Risk Factors for Penile Fracture After Intralesional Collagenase Clostridium histolyticum in Peyronie's Disease.

OBJECTIVE: To evaluate risk factors leading to corporal rupture after Collagenase Clostridium histolyticum (CCh). Peyronie's disease (PD) is a fibrotic condition of the penis characterized by abnormal plaque formation. Intralesional CCh is the only FDA-approved medication for PD, however, it can lead to corporal rupture, a potential surgical emergency. METHODS: We retrospectively reviewed medical records from Veterans diagnosed with PD who were under treatment with CCh using the Veterans Administration Informatics and Computing Infrastructure (VINCI). Using International Classification of Diseases and Current Procedural Terminology codes, we identified men who suffered a corporal rupture after CCh. Individual charts were reviewed to determine potential risk factors and events leading to corporal rupture. RESULTS: We identified 17,647 veterans who were diagnosed with PD, of which 8.7% (1541) received at least one injection of CCh for PD. Of them, 0.7% (11/1541) veterans suffered corporal rupture. Within these 11 patients, the median number of CCH injections was 6 with a median initial curvature of 35°. Fracture occurred at a median of 8days after CCH injection. The majority of fractures were secondary to spontaneous erections or sexual intercourse. Finally, six patients had their fracture repaired surgically while the remaining were managed conservatively. CONCLUSION: Most fractures occurred within 2weeks of CCh injections and were associated with sexual intercourse and spontaneous morning erections.

A multi-institutional study of 1,111 men with 4K score, multiparametric magnetic resonance imaging, and prostate biopsy.

OBJECTIVE: Prostate magnetic resonance imaging (MRI) and biomarkers are often used in conjunction to enhance the selection process for prostate biopsy. However, the optimal sequence of ordering these tests has not been established. A comprehensive evaluation was conducted on a large multi-institutional cohort of patients who underwent MRI, 4K score, and biopsy of the prostate to examine the impact of utilizing both tests vs. either test alone and to determine if the order in which these tests are administered affects the ability to detect clinically significant prostate cancer (csCaP). METHODS AND MATERIALS: We evaluated men from 8 different institutions who were referred for prostate cancer evaluation and underwent MRI, 4K score test, and prostate biopsy. The primary outcome was the presence of csCaP, defined as grade group 2 or higher cancer on a biopsy of the prostate. We used logistic regression, calibration plots, and decision curve analysis to evaluate using a 4K score or MRI alone vs. both tests together for detecting csCaP. In addition, we evaluated several strategies using one or both tests for selecting men for biopsy and compared them based on the proportion of biopsies avoided and the csCaP's missed. RESULTS: Among the 1,111 men who formed the final cohort, 553 (49.8%) had prostate cancer, and 353 (31.8%) had csCaP. We found that using MRI and 4K score together had better discrimination, calibration, and a higher clinical utility on decision curve analysis compared to using either test individually. Using both tests together resulted in fewer biopsies avoided and missed cancers compared to using either test alone. Strategies that sequence MRI and 4K score tests resulted in the largest biopsy reduction, with no appreciable difference between starting with an MRI vs. a biomarker. CONCLUSIONS: We found that using both an MRI and 4K score together was superior to using either test alone but found no appreciable difference between starting with an MRI vs. starting with a 4K score. Prospective studies are needed to identify the best strategy to sequence MRI and biomarkers in the evaluation of csCaP.

A Case Report on "Pearling": Removal of Infected Objects During Circumcision.

The insertion of foreign bodies underneath the skin of the penis is commonly referred to as "pearling." Although rare, there are case reports that describe acute complications such as infection and damage to surrounding penile neurovascular structures; however, there is a paucity of data describing long-term complications and surgical management of such cases. A 43-year-old male presented with a penile abscess secondary to "pearling" five years after insertion. His abscess was drained and selected foreign objects were subsequently removed during a simultaneous circumcision procedure. This report describes a case in which surgical removal of penile foreign bodies was performed during a circumcision without the need for additional incisions. The case is unique in that it details a complication five years after initial insertion with microbiological data to guide adequate treatment.

