Legal Outcomes of Litigation after Iatrogenic Genitourinary Trauma.

INTRODUCTION: To evaluate plaintiff and defendant characteristics associated with iatrogenic genitourinary trauma litigation and outcomes of closed claims. METHODS: LexisNexis was queried in April 2023 using terms related to genitourinary organs and injury, and manually reviewed for iatrogenic cases. Case details including defendant, organ involvement, and legal outcome were obtained. Multinomial regression analysis was performed to identify factors associated with outcome. RESULTS: 410 cases involving 611 defendants were identified, with the ureter the most commonly affected organ (202/410, 49.3%). Most cases involved adult plaintiffs (380, 92.7%) and resulted in favor of the defense (227, 55.4%). Injuries resulted most frequently from gynecologic surgeries (179, 43.7%). Defendants were most commonly obstetricians/gynecologists (243/611, 39.8%) and urologists (168, 27.5%). Penile (OR 6.3 [95% CI 2.5-16.1]) and urethral (OR 4.8 [2.0-11.7]) injuries were associated with greater odds of a plaintiff verdict relative to ureter injury. A plaintiff verdict was also more likely when defendants were academic hospitals compared to individual practitioners (OR 4.3 [1.9-9.9]). In cases ruling in favor of the plaintiff, indemnity payments were larger when the defendants were comprised of individual practitioners compared to a hospital or medical group (median $549,613 vs. $250,000, p < 0.001). CONCLUSION: Urologists may be involved in medical malpractice lawsuits for iatrogenic injury even when they are uninvolved in the index procedure. Most cases that reach litigation result in defense verdicts regardless of the genitourinary organ injured. Defendant characteristics associated with plaintiff verdicts are more nuanced, and providers should be aware of potential downstream effects of litigation.

Testosterone deficiency in men with end stage renal disease and kidney transplantation: a narrative review.

Testosterone deficiency is a prevalent condition that frequently affects individuals with end-stage renal disease (ESRD) and those who have undergone renal transplantation. While the etiology of this condition is complex, its implications in this population are far-reaching, impacting various domains such as endocrine profile, sexual and erectile function, bone mineral density (BMD), anemia, and graft survival following renal transplantation. Herein, we review the most recent literature exploring the pathophysiology of testosterone deficiency in ESRD and renal transplant patients, examining its diverse effects on this demographic, and assessing the advantages of testosterone replacement therapy (TRT). Existing evidence suggests that TRT is a safe intervention in ESRD and renal transplant patients, demonstrating improvements across multiple domains. Despite valuable insights from numerous studies, a critical need persists for larger, high-quality prospective studies to comprehensively grasp the nuances of TRT, especially in this vulnerable population. Proactive screening and treatment of testosterone deficiency may prove beneficial, emphasizing the urgency for further research in this area.

The association of socioeconomic status with semen parameters in a cohort of men in the United States.

BACKGROUND: Socioeconomic differences are present within the population of men who experience infertility and seek treatment. OBJECTIVE: To study the association of socioeconomic status with semen parameters in a group of men using mail-in semen analyses. MATERIALS AND METHODS: The records of 11,134 men that used mail-in semen analyses from a fertility company were identified. Their demographic information, semen parameters, and ZIP codes were collected. Area deprivation index (ADI) was used as a proxy for socioeconomic status and was calculated for each individual using their ZIP codes in order to measure their level of socioeconomic deprivation. A higher ADI signifies a more deprived area. The association between ADI and the semen parameters of this group was measured using linear regression analysis adjusted for age. RESULTS: 11,134 men were included in the study with a median age of 35 years (interquartile range (IQR): 32-40) and a median ADI of 83 (IQR: 68-97). The cohort had a median sperm concentration of 31 million/mL (IQR: 14-59), median total sperm count of 123 million (IQR: 57-224), median total motile sperm of 35 million (IQR: 9-95), median total motility of 32% (IQR: 15-52), progressive motility of 22% (IQR: 9-38), and morphology percent normal of 4% (IQR: 2-7). Higher ADI, indicating lower socioeconomic status, was negatively associated with various semen parameters, including sperm concentration, total sperm count, total motile sperm, and total and progressive motility. DISCUSSION AND CONCLUSION: Men who live in more deprived areas are more likely to have worse semen parameters. Further research is needed to thoroughly examine the impact of socioeconomic status on male fertility. A comprehensive approach that targets upstream social, economic, and healthcare factors can possibly alleviate the negative association of socioeconomic status with fertility and semen parameters.

