Lifetime Health and Economic Outcomes of Biparametric Magnetic Resonance Imaging as First-Line Screening for Prostate Cancer : A Decision Model Analysis.

BACKGROUND: Contemporary prostate cancer (PCa) screening uses first-line prostate-specific antigen (PSA) testing, possibly followed by multiparametric magnetic resonance imaging (mpMRI) for men with elevated PSA levels. First-line biparametric MRI (bpMRI) screening has been proposed as an alternative. OBJECTIVE: To evaluate the comparative effectiveness and cost-effectiveness of first-line bpMRI versus PSA-based screening. DESIGN: Decision analysis using a microsimulation model. DATA SOURCES: Surveillance, Epidemiology, and End Results database; randomized trials. TARGET POPULATION: U.S. men aged 55 years with no prior screening or PCa diagnosis. TIME HORIZON: Lifetime. PERSPECTIVE: U.S. health care system. INTERVENTION: Biennial screening to age 69 years using first-line PSA testing (test-positive threshold, 4 µg/L) with or without second-line mpMRI or first-line bpMRI (test-positive threshold, PI-RADS [Prostate Imaging Reporting and Data System] 3 to 5 or 4 to 5), followed by biopsy guided by MRI or MRI plus transrectal ultrasonography. OUTCOME MEASURES: Screening tests, biopsies, diagnoses, overdiagnoses, treatments, PCa deaths, quality-adjusted and unadjusted life-years saved, and costs. RESULTS OF BASE-CASE ANALYSIS: For 1000 men, first-line bpMRI versus first-line PSA testing prevented 2 to 3 PCa deaths and added 10 to 30 life-years (4 to 11 days per person) but increased the number of biopsies by 1506 to 4174 and the number of overdiagnoses by 38 to 124 depending on the biopsy imaging scheme. At conventional cost-effectiveness thresholds, first-line PSA testing with mpMRI followed by either biopsy approach for PI-RADS 4 to 5 produced the greatest net monetary benefits. RESULTS OF SENSITIVITY ANALYSIS: First-line PSA testing remained more cost-effective even if bpMRI was free, all men with low-risk PCa underwent surveillance, or screening was quadrennial. LIMITATION: Performance of first-line bpMRI was based on second-line mpMRI data. CONCLUSION: Decision analysis suggests that comparative effectiveness and cost-effectiveness of PCa screening are driven by false-positive results and overdiagnoses, favoring first-line PSA testing with mpMRI over first-line bpMRI. PRIMARY FUNDING SOURCE: National Cancer Institute.

Salvage vesiculectomy for local prostate cancer recurrence: surgical technique and early post-operative outcomes.

PURPOSE: Isolated recurrence in remnants of the seminal vesicles (SV) after treatment of primary prostate cancer (PCa) has become a more frequent entity with the widespread use of more sensitive next-generation imaging modalities. Salvage vesiculectomy is hypothesized to be a worthwhile management option in these patients. The primary goal of this study is to describe the surgical technique of this new treatment option. Secondary outcomes are peri- and post-operative complications and early oncological outcomes. METHODS: Retrospective multicenter study, including 108 patients with solitary recurrence in the SV treated between January 2009 and June 2022, was performed. Patients with local recurrences outside the SVs or with metastatic disease were excluded. Both SVs were resected using a robot-assisted or an open approach. In selected cases, a concomitant lymphadenectomy was performed. RESULTS: Overall, 31 patients (29%) reported complications, all but one grade 1 to 3 on the Clavien-Dindo Scale. A median PSA decrease of 2.07 ng/ml (IQR: 0.80-4.33, p < 0.001), translating into a median PSA reduction of 92% (IQR: 59-98%) was observed. At a median follow-up of 14 months, freedom from secondary treatment was 54%. Lymphadenectomy had a significant influence on PSA reduction (p = 0.018). CONCLUSION: Salvage vesiculectomy for PCa recurrence limited to the SV is a safe procedure with excellent PSA response and is a potential curative treatment in a subset of patients. A concomitant lymphadenectomy can best be performed in all patients that did not underwent one at primary treatment.

Effect of Cannabidiol Oil on Post-ureteroscopy Pain for Urinary Calculi: A Randomized, Double-blind, Placebo-controlled Trial.