Prevalence of secondary erythrocytosis in men receiving testosterone therapy A matched-cohort analysis of intranasal gel, injections, and pellets.

INTRODUCTION: Increased hematocrit (HCT) is a common adverse effect in men on testosterone therapy (TTh). We aimed to uncover differences in HCT changes among men receiving different forms of TTh. METHODS: We conducted a single-center, retrospective, matched-cohort study of patients treated for testosterone deficiency (TD) to investigate the effect of three TTh regimens on HCT. We included men who received intranasal testosterone (NT), intramuscular testosterone (TC), or subcutaneous testosterone pellet (TP) regimens between January 2011 and December 2020. We matched treatment cohorts 1:1:1 for age, body mass index (BMI), and history of obstructive sleep apnea (OSA). Those taking TTh for <16 weeks were excluded. Comparison between groups was performed with Mann-Whitney U test, Student's t-test, ANOVA, or Kruskal-Wallis test as appropriate. RESULTS: Seventy-eight matched-cohort individuals with TD received either NT, TC, or TP. The most common TD symptoms prior to initiation of TTh were erectile dysfunction (38%), low libido (22%), and lack of energy (17%). Baseline serum testosterone and HCT were higher in NT recipients (p<0.05). As expected, all men receiving TTh were found to have increased serum testosterone levels at followup (p<0.001). Relative to their respective baselines, men receiving TC experienced the greatest increase in serum testosterone (240.8 ng/dL to 585.5 ng/dL), followed by NT (230.3 ng/dL to 493.5 ng/dL) and TP (210.8 ng/dL to 360.5 ng/dL) (all p<0.001). TC and TP were associated with significant increases in HCT (4.4% and 1.7%) while NT was associated with a decrease in HCT (-0.8%) at 16-week followup. CONCLUSIONS: When controlled for age, BMI, and OSA, men receiving NT experienced decreased HCT compared to TC or TP at 16-week followup. Intranasal testosterone, while able to increase serum testosterone levels to reference range, does not appear to have a significant impact on HCT compared to the longer-acting forms of TTh.

Stem-Cell, Shockwave, and Platelet Rich Plasma Therapy for the Treatment of Erectile Dysfunction and Peyronie's Disease: A Survey of Clinics Across the USA.

OBJECTIVE: To identify clinics offering off-label therapies for erectile dysfunction (ED) and Peyronie's disease (Pyd) including stem cell, platelet-rich plasma (PRP), and shockwave therapy and to determine the transparency they provided to patients inquiring about these treatment modalities. METHODS: Clinics were identified in different regions in the US using a systematic search on online website directories and were approached by asking a series of standardized questions regarding the cost of treatment, duration of therapy, the medical staff involved, and patient outcome data. A total of 26 clinics were surveyed for stem cell therapy, 26 for PRP treatment, and 27 for shockwave therapy. RESULTS: Of the 79 clinics contacted, 93.7% provided some answers to the questions we asked, with a majority offering treatments for both ED and Pyd. The cost of treatment varied widely between clinics. The average cost per stem cell therapy injection was $5291, PRP per injection was $1336, and shockwave therapy per session was $413. A physician was involved in 67% of treatments, and only 6 of 79 clinics reported that a urologist was involved. Over 75% of the clinics reported patient satisfaction following treatment. Durability of benefits to patients ranged from months to years according to the clinics' reports. CONCLUSION: Our data not only demonstrate the widespread use of off-label therapies for ED and PyD across the United States but also the lack of scientific data to support the claims made to patients. This study highlights the need for more oversight and standardization in novel regenerative therapies for ED and PyD.

Is Time Spent on Prior Authorizations Associated With Approval?

Advanced practice providers increasingly assume responsibility for prior authorizations (PAs). We hypothesized that the time burden of PAs will be correlated with increased approval. We collected several variables (ie, type, method, time spent, use of peer to peer, and outcome) for all PAs completed by a departmental nurse practitioner in 1 region. Chi-square tests and 2 sample t tests were used to assess significance. There was no significant association between the method of request, the number of attempts, and the time spent to approved PA. Further research is needed to determine ways to decrease the time and opportunity cost associated with PAs.

Platelet-rich Plasma for the Treatment of Erectile Dysfunction: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial.

PURPOSE: We assessed the safety and efficacy of 2 injections of platelet-rich plasma for treating mild to moderate erectile dysfunction by conducting a prospective, randomized, double-blind, placebo-controlled clinical trial. MATERIALS AND METHODS: Men with mild to moderate erectile dysfunction (International Index of Erectile Function scores 11-25) were randomized to receive either 2 injections of platelet-rich plasma or placebo separated by 1 month. Primary outcome was percentage of men meeting minimum clinically important difference at 1 month after the second injection. Secondary outcomes were change in International Index of Erectile Function at 1, 3, and 6 months, and changes in penile vascular parameters and adverse events at 6 months. RESULTS: We randomized 61 men: 28 into platelet-rich plasma and 33 into placebo. There was no difference between groups in percentage of men meeting minimum clinically important difference at 1 month: 14 (58.3%) in platelet-rich plasma vs 15 (53.6%) in placebo (P = .730). Mean International Index of Erectile Function-Erectile Function domain changed from 17.4 (95% CI 15.8-19.0) to 21 (17.9-24.0) at 1 month in men receiving platelet-rich plasma, vs 18.6 (17.3-19.8) to 21.6 (19.1-24.1) in the placebo group; however, there was no significant difference between groups (P = .756). There were no major adverse events and only 1 minor adverse event in each group. There were no changes in penile Doppler parameters from baseline to 6 months. CONCLUSIONS: The results of our prospective, double-blind, randomized, placebo-controlled clinical trial suggest that 2 injections of intracavernosal platelet-rich plasma separated by 1 month in men with mild to moderate erectile dysfunction is safe, but we found no difference in efficacy between platelet-rich plasma and placebo.

Collagenase Clostridium histolyticum Treatment Improves Degree of Curvature in Peyronie's Disease with Calcified Plaques.

BACKGROUND: Peyronie's disease (PD) is a fibrotic condition of the penis characterized by abnormal plaque formation. Intralesional collagenase Clostridium histolyticum (CCh) is effective in noncalcified PD; however, its effectiveness in calcified PD is not well characterized. OBJECTIVE: To assess curvature improvement in calcified PD plaques treated with CCh. DESIGN, SETTING, AND PARTICIPANTS: We prospectively evaluated men with calcified PD electing CCh treatment at our institution from October 2018 to November 2020. We assessed curvature with artificial erection and goniometer before and at least 3 mo after treatment. We classified the type of plaque calcification based on ultrasound. INTERVENTION: Intralesional CCh. Each treatment cycle consisted of two CCh injections (0.58 mg) into the plaque at the point of maximal penile curvature. The second injection was performed 72 h to 1 wk later, after which participants began modeling. All men were intended to receive a total of eight injections in four cycles, each 6 wk apart. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Change in penile curvature after CCh was measured. We assessed for differences in outcomes based on the number of injections and type of calcification. Unless otherwise specified, data are presented as medians (interquartile range). RESULTS AND LIMITATIONS: Sixty men with calcified PD elected CCh; 47 had complete follow-up data. Thirty-nine men completed treatments with eight injections, while the remaining discontinued after a median of five (four to six) injections. There was no difference in response between type 2 and type 3 plaques. Curvature significantly improved by 17.5° (37.5-10.0°) in patients who completed treatment and by 15.0° (20.0-0.0°) in those who discontinued. Limitations include a small sample. CONCLUSIONS: Men with calcified PD plaques improve with CCh treatment and show similar improvements regardless of calcification type. PATIENT SUMMARY: In this study, we evaluated the efficacy of collagenase Clostridium histolyticum (CCh) treatment in calcified Peyronie's disease (PD) plaques. We found that treatment in calcified plaques demonstrated significant improvement in curvature and the grading of calcification did not impact the degree of curvature improvement. We conclude that participants with calcified PD plaques can benefit from nonsurgical CCh treatment.

