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.

Does preoperative screening VCUG affect the outcomes and complications of pyeloplasty in patients with ureteropelvic junction obstruction?

INTRODUCTION: The role of voiding cystourethrogram (VCUG) in evaluating vesicoureteral reflux (VUR) in patients with known ureteropelvic junction obstruction (UPJO) remains unclear. While VCUG is frequently performed, the incidence of concomitant VUR and UPJO is low, and VUR is often low-grade with high rates of spontaneous regression. OBJECTIVE: To analyze the clinical relevance of VCUG in patients with UPJO by determining its incidence and studying the difference in clinical outcomes between patients with known, unknown, and negative VUR. STUDY DESIGN: Retrospective review of patients with UPJO who underwent pyeloplasty from 2012 to 2020 with <18 years-old, unilateral UPJO, postoperative follow-up of ≥2 months and had at least 1 renal ultrasound (US) after pyeloplasty. Results were compared among 3 groups: patients who underwent VCUG before pyeloplasty and were found to have VUR (group 1), patients who underwent VCUG before pyeloplasty without VUR (group 2), and patients who did not have a VCUG before pyeloplasty (group 3). RESULTS: A total of 275 patients met the inclusion criteria, of which 21 patients were classified in group 1, 166 patients in group 2, and 88 patients in group 3 (Table). The age at preoperative VCUG was 14.7 ± 32.9 months in group 1 and 15.17 ± 35.8 months in group 2 (p = 0.960). Overall, the incidence of concomitant UPJO and VUR was 11.2%. In group 1 the initial VUR grade was 5 in 2 patients, 4 in 3, 3 in 5, 2 in 7, and 1 in 4 patients. Of these, only 1 patient required ureteral reimplantation after pyeloplasty. Post-pyeloplasty, no significant differences were observed in complications (p = 0.7436), length of follow up (p = 0.3212), SFU grade 4 hydronephrosis (p = 0.2247), postoperative UTIs (p = 0.1047) and pyeloplasty success rate (p = 0.4206) among the 3 groups. Despite the use of antibiotic prophylaxis being significantly different amongst the three groups (p < 0.001), it was not associated with a lower incidence of postoperative UTIs (group 1 p = 0.068, group 2 p = 0.486, group 3 p = 1). In patients with reflux, an increase in age was associated with a decrease in the rates of complications (p = 0.019). CONCLUSION: We found no significant difference in the outcomes in patients who had a preoperative VCUG as compared to those who did not. The preoperative diagnosis of VUR by VCUG changed the management in less than 1% of the study population and thus its role in patients with UPJO should be reevaluated.

Association between body mass index, metabolic syndrome and common urologic conditions: a cross-sectional study using a large multi-institutional database from the United States.

INTRODUCTION: The study aims to determine whether body mass index (BMI), metabolic syndrome (MS) or its individual components (primary hypertension, type 2 diabetes mellitus and dyslipidemias) are risk factors for common urological diseases. MATERIALS AND METHODS: Cross-sectional study with data collected on February 28, 2022 from the TriNetX Research Network. Patients were divided in cohorts according to their BMI, presence of MS (BMI > 30 kg/m2, type 2 diabetes mellitus, primary hypertension and disorders of lipoprotein metabolism) and its individual components and its association with common urological conditions was determined. For each analysis, odds ratio (OR) with 95% confidence intervals were calculated. Statistical significance was assessed at p < .05. RESULTS: BMI > 30 kg/m2 was associated with increased risk of lithiasis, kidney cancer, overactive bladder, male hypogonadism, benign prostatic hyperplasia, and erectile dysfunction (p < .05). On the contrary, BMI was inversely associated with ureteral, bladder and prostate cancer (p < .05). In all urological diseases, MS was the strongest risk factor, with prostate cancer (OR = 2.53) showing the weakest and male hypogonadism the strongest (OR = 13.00) associations. CONCLUSIONS: MS and its individual components were significant risk factors for common urological conditions. Hence holistic approaches with lifestyle modification might prevent common urological disease.Key messagesOverall, metabolic syndrome is the strongest risk factor for all the analysed urological diseases.Abnormally high body mass index can be a risk or protective factor depending on the threshold and urological disease that are being evaluated.Metabolic syndrome and increased BMI should be considered important factors associated to the prevalence of common urological diseases.

