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.

Access to Care and Health Care Utilization Among Patients With Nephrolithiasis.

OBJECTIVE: To characterize the impact of nephrolithiasis diagnosis and treatment on health care utilization and identify predictors of barriers to care in the patient population. METHODS: We conducted a retrospective cohort study using the All of Us Database, a National Institutes of Health database targeting recruitment of underrepresented populations. Patients with a diagnosis of kidney stones were included and matched to a control group. Primary outcomes were patients' self-reported health care access and utilization. Univariable and multivariable regression analyses were performed. RESULTS: 9173 patients with a diagnosis of nephrolithiasis were included and matched to 9173 controls without a diagnosis of nephrolithiasis. Patients with kidney stones were less likely to have had >1 year since last provider visit (1.7% vs 3.8%, P <.001), but did not report increased delays obtaining care (31%), inability to afford care (11.4%), or higher likelihood of skipping medications (12.9%). Among patients with stones, 1208 (13.2%) had been treated surgically. On multivariable analysis, younger age, female sex, lower income, lower education, non-insured status, and lower physical and mental health were all associated with delays obtaining care, difficulty affording care, skipping medications, and/or prolonged time since seeing a provider. CONCLUSION: A diagnosis of nephrolithiasis and subsequent surgical intervention were not associated with an increase in patient-reported barriers to care. However, among patients with nephrolithiasis, younger, comorbid, female patients from lower socioeconomic status are at significant risk of being unable to access and utilize treatment.

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.

Comparative cost-effectiveness of contemporary treatment strategies for stage IIA seminoma.

BACKGROUND: The Surgery in Early Metastatic Seminoma (SEMS) trial examined retroperitoneal lymph node dissection as first-line treatment for patients with isolated 1-3 cm retroperitoneal lymphadenopathy. To date, the standard of care for these patients has been either chemotherapy or radiotherapy. Herein, we evaluated the relative cost-effectiveness of these management strategies. METHODS: A microsimulation model assessed the cost-effectiveness of retroperitoneal lymph node dissection, chemotherapy, and radiotherapy for stage IIA seminoma. Sensitivity analyses were performed to evaluate model robustness. Retroperitoneal lymph node dissection recurrence probabilities were obtained from the SEMS trial. All other probability and utility values were obtained from published literature. Primary outcomes included costs from a commercial insurer's perspective, effectiveness (quality adjusted life-years [QALYs]), and incremental cost-effectiveness ratios using a willingness-to-pay threshold of $100 000/QALY. RESULTS: At a lifetime horizon, the mean costs per patient for retroperitoneal lymph node dissection, radiotherapy, and chemotherapy were $58 469, $98 783, and $104 096, and the mean QALYs were 40.61, 40.70, and 39.15, respectively. Retroperitoneal lymph node dissection was found to be the most cost-effective approach because of high costs and accrued disutility of chronic toxicities associated with radiotherapy (cost-effectiveness ratios = $433 845/QALY) and chemotherapy (dominated). On 1-way sensitivity analyses, retroperitoneal lymph node dissection was no longer cost-effective if the probabilities of infertility and cardiovascular toxicity after radiotherapy were less than 13% and 16%, respectively, or if the 2-year probability of progression after retroperitoneal lymph node dissection was more than 26%. CONCLUSIONS: Retroperitoneal lymph node dissection was the most cost-effective treatment approach for stage IIA seminoma. These findings support clinical guideline consideration of including retroperitoneal lymph node dissection as a treatment option for well-selected patients with stage IIA seminoma.

Reuse and Reprocessing of Endoscopic Instruments: For.

Reusable endoscopes appear to be most environmentally sustainable when the carbon footprint of routine device maintenance is optimized. Single-use endoscopes may offer cost-savings in clinical settings that accelerate device damage, such as prolonged procedure time or complex patient anatomy. For many urology practices, a hybrid approach that integrates single-use and reusable devices may be most economically sensible and environmentally sound.

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.

Evaluation of the Cost-Effectiveness of Surgical Treatment Options for Benign Prostatic Hyperplasia.