Majority of men with premature ejaculation do not receive pharmacotherapy.

Premature ejaculation is the most common male sexual dysfunction, with therapies including selective serotonin reuptake inhibitors, clomipramine, topical anesthetics, dapoxetine and tramadol. However, it is currently unknown how many men are receiving pharmacotherapy for premature ejaculation. Using the TriNetX Research network, a large multicenter database containing over 75 million patient records from hospitals across the United States, we evaluated prescribing patterns for treatment of premature ejaculation and assessed variations in prescription patterns among patients from 2015-2021. In addition, we examined if the prescription patterns for tramadol changed with the establishment of Prescription Drug Monitoring Programs. We found that most men (51.7%) were not receiving any pharmacotherapy for premature ejaculation. However, men with mental health disorders, were more likely (56.0%), to have been treated than those without (44.4%). On further analysis, men with mental health diagnoses were significantly more likely to be treated with Selective Serotonin Reuptake Inhibitors (45.0 vs 32.2%) and Tramadol (5.1% vs 3.5%). While the pharmacotherapy for premature ejaculation has been well researched, our findings revealed that most patients diagnosed with premature ejaculation do not receive pharmacotherapy and that patients are more likely to be prescribed premature ejaculation medications if they have a pre-existing mental health diagnosis.

Comparison of Intratesticular Testosterone between Men Receiving Nasal, Intramuscular, and Subcutaneous Pellet Testosterone Therapy: Evaluation of Data from Two Single-Center Randomized Clinical Trials.

PURPOSE: Testosterone replacement therapy (TRT) can potentially cause decreased spermatogenesis and subsequent infertility. Recent studies have suggested that 17-hydroxyprogesterone (17-OHP) is a reliable surrogate for intratesticular testosterone (ITT) that is essential for spermatogenesis. We evaluated data from two ongoing open-label, randomized, two-arm clinical trials amongst different treatment preparations (Trial I) subcutaneous testosterone pellets (TP) and (Trial II) intranasal testosterone (NT) or intramuscular testosterone cypionate (TC). MATERIALS AND METHODS: Seventy-five symptomatic hypogonadal men (2 serum testosterone <300 ng/dL) were randomized into open label randomized clinical trials. Eligible subjects received 800 mg TP, 11 mg TID NT or 200 mg ×2 weeks TC. 17-OHP and Serum testosterone were evaluated at baseline and follow-up. The primary outcome was changes in 17-OHP. Secondary outcome was changes in serum testosterone. Data was analyzed by two-sample and single-sample t-tests, and determination of equal or unequal variances was computed using F-tests. RESULTS: Median participant age was 45 years old, with overall baseline 17-OHP of 46 and serum testosterone of 223.5 ng/dL. 17-OHP significantly decreased in subjects prescribed long-acting TP or TC. The 4-month change in 17-OHP in the NT group (-33.3% from baseline) was less than the change seen in TC (-65.3% from baseline) or TP (-44% from baseline) (p=0.005). All testosterone formulations increased serum testosterone levels at follow-up, with the largest increase seen in TC (+157.6%), followed by NT (+114.3%) and TP (+79.6%) (p=0.005). CONCLUSIONS: Short-acting nasal testosterone appear to have no impact on serum 17-OHP especially in comparison to long-acting testosterone formulations. All modalities saw significant increases in serum testosterone levels at follow-up. NT and other short acting testosterone formulations may better preserve ITT and be beneficial for hypogonadal men seeking to maintain fertility potential while on TRT.

Diagnosis and treatment patterns of Peyronie's disease among different racial, ethnic, and regional groups in the Veterans Affairs healthcare system.