Efficacy and safety outcomes of a compounded testosterone pellet versus a branded testosterone pellet in men with testosterone deficiency: a single-center, open-label, randomized trial.

Background: Testosterone deficiency (TD) is a prevalent condition, especially in men ≥45 years old, and testosterone therapy (TTh) can improve the quality of life in these patients. Aim: To evaluate the safety profile of compounded subcutaneous testosterone pellets and to compare the efficacy between compounded and market brand testosterone pellets for TTh: E100 (Empower Pharmacy) and Testopel (Food and Drug Administration approved), respectively. Methods: This was a prospective, phase 3, randomized, noninferiority clinical trial. We enrolled 75 men diagnosed with TD and randomized them 1:1 to a market brand group and a compounded pellet group. The patients were implanted with their respective testosterone pellets: Testopel (10 pellets of 75 mg) and E100 (8 pellets of 100 mg). Outcomes: We evaluated adverse events after implantation and followed men at 2, 4, and 6 months for morning laboratory levels (prior to 10 am): serum testosterone, estradiol, hematocrit, and prostate-specific antigen. Results: After randomization, 33 participants were enrolled in the Testopel arm and 42 in the E100 arm. Serum testosterone levels were similar between the groups at 2, 4, and 6 months, with most men (82%) dropping to <300 ng/dL by the end of the trial. Adverse events were also similar, such as elevations in prostate-specific antigen, estradiol, and hematocrit. Most dropouts were related to persistent TD symptoms and serum testosterone <300 ng/dL, with similar rates between the groups in the study. Clinical Implications: Men treated with Testopel and E100 pellets had comparable serum testosterone levels and similar adverse event rates, providing an effective choice of long-term TTh among men with TD. Strengths and Limitations: Strengths include the prospective, randomized, single-blinded study design and adequate follow-up. Limitations include the lack of external validity and the single-institution cohort. Conclusion: E100 compounded testosterone pellets are a noninferior option of TTh as compared with Testopel for men presenting with TD.

The Development of an Artificial Intelligence Model Based Solely on Computer Tomography Successfully Predicts Which Patients Will Pass Obstructing Ureteral Calculi.

OBJECTIVE: To improve upon prior attempts to predict which patients will pass their obstructing ureteral stones, we developed a machine learning algorithm to predict the passage of obstructing ureteral stones using only the CT scan at a patient's initial presentation. METHODS: We obtained Institutional Review Board approval to conduct a retrospective study by extracting data from all patients with an obstructing 3-10 mm ureteral stone. We included patients with sufficient data to be categorized as having either passed or failed to pass an obstructing ureteral stone. We developed a 3D-convolutional neural network (CNN) model using a dynamic learning rate, the Adam optimizer, and early stopping with 10-fold cross-validation. Using this model, we calculated the area under the curve (AUC) and developed a model confusion matrix, which we compared with a model based only on the largest dimension of the stone. RESULTS: A total of 138 patients met inclusion criteria and had adequate images that could be preprocessed and included in the study. Seventy patients failed to pass their ureteral stones, and 68 patients passed their stones. For the 3D-CNN model, the mean AUC was 0.95 with an overall mean sensitivity of 95% and mean specificity of 77%, which outperformed the model based on stone-size. CONCLUSION: The 3D-CNN model predicts which patients will pass their obstructing ureteral stones based on CT scan alone and does not require any further measurements. This can provide useful clinical information which may help obviate the need for a delay in care for patients who inevitably require surgical intervention.