OBJECTIVE: To compare the cost-effectiveness of surgical interventions for BPH. METHODS: Using a Markov model, a cost-utility analysis was performed comparing HoLEP, B-TURP, WVTT, and PUL for prostate size <80cc (index patient 1) and HoLEP and SP for prostate size >80cc (index patient 2). Model probabilities and utility values were drawn from the literature. Analysis was performed at a 5-year time horizon with extrapolation to a lifetime horizon. Primary outcomes included quality-adjusted life years (QALYs), 2021 Medicare costs, and incremental cost-effectiveness ratios (ICERs) with a willingness-to-pay threshold of $100,000/QALY. Univariate and probabilistic sensitivity analyses were performed. RESULTS: At 5 years, costs per patient for index patient 1 were $3292 (WVTT), $6532 (HoLEP), $6670 (B-TURP), and $10,257 (PUL). HoLEP resulted in the highest QALYs (4.66), followed by B-TURP (4.60), PUL (4.38), and WVTT (4.38). This translated to HoLEP being most cost-effective (ICER $11,847). For index patient 2, HoLEP was less costly ($6,585 vs $15,404) and more effective (4.654 vs 4.650) relative to SP. On sensitivity analysis for index patient 1, B-TURP became most cost-effective if cost of HoLEP increased two-fold or chronic stress incontinence following HoLEP increased ten-fold. When follow-up time was varied, WVTT was preferred at very short follow up (<1 year), and HoLEP became more strongly preferred with longer follow up. CONCLUSION: At 5 years follow up, HoLEP is a cost-effective surgical treatment for BPH- independent of gland size.

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.

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.

Cost-effectiveness Analysis of Early Sling Loosening Versus Delayed Sling Lysis in the Management of Voiding Dysfunction After Midurethral Sling Placement.

OBJECTIVE: The aim of this study was to perform a cost-effectiveness analysis comparing the management for ongoing voiding dysfunction after midurethral sling placement, including early sling loosening and delayed sling lysis. METHODS: A Markov model was created to compare the cost-effectiveness of early sling loosening (2 weeks) versus delayed sling lysis (6 weeks) for the management of persisting voiding dysfunction/retention after midurethral sling placement. A literature review provided rates of resolution of voiding dysfunction with conservative management, complications, recurrent stress urinary incontinence, or ongoing retention, as well as quality-adjusted life years (QALYs). Costs were based on 2020 Medicare reimbursement rates. Incremental cost-effectiveness ratios were compared using a willingness-to-pay threshold of $100,000/QALY. One-way and probabilistic sensitivity analyses were performed. RESULTS: At 1 year, early sling loosening resulted in increased costs ($3,575 vs $1,836) and higher QALYs (0.948 vs 0.925) compared with delayed sling lysis. This translated to early sling loosening being the most cost-effective strategy, with an incremental cost-effectiveness ratio of $74,382/QALY. The model was sensitive to multiple variables on our 1-way sensitivity analysis. For example, delayed sling lysis became cost-effective if the rate of voiding dysfunction resolution with conservative management was greater than or equal to 57% or recurrent stress urinary incontinence after early loosening was greater than or equal to 9.6%. At a willingness-to-pay threshold of 100,000/QALY, early sling loosening was cost-effective in 82% of microsimulations in probabilistic sensitivity analysis. CONCLUSIONS: Early sling loosening represents a more cost-effective management method in resolving ongoing voiding dysfunction after sling placement. These findings may favor early clinical management in patients with voiding dysfunction after midurethral sling placement.

Cost-effectiveness of Retrograde Intrarenal Surgery, Standard and Mini Percutaneous Nephrolithotomy, and Shock Wave Lithotripsy for the Management of 1-2cm Renal Stones.

OBJECTIVE: To perform a cost-effectiveness evaluation comparing the management options for mid-size (1-2cm) renal stones including percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and shockwave lithotripsy (SWL). METHODS: A Markov model was created to compare cost-effectiveness of PCNL, mini-PCNL, RIRS, and SWL for 1-2cm lower pole (index patient 1) and PCNL, RIRS, and SWL for 1-2 cm non-lower pole (index patient 2) renal stones. A literature review provided stone free, complication, retreatment, secondary procedure rates, and quality adjusted life years (QALYs). Medicare costs were used. The incremental cost-effectiveness ratio (ICER) was compared with a willingness-to-pay(WTP) threshold of $100,000/QALY. One-way and probabilistic sensitivity analyses were performed. RESULTS: At 3 years, costs for index patient 1 were $10,290(PCNL), $10,109(mini-PCNL), $5,930(RIRS), and $10,916(SWL). Mini-PCNL resulted in the highest QALYs(2.953) followed by PCNL(2.951), RIRS(2.946), and SWL(2.943). This translated to RIRS being most cost-effective followed by mini-PCNL(ICER $624,075/QALY) and PCNL(ICER $946,464/QALY). SWL was dominated with higher costs and lower effectiveness. For index patient 2, RIRS dominated both PCNL and SWL. For index patient 1: mini-PCNL and PCNL became cost effective if cost ≤$5,940 and ≤$5,390, respectively. SWL became cost-effective with SFR ≥75% or cost ≤$1,236. On probabilistic sensitivity analysis, the most cost-effective strategy was RIRS in 97%, mini-PCNL in 2%, PCNL in 1%, and SWL in 0% of simulations. CONCLUSION: For 1-2cm renal stones, RIRS is most cost-effective. However, mini and standard PCNL could become cost-effective at lower costs, particularly for lower pole stones.

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.

A Serum C-Reactive Protein and Procalcitonin-Based Risk Score to Predict Urinary Infection in Patients with Obstructive Urolithiasis Undergoing Decompression.

Objective: The aim of this study was to develop a risk score utilizing C-reactive protein (CRP) and procalcitonin to better predict a clinical infection for patients with obstructive urolithiasis. Methods: A retrospective review was performed of patients presenting to the emergency room from December 2017 to February 2019 and who underwent upper urinary tract decompression due to concern for infection in the setting of obstructing urolithiasis. Over 30 clinical parameters were assessed and a composite risk score was created. Univariate and multivariate, forward, stepwise regression analyses were performed to identify predictors of true urinary tract infection (UTI). Results: Ninety-eight patients met inclusion criteria, of which a true UTI was identified in 50 (51%). The standard model of serum white blood cells >15 or temperature >38°C had an area under curve (AUC) of only 0.67 to predict UTI. A multivariable regression-based 4-point risk score (1 point for each of the following: positive urinary Gram stain, perinephric fat stranding on CT, serum CRP >21.95, and serum procalcitonin >0.36) had an AUC of 0.91 to predict UTI. Individually, these components had an AUC of 0.68, 0.68, 0.80, and 0.77, respectively. The chances of confirmed UTI were 8%, 11%, 68%, and 100% for risk scores of 0, 1, 2, and 3 to 4, respectively (p < 0.001). Conclusions: Only 50% of patients with a suspected UTI and an obstructing stone were ultimately confirmed to have a UTI. A risk score consisting of Gram stain, perinephric fat stranding, CRP, and procalcitonin can improve UTI prediction and warrants further study.

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.

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.

Megacystis microcolon intestinal hypoperistalsis syndrome: Case series and updated review of the literature with an emphasis on urologic management.

INTRODUCTION: Megacystis microcolon intestinal hypoperistalsis (MMIHS) is a rare disorder characterized by distended nonobstructed bladder, microcolon, and decreased intestinal peristalsis. MMIHS has a particularly poor prognosis; however, when appropriately managed, survival can be prolonged. STUDY DESIGN: A systematic review (1996-2016) was performed with the key words "megacystis microcolon intestinal hypoperistalsis syndrome." In addition, a case series of four patients is presented as well as algorithms for the diagnosis and treatment of MMIHS. RESULTS: 135 patients with MMIHS were identified in the literature. 73% (88/121) of the patients were female, 65% underwent diagnostic biopsy (64/99), and 63% (66/106) were identified with prenatal imaging. The majority of patients were treated with TPN as well as gastrostomy or ileostomy and CIC, however 15% (18/116) received multivisceral or intestinal transplant, and 30% (22/73) had a vesicostomy. The survival rate was 57% (68/121). CONCLUSION: Appropriate management of MMIHS patients is crucial. An enlarged, acontractile bladder in a child with bowel motility problems should be considered diagnostic. Bladder distension can be managed with CIC or vesicostomy in addition to prophylactic antibiotics if frequent urinary tract infections are present. These patients often require gastrostomy or ileostomy as well as total parenteral nutrition. This management has led to significant improvement in survival rates.