PURPOSE: Post-ureteroscopy stent placement carries significant morbidity which can interfere with daily life. This discomfort unfortunately leads to high utilization of opioid pain medications, which have a known risk of addiction. Cannabidiol oil represents an alternative analgesic that has proven anti-inflammatory and antinociceptive effects. The purpose was to evaluate the effect of a Food and Drug Administration-approved cannabidiol oil (Epidiolex) on pain control and opioid usage in the post-ureteroscopy setting. MATERIALS AND METHODS: This was a prospective, randomized, double-blind, placebo-controlled trial at a tertiary care center. Ninety patients undergoing ureteroscopy with stent placement for urinary stone disease were randomized 1:1 to placebo or 20 mg cannabidiol oil daily for 3 days postoperatively. Both groups were prescribed a rescue narcotic, tamsulosin, oxybutynin, and phenazopyridine. Daily pain scores, medication usage, and ureteral stent symptoms using the validated Ureteral Stent Symptom Questionnaire were recorded postoperatively. RESULTS: Both the placebo and cannabidiol oil groups were not different in pre- and perioperative characteristics. There was no difference in pain scores or opioid usage between groups postoperatively. The level of discomfort with ureteral stents was also not different between groups when comparing physical activity, sleep, urination, and activities of daily life. CONCLUSIONS: This randomized, blinded, placebo-controlled trial showed that cannabidiol oil is safe but ineffective when compared to placebo in reducing post-ureteroscopic stent discomfort or opioid usage. Despite the availability of numerous analgesic agents, stent symptoms continue to be a dissatisfier for most patients, suggesting additional work needs to focus on novel interventions and pain control.

Cost-effectiveness of Adjuvant Pembrolizumab After Nephrectomy for High-risk Renal Cell Carcinoma: Insights for Patient Selection From a Markov Model.

PURPOSE: The KEYNOTE-564 trial demonstrated that adjuvant pembrolizumab after nephrectomy for clear cell renal cell carcinoma decreased the risk of disease progression and potentially overall mortality as well. Herein, we used a Markov model to weigh the costs, toxicities, and efficacy of pembrolizumab to further investigate its utility. MATERIALS AND METHODS: Decision-analytic Markov modeling was used to conduct a cost-utility analysis of adjuvant pembrolizumab versus observation after nephrectomy for high-risk clear cell renal cell carcinoma, using data from KEYNOTE-564 to inform model probabilities. Primary outcomes were quality-adjusted life years, Medicare costs, and incremental cost-effectiveness ratios. The willingness-to-pay threshold utilized was $100,000/quality-adjusted life year. RESULTS: At 5 years, adjuvant treatment with pembrolizumab resulted in 0.3 additional quality-adjusted life years at an additional cost of $99,484 relative to observation. Pembrolizumab was found not to be cost-effective at a 5-year time horizon (incremental cost-effectiveness ratio=$326,534). On sensitivity analysis, pembrolizumab became cost-effective if its per cycle cost was <$5,064 (base=$10,278) or its 5-year progression benefit was >18.8% (base 9%). Upon simulation, pembrolizumab was cost-effective for 29% of patients at 5 years. Specifically, we found that pembrolizumab would be cost-effective at 5 years for patients with at least a 59% 5 year risk of progression, which corresponds to a Mayo Progression-free Survival Score ≥10. CONCLUSIONS: At current prices, adjuvant pembrolizumab was found to be cost-effective only for the highest risk subset of clear cell renal cell carcinoma patients 5 years after treatment, including patients with complete metastasectomy, regional lymph node involvement, or ≥7cm pT3 tumors with sarcomatoid features. Longer-term trial data, including overall survival results, are necessary to confirm these extrapolations.

Healthcare system contact following ureteroscopy: does discharge instruction readability matter?

INTRODUCTION: We aimed to assess the impact of discharge instruction (DCI) readability on 30-day postoperative contact with the healthcare system. MATERIALS AND METHODS: Utilizing a multidisciplinary team, DCI were modified for patients undergoing cystoscopy, retrograde pyelogram, ureteroscopy, laser lithotripsy, and stent placement (CRULLS) from a 13th grade to a 7th grade reading level. We retrospectively reviewed 100 patients including 50 consecutive patients with original DCI (oDCI) and 50 consecutive patients with improved readability DCI (irDCI). Clinical and demographic data collected including healthcare system contact (communications [phone or electronic message], emergency department [ED], and unplanned clinic visits) within 30 days of surgery. Uni/multivariate logistic regression analyses used to identify factors, including DCI-type, associated with increased healthcare system contact. Findings reported as odds ratios with 95% confidence intervals and p values (< 0.05 significant). RESULTS: There were 105 contacts to the healthcare system within 30 days of surgery: 78 communications, 14 ED visits and 13 clinic visits. There were no significant differences between cohorts in the proportion of patients with communications (p = 0.16), ED visits (p =1.0) or clinic visits (p = 0.37). On multivariable analysis, older age and psychiatric diagnosis were associated with significantly increased odds of overall healthcare contact (p = 0.03 and p = 0.04) and communications (p = 0.02 and p = 0.03). Prior psychiatric diagnosis was also associated with significantly increased odds of unplanned clinic visits (p = 0.003). Overall, irDCI were not significantly associated with the endpoints of interest. CONCLUSIONS: Increasing age and prior psychiatric diagnosis, but not irDCI, were significantly associated with an increased rate of healthcare system contact following CRULLS.

