Oncologic Outcomes of Testosterone Therapy for Men on Active Surveillance for Prostate Cancer: A Population-based Analysis.

Background and objective: There is insufficient evidence on the oncologic risks of testosterone therapy for men with prostate cancer managed with active surveillance. We carried out a retrospective study to assess the effect of testosterone therapy on oncologic outcomes for men on active surveillance for prostate cancer. Methods: Surveillance, Epidemiology and End Results (SEER)-Medicare linked data were used to identify men diagnosed with prostate cancer from 2008 to 2017 who were managed with active surveillance and received testosterone (n = 167) or no testosterone (n = 6658) therapy. Outcomes included conversion from active surveillance to active treatment (radical prostatectomy, cryotherapy, radiation, or androgen deprivation therapy), prostate cancer-specific mortality, and overall mortality. Statistically significant factors on univariable analysis were included in a Cox proportional-hazards regression model for multivariable analysis. Key findings and limitations: The median age was 71 yr (interquartile range [IQR] 68-74) in the testosterone group and 72 yr (IQR 69-75) in the no-testosterone group, with corresponding median follow-up after prostate cancer diagnosis of 5.2 yr (IQR 3.4-7.8) and 4.7 yr (IQR 3.2-6.9). There were no prostate cancer-specific deaths in the testosterone group and 39 (0.6%) in the no-testosterone group. Testosterone therapy was not associated with conversion to active treatment (hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.46-0.97; p = 0.033) or overall mortality (HR 1.02, 95% CI 0.68-1.53; p > 0.9). Conclusions and clinical implications: In the first population-based, nationally representative study of testosterone therapy for men on active surveillance for prostate cancer, testosterone therapy did not increase the risk of conversion to active therapy or worsen mortality. Prospective studies are needed to confirm these findings. Patient summary: For men on active surveillance for prostate cancer, we assessed the effect of testosterone therapy. We found that testosterone therapy did not increase the risk of proceeding to active therapy or of death from prostate cancer.

Differing Recommendations on Prostate Biopsy Approach to Minimize Infections: An Examination of the European Association of Urology and American Urological Association Guidelines.

The European Association of Urology and American Urological Association offer differing recommendations on the prostate biopsy approach to use to minimize infection. Current level 1 evidence demonstrates no difference in infectious complications.

Assessing the safety of minimally invasive partial nephrectomy in octogenarians.

As life expectancy continues to rise, there is a growing cohort of octogenarians that can have oncologic benefit from a partial nephrectomy. This study aims to analyze a large national dataset to compare the safety and outcomes in octogenarians receiving a nephrectomy. The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database was utilized. All subjects 80-89 years old who received a minimally invasive partial nephrectomy (CPT: 50543) or radical nephrectomy (CPT: 50545, 50546) from 2016 to 2020 were included. Baseline characteristics, comorbidities, and postoperative complications were compared. Chi-square analysis and student t-tests were used to analyze categorical and continuous variables, respectively. 1765 procedures were performed on octogenarians, of which 1299 (73.6%) received a radical nephrectomy and 466 (26.4%) received a partial nephrectomy. When comparing preoperative comorbidities, octogenarians undergoing partial nephrectomy had lower rates of dyspnea at exertion (7.3 vs. 10.6%, p = 0.04), COPD (2.8 vs. 5.9%, p = 0.01), and chronic steroid use (1.5 vs. 3.3%, p = 0.04). No statistically significant differences were seen in any minor (Clavien 1/2) or major post-operative complications (Clavien 3/4). Readmissions were higher in those who received a partial nephrectomy (10.5 vs. 6.5%, p = 0.01); however, there were no significant differences in reoperation (2.4 vs. 1.7%, p = 0.36) or mortality (1.3 vs. 1.8%, p = 0.48). Partial nephrectomy is a safe and feasible operation in octogenarians. Preoperative counseling and appropriate patient selection remain imperative.

Can men 75 and older safely receive a minimally invasive radical prostatectomy?

