Publications by authors named "Hiten D Patel"

114 Publications

Testicular ultrasound underestimates the size of small testicular masses: a radiologic-pathologic correlation study.

World J Urol 2021 Mar 12. Epub 2021 Mar 12.

Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Park 213, Baltimore, MD, 21287, USA.

Purpose: Increasing use and resolution of testicular ultrasound imaging has resulted in a greater diagnosis of non-palpable small testicular masses and subsequent over-treatment with orchiectomy. Our aim was to determine the diagnostic accuracy of testicular ultrasound to accurately determine the pathologic size of small testicular masses (SMTMs) and to evaluate the association of various measurements with benign pathology.

Methods: Retrospectively, an institutional testicular cancer database was reviewed to evaluate the patients who underwent an orchiectomy for a testicular mass seen on ultrasound from 2003 to 2017. Three-dimensional measurements were compared from the ultrasound and pathology specimens, including other measures such as tumor volume and percentage of testicular volume. Finally, the predictive accuracy of maximum diameter and tumor volume to predict benign pathology was evaluated using receiver-operating curve analysis.

Results: We identified 208 patients and showed that ultrasound significantly underestimated sub-centimeter testicular masses (mean difference 0.56 cm, 95%CI 0.89-0.14, p = 0.004) and testicular masses between 1 and < 2 cm (mean difference 0.50 cm, 95%CI 0.97-0.15, p = 0.009). Tumor volume measured on ultrasound was consistently similar to pathologic tumor volume across all sizes and was significantly correlated (Spearman's Rho = 0.81). Mass volume had a greater predictive accuracy for benign pathology than maximum diameter using a 1 cm cut-off (AUC 0.65 vs 0.60).

Conclusion: Using the maximal diameter, testicular ultrasound significantly miscalculated the pathologic dimensions of masses less than 2 cm compared to orchiectomy specimens. Volumetric measurements may better represent actual tumor sizes for SMTMs and may be a more useful measure for identifying those a higher risk for benign pathology, however, further studies are required.
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http://dx.doi.org/10.1007/s00345-021-03655-zDOI Listing
March 2021

Management Trends in Pediatric Nonseminomatous Germ Cell Tumors.

Urology 2021 Feb 27. Epub 2021 Feb 27.

Department of Urology, Loyola University Medical Center, Maywood, IL; Department of Urology, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.

Objective: To characterize post-orchiectomy treatment trends in prepubescent and adolescent patients with nonseminomatous germ cell tumors (NSGCT) and identify patient and hospital factors associated with receiving surveillance or treatment (chemotherapy or RPLND) after orchiectomy.

Methods: Patients <18 years old diagnosed with NSGCT from 2006 to 2016 were extracted from the National Cancer Database. Patients were stratified into prepubescent (<12 years old) and adolescent (age 13-17) cohorts. National trends and multivariable logistic regression for odds of undergoing treatment were identified.

Results: Documentation of use of post-orchiectomy treatment or surveillance was available for 1006 patients. This population was divided into a prepubescent cohort (≤12 years of age, n = 153) and an adolescent cohort (13-17 years of age, n = 853). 545 (54.4%) patients proceeded with treatment. The proportion of patients undergoing treatment in each cohort remained similar over time, but there was a shift in the adolescent cohort away from RPLND towards chemotherapy. In the prepubescent cohort, pathologic stage group III was associated with undergoing treatment. Older age, >50 miles travel to treatment facility, and higher pathologic stage group were associated with treatment in the adolescent cohort. Black race was associated with decreased odds of undergoing treatment among adolescents.

Conclusion: National treatment trends regarding NSGCT remained similar over a decade. Higher disease stage in prepubescent patients lead to additional post-orchiectomy treatment. Adolescents with NSGCT were more likely to undergo post-orchiectomy treatment if they were older, traveled farther to a treatment center, and had a higher disease stage.
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http://dx.doi.org/10.1016/j.urology.2021.02.024DOI Listing
February 2021

Reply by Authors.

J Urol 2021 May 26;205(5):1293. Epub 2021 Feb 26.

The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.

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http://dx.doi.org/10.1097/JU.0000000000001575.03DOI Listing
May 2021

Advances in the selection of patients with prostate cancer for active surveillance.

Nat Rev Urol 2021 Apr 23;18(4):197-208. Epub 2021 Feb 23.

The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Early identification and management of prostate cancer completely changed with the discovery of prostate-specific antigen. However, improved detection has also led to overdiagnosis and consequently overtreatment of patients with low-risk disease. Strategies for the management of patients using active surveillance - the monitoring of clinically insