Amateur Versus Professional Users of the YO® Home Sperm Test: An Assessment of Usability.

OBJECTIVES: To assess the accuracy of home-test use by a real-world / amateur user. METHODS: This multi-site study investigated whether amateur users could use the FDA cleared YO® Home Sperm Test to obtain accurate MSC results when compared to trained laboratory technicians. The qualitative motile sperm concentration (MSC) results of amateur and professional YO users were compared to each other as well as to the results of an established automated sperm quality analyzer (SQA-V above and below a 6m/mL MSC cut-off). RESULTS: This was a blinded, prospective study of 316 amateur users and 3 professional laboratory technicians across 3 study sites. Amateur vs. Professional YO users demonstrated accuracy of >97%. Qualitative results of amateurs and professionals vs. SQA-V results showed >95.7% accuracy. CONCLUSION: Amateur users with no prior training were able to follow the YO test directions to receive highly accurate qualitative MSC results. The YO test is user-friendly and can be used as an effective initial home screening tool to gain preliminary insight into the fertility status of the male in a real-world setting. Furthermore, the YO test results correlated with those obtained by the FDA cleared SQA-V laboratory analyzer, confirming that the YO test delivers accurate MSC results in the hands of amateur users.

Practice and development of male contraception: European Academy of Andrology and American Society of Andrology guidelines.

BACKGROUNDS: Despite a wide spectrum of contraceptive methods for women, the unintended pregnancy rate remains high (45% in the US), with 50% resulting in abortion. Currently, 20% of global contraceptive use is male-directed, with a wide variation among countries due to limited availability and lack of efficacy. Worldwide studies indicate that >50% of men would opt to use a reversible method, and 90% of women would rely on their partner to use a contraceptive. Additional reasons for novel male contraceptive methods to be available include the increased life expectancy, sharing the reproductive risks among partners, social issues, the lack of pharma industry involvement and the lack of opinion makers advocating for male contraception. AIM: The present guidelines aim to review the status regarding male contraception, the current state of the art to support the clinical practice, recommend minimal requirements for new male contraceptive development and provide and grade updated, evidence-based recommendations from the European Society of Andrology (EAA) and the American Society of Andrology (ASA). METHODS: An expert panel of academicians appointed by the EAA and the ASA generated a consensus guideline according to the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system. RESULTS: Sixty evidence-based and graded recommendations were produced on couple-centered communication, behaviors, barrier methods, semen analysis and contraceptive efficacy, physical agents, surgical methods, actions before initiating male contraception, hormonal methods, non-hormonal methods, vaccines, and social and ethical considerations. CONCLUSION: As gender roles transform and gender equity is established in relationships, the male contribution to family planning must be facilitated. Efficient and safe male-directed methods must be evaluated and introduced into clinical practice, preferably reversible, either hormonal or non-hormonal. From a future perspective, identifying new hormonal combinations, suitable testicular targets, and emerging vas occlusion methods will produce novel molecules and products for male contraception.

Attitudes towards disposition of cryopreserved sperm in the event of death.

INTRODUCTION: To evaluate patient preference for sperm disposition in case of death based on demographic factors and infertility etiology. MATERIALS AND METHODS: This retrospective cohort study was performed at a university hospital-affiliated fertility center. Charts of 550 men undergoing cryopreservation for assisted reproductive technologies (ART) between 2016-2019 were reviewed to create a descriptive dataset. Patients previously signed consent forms stating their preference for sperm transfer to their partner or disposal in the event of their subsequent death. Patients undergoing sperm cryopreservation for the purpose of ART were analyzed to assess associations between demographic characteristics and etiology of infertility and their choice to either transfer sperm to their partner or discard. RESULTS: A total of 84.9% (342/403) of patients included in final analyses elected to transfer their sperm to their partner in the event of their death. Factors associated with a significantly increased likelihood to transfer versus discard included a male-factor infertility diagnosis compared to female-factor infertility diagnosis (transfer rate 89.3% vs. 79.9%; p = .022) and commercial insurance coverage versus non-commercial/no insurance coverage (transfer rate 86.3% vs. 75.0%, p = .029). No significant differences relating to age, race/ethnicity, occupation classification, marital status or duration of marriage, or prior paternity were found. CONCLUSION: A majority of male patients seeking sperm cryopreservation for ART elected to transfer their sperm to their partner if future death should occur. There does not appear to be a clear factor that would impact this decision based on demographic characteristics.

Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety.

BACKGROUND: Long-term data evaluating the efficacy and safety of oral testosterone undecanoate (oral TU; JATENZO) in adult hypogonadal men provides important information for healthcare professionals who prescribe testosterone replacement therapy (TRT). AIM: To determine the efficacy and safety of long-term oral TU therapy, including its impact on total testosterone (T) levels and psychosexual functioning. METHODS: Hypogonadal men, between 18 and 75 years old, (mean age 56.2; 87.2% white) who completed a 12-month, open-label, multicenter, randomized, active-controlled trial were given the opportunity to enroll in a 12-month extension study. Among the 129 eligible TU-treated subjects, 86 chose this option, and 69 completed 24 months of uninterrupted oral TU therapy. OUTCOMES: The efficacy of oral TU was documented by measuring total serum T concentrations; sexual function was measured using the Psychosexual Daily Questionnaire (PDQ). For safety, liver function tests, cardiovascular endpoints, and prostate health were measured. RESULTS: Over 2 years, total serum T concentrations for patients treated with oral TU were in the eugonadal range (300-1,000 ng/dL [10-35 nmol/L]; mean ± SD: 617 ± 427 ng/dL [21 ± 15 nmol/L]) and increased significantly from baseline (P < .0001). For sexual function, mean score changes versus baseline for all PDQ domains at all time points were significantly improved (P < .0011 for all). For the sexual activity and sexual desire components, patient scores were consistently greater than validated thresholds for clinically meaningful change. Typical T-induced safety changes were observed, including a 3-6 mm Hg increase in systolic blood pressure (P < .05); a slight increase in hematocrit (P < .0001) that stayed <48% throughout the study; no clinically significant changes in prostate-specific antigen levels; and decreased high-density lipoprotein cholesterol (-9.8 ± 0.9 mg/dL from baseline; P < .0001). There were no clinically significant changes from baseline in liver function tests. CLINICAL IMPLICATIONS: Over 2 years of treatment, this novel oral TU formulation maintained total T concentrations in mideugonadal ranges, with improvements in sexual function and no clinically significant changes in liver function or other safety concerns previously associated with oral TRT. STRENGTHS & LIMITATIONS: These are the first long-term data to evaluate the efficacy and safety of a novel formulation of oral TU; the comparative long-term safety of oral TU would be strengthened by confirmatory studies versus other TRT formulations. CONCLUSION: Oral TU offers a safe and effective long-term treatment option for men with hypogonadism. Honig S, Gittelman M, Kaminetsky J, et al. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. J Sex Med 2022;19:1750-1758.

Assisted reproductive technology cycles involving male factor infertility in the United States, 2017-2018: data from the National Assisted Reproductive Technology Surveillance System.

Objective: To describe the prevalence and treatment characteristics of assisted reproductive technology (ART) cycles involving specific male factor infertility diagnoses in the United States. Design: Cross-sectional analysis of ART cycles in the National ART Surveillance System (NASS). Setting: Clinics that reported patient ART cycles performed in 2017 and 2018. Patients: Patients who visited an ART clinic and the cycles were reported in the NASS. The ART cycles included all autologous and donor cycles that used fresh or frozen embryos. Interventions: Not applicable. Main Outcome Measures: Analyses used new, detailed reporting of male factor infertility subcategories, treatment characteristics, and male partner demographics available in the NASS. Results: Among 399,573 cycles started with intent to transfer an embryo, 30.4% (n = 121,287) included a male factor infertility diagnosis as a reason for using ART. Of these, male factor only was reported in 16.5% of cycles, and both male and female factors were reported in 13.9% of cycles; 21.8% of male factor cycles had >1 male factor. Abnormal sperm parameters were the most commonly reported diagnoses (79.7%), followed by medical condition (5.3%) and genetic or chromosomal abnormalities (1.0%).Males aged ≤40 years comprised 59.6% of cycles with male factor infertility. Intracytoplasmic sperm injection was the primary method of fertilization (81.7%). Preimplantation genetic testing was used in 26.8%, and single embryo transfer was used in 66.8% of cycles with male factor infertility diagnosis. Conclusions: Male factor infertility is a substantial contributor to infertility treatments in the United States. Continued assessment of the prevalence and characteristics of ART cycles with male factor infertility may inform treatment options and improve ART outcomes. Future studies are necessary to further evaluate male factor infertility.