Men 75 and older presenting with localized prostate cancer have traditionally not been managed with surgery. Therefore, we compared the morbidity and operative outcomes of radical prostatectomy (RP) in men 75 and older to their younger counterparts. We utilized the American College of Surgeons National Surgical Quality Improvement Program database to gather subjects who received a minimally invasive RP (CPT: 55866) from 2016 to 2020. This cohort was then stratified by age to compare men 18-74 years old and men 75 and older. The preclinical profile, complications, and outcomes were analyzed. Chi-square and Mann-Whitney U test were used to analyze categorical and continuous variables, respectively. Of the 48,485 men identified, 2,009 (4.1%) were ≥ 75 years old. Within the 75 and older cohort, the median age was 76 (IQR: 75-78), the median BMI was 27.3 (IQR: 24.9-29.9), and 1,601 (79.7%) were Caucasian. Men 75 and older had higher rates of Clavien 3 (1.3% vs. 0.8%, p = 0.02) and Clavien 4 (7.8% vs. 5.0%, p < 0.001) complications. Reoperative rates (1.7% vs. 1.1%, p = 0.01), readmission rates (6.5% vs. 4.1%, p < 0.001), and mortality (0.4% vs. 0.1%, p < 0.001) were all higher in men 75 and older. Multivariate analysis shows older age to be a risk factor for readmission (OR 1.58, 95%CI 1.31-1.90). Complications and 30-day outcomes remain within an acceptable range to offer surgery in men 75 and older. Age alone should not disqualify men from receiving a RP, but appropriate patient selection and counseling are necessary.

National Utilization, Reimbursement, and Urban Versus Rural Trends of Extracorporeal Shockwave Lithotripsy and Ureteroscopic Laser Lithotripsy.

OBJECTIVE: To describe temporal utilization and reimbursement trends of extracorporeal shockwave lithotripsy (ESWL) and ureteroscopy (URS) with laser lithotripsy. METHODS: The Medicare Provider Utilization and Payment Database was queried for all ESWL and URS performed between 2013 and 2020 using Current Procedural Terminology codes: ESWL - 50590; URS - 52352, 52353, 52356. Cases that lacked rural or urban identification codes were excluded. A total of 347,174 ESWL and 401,899 URS cases were identified. Linear regression was performed with statistical significance set to 95% confidence intervals. RESULTS: There was a significant upward trend for URS utilization over the study period (R2 = 0.91, P <.001), but there was not a significant trend for ESWL utilization. In 2013, ESWL was used more frequently than URS, but by 2016, URS was used more frequently than ESWL. From 2013 to 2019, URS utilization increased by 241% and 168% by urban and rural urologists, respectively. URS was also associated with a slight increase in physician reimbursement over time (R2 = 0.87, P <.001), whereas there was no association between ESWL and physician reimbursement. For URS, rural and urban urologists were reimbursed an average of $312.07 (standard deviation [SD] $14.03) and $404.86 (SD $21.96), respectively. For ESWL, rural and urban urologists were reimbursed an average of $456.22 (SD $5.74) and $562.66 (SD $16.68), respectively. CONCLUSION: According to the Medicare database, URS has surpassed ESWL in utilization, especially by urban urologists. Physician reimbursement for ESWL remained higher than URS reimbursement, though URS reimbursement increased slightly in recent years.

Same-Day Discharge After Robot-Assisted Partial Nephrectomy: Is It Worth It?