Comparative cost-effectiveness of neoadjuvant chemotherapy regimens for muscle-invasive bladder cancer: Results according to VESPER data.

BACKGROUND: The VESPER trial demonstrated improved progression-free (PFS) and (preliminarily) overall survival (OS) with six cycles of neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVACx6) versus four cycles of gemcitabine and cisplatin (GCx4) before radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC), but with increased toxicity. This study compares the cost-effectiveness of these regimens. METHODS: A cost-effectiveness analysis of neoadjuvant ddMVACx6 and GCx4 was performed using a decision-analytic Markov model with 5-year, 10-year, and lifetime horizons. Probabilities were derived from reported VESPER data. Utility values were obtained from the literature. Primary outcomes were effectiveness measured in quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER) with a willingness to pay threshold of $100,000 per QALY. One-way and probabilistic sensitivity analyses were performed to evaluate the robustness of the model. RESULTS: At 5 years, ddMVACx6 improved QALYs by 0.30 at an additional cost of $16,100, rendering it cost-effective relative to GCx4 (ICER: $53,284/QALY). Additionally, probabilistic sensitivity analysis found ddMVACx6 to be cost-effective in 79% and 81% of microsimulations at10-year and lifetime horizons, respectively. One-way sensitivity analysis demonstrated a minimum difference in 5-year progression of 0.9% and progression mortality of 0.7% between ddMVACx6 and GCx4 was necessary for ddMVACx6 to remain cost-effective. CONCLUSIONS: Neoadjuvant ddMVACx6 was more cost-effective than GCx4 for MIBC. These data, together with the improved PFS and (albeit preliminary) OS noted in VESPER, support use of this regimen in appropriate candidates for neoadjuvant chemotherapy before RC. LAY SUMMARY: We performed a benefit-to-cost analysis using evidence from a randomized controlled trial that compared two different chemotherapy treatments before bladder removal for bladder cancer that had invaded into the bladder muscle. Despite being more expensive and having a greater likelihood of toxicity, six cycles of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin was more cost-effective (or had higher value) than four cycles of gemcitabine and cisplatin.

A novel upper tract ureteroscopic biopsy technique: the "form tackle".

INTRODUCTION AND OBJECTIVE: Upper tract urothelial carcinoma (UTUC) represents 5% of all urothelial malignancies (1-3). Accurate pathologic diagnosis is key and may direct treatment decisions. Current ureteroscopic biopsy techniques include cold-cup, backloaded cold-cup and stone basket (4-6). The study objective was to compare a standard cold-cup biopsy technique to a novel cold-cup biopsy technique and evaluate histopathologic results. MATERIALS AND METHODS: We developed a novel UTUC biopsy technique termed the "form tackle" biopsy. Ureteroscope is passed into ureter/renal collecting system. Cold-cup forceps are opened and pressed into the lesion base (to engage the urothelial wall/submucosal tissue) then closed. Ureteroscope/forceps are advanced forward 3-10mm and then extracted from the patient. We compared standard versus novel upper tract biopsy techniques in a series of patients with lesions ≥1cm. In each procedure, two standard and two novel biopsies were obtained from the same lesion. The primary study aim was diagnosis of malignancy. IRB approved: 21-006907. RESULTS: Fourteen procedures performed on 12 patients between June 2020 and March 2021. Twenty-eight specimens sent (14 standard, 14 novel) (Two biopsies per specimen). Ten procedures with concordant pathology. In 4 procedures the novel biopsy technique resulted in a diagnosis of UTUC (2 high-grade, 2 low-grade) in the setting of a benign standard biopsy. Significant difference in pathologic diagnoses was detected between standard and novel upper tract biopsy techniques (p=0.008). CONCLUSIONS: The "form tackle" upper tract ureteroscopic biopsy technique provides higher tissue yield which may increase diagnostic accuracy. Further study on additional patients required. Early results are encouraging.

Cost-Effectiveness Analysis of Pembrolizumab for Bacillus Calmette-Guérin-Unresponsive Carcinoma In Situ of the Bladder.

PURPOSE: Patients with bacillus Calmette-Guérin-unresponsive carcinoma in situ are treated with radical cystectomy or salvage intravesical chemotherapy. Recently, pembrolizumab was approved for bacillus Calmette-Guérin-unresponsive carcinoma in situ. MATERIALS AND METHODS: We used a decision-analytic Markov model to compare pembrolizumab, salvage intravesical chemotherapy (with gemcitabine-docetaxel induction+monthly maintenance) and radical cystectomy for patients with bacillus Calmette-Guérin-unresponsive carcinoma in situ who are radical cystectomy candidates (index patient 1) or are unwilling/unable to undergo radical cystectomy (index patient 2). The model used a U.S. Medicare perspective with a 5-year time horizon. One-way and probabilistic sensitivity analyses were performed. Incremental cost-effectiveness ratios were compared using a willingness to pay threshold of $100,000/quality-adjusted life year. RESULTS: For index patient 1, pembrolizumab was not cost-effective relative to radical cystectomy (incremental cost-effectiveness ratios $1,403,008/quality-adjusted life year) or salvage intravesical chemotherapy (incremental cost-effectiveness ratios $2,011,923/quality-adjusted life year). One-way sensitivity analysis revealed that pembrolizumab only became cost-effective relative to radical cystectomy with a >93% price reduction. Relative to radical cystectomy, salvage intravesical chemotherapy was cost-effective for time horizons <5 years and nearly cost-effective at 5 years (incremental cost-effectiveness ratios $118,324/quality-adjusted life year). One-way sensitivity analysis revealed that salvage intravesical chemotherapy became cost-effective relative to radical cystectomy if risk of recurrence or metastasis at 2 years was less than 55% or 5.9%, respectively. For index patient 2, pembrolizumab required >90% price reduction to be cost-effective (incremental cost-effectiveness ratios $1,073,240/quality-adjusted life year). Pembrolizumab was cost-effective in 0% of 100,000 microsimulations in probabilistic sensitivity analyses for both index patients. CONCLUSIONS: At its current price, pembrolizumab is not cost-effective for bacillus Calmette-Guérin-unresponsive carcinoma in situ relative to radical cystectomy or salvage intravesical chemotherapy. Although gemcitabine-docetaxel is not cost-effective relative to radical cystectomy at 5 years, further studies may validate its cost-effectiveness if recurrence and metastasis thresholds are met.

Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis.

PURPOSE: The primary rationale for antimicrobial prophylaxis (AP) is to decrease the incidence of surgical site infection (SSI) and other preventable periprocedural infections, with the secondary goal of reducing antibiotic overuse. This Best Practice Statement (BPS) updates the prior American Urological Association (AUA) BPS and creates a comprehensive and user-friendly reference for clinicians caring for adult patients who are undergoing urologic procedures. MATERIALS AND METHODS: Recommendations are based on a review of English language peer-reviewed literature from 2006 through October 2018 and were made by consensus by a multidisciplinary panel. The search parameters included timing, re-dosing, and duration of AP across urologic procedures where there was the possibility of SSI. Excluded from the search were the management of infections outside the genitourinary (GU) tract and pediatric procedures. RESULTS: Single-dose AP is recommended for most urologic cases and antimicrobials should only be used when medically necessary, for the shortest duration possible, and not beyond case completion. Surgeons are the most accurate discerners of an SSI, and should use standard definitions to make better calculations of patient risk. The risk classification developed is dependent on the likelihood of developing SSI, and not the associated consequences of SSI. CONCLUSIONS: The AUA developed a multi-disciplinary BPS to guide clinicians on the proper usage of AP across urologic procedures and wound classifications. It is recommended that the lowest dose of antimicrobials be administered to decrease the risk of infection and to minimize the risk of drug-resistant organisms.

Cost-Effectiveness of Maintenance bacillus Calmette-Guérin for Intermediate and High Risk Nonmuscle Invasive Bladder Cancer.

PURPOSE: While guidelines support the use of maintenance bacillus Calmette-Guérin for patients with intermediate and high risk nonmuscle invasive bladder cancer, in an era of bacillus Calmette-Guérin shortage we explored the cost-effectiveness of maintenance bacillus Calmette-Guérin. MATERIALS AND METHODS: A Markov model compared the cost-effectiveness of maintenance bacillus Calmette-Guérin to surveillance after induction bacillus Calmette-Guérin for intermediate/high risk nonmuscle invasive bladder cancer from a U.S. Medicare perspective. Five-year oncologic outcomes, toxicity rates and utility values were extracted from the literature. Univariable and multivariable sensitivity analyses were conducted. A willingness to pay threshold of $100,000 per quality adjusted life year was considered cost-effective. RESULTS: At 5 years mean costs per patient were $14,858 and $13,973 for maintenance bacillus Calmette-Guérin and surveillance, respectively, with quality adjusted life years of 4.046 for both, making surveillance the dominant strategy. On sensitivity analysis full dose and 1/3 dose maintenance bacillus Calmette-Guérin became cost-effective if the absolute reduction in 5-year progression was greater than 2.1% and greater than 0.76%, respectively. On further sensitivity analysis full dose and 1/3 dose maintenance bacillus Calmette-Guérin became cost-effective when maintenance bacillus Calmette-Guérin toxicity equaled surveillance toxicity. In multivariable sensitivity analyses using 100,000 Monte-Carlo microsimulations, full dose and 1/3 dose maintenance bacillus Calmette-Guérin was cost-effective in 17% and 39% of microsimulations, respectively. CONCLUSIONS: Neither full dose nor 1/3 dose maintenance bacillus Calmette-Guérin appears cost-effective for the entire population of patients with intermediate/high risk nonmuscle invasive bladder cancer. These data support prioritizing maintenance bacillus Calmette-Guérin for the subset of patients with high risk nonmuscle invasive bladder cancer most likely to experience progression, in particular those who tolerated induction bacillus Calmette-Guérin well. Overall, our findings support the American Urological Association policy statement to allocate bacillus Calmette-Guérin for induction rather than maintenance therapy during times of bacillus Calmette-Guérin shortage.

Cost-Effectiveness of Active Surveillance, Radical Prostatectomy and External Beam Radiotherapy for Localized Prostate Cancer: An Analysis of the ProtecT Trial.

PURPOSE: Despite increasing emphasis on value based care, to our knowledge the cost-effectiveness of prostate cancer management options has not been compared using prospective clinical trial data. The ProtecT (Prostate Testing for Cancer and Treatment) trial demonstrated no difference in survival in patients randomized to active surveillance, external beam radiotherapy or radical prostatectomy. We compared cost-effectiveness among the arms of ProtecT. MATERIALS AND METHODS: Using a Markov model we compared the cost-effectiveness of active surveillance, radical prostatectomy and external beam radiotherapy based on ProtecT outcomes, specifically 6-year quality of life data and 10-year oncologic data. Costs were based on 2017 Medicare reimbursement while utility values were assigned using the literature. Univariable and multivariable sensitivity analyses were performed. RESULTS: Six years after randomization the mean costs per patient were $12,143 for active surveillance, $17,781 for radical prostatectomy and $29,238 for external beam radiotherapy. The incremental cost-effectiveness ratio relative to active surveillance was $127,752/QALY for radical prostatectomy and $381,894/QALY for external beam radiotherapy. Ten years after randomization radical prostatectomy ($5,627/QALY) and external beam radiotherapy ($78,291/QALY) were more cost-effective than active surveillance. The model was sensitive to the metastasis rate on active surveillance with a threshold of 2.4% at 10 years, below which active surveillance was more cost-effective than radical prostatectomy. On multivariable sensitivity analysis at 10 years using a willingness to pay threshold of $100,000/QALY the most cost-effective strategy was radical prostatectomy in 45% of model microsimulations, external beam radiotherapy in 30% and active surveillance in 25%. CONCLUSIONS: Although active surveillance represents a cost-effective strategy to manage localized prostate cancer during the initial several years after diagnosis, the relative cost-effectiveness of treatment emerges with extended followup.

Comparative Cost-effectiveness of Surgery, Collagenase Clostridium Histolyticum, and Penile Traction Therapy in Men with Peyronie's Disease in an Era of Effective Clinical Treatment.

BACKGROUND: Traditionally, surgery has been considered the gold standard treatment for Peyronie's disease (PD). Less-invasive alternatives, such as collagenase Clostridium histolyticum (CCH) and traction therapy, have been proposed and proven effective. AIM: To compare cost-effectiveness of management options for PD. METHODS: A Markov analytic model was created to compare the cost-effectiveness of treatment with a novel traction device, RestoreX (RXPTT), vs CCH vs surgery. Outcomes were derived from single-institution, prospective data of 63 men treated with RXPTT, 115 with CCH, and 23 with plication or incision and grafting. Costs were based on 2017 Medicare reimbursement and utility values from the literature. MAIN OUTCOME MEASURES: Model outcomes included complications for each treatment arm, as well as the probability of success, which was defined as ≥20% improvement in curvature. Univariable and multivariable sensitivity analyses were performed to test the robustness of the model. RESULTS: Overall success rates were 96% (surgery), 66% (CCH), and 48% (RXPTT). At 10 years after treatment, RXPTT was the most cost-effective, with mean costs per patient of $883 (RXPTT), $11,419 (surgery), and $33,628 (CCH). CCH and surgery both resulted in a gain of quality adjusted life years (QALYs) relative to RXPTT (9.44 and 9.36 vs 9.27, respectively). Sensitivity analysis demonstrated greater cost-effectiveness for surgery if lower (≤46%) rates of postoperative erectile dysfunction or length loss (≤3%). CCH became more cost-effective at lower costs (≤$16,726) or higher success rates (≥76%). On multivariable sensitivity analysis at a willingness to pay threshold of $100,000/QALY, the most cost-effective strategy was RXPTT in 49%, surgery in 48%, and CCH in 3% of simulations. At a willingness to treat threshold of $150,000/QALY, the most cost-effective treatment option was RXPTT in 33%, surgery in 55%, and CCH in 12% of simulations. CLINICAL IMPLICATIONS: In an era of value-based care, this model can guide cost-effective treatment selection on the basis of provider, patient, and payer characteristics. STRENGTHS & LIMITATIONS: The current study represents the first cost-effectiveness comparison of treatment modalities for PD and is strengthened by prospective data collection, large CCH and traction sample sizes, and robust sensitivity analyses. Consistent with cost-effective models, the model is limited by assumptions and may not apply to all scenarios. CONCLUSIONS: RXPTT represents a more cost-effective method for achieving ≥20% curvature improvement compared with surgery or CCH. Depending on treatment goals, rate of surgical complications, and willingness to pay threshold, surgery and CCH may become more cost-effective in select scenarios. Wymer K, Kohler T, Trost L. Comparative Cost-effectiveness of Surgery, Collagenase Clostridium Histolyticum, and Penile Traction Therapy in Men with Peyronie's Disease in an Era of Effective Clinical Treatment. J Sex Med 2019;16:1421-1432.

Adherence to National Comprehensive Cancer Network® Guidelines for Testicular Cancer.

PURPOSE: Testicular cancer is the most common malignancy among young men and well established treatment guidelines exist to optimize outcomes. We characterized errors in the management of testicular cancer observed among patients seen at 3 referral centers in the United States. MATERIALS AND METHODS: We retrospectively reviewed data from 593 patients presenting with testicular cancer to 3 academic medical centers from 2007 to 2016. Nonguideline directed care was defined as management differing from National Comprehensive Care Network guideline recommendations. Cases of nonguideline directed care were systematically described. Patient and tumor characteristics were compared between guideline directed care and nonguideline directed care. Multivariable logistic regression was used to identify predictors of nonguideline directed care, and Cox regression modeling was used to assess the association between nonguideline directed care and relapse-free survival. RESULTS: Nonguideline directed care was identified in 177 of 593 (30%) patients. Inappropriate imaging (44%) and overtreatment (40%) were the most common classifications. Misdiagnosis (24%) and under treatment (16%) occurred relatively frequently, while inappropriate treatment (6%) was rare. Multivariable Cox regression modeling controlling for race, tumor stage and tumor histology identified nonguideline directed care as a significant predictor of relapse (HR 2.49, 95% CI 1.61-3.85, p <0.01). CONCLUSIONS: Nonguideline directed care of patients with testicular cancer is common, most frequently in the form of inappropriate imaging and overtreatment. Nonguideline directed care leads to delayed definitive therapy, unnecessary morbidity and higher rates of relapse.

Urolithiasis in pregnancy: a cost-effectiveness analysis of ureteroscopic management vs ureteral stenting.

OBJECTIVE: The purpose of this study was to determine the cost-effectiveness of serial stenting vs ureteroscopy for treatment of urolithiasis during pregnancy as a function of gestational age (GA) at diagnosis. STUDY DESIGN: We built decision analytic models for a hypothetical cohort of pregnant women who had received a diagnosis of symptomatic ureteral calculi and compared serial stenting to ureteroscopy. We assumed ureteral stent replacement every 4 weeks during pregnancy, intravenous sedation for stent placement, and spinal anesthetic for ureteroscopy. Outcomes were derived from the literature and included stent infection, migration, spontaneous kidney stone passage, ureteral injury, failed ureteroscopy, postoperative urinary tract infection, sepsis, and anesthetic complications. Four separate analyses were run based on the GA at diagnosis of urolithiasis. Using direct costs and quality-adjusted life years, we reported the incremental costs and effectiveness of each strategy based on GA at kidney stone diagnosis and calculated the net monetary benefit. We performed 1-way and Monte-Carlo sensitivity analyses to assess the strength of the model. RESULTS: Ureteroscopy was less costly and more effective for urolithiasis, irrespective of GA at diagnosis. The incremental cost of ureteroscopy increased from -$74,469 to -$7631, and the incremental effectiveness decreased from 0.49 to 0.05 quality-adjusted life years for a kidney stone diagnosed at 12 and 36 weeks of gestation, respectively. The net monetary benefit of ureteroscopy progressively decreased for kidney stones that were diagnosed later in pregnancy. The model was robust to all variables. CONCLUSION: Ureteroscopy is less costly and more effective relative to serial stenting for urolithiasis, regardless of the GA at diagnosis. Ureteroscopy is most beneficial for women who received the diagnosis early during pregnancy.