Improving resident learning on vasectomy: a national survey on urology resident vasectomy training.

INTRODUCTION: Resident training in vasectomy, especially in the office setting on the awake patient, may be limited. The aim of this study is to understand resident exposure to vasectomy and to identify barriers to learning. MATERIALS AND METHODS: An anonymous 18-question survey was distributed to urology residents of the 135 ACGME-accredited urology residencies in the United States. Residents were asked to specify the total number of vasectomies they had performed and in what environment (operating room versus office), their comfort performing vasectomy independently, and any barriers to learning the procedure. RESULTS: In total, 119 residents responded to the survey, representing a 10% response rate. Vasectomy case volumes were variable, with 36.7% of residents logging ≤ 20 vasectomies by their final year of training. Total of 23.4% indicated they did not receive training in perioperative counseling for patients considering vasectomy. Only 64.7% of all residents felt comfortable in the office setting versus 89.1% who felt comfortable in the operating room (p < 0.001). This difference persisted throughout training, and 16.7% of residents in their final year of residency were uncomfortable performing office vasectomy. Total of 60.5% of respondents cited one or more barriers to training, with lack of surgical volume (38.7%), lack of vasectomies in the resident clinic (29.4%), and lack of autonomy when performing the procedure (22.7%) being the most common. CONCLUSIONS: Residents are significantly less comfortable performing vasectomy in the office setting versus in the operating room, including in their graduating year. Residents describe low volume and lack of autonomy as barriers to vasectomy training.

Sexual Metrics in Transgender Women: Transitioning From International Index of Erectile Function to Female Sexual Function Index.

INTRODUCTION: Feminizing gender-affirming surgery (GAS) has been an increasingly used procedure in the United States and worldwide for transgender women with gender dysphoria. Studies on patient-reported quality of life outcomes in those undergoing GAS remain limited. OBJECTIVE: To provide recent insights from the literature on sexual metrics in the evaluation of the transgender women. METHODS: We queried PubMed to identify studies assessing sexual function metrics in those undergoing feminizing GAS. RESULTS: There is no single validated method to establish preoperative and postoperative sexual function. Assessment currently remains institutionally dependent. Evaluation can involve questionnaires including but not limited to the International Index of Erectile Function, the Female Sexual Function Index, and the Male to Female Sexual Function Index. CONCLUSION: In this literature review, we discuss considerations for the evaluation of sexual function for patients considering feminizing GAS with vaginoplasty. Although we describe some of the major tools currently used in evaluating sexual function in this patient population, a need for a validated method remains. Syed JS, Honig S. Sexual Metrics in Transgender Women: Transitioning From International Index of Erectile Function to Female Sexual Function Index. Sex Med Rev 2021;9:236-243.

Development and validation of a novel mail-in semen analysis system and the correlation between one hour and delayed semen analysis testing.

OBJECTIVE: To develop and validate a novel, mail-in semen analysis (SA) system. DESIGN: Prospective cohort. SETTING: Not applicable. PATIENT(S): Ejaculates from normospermic men. INTERVENTION(S): One-hour SA, then repeat SAs (on same ejaculate) over 52 hours using a novel technique for maintaining sperm viability. MAIN OUTCOME MEASURE(S): World Health Organization SA parameters. RESULT(S): One-hour SA on 104 ejaculates in the validation phase of the study demonstrated normal semen parameters. With up to 52 hours of observation and four subsequent SA measurements/ejaculate, concentration remained stable, motility decreased by 0.39%/h, and normal morphology decreased by 0.1%/h. Measured 1-hour and calculated motility (correlation coefficients 0.87) and morphology (correlation coefficients 0.82) strongly were correlated. CONCLUSION: This novel, mail-in, Clinical Laboratory Improvement Amendments-approved SA testing system demonstrates a strong degree of correlation between 1-hour and delayed SA testing. Given the linear motility and morphology decrease and stability of sperm concentration, this test may be used in clinical practice to evaluate semen quality for fertility evaluations. Furthermore, this approach significantly improves the ease, comfort, and efficiency of obtaining a SA, likely breaking down early barriers to accessing successfully a male fertility evaluation.