Peyronie's Disease, which is known to have racial/ethnic disparities in the general population, has never been studied in the veteran population. We compared the diagnosis and treatment rates for Peyronie's Disease among United States veterans of various racial-ethnic backgrounds at Veterans Affairs medical centers, which are equal-access systems. We queried the Veterans Affair Informatics and Computing Infrastructure to identify 17,647 Peyronie's Disease patients in the United States by ICD-9 or ICD-10 code between 2015-2020. We assessed demographic characteristics, clinical characteristics, Veterans Affairs facility information, and treatment patterns. Racial-ethnic demographics of veterans with Peyronie's Disease were 71.4% White, 15.4% Black, 5.8% Hispanic, 1.6% Native American, 0.3% Asian, and 5.4% unknown. Treatment rate was 13.6% overall, 13.6% of Whites (ref), 14.3% of Blacks (p = 0.2985), 13.5% of Hispanics (p = 0.9205), 9.1% of Asians (p = 0.3319), 16.7% of Native Americans (p = 0.1406), and 9.6% of unknown (p = 0.0041). White patients were more likely to receive injectional therapy and less likely to undergo surgery than Black patients. Peyronie's Disease patients at Veterans Affairs facilities are treated at the same rate, indicating that equal-access healthcare systems may mitigate racial-ethnic disparities. Further research is necessary to account for differences in disease severity and Veterans Affairs surgeon availability.

A Phase 2 Randomized, Placebo-controlled Crossover Trial to Evaluate Safety and Efficacy of Platelet-rich Plasma Injections for Peyronie's Disease: Clinical Trial Update.

Intralesional injection of platelet-rich plasma for Peyronie's disease appears to be safe according to early observations from an ongoing clinical trial. Efficacy data remain elusive until completion of the trial.

The incidence of surgical intervention in veterans treated with Collagenase clostridium histolyticum.

Peyronie's disease (PD) can be managed with surgery or intralesional injections of Collagenase clostridium histolyticum (CCH) however both are associated with side effects and variable results. It is unclear how many patients elect to undergo additional surgical correction after CCH. To answer this, we analyzed the Department of Veterans Affairs Informatics and Computing Infrastructure (VINCI) software. We performed a retrospective analysis over a 5-year period for patients with PD, at least one injection of CCH and surgical CPT codes. In total, 17,646 patients with PD were analyzed with 1541 treated with CCH. Only 51 (3.3%) were treated with secondary surgical intervention after CCH. Three main surgical procedures were performed: penile plication (51%), penile prosthesis (29%) and plaque excision and grafting (20%). Of the 51 men who underwent surgical corrections post CCH, the most common reason was lack of response/residual curvature (62.8%), followed by ED (29.4%). Previous literature shows that CCH was effective for only 60.8% of patients, potentially leaving the remaining in need of additional treatment. Despite this we found that only 3.3% received secondary therapy in the VA medical system, with residual curvature being the most common reason.

Association Between MitoScore, BMI, and Body Fat Percentage as a Predictive Marker for the Outcome of In-Vitro Fertilization (IVF).

Background Infertility is defined as the inability to establish a pregnancy within 12 months of regular and unprotected sexual intercourse. In response to these problems, assisted reproductive techniques (ARTs) have made profound impacts on the therapeutic management of infertility. However, in-vitro fertilization (IVF) success rates are confounded by several internal and external factors. A relatively new approach to embryo assessment is known as MitoScore (Igenomix, Miami, USA). As a result, we sough to evaluate whether MitoScore can help in predicting in IVF outcomes, and to assess the relationship between MitoScore, BMI, and body fat percentage in determining the success of ARTs. Methods Using retrospective cohort, a study population consisting of 166 women aged 26-43 who were undergoing ART with pre-implantation genetic testing for aneuploidy (PGT-A) was assessed to determine if MitoScore, BMI, and body fat percentage impacted IVF outcomes. Results MitoScore, BMI, and body fat percentage were significantly lower in pregnant women as compared to non-pregnant women. Furthermore, MitoScore was correlated with subclasses of IVF outcomes (delivery, biochemical pregnancy, and spontaneous abortion) and was found to be positively correlated with BMI in patients with biochemical pregnancies. Conclusion Our findings suggest that MitoScore, BMI, and body fat percentage could act as critical parameters in determining the success of ART. However, the association between MitoScore, BMI, and body fat percentage does not appear to be a significant confounding factor to determine pregnancy outcome at this stage. Still, many factors need to be considered to establish the correlation reliably.