The cost-effectiveness of a trial of labor accrues with multiple subsequent vaginal deliveries.

OBJECTIVE: The purpose of this study was to estimate costs and outcomes of subsequent trials of labor after cesarean delivery (TOLAC) compared with elective repeat cesarean deliveries (ERCD). STUDY DESIGN: To compare TOLAC and ERCD, maternal and neonatal decision analytic models were built for each hypothetic subsequent delivery. We assumed that only women without previa would undergo TOLAC for their second delivery, that women with successful TOLAC would desire future TOLAC, and that women who chose ERCD would undergo subsequent ERCD. Main outcome measures were maternal and neonatal mortality and morbidity rates, direct costs, and quality-adjusted life years. Values were derived from the literature. One-way and Monte-Carlo sensitivity analyses were performed. RESULTS: TOLAC was less costly and more effective for most models. A progression of decreasing incremental cost and increasing incremental effectiveness of TOLAC was found for maternal outcomes with increasing numbers of subsequent deliveries. This progression was also displayed among neonatal outcomes and was most prominent when neonatal and maternal outcomes were combined, with an incremental cost and effectiveness of -$4700.00 and .073, respectively, for the sixth delivery. Net-benefit analysis showed an increase in the benefit of TOLAC with successive deliveries for all outcomes. The maternal model of the second delivery was sensitive to cost of delivery and emergent cesarean delivery. Successive maternal models became more robust, with the models of the third-sixth deliveries sensitive only to cost of delivery. Neonatal models were not sensitive to any variables. CONCLUSION: Although nearly equally effective relative to ERCD for the second delivery, TOLAC becomes less costly and more effective with subsequent deliveries.

Trends in patient complexity, practice setting, and surgeon reimbursement for urolithiasis: do rural urologists pay the price?

OBJECTIVES: To evaluate the relationship between patient complexity, practice setting, and surgeon reimbursement for ureteroscopy and percutaneous nephrolithotomy (PCNL). METHODS: The "2021 Medicare Physician and Other Provider" file was used to collect Rural-Urban Commuting Area (RUCA) codes and hierarchical condition category (HCC) scores of urologists. Higher HCC score corresponds to higher medical complexity and higher RUCA code corresponds to a more rural area. Medicare reimbursement for ureteroscopy and PCNL were collected. Linear regressions were performed to predict change in reimbursement based on RUCA and HCC scores. RESULTS: In 2021, 52,816 procedures under CPT code 52356 (ureteroscopy) and 1649 procedures under 50080 or 50081 (PCNL) were billed to Medicare. Mean reimbursement was $338.24 for ureteroscopy and $957.89 for PCNL. For ureteroscopy, higher HCC score predicted lower reimbursement (p<0.001). Higher HCC score predicted higher reimbursement for PCNL (p<0.01). Average RUCA for ureteroscopy was higher than for PCNL (p=0.02). Rural location predicted lower reimbursement for ureteroscopy (p<0.001), however there was no association for PCNL. CONCLUSIONS: For ureteroscopy, higher-risk patients are associated with lower reimbursement while the opposite holds true for PCNL. Rural practices were associated with lower reimbursement for ureteroscopy, but there was no association between location and PCNL reimbursement. Together, these findings suggest practice pattern variation between ureteroscopy and PCNL and highlight gaps in reimbursement policy. Risk-adjusted reimbursement should be considered to incentivize urologists to treat complex patients within their practice scope.

Evaluation of Private Payer and Patient Out-of-Pocket Costs Associated With the Surgical Management of Benign Prostatic Hyperplasia.