Multicenter investigation on the influence of climate in penile prosthesis infection.

The purpose of this study is to investigate the relationship between inflatable penile prosthesis (IPP) infection, time of year, climate, temperature and humidity. This is a retrospective IRB-approved analysis of 211 patients at 25 institutions who underwent salvage procedure or device explant between 2001 and 2016. Patient data were compiled after an extensive review of all aspects of their electronic medical records. Climate data were compiled from monthly norms based on location, as well as specific data regarding temperature, dew point, and humidity from dates of surgery. Rigorous statistical analysis was performed. We found that penile prosthesis infections occurred more commonly in June (n = 24) and less frequently during the winter months (n = 39), with the lowest number occurring in March (n = 11). One-hundred thirty-nine infections occurred at average daily temperatures greater than 55 °F, compared to 72 infections at less than 55 °F. The incidence rate ratio for this trend was 1.93, with a p-value of <0.001. Humidity results were similar, and fungal infections correlate with daily humidity. Infected implants performed in the fall and summer were over 3 and 2.3 times, respectively, more likely to grow Gram-positive bacteria compared to implants performed in spring (p = 0.004; p = 0.039). This was consistent across geographic location, including in the Southern hemisphere. We found trends between climate factors and IPP infection like those seen and proven in other surgical literature. To our knowledge these data represent the first exploration of the relationship between temperature and infection in prosthetic urology.

Multicenter Investigation of Fungal Infections of Inflatable Penile Prostheses.

BACKGROUND: Fungal infections of inflatable penile prostheses (IPPs) are inadequately understood in the literature. AIM: To review a multi-institution database of IPP infections to examine for common patient and surgical factors related to IPP fungal infections. METHODS: This is a retrospective Institutional Review Board-approved analysis of 217 patients at 26 institutions who underwent salvage or device explant between 2001 and 2018. Patient data were compiled after an extensive record review. OUTCOMES: 26 patients (12%) with fungal infections were identified. RESULTS: 23 of 26 patients (83%) with a fungal IPP infection were either diabetic or overweight. 15 patients had undergone primary IPP implantation, and the other 11 had previously undergone an average of 1.7 IPP-related surgeries (range 1-3; median 2). The average age at implantation was 63 years (range 31-92; median 63). 18 of the 26 patients with fungal infection had diabetes (69%), with a mean hemoglobin A1c (HbA1c) value of 8.4 (range 5.8-13.3; median 7.5). Twenty-two patients (85%) were overweight or obese. The mean body mass index for all patients was 30.1 kg/m2 (range 23.7-45 kg/m2; median 28.4 kg/m2), and that for diabetic patients was 30.8 kg/m2 (range 24.1-45 kg/m2, median 29.7 kg/m2). Ninety-one percent of implants were placed with intravenous antibiotics, consistent with current American Urological Association guidelines: an aminoglycoside plus first- or second-generation cephalosporin or vancomycin or ampicillin/sulbactam or piperacillin/tazobactam. 65% (17 of 26) of infected IPPs had only fungal growth in culture. No patient had concomitant immunosuppressive disease or recent antibiotic exposure before IPP implantation. CLINICAL IMPLICATIONS: More than two-thirds of the fungal infections occurred in diabetic patients and 85% occurred in overweight or obese patients, suggesting that antifungal prophylaxis may be appropriate in these patients. STRENGTHS & LIMITATIONS: This is the largest series of fungal infections reported to date in the penile prosthesis literature. The overall number of such cases, however, remains small. CONCLUSION: Fungal infections represent 12% of all penile prosthesis infections in our series and were seen mostly in diabetic or overweight patients, who may benefit from antifungal prophylaxis. Gross MS, Reinstatler L, Henry GD, et al. Multicenter Investigation of Fungal Infections of Inflatable Penile Prostheses. J Sex Med 2019;16:1100-1105.