Sexual Dysfunction Among Adolescent and Young Adult Men Diagnosed with Cancer.

Purpose: Adolescent and young adult (AYA) cancer patients frequently demonstrate sexual dysfunction; however, there is a lack of data quantifying the severity and frequency. Methods: Males aged 18-39 years, diagnosed with cancer of any kind and who were scheduled to begin, were actively receiving, or had completed cancer treatment within 6 months, were offered validated surveys during their oncology appointment. These surveys included the International Index of Erectile Function (IIEF-6), Masturbation Erection Index (MEI), 36-Item Short Form Survey, and 5-point Likert scales to assess their desire and ability to engage in sex and masturbation. Results: Forty subjects completed the IIEF survey with a mean score of 17.7 ± 11, erectile dysfunction (ED) prevalence accordingly was 58%. Thirty-eight subjects completed the MEI with a mean score of 25.3 ± 5.3, ED prevalence was again 58%. Age and IIEF scores demonstrated a statistically significant (p < 0.05, n = 38) Pearson's correlation coefficient of 0.40, patients younger than 30 years had an ED prevalence of 72% (mean IIEF 13), whereas patients aged 30 years and older had an ED prevalence of 45% (mean IIEF 22). All treatment modalities had ED rates >30%: chemotherapy demonstrated the highest prevalence at 64% (mean IIEF 17), whereas radiation therapy had the lowest prevalence at 33% (mean IIEF 23). Conclusion: This study demonstrates that the prevalence of sexual dysfunction among male AYA patients undergoing treatment for cancer is high. AYA oncologists should discuss potential sexual health concerns when treating this population. The exact cause of ED (non-organic vs. organic) within this group should be explored further.

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.

A comparison of adverse pregnancy events between ureteral stents and percutaneous nephrostomy tubes in the treatment of nephrolithiasis during pregnancy: A propensity score-matched analysis of a large multi-institutional research network.

PURPOSE: To investigate rates of adverse pregnancy events associated with the use of percutaneous nephrostomy tubes (PCN) versus ureteral stents in the treatment of nephrolithiasis during pregnancy. METHODS: We queried the TriNetX Diamond Network database to evaluate pregnant women (ICD-10 Z34, O09) with a history of nephrolithiasis (N20-23) who underwent a PCN (CPT 50432) or ureteral stent (52332) placement up to 6 months before delivery (O80-82). We controlled for the following potentially confounding variables through propensity score matching: age, race, ethnicity, acute pyelonephritis (N10), infections of the genitourinary tract in pregnancy (O23.0), and other sepsis (A41) at the time of stent or PCN placement. RESULTS: We identified 2,999 pregnant women who underwent ureteral stent placement and 321 who underwent PCN. Following propensity score matching, we found there to be no significant difference in the rate of premature labor or delivery (aOR 1.08, 95% CI 0.735-1.588), premature rupture of membranes (0.889, 0.453-1.743), intrauterine infection (0.906, 0.379-2.165), or c-Sect. (0.825, 0.408-1.667). Within 6 months of their initial procedure, women with a ureteral stent experienced a significantly decreased rate of subsequent urinary tract infection (UTI) or pyelonephritis (0.52, 0.38-0.71), inpatient hospital stay (0.40, 0.26-0.64), emergency department visit (0.65, 0.48-0.89), and repeat exchange procedure (0.70, 0.51-0.96). CONCLUSION: In the treatment of nephrolithiasis during pregnancy, PCN versus ureteral stent placement does not confer a significant difference in rates of adverse pregnancy events. However, ureteral stent placement was associated with a lower incidence of hospital admissions, emergency department visits, exchange procedures, and new UTIs or pyelonephritis.

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.

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.

Racial and socioeconomic disparities in cost and postoperative complications following sacrocolpopexy in a US National Inpatient Database.