Uncovering the interhospital price variations for vasectomies in the United States.

Due to the historic lack of transparency in healthcare pricing in the United States, the degree of price variation for vasectomy is largely unknown. Our study aims to assess characteristics of hospitals reporting prices for vasectomy as well as price variation associated with hospital factors and insurance status. A cross-sectional analysis was performed in October, 2022 using the Turquoise Database which compiles publicly available hospital pricing data. The database was queried for vasectomy prices to identify the cash (paid by patients not using insurance), commercial (negotiated by private insurers) and Medicare and Medicaid prices for vasectomies. Hospital characteristics of those that reported a price for vasectomy and those that did not were compared and pricing differences based on hospital ownership and reimbursement source were determined using multivariable linear regression analysis. Overall, only 24.7% (1657/6700) of hospitals reported a price for vasectomy. Those that reported a price had more beds (median 117 vs 80, p < 0.001), more physicians (median 1745 vs 1275, p < 0.001). They were also more likely to be nonprofit hospitals (77% vs 14%, p < 0.001) and to be in well-resourced areas (ADI 91.7 vs 94.4, p < 0.001). Both commercial prices and cash prices for vasectomy were lower at nonprofit hospitals than at for-profit hospitals (commercial: $1959.47 vs $2861.56, p < 0.001; cash: $1429.74 vs $3185.37, p < 0.001). Our study highlights the current state of pricing transparency for vasectomy in the United States. Patients may be counseled to consider seeking vasectomy at a nonprofit hospital to reduce their costs, especially when paying with cash. These findings also suggest a need for new policies to target areas with decreased price transparency to reduce price disparities.

Driving Time and Compliance With Postvasectomy Semen Analysis Drop-Off.

OBJECTIVE: Current literature demonstrates low rates of compliance with postvasectomy semen analysis (PVSA). This study sought to determine factors that correlate with noncompliance with PVSA. METHODS: A retrospective chart review was conducted for patients who underwent vasectomy within our institution. ArcGIS was used to securely calculate the shortest driving time from each patient's home to the single PVSA drop-off site. Kruskal-Wallis and chi-square tests analyzed characteristics of patients who did and did not submit PVSA samples, and odds ratios were calculated via multivariable logistic regression. RESULTS: Overall, 515 of 850 patients met inclusion criteria and 219 (42.5%) of these had no recorded PVSA. Of those with a PVSA, 59% were completed within 16 weeks. Compliance with PVSA was associated with a shorter median driving time (30.6 minutes vs 34.2 minutes), more vasectomy in the operating room (19% vs 10%), and attending a follow-up appointment (40% vs 17%) (P < .005 for all). Age at vasectomy, race, ethnicity, BMI, paternity, and location of preoperative consultation did not significantly differ between the groups. Each 30 minutes of driving time was associated with a 48% reduction in the odds of a patient submitting PVSA at any time (OR 0.52 [0.37, 0.73]). CONCLUSION: As driving time to a drop-off center appears to be a significant barrier to PVSA compliance, providers should consider alternative collection methods such as at-home or in-office semen analysis.

Methodological rigour in preclinical urology: a systematic review reporting research quality over a 14-year period.