COVID-19 vaccination not associated with increased risk of erectile dysfunction.

Although mRNA COVID-19 vaccines have proven to be safe and effective against SARS-CoV-2, vaccination rates have slowed, with some individuals citing impotence as a concern. Therefore, we conducted a survey of the US males to evaluate the impact of COVID-19 vaccination on erectile function. We hypothesized that vaccinated men would not have a higher risk of ED compared to unvaccinated men. Amazon Mechanical Turk (MTurk) was utilized to survey the US adult male population between August 26 and September 2, 2021. Survey participation was open to 1000 males over the age of 18 and currently living in the United States regardless of vaccination status or the past medical history of COVID-19. Selection criteria included respondents ≥45 years old, no history of physician-diagnosed ED, biologically born, and identify as male. Participants completed an anonymous 16-question survey that included a multidimensional scale used to evaluate ED, the International Index of Erectile Function (IIEF-5). Among vaccinated men, the median IIEF-5 score was 20 [16-24] compared to 22 [17.5-25] in the unvaccinated group (p = 0.195). The multivariable-adjusted analysis demonstrated that vaccination against COVID-19 was not associated with increased risk of ED. Overall, this cross-sectional survey showed that COVID-19 vaccination was not associated with an increased risk of erectile dysfunction in males 45 years and older.

An evaluation of race-based representation among men participating in clinical trials for prostate cancer and erectile dysfunction.

Background: Inclusion of ethnic/racial minorities in clinical trials is essential to fully assess therapeutic efficacy. It is well-known that populations respond dissimilarly to interventions. Our objective is to analyze the inclusion of minority men in clinical trials for erectile dysfunction (ED). Methods: We searched ClinicalTrials.gov for the disease keyword: "Erectile Dysfunction" and used "Prostate Cancer" for comparison. Completed trials which reported demographic data were included for analysis. Literature was reviewed to determine the prevalence of ED and prostate cancer (PC) among Hispanic, Black, White, and Asian men. The proportion of individuals of each group that participated in trials is divided by the proportion of each group in the disease population to calculate the "Participation to Prevalence Ratio" (PPR). PPRs between 0.8 and 1.2 indicates adequate representation, <0.8 is under-representation and >1.2 is over-representation. Results: A total of 312 trials were assessed: 289 for prostate cancer and 23 for ED. Hispanic men comprised 11.8% of ED trial participants and 4.6% of prostate cancer trial participants, yet represented 18% of ED patients and 7.3% of PC patients. Black/African-American (AA) men accounted for 10.2% of ED trial participants and 9.4% of PC trial participants, but comprise 16% of ED patients, and 16.3% of PC patients. Hispanic and AA men are under-represented in trials for ED and Prostate Cancer (Hispanic ED PPR = 0.66; Hispanic PC PPR = 0.63; AA ED PPR = 0.64; AA PC PPR = 0.58). Conclusion: Our analysis shows that both Hispanic and AA men are underrepresented in both ED and PC clinical trials.

Racial and Ethnic Inequality in Survival Outcomes of Women With Triple Negative Breast Cancer.