PURPOSE: We sought to determine the association between socioeconomic factors, procedural costs, and postoperative complications among patients who underwent sacrocolpopexy. METHODS: The 2016-2017 US National Inpatient Sample from the Healthcare Cost and Utilization Project was used to identify females > 18 years of age with an ICD10 diagnosis code of apical prolapse who received open or laparoscopic/robotic sacrocolpopexy. We analyzed relationships between socioeconomic factors, procedural costs, and postoperative complications in these patients. Multivariate logistic and linear regressions were used to identify variables associated with increased complications and costs, respectively. RESULTS: We identified 4439 women who underwent sacrocolpopexy, of which 10.7% had complications. 34.6% of whites, 29.1% of Blacks, 29% of Hispanics, and 34% of Others underwent a laparoscopic/robotic procedure. Hispanic patients had the highest median charge associated with surgical admission for sacrocolpopexy at $51,768, followed by Other ($44,522), White ($43,471), and Black ($40,634) patients. Procedure being within an urban teaching hospital (+ $2602), laparoscopic/robotic (+ $6790), or in the West (+ $9729) were associated with a significantly higher median cost of surgical management. CONCLUSIONS: In women undergoing sacrocolpopexy, the protective factors against postoperative complications included private insurance status, a laparoscopic approach, and concurrent hysterectomy. Procedures held within an urban teaching hospital, conducted laparoscopically/robotically or in the West are associated with significantly higher costs of surgical management. Hispanic patients observe significantly higher procedure charges and costs, possibly resulting from the large number of this ethnic group living in the Western United States.

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.

Incidence of fertility preservation procedures in prepubertal individuals with cancer.

BACKGROUND: Fertility Preservation (FP) for children and adolescents with cancer is underutilized. In prepubertal individuals, ovarian and testicular tissue can be frozen; however, this is still considered largely experimental. Our objective was to identify trends of FP in prepubertal individuals. METHODS: We performed a retrospective study of prepubertal children with cancer identified through the Pediatric Health Information System from 2011 to 2020. Children who underwent a testicular or ovarian biopsy were included. Any patients with testicular or ovarian malignancy, or other diagnoses which may have required a gonadal biopsy were excluded. RESULTS: A total of 418 boys under 13 and 333 girls under 12 who underwent a gonadal biopsy were identified. There was a total of 66,929 new cancer diagnoses in girls and 86,001 new cancer diagnoses in boys during this time. The most common cancer diagnosis was hematologic in both boys (50.96%) and girls (36.64%). A concurrent procedure at time of gonadal biopsy was performed in 84% of boys and 62% of girls, with line insertion being the most common. The only predictive variable of receiving a gonadal biopsy was increasing year. Overall, only 0.04% of children had a gonadal biopsy for FP during this time period. CONCLUSIONS: Gonadal biopsy rates have increased in prepubertal children with cancer, presumably for FP. While recent international guidelines support FP in this group, our findings highlight the need to establish protocols and tracking for FP procedures in the US.

Impact of COVID-19 pandemic on diagnosis and surgical management of common urological conditions: results from multi-institutional database analysis from the United States.

OBJECTIVE: To determine real life impact during the first pandemic year on diagnosis and surgical management of common urological diseases and 90-day postoperative mortality following common urological surgeries. METHODS: Cross-sectional study from 2016 to 2021. We used TriNetX to obtain the data. Patients with a diagnosis of six common non-oncologic and five oncologic urologic conditions were included. Twenty-four surgical interventions were also analyzed. The total number of diagnosis and surgical procedures were compared yearly from 2016 to 2021 and Chi-square test was used for statistical analysis. Additionally, monthly changes were evaluated during the first pandemic year and a z score period time was reported. The 90-day post-operative mortality rates during the first pandemic year were compared to the preceding year. RESULTS: Overall, a decrease in diagnosis and surgeries were observed during the first pandemic year, with maximum drop in April 2020. Among non-oncological conditions, the decrease in diagnosis of enlarged prostate (5.3%), nephrolithiasis (9.4%), urinary incontinence (18.7%), and evaluation for male sterilization (14.8%) reached statistical significance (P < 0.05 in all). Prostate cancer was the only cancer whose diagnosis showed statistically significant decrease (6.2%, P < 0.05). The surgical case load for benign conditions showed higher reduction (13.1-25%) than for malignant conditions (5.9-16.3%). There was no change in 90-day post-operative mortality in any of the analyzed surgeries. CONCLUSIONS: Our study showed that although healthcare delivery decreased in the first pandemic year, causing a decline in the diagnosis and surgical treatment of several diseases, surgical interventions did not increase the risk of death.

