses for Formulation-A.