OBJECTIVE: To evaluate and compare the financial burden of various surgical interventions for the management of benign prostatic hyperplasia (BPH). METHODS: We identified commercially insured men with a diagnosis of BPH who underwent a procedure of interest (simple prostatectomy (SP), transurethral resection of the prostate (TURP), holmium laser enucleation of the prostate (HoLEP), photovaporization of the prostate (PVP), prostatic urethral lift (PUL), or water vapor thermal therapy (WVTT)) between 2015 and 2021 with the OptumLabs Data Warehouse. Primary outcome was total health care costs (THC) which included both patient out-of-pocket (OOP) and health plan paid costs for the index procedure and combined follow-up years 1-5. A generalized linear model was used to estimate adjusted costs controlling for demographic and clinical characteristics. Patients undergoing WVTT were excluded from extended follow-up analyses due to limited data. RESULTS: Among 25,407 patients with BPH, 10,117 (40%) underwent TURP, 6353 (25%) underwent PUL, 5411 (21%) underwent PVP, 1319 (5%) underwent SP, 1243 (5%) underwent WVTT, and 964 (4%) underwent HoLEP. Index procedure costs varied significantly with WVTT being the least costly [THC: $2637 (95% confidence interval (CI): $2513-$2761)], and SP being the costliest [THC: $14,423 (95% CI: $12,772-$16,075)]. For aggregate index and 5-year follow-up costs, HoLEP ($31,926 [95% CI: $29,704-$34,148]) was the least costly and PUL ($36,596 [95% CI: $35,369-37,823]) was the costliest. CONCLUSION: BPH surgical treatment is associated with significant system-level health care costs. The level of impact varies between procedures. Minimally invasive options, such as WVTT, may offer initial cost reductions; however, HoLEP and SP are associated with lower follow-up costs.

Are adverse events during surgery for benign prostatic hyperplasia device related? A review of the MAUDE database.

PURPOSE: The Manufacturer and User Facility Device Experience database contains anonymous, voluntary medical device reports. A review of device-related adverse events associated with Benign Prostatic Hyperplasia surgeries was completed. The objective was to evaluate the occurrence and contributing factors to clinically significant complications in a cohort of patients electing to undergo surgical intervention for Benign Prostatic Hyperplasia. METHODS: The Manufacturer and User Facility Device Experience database was queried for "Aquablation, Greenlight Laser, Holmium Laser, Morcellator, Water Vapor Thermal Therapy, Loop Resection, and Prostatic Urethral Lift" from 2018 through 2021. A complication classification system (Level I-IV) based on the Clavien-Dindo system was used to categorize events. These events were then correlated with procedural technology malfunctions and classified as "device related" and "non-device related." Chi squared analysis was performed to identify associations between procedural technology and complication classification distribution. RESULTS: A total of 873 adverse events were identified. The adverse events were classified into level I (minimal harm) versus levels II-IV (clinically significant). Aquablation (p < 0.017) and Water Vapor Thermal Therapy (p < 0.012) were associated with a higher proportion of reports with Level II-IV complications compared with other procedure types. Level II-IV complications were not associated with a reported device related malfunction. CONCLUSIONS: Aquablation and water vapor thermal therapy demonstrated noteworthy clinically significant complications which were not driven by device-related malfunctions.

The Impact of Standard vs Early Apical Release Holmium Laser Enucleation of the Prostate Technique on Postoperative Incontinence and Quality of Life.

OBJECTIVE: To investigate the difference in postoperative incontinence and quality of life comparing standard vs early apical release (EAR) Holmium Laser Enucleation of the Prostate (HoLEP). METHODS: A retrospective review was performed to identify patients who underwent HoLEP from December 2021 to December 2022 at a single tertiary referral center with two participating consultant urologists. Patients were assessed with questionnaires and evaluated clinically. We performed propensity score matching with a logistic regression and a 1:1 matching method. A propensity score-adjusted logistic regression (PSRM) was performed to compare the pads per day between surgical techniques controlling for age, prostate size, preoperative survey data, uroflow, and postvoid residual. RESULTS: One hundred fourteen patients underwent HoLEP, of which 60 patients were treated with EAR and 54 patients with standard technique. EAR technique demonstrated shorter operative times (P = .046). The EAR cohort demonstrated improved AUASS (P = .034, P = .001), QOL (P = .001, P <.001), and continence rates (P <.001, P <.001) at 6 and 12weeks postoperatively. PSRM showed that the standard HoLEP increased the risk of requiring ≥2 pads per day 4.2x (P = .031, HR 95%, CI=1.16, 15.35) and 8.3x (P <.001, HR 95% CI 3.17, 21.6) at 6 and 12weeks postoperatively. CONCLUSION: EAR technique promoted earlier return of continence and improved quality of life within 6weeks of surgery.