Varicocele is underdiagnosed in men evaluated for infertility: Examination of multi-center large-scale electronic health record data.

Varicocele is the most common reversible cause of male infertility, affecting up to 20% of healthy men and 40% of men with primary infertility. The objective of this study was to investigate the prevalence of varicocele in men evaluated for infertility, and to determine rates of subsequent varicocele repair. Since reproductive endocrinologists are the first specialists seen for male infertility care in North America, we hypothesized that varicocele would be underdiagnosed when compared to its reported prevalence among men with infertility. TriNetX, a large, multicenter electronic health record (EHR) database was queried to establish a cohort of all men (above 18 years of age) with a diagnosis of male infertility. This cohort was used to identify those with ensuing varicocele diagnosis. Men who received varicocelectomy or venous embolization after a diagnosis of varicocele were then identified. Out of 101,309 men with a diagnosis of male infertility in the network, only 9768 (9.6%) had a diagnosis of varicocele. Mean age of men with varicocele was 34. Varicocelectomy or venous embolization was performed in 1699 (20.2%) and 69 (0.76%) of men with varicocele, respectively. In this cross-sectional EHR study, varicocele was underdiagnosed in men evaluated for infertility when compared with prior epidemiological studies.

Socioeconomic differences associated with consumption of a plant-based diet: Results from the national health and nutrition examination survey.

BACKGROUND: A plant-based diet (PBD) has been associated with potential health benefits, but factors that may affect access to and consumption of a PBD are not well defined. AIM: To determine the association between socioeconomic status and plant-based dietary consumption among participants enrolled in the National Health and Nutrition Examination Survey (NHANES). METHODS: This was a cross-sectional study using data obtained from the NHANES database. The following covariates were assessed: age, sex, race/ethnicity, educational level, marital status, smoking status, physical activity, alcohol use, history of diabetes, and hypertension. Socioeconomic status was categorized according to poverty-income ratio (PIR). Food frequency questionnaires were used to calculate previously validated plant-based diet index (PDI) and healthful plant-based diet index (hPDI). Multivariable-adjusted logistic regression was performed to determine the association between PIR, clinical, demographic, and plant-based diet indices. RESULTS: A total of 5037 participants were in the final analytic sample. Median age of participants was 51 ± 18.5 years. Overall PDI and hPDI were 50 [46-54] and 52 [47-57], respectively. Median PDI index was significantly different among PIR groups (PDI, p = 0.018; hPDI, p < 0.001). On multivariable analysis, participants in the poorest socioeconomic group (PIR ≤ 130%) were more likely to have lower consumption of a healthful PBD (hPDI). CONCLUSION: Lower socioeconomic status (PIR ≤ 130%) was associated with decreased consumption of a healthful plant-based diet. These data suggest that socioeconomic disparities may limit consumption of healthier food and contribute to the high prevalence of adverse health conditions that exist in certain population groups.

Is tadalafil associated with decreased risk of major adverse cardiac events or venous thromboembolism in men with lower urinary tract symptoms?