Genitourinary Complications of Gender-Affirming Surgery.

PURPOSE OF REVIEW: Gender-affirming surgery has become a more common procedure in the last 5 years. Feminizing genitoplasty typically involves inversion of penile skin as a neovagina, urethral shortening, and glans reduction to create a neoclitoris. Masculinizing genitoplasty is more complex, typically is performed in multiple stages, and has more inherent urologic risks. RECENT FINDINGS: The most common urologic complications involve voiding dysfunction, specifically meatal stenosis or fistula to the urinary tract. Urethral stricture, fistula, urinary retention, and voiding dysfunction are very common and require early recognition and intervention. This includes placement of catheter drainage, if necessary with the appropriate urologic instrumentation. Genital risks relating to phallus health are rare, but risks associated with placement of penile prosthesis for sexual function are common and require immediate attention. Urological complications after gender-affirming surgery are common, and the general urologist and urogynecologist should be able to identify and treat problems in this population after review of this chapter.

Gender-Affirming Surgery: Current Concepts.

Gender-affirming surgeries (GASs), previously known as gender reassignment surgeries, are surgical procedures born from plastic and reconstructive surgery, colorectal surgery, urology, and gynecology. A multidisciplinary approach is essential for the care of transgender patients. The urologist plays a vital role, both in the perioperative period and as part of continued care. This publication will review the current concepts of genital GAS as it pertains to the practicing urologist. The most utilized surgical techniques will be described along with their notable complications and management options.

Multicenter Investigation of the Micro-Organisms Involved in Penile Prosthesis Infection: An Analysis of the Efficacy of the AUA and EAU Guidelines for Penile Prosthesis Prophylaxis.

INTRODUCTION: Penile prosthesis infections remain challenging despite advancements in surgical technique, device improvements, and adoption of antibiotic prophylaxis guidelines. AIM: To investigate penile prosthesis infection microbiology to consider which changes in practice could decrease infection rates, to evaluate current antibiotic prophylaxis guidelines, and to develop a proposed algorithm for penile prosthesis infections. METHODS: This retrospective institutional review board-exempt multi-institutional study from 25 centers reviewed intraoperative cultures obtained at explantation or Mulcahy salvage of infected three-piece inflatable penile prostheses (IPPs). Antibiotic usage was recorded at implantation, admission for infection, and explantation or salvage surgery. Cultures were obtained from purulent material in the implant space and from the biofilm on the device. MAIN OUTCOME MEASURES: Intraoperative culture data from infected IPPs. RESULTS: Two hundred twenty-seven intraoperative cultures (2002-2016) were obtained at salvage or explantation. No culture growth occurred in 33% of cases and gram-positive and gram-negative organisms were found in 73% and 39% of positive cultures, respectively. Candida species (11.1%), anaerobes (10.5%) and methicillin-resistant Staphylococcus aureus (9.2%) constituted nearly one third of 153 positive cultures. Multi-organism infections occurred in 25% of positive cultures. Antibiotic regimens at initial implantation were generally consistent with American Urological Association (AUA) and European Association of Urology (EAU) guidelines. However, the micro-organisms identified in this study were covered by these guidelines in only 62% to 86% of cases. Antibiotic selection at admissions for infection and salvage or explantation varied widely compared with those at IPP implantation. CONCLUSION: This study documents a high incidence of anaerobic, Candida, and methicillin-resistant S aureus infections. In addition, approximately one third of infected penile prosthesis cases had negative cultures. Micro-organisms identified in this study were not covered by the AUA and EAU antibiotic guidelines in at least 14% to 38% of cases. These findings suggest broadening antibiotic prophylaxis guidelines and creating a management algorithm for IPP infections might lower infection rates and improve salvage success. Gross MS, Phillips EA, Carrasquillo RJ, et al. Multicenter Investigation of the Micro-Organisms Involved in Penile Prosthesis Infection: An Analysis of the Efficacy of the AUA and EAU Guidelines for Penile Prosthesis Prophylaxis. J Sex Med 2017;14:455-463.