Introduction and Objective: Robot-assisted partial nephrectomy (RAPN) has traditionally been performed as an inpatient procedure; however, recent studies have suggested the feasibility of same-day discharge (SDD) after RAPN. We aimed to evaluate the safety and cost-effectiveness of SDD for RAPN. Methods: A retrospective analysis was conducted on patients undergoing RAPN between January 2015 and July 2021. Comparison before and after the implementation of an SDD protocol was assessed through differences in postanesthesia care unit (PACU) time, length of stay, 30-day readmission rate, 30-day return to emergency department (ED) rates, unplanned office visits (OVs), and need for secondary procedures. A cost-efficacy model was generated to estimate the difference in expenditure between SDD and inpatient RAPN. Results: In total, 192 patients underwent RAPN with 74 being SDD and 118 being admitted postoperatively. After SDD protocol implementation, the percentage of patients discharged from the PACU increased from 0% to 76%. The safety profile of SDD was similar to the inpatient group, with no differences in readmission rates (1.4% vs 5.1%, p = 0.18) or return to ED (5.4% vs 9.3%, p = 0.33). Compared with inpatient RAPN, SDD was associated with increased time in PACU (375 vs 251 minutes, p < 0.001), resulting in an additional expenditure of $1,622 per patient. SDD patients were more likely to return for one or more unplanned OVs (17.6% vs 6.8%, p = 0.02). Overall, the total cost of SDD was significantly lower than inpatient RAPN ($5,222 per patient vs $8,425, p < 0.001). Conclusion: Despite a shorter postoperative monitoring period, SDD appears safe, with equivalent readmission rates, return to ED, and secondary procedures. SDD for RAPN saves ∼$3,000 per patient. In implementing an SDD protocol, clinicians should be cognizant of increased demands on PACU infrastructure and be willing to provide additional support in the office setting.

Post-cystoscopy infections and device malfunctions in reprocessed flexible cystoscopes in a national database.

INTRODUCTION: Flexible cystoscopes can be multi-use devices that visually inspect genitourinary structures such as the bladder and urethra. The objective of this study is to characterize the adverse events and associated device malfunctions of reusable flexible cystoscopes and to provide information on contamination and post-procedural infections. MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for all adverse events and device malfunctions related to the use of flexible cystoscopes between January 2015 and December 2020. The MAUDE adverse event classification system was used to standardize the severity of complications and special focus was taken to identify clusters of events related to a single device. RESULTS: A total of 335 adverse events related to flexible cystoscopes were identified. Most adverse events associated with patient harm were caused by infection (n = 121), which included 19 cases of sepsis, one ICU admission, and one death. Among the infections, 29 cases showed growth of the same organism in both the device and patient. There were five infectious outbreaks identified and each outbreak was attributed to a single cystoscope. Other adverse events included mechanical malfunction (n = 6) and allergic reaction (n = 1). CONCLUSIONS: Our findings highlight the risk of post-procedural infection associated with flexible cystoscope contamination. Further studies are needed to characterize the prevalence and incidence of flexible cystoscope contamination and to develop strategies to prevent post-procedural infection.

Contemporary Clinical Research in the Management of Pelvic Organ Prolapse in the United States: A Systematic Review.

IMPORTANCE: Pelvic organ prolapse (POP) can cause bothersome symptoms that negatively affect quality of life. Management strategies include observation, conservative management, and surgery. OBJECTIVE: The purpose of this study was to evaluate the current focus of research in POP. STUDY DESIGN: We queried clinicaltrials.gov, a registry of clinical research studies maintained by the U.S. National Library of Medicine, for active, recruiting, and enrolling studies involving POP. RESULTS: A total of 104 unique clinical trials were included for analysis. Investigators most commonly specialized in obstetrics and gynecology (obstetrician-gynecologists [ob-gyns]; n = 66, 57.9%); urologists numbered 5 (4.4%). The most common subspecialty was urogynecology (n = 46, 40.4%). Seventy-six percent of clinical research involved surgical intervention. The second most common field of research was diagnostic evaluation of POP (8.4%). Only 12.1% of clinical research focused on conservative measures, and 2.8% investigated medications. Objective outcome measures were used more often than subjective or mixed measures (42.3%, 22.3%, and 32.7%, respectively). The most common outcome measure was Pelvic Organ Prolapse Quantification (14.5%), followed by the mixed measure, "composite success" (8.7%). CONCLUSIONS: Urologists are less involved in POP research than ob-gyns. Urogynecologists from either background are most involved. Most clinical research involves surgical management of POP, despite the fact that less than 20% of women pursue surgical correction. Despite dubious concordance with quality of life, objective outcome measures are used more often than subjective or mixed measures to assess severity of POP. Clinical research in POP should be directed to better align with the needs and preferences of patients.