OBJECTIVE: To investigate the prevalence and trends of essential study design elements in preclinical urological studies, as well as key factors that may improve methodological rigour, as the demand for methodological rigour in preclinical studies is increasing since research reproducibility and transparency in the medico-scientific field are being questioned. METHODS AND RESULTS: PubMed was searched to include preclinical urological studies published between July 2007 to June 2021. A total of 3768 articles met the inclusion criteria. Data on study design elements and animal models used were collected. Citation density was also examined as a surrogate marker of study influence. We performed an analysis of the prevalence of seven critical study design elements and temporal patterns over 14 years. Randomisation was reported in 50.0%, blinding in 15.0%, sample size estimation in 1.0%, inclusion of both sexes in 6.3%, statistical analysis in 97.1%, housing and husbandry in 47.7%, and inclusion/exclusion criteria in 5.0%. Temporal analysis showed that the implementation of these study design elements has increased, except for inclusion of both sexes and inclusion/exclusion criteria. Reporting study design elements were associated with increased citation density in randomisation and statistical analysis. CONCLUSIONS: The risk of bias is prevalent in 14-year publications describing preclinical urological research, and the quality of methodological rigour is barely related to the citation density of the article. Yet five study design elements (randomisation, blinding, sample size estimation, statistical analysis, and housing and husbandry) proposed by both the National Institutes of Health and Animal Research: Reporting of In Vivo Experiments guidelines have been either well reported or are being well reported over time. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022233125.

The Racial and Socioeconomic Characteristics of Men Using Mail-in Semen Testing Kits in the United States.

OBJECTIVE: To describe the racial and socioeconomic characteristics of men using mail-in semen testing kits for their fertility care in the United States over 3 years. METHODS: A cross-sectional analysis was conducted of men who used mail-in semen analyses from a single direct-to-consumer (DTC) fertility platform between 2020 and 2022. Age, race/ethnicity, place of residence, and education level of men using mail-in semen analysis kits was collected from user questionnaires. Zip code level socioeconomic status was estimated using the Area Deprivation Index (ADI). These characteristics were compared to the overall population of the United States. RESULTS: 4342 men used mail-in semen analyses from a single DTC fertility company between 2020 and 2022 and completed the questionnaire. The median age of this cohort was 36 (IQR: 32,40) years. The group consisted of predominantly white men (72%), with 7.9% Asian and only 5.1% Black, 3.2% Hispanic, 0.4% Indian American, 0.1% pacific islander, 5.8% mixed race, and 2.8% other groups. 45.8% of the group had completed college, 22% had a master's degree, and 9% had a doctoral degree. The mean ADI was 83.47 (SD 21.44) compared to the average ADI of 100 for the general US population (P < .005). CONCLUSION: DTC mail-in semen analyses have the potential to improve access to affordable fertility care. Racial and ethnic minorities and lower socioeconomic classes are underrepresented for men seeking DTC fertility testing as they are for men presenting for in-office fertility care. Additional studies are needed to determine the factors responsible for these discrepancies.

Trends in testosterone prescription during the release of society guidelines.

The American Urological Association and Endocrine Society published guidelines for the management of testosterone deficiency in 2018. Testosterone prescription patterns have varied widely recently, owing to increased public interest and emerging data on the safety of testosterone therapy. The effect of guideline publication on testosterone prescribing is unknown. Thus, we aimed to assess testosterone prescription trends using Medicare prescriber data. Specialties with over 100 testosterone prescribers from 2016-2019 were analyzed. Nine specialties were included (in order of descending prescription frequency): family practice, internal medicine, urology, endocrinology, nurse practitioners, physician assistants, general practice, infectious disease, and emergency medicine. The number of prescribers grew by a mean of 8.8% annually. There was a significant increase in average claims per provider from 2016 to 2019 (26.4 to 28.7, p < 0.0001), with the steepest increase occurring between 2017 and 2018 when the guidelines were released (27.2 to 28.1, p = 0.015). The largest increase in claims per provider was among urologists. Advanced practice providers comprised 7.5% of Medicare testosterone claims in 2016 and 11.6% in 2019. While no causation can be established, these results suggest that professional society guidelines are associated with increasing numbers of testosterone claims per provider, especially among urologists. The changing demographics of prescribers justifies targeted education and further research.

Comparison of Hematocrit Change in Testosterone-deficient Men Treated With Intranasal Testosterone Gel vs Intramuscular Testosterone Cypionate: A Randomized Clinical Trial.

PURPOSE: Our primary aim was to compare changes in hematocrit in testosterone-deficient men treated with intranasal testosterone gel vs intramuscular testosterone cypionate. MATERIALS AND METHODS: This 2-arm, open-label, randomized trial recruited men with testosterone deficiency at the University of Miami between August 2020 and October 2022. Men with 2 total testosterone levels <350 ng/dL and hypogonadal symptoms, aged 18-75 years were randomly assigned to receive either intranasal testosterone gel 11 mg 3 times daily or intramuscular testosterone cypionate 200 mg every 2 weeks. The primary outcome was change in hematocrit after 4 months of treatment. Secondary outcomes were changes in serum testosterone, estradiol, prostate-specific antigen, 17-hydroxyprogesterone, and the 6-item International Index of Erectile Function. RESULTS: Of the 81 men randomized, 54 completed treatment (intranasal n=23; intramuscular n=31). The mean age was 47.5 vs 49.5 years, with mean baseline testosterone of 244.6 vs 240.7 ng/dL and mean hematocrit of 44.4% vs 42.7% in intranasal vs intramuscular groups, respectively. Men who received intramuscular injections had a significant increase after 4 months of treatment in mean hematocrit from 42.7% to 46.6% (P < .0001), but there was no significant change in men who received intranasal gel (P = .233). Men in both groups experienced significantly increased serum testosterone levels throughout the study period, though a larger increase was seen in men treated with intramuscular injections (mean change 511 vs 283, P = .025). Men who received injections also experienced an increase in estradiol (mean change 22.9, P < .001), decrease in 17-hydroxyprogesterone (mean change -39.8, P < .0001), and increase in the 6-item International Index of Erectile Function score (mean change 4.8, P = .015); men treated with intranasal gel experienced no such changes. Prostate-specific antigen levels were stable in both groups. CONCLUSIONS: Intranasal testosterone gel does not appear to significantly affect hematocrit levels. Men who wish to avoid polycythemia or changes in estradiol or 17-hydroxyprogesterone levels may benefit from short-acting testosterone therapy formulations such as intranasal gel.

Evaluating the readability of online testosterone search results.

With the budding interest in testosterone therapy (TTh), online health information plays a significant role in patients' health care decisions. Therefore, we evaluated the source and readability of web-based information available to patients regarding TTh on Google. From Google search terms "Testosterone Therapy" and "Testosterone Replacement", 77 unique sources were identified. Sources were categorized as Academic, Commercial, Institutional, or Patient Support, then evaluated using validated readability and English language text assessment tools: the Flesch Reading Ease score, Flesch Kincade, Gunning Fog, Simple Measure of Gobbledygook (SMOG), Coleman-Liau Index and Automated Readability index. The average grade level for understanding academic sources was 16 (college senior); commercial, institutional, and patient support sources were 13 (college freshman); 8 and 5 grade levels, respectively, above the average U.S. adult. Patient support sources were most prevalent, while commercial sources were the least at 35 and 14%, respectively. The average reading ease score was 36.8, indicative of difficult-to-read material overall. These results indicate that the most immediate online sources for TTh information exceed the average reading level of most adults within the U.S., hence more effort should be taken to publish accessible and readable material to improve patient health literacy.

Evaluation and management of male genital tract infections in the setting of male infertility: an updated review.

PURPOSE OF REVIEW: Male infertility may be secondary to male genital tract infection (MGTI) in an estimated 15% of cases. In the absence of overt clinical signs, evaluation for MGTI beyond semen analysis is not well established. Therefore, we review the literature on the evaluation and management of MGTI in the setting of male infertility. RECENT FINDINGS: A set of international guidelines recommends semen culture and PCR testing, but the significance of positive results remains unclear. Clinical trials evaluating anti-inflammatory or antibiotic treatment report improvements in sperm parameters and leukocytospermia, but data on the effect on conception rates are lacking. Human papillomavirus (HPV) and the novel coronavirus (SARS-CoV-2) have been associated with poor semen parameters and decreased conception rates. SUMMARY: The finding of leukocytospermia on semen analysis prompts further evaluation for MGTI, including focused physical examination. The role of routine semen culture is controversial. Treatment options include anti-inflammatories; frequent ejaculation; and antibiotics, which should not be used in the absence of symptoms or microbiological infection. SARS-CoV-2 represents a subacute threat to fertility that should be screened for in the reproductive history along with HPV and other viruses.

Color Doppler ultrasound imaging in varicoceles: Is the difference in venous diameter encountered during Valsalva predictive of palpable varicocele grade?

Objective: The clinical grading system for varicoceles is subjective and dependent on clinician experience. Color Doppler ultrasound (US) has not been standardized in the diagnosis of varicoceles. We aimed to determine if US measurement of varicocele could be predictive of World Health Organization (WHO) varicocele grade. Methods: Men who presented for either scrotal pain or infertility to a tertiary men's health clinic underwent physical examination, and varicoceles were graded following WHO criteria (0=subclinical, 1, 2, 3). US was used to measure largest venous diameter in the pampiniform plexus bilaterally at rest and during Valsalva maneuver. Receiver operator characteristic curve analysis was used to determine if resting diameter, diameter during Valsalva, or change in diameter between at rest and during Valsalva provided the highest sensitivity and specificity for determining clinical grade. Threshold values for diameter were determined from these receiver operator characteristic curves. Results: A total of 102 men (50 with clinical varicocele and 52 with subclinical varicocele) were included. Diameter at rest was the best ultrasonographic discriminator between subclinical and clinical varicoceles (area under the curve [AUC]=0.67) with a diameter threshold of 3.0 mm (sensitivity 79%, specificity 42%). Diameter during Valsalva had the greatest AUC for determining clinical Grades 1 versus 2 (AUC=0.57) with diameter threshold of 5.7 mm (sensitivity 71%, specificity 33%). For differentiating between Grades 2 and 3, diameter at rest had the greatest AUC of 0.65 with a threshold of 3.6 mm (sensitivity 71%, specificity 58%). Conclusion: Our results corroborate other studies that have shown a weak correlation between US and clinical grading. The use of diameter during Valsalva was less predictive than diameter at rest and was only clinically significant in differentiating between Grade 1 and 2 varicocele. A standardized method for determining clinically relevant varicoceles on US would allow for improved patient counseling and clinical decision-making.

Trends in Antimicrobial Prophylaxis for Inflatable Penile Prosthesis Surgery From a Large National Cohort.

OBJECTIVE: To assess changes in antibiotic prophylaxis for inflatable penile prosthesis surgery following publication of the American Urological Association (AUA) Best Practice Statement in April 2008. MATERIALS AND METHODS: The Premier Healthcare Database was queried for inflatable penile prosthesis surgeries from January 2000 to March 2020. The primary outcome was administration of an AUA-adherent antimicrobial regimen and secondary outcome was 90-day explant. Piecewise linear regression was used to compare antimicrobial trends before vs after guideline publication. Multivariable logistic regression models were constructed for primary and secondary outcomes. RESULTS: A total of 26,574 patients who underwent inflatable penile prosthesis surgery were identified, of whom 17,754 (67%) received AUA-adherent antibiotics. After guideline publication, there was a 42% relative increase in AUA-adherent regimen usage, with an increase in the usage trend on piecewise linear regression (from 0.1% to 0.8% of encounters per quarter, R2 = 0.75, P < .001). Increased usage trends were also observed for gentamicin (from 0.0% to 1.0% of encounters per quarter, R2 = 0.84, P < .001) and vancomycin (0.1%-0.7%, R2 = 0.77, P < .001). On multivariable regression, odds of AUA-adherence increased after guideline publication (OR: 1.67, 95% CI: 1.54-1.80, P < .001) and with surgery by a high-volume surgeon (OR: 2.21, 95% CI: 2.07-2.35, P < .01). Nonadherence to an AUA-recommended regimen with use of nonstandard antibiotics (OR: 1.16, 95% CI: 0.78-1.71, P = .5) or excess antibiotics (OR: 0.91, 95% CI: 0.62-1.30, P = .6) was not independently associated with increased risk of 90-day explant. CONCLUSIONS: Publication of the AUA Best Practice Statement was associated with subsequent increases in the usage of guideline-adherent antibiotic regimens, particularly vancomycin and gentamicin, despite absence of level-1 evidence supporting this combination.

Trends in testosterone prescription amongst medical specialties: a 5-year CMS data analysis.

Testosterone Therapy (TTh) trends have changed as a result of clinical research and market forces over the past several years. Understanding the trends or preferences regarding testosterone prescriptions remains unknown. Our objective was to assess both regional and national trends in TTh prescriptions amongst medical specialties within the United States between 2013 and 2017. Publicly available data from the Center for Medicare and Medicaid Services (CMS) Part D Prescriber database with regards to TTh prescriptions across a 5-year span (January 1, 2013-December 31, 2017) were analyzed. TTh therapies were consolidated into four categories: Topical, Oral, Injection and Pellet. Statistical analysis utilizing R 4.0.2 was performed on the resulting data. Trends in prescription modality claim count and cost were plotted over the study period while statistical analysis evaluated associations between TTh modality and medical specialist. We found that Endocrinologists and Urologists prescribed topical testosterone more than all other specialties (60.4% and 53.5%, respectively), while Family and Internal medicine physicians were more likely to prescribe injections (59.82% and 50.69%, respectively). Oral and pellet testosterone were rarely prescribed across all specialties. In conclusion, the wide variation in modalities of testosterone prescriptions illustrates an opportunity for treatment guidelines to be streamlined across all specialists to improve patient outcomes.

Is Reddit a reliable source for information on erectile dysfunction treatment?

Patients may turn to social media websites, such as Reddit, for information on erectile dysfunction prior to seeking care from a physician. We sought to identify, characterize, and assess the quality of the erectile dysfunction treatments discussed on the highly influential Reddit website. We assessed 2634 comments from two subreddits, r/AskMen and r/ErectileDysfunction, for positive and negative statements regarding treatments for erectile dysfunction. A total of 45 unique treatments were discussed and consisted of changes in sexual behavior (30%), lifestyle changes (29%), medical interventions (23%), talking with a partner about ED (10%), and use of supplements (8%). Only 24.4% of all treatments discussed are in line with current American Urological Association guidelines. Only 43.8% of all positive statements made endorsed a guidelines-based treatment, indicating a high rate of self-proclaimed success with alternative therapies. Our results indicate that there is active discussion of erectile dysfunction treatment on Reddit with a wide range of therapies recommended, however, the majority of the recommendations are not supported by strong clinical evidence.

Comparing Rates of Polycythemia in Hypogonadal Men Using Nasal Testosterone Gel Versus Intramuscular Testosterone: Update of a Randomized Clinical Trial.

Men with hypogonadism who use intranasal testosterone are less likely to develop polycythemia than men using intramuscular testosterone cypionate.

Guideline-Discordant Care Among Direct-to-Consumer Testosterone Therapy Platforms.

This cross-sectional study examines whether direct-to-consumer platforms provide guideline-concordant care regarding testosterone therapy.