PURPOSE: To evaluate the association of tadalafil, a phosphodiesterase-5 inhibitor (PDE5I), with major adverse cardiac events (MACE) or venous thromboembolism (VTE) in men with lower urinary tract symptoms (LUTS). METHODS: Data was obtained from the TriNetX Research Network, ICD-10 codes were used to identify men with LUTS, MACE, and VTE. In addition, demographic characteristics and use of tadalafil or alpha-blocker was evaluated. Then, unbalanced and balanced association analyses was performed to assess the relation between tadalafil and/or alpha-blocker use with MACE/VTE. RESULTS: After participant selection, analysis included 821,592 men that did not use an alpha blocker or tadalafil, 5,004 men that used tadalafil but no alpha blocker, 327,482 men that used an alpha blocker but no tadalafil, and 6,603 men that used both an alpha blocker and tadalafil. On balanced analysis, tadalafil was independently associated with a decreased risk of MACE/VTE within a 3-year time period (OR = 0.59, 95%CI 0.49-0.70, p < 0.0001). Among men with a history of alpha blocker use, tadalafil use was also independently associated with a decreased risk of MACE or VTE, both before and after controlling for potentially confounding variables (OR = 0.57, 95%CI: 0.50-0.66; p < 0.0001). CONCLUSIONS: In our study, tadalafil was associated with a decreased risk of MACE/VTE in men with LUTS with and without a history of alpha blocker use. It is time to perform further long-term prospective randomized studies to further analyze the cardiovascular effects of PDE5Is as combination treatment with alpha blockers in the management of LUTS.

Testosterone Therapy is Associated With Depression, Suicidality, and Intentional Self-Harm: Analysis of a National Federated Database.

BACKGROUND: Long-term use of testosterone can be associated with mood destabilizing effects. Most studies investigating psychiatric complications of anabolic steroids have used small samples, but a comprehensive assessment of the risk of developing mental health disorders after testosterone use has not been performed at the population level. AIM: To determine whether testosterone therapy is associated with major depressive disorder or suicide attempts in men. METHODS: We conducted a retrospective cohort study of 70.3 million electronic health records collected from 46 healthcare organizations encompassing flagship hospitals, satellite hospitals, and outpatient clinics since 2008 to determine whether testosterone use is associated with major depressive disorder and suicide attempts in a large population. We included men 18 or older who either used testosterone or did not, defined by reported use, insurance claim, or prescription use of testosterone documented in the electronic health record. We propensity-score matched by age, race, ethnicity, obesity, and alcohol-related disorder. Additionally, a sub-group analysis was performed in testosterone deficient (<300 ng/dL) men comparing those with TD on testosterone therapy to a control group of men with TD who are not using testosterone. OUTCOMES: We determined measures of association with a new diagnosis of major depressive disorder and suicide attempt or intentional self-harm following testosterone use within 5 years. RESULTS: A total of 263,579 men who used testosterone and 17,838,316 men who did not were included in the analysis. Testosterone use was independently associated with both Major Depressive Disorder (OR 1.99, 95% CI 1.94-2.04, P < .0001) and Suicide Attempt/Intentional Self-Harm (OR 1.52, 95% CI 1.40-1.65, P < .0001). Results remained significant in testosterone deficient sub-group analysis. CLINICAL IMPLICATIONS: Men who use testosterone should be screened for and counseled about risks of depression and suicidality. STRENGTHS AND LIMITATIONS: Strengths of this study include a large sample size, the ability to account for chronology of diagnoses, the use of propensity score matching to control for potentially confounding variables, and the consistency of results with sub-group analyses. Limitations include the potential for incorrect coding within the electronic health record, a lack of granular information regarding testosterone therapy adherence, the possibility that unrecorded testosterone or anabolic steroid use were prevalent but not captured within the control group, and a lack of data regarding testosterone withdrawal. CONCLUSION: Testosterone use is independently associated with new-onset mental health disorders. Future studies are necessary to elucidate the role that androgen withdrawal plays and whether a causal relationship exists. Nackeeran S, Patel MS, Nallakumar DT, et al. Testosterone Therapy is Associated With Depression, Suicidality, and Intentional Self-Harm: Analysis of a National Federated Database. J Sex Med 2022;19:933-939.