Purpose Triple-negative breast cancer (TNBC) is the most lethal group of breast cancers. Socioeconomic factors may contribute to differences in survival rates. This study aims to identify racial/ethnic disparities in five-year survival rates among women affected by TNBC in the United States. Methods This retrospective study analyzed data from the 2010-2016 Surveillance, Epidemiology, and End Results Program database. Patients with a primary malignancy of triple-negative breast cancer were included in this study. Cancer-specific survival was measured at five years post-diagnosis. Cox regression models were used to calculate hazard ratios (HR) and corresponding 95% confidence intervals (CI). Results From 2010-2016, there were 26,963 women with a primary diagnosis of TNBC. After adjustment for age, insurance, marital status, stage, and surgery type, Hispanic women had the highest hazard of death when compared to White women (adjusted (adj) HR, 1.14, p<0.001). Further, non-Hispanic Black women also had a lower survival probability when compared to White women (adj HR, 1.06, p=0.002). Conclusion This study reveals that Hispanic women had the highest hazard of death when compared to White women. As TNBC is the most fatal breast cancer, future studies should investigate socioeconomic factors that may worsen prognosis of this disease.

Efficacy and Safety of Human Chorionic Gonadotropin Monotherapy for Men With Hypogonadal Symptoms and Normal Testosterone.

Background Male hypogonadism has a prevalence of about 6% and is defined by two-morning testosterone levels below 300 ng/dl associated with symptoms. This definition presents a challenging problem for patients without other medical problems but with symptoms of low testosterone (T) who do not meet the biochemical criteria for therapy. Objectives Our objective was to evaluate changes in symptoms and side effects in men with T levels >300ng/dL using human chorionic gonadotropin (hCG) monotherapy for the treatment of hypogonadal symptoms. Methods After IRB approval, 31 male patients treated with hCG monotherapy for low T symptoms were retrospectively reviewed. We evaluated changes in hormones, hypogonadal symptoms, and the incidence of thromboembolic events before and after starting hCG. Results We found subjective improvement in erectile dysfunction, 86% (19/22), and libido, 80% (20/25), with no patient experiencing a thromboembolic event. In addition, no change was observed in the follicle-stimulating hormone, luteinizing hormone, estradiol, hematocrit, hemoglobin A1c, and prostate-specific antigen. Conclusion Weekly treatment with hCG appears safe and can improve hypogonadal symptoms in patients with T >300 ng/dl without changes to hematocrit, prostate-specific antigen, and hemoglobin A1c.

The Safety of Human Chorionic Gonadotropin Monotherapy Among Men With Previous Exogenous Testosterone Use.

Background and objective Human chorionic gonadotropin (hCG) is homologous to luteinizing hormone (LH) and stimulates endogenous testosterone (T) production. Current American Urological Association (AUA) guidelines recommend hCG for T-deficient men who wish to preserve their fertility. However, there is no data available regarding the long-term efficacy and safety of hCG monotherapy in men with a history of exogenous T use. We hypothesized that transitioning to hCG would be a safe and effective option in this population. Methodology We performed a retrospective analysis involving 28 men with previous exogenous T use who were switched to hCG monotherapy and underwent follow-up lab work at least one month later. We evaluated changes in hormones [T, LH, follicle-stimulating hormone (FSH), and estradiol], hematocrit (HCT), glycated hemoglobin (HbA1c), and prostate-specific antigen (PSA). Results Among the entire cohort, we found no significant change in mean hormone levels (including T), HbA1c, or PSA. There was a significant (p<0.05) decrease in HCT (45.27 ±4.06 to 44.16 ±3.48%, n=15). No thromboembolic events were reported. Additionally, among men who had their baseline labs completed outside their previous T therapy therapeutic time window prior to starting hCG monotherapy, there was a statistically significant increase in mean T levels (307.36 ±148.74 to 422.11 ±268.15 ng/dL, n=30 and 31, pre- and post-hCG, respectively) and a statistically significant decrease in mean PSA levels (0.91 ±0.35 to 0.69 ±0.23 ng/mL, n=5). Conclusions These results suggest that hCG is a safe and effective alternative to traditional T therapy for men with a history of exogenous T use and may lead to an advantageous decrease in HCT. hCG may serve as an alternative form of T therapy with a lower risk for secondary erythrocytosis, and further research is warranted to gain deeper insights into the topic.