Medications Most Commonly Associated With Erectile Dysfunction: Evaluation of the Food and Drug Administration National Pharmacovigilance Database.

BACKGROUND: Erectile dysfunction (ED) is an adverse effect of many medications. AIM: We used a national pharmacovigilance database to assess which medications had the highest reported frequency of ED. METHODS: The Food and Drug Administration Adverse Event Reporting System (FAERS) was queried to identify medications with the highest frequency of ED adverse event reports from 2010 to 2020. Phosphodiesterase-5 inhibitors and testosterone were excluded because these medications are often used as treatments for men with ED. The 20 medications with the highest frequency of ED were included in the disproportionality analysis. OUTCOMES: Proportional Reporting Ratios (PRRs) and their 95% confidence intervals were calculated. RESULTS: The 20 medications accounted for 6,142 reports of ED. 5-α reductase inhibitors (5-ARIs) and neuropsychiatric medications accounted for 2,823 (46%) and 2,442 (40%) of these reports respectively. Seven medications showed significant levels of disproportionate reporting with finasteride and dutasteride having the highest PRRs: 110.03 (103.14-117.39) and 9.40 (7.83-11.05) respectively. The other medications are used in a wide variety of medical fields such as cardiology, dermatology, and immunology. CLINICAL IMPLICATIONS: Physicians should be familiar with these medications and understand their respective mechanisms of action, so that they may counsel patients appropriately and improve their quality of life. STRENGTHS AND LIMITATIONS: The strength of the study is its large sample size and that it captures pharmacologic trends on a national level. Quantitative and comparative "real-world" data is lacking for the most common medications associated with ED. The limitation is that the number of reported events does not establish causality and cannot be used to calculate ED incidence rates. CONCLUSION: In a national pharmacovigilance database, 5-ARIs and neuropsychiatric medications had the highest reports of ED adverse effects. There were many other medications used in a variety of medical fields that were also associated with ED. Kaplan-Marans E, Sandozi A, Martinez M, et al. Medications Most Commonly Associated With Erectile Dysfunction: Evaluation of the Food and Drug Administration National Pharmacovigilance Database. Sex Med 2022;10:100543.

Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device-Related Adverse Events in a National Registry.

Purpose: Aquablation, prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT) have demonstrated efficacy for the treatment of benign prostatic hyperplasia (BPH). Our objective was to describe device malfunctions and complications to help guide procedural selection and performance. Materials and Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was examined for reports related to the use of these three procedures for the treatment of BPH between January 1, 2015, and July 1, 2020. Reports were evaluated for device malfunctions and surgical complications using a previously described externally validated classification system developed for the MAUDE database. Chi square analysis was used for statistical comparison between groups. Results: A total of 391 adverse events were reported: aquablation (n = 102), PUL (n = 132), and TWVT (n = 157). There were 79 (78%) severe or life-threatening adverse events for aquablation vs 69 (52%) for PUL vs 24 (15%) for TWVT (p < 0.001). There were 4 cases of rectal perforation with aquablation and 25 cases of the PUL implants needing to be removed or causing a problem with a later procedure. Blood transfusion frequencies were aquablation-32 (31%), PUL-21 (16%), and TWVT-1 (1%). The most common device malfunctions were: aquablation-motion error (n = 8), handpiece fracture/attachment malfunction (n = 8); PUL-device misfire (n = 27), needle fragmentation (n = 21); TWVT-unresolvable error message (n = 19). Conclusions: In a national database, aquablation and PUL had noteworthy complications or device-related malfunctions such as rectal perforation and the improper placement or failed deployment of the PUL implants. Both patients and providers should be aware of potential risks when selecting these novel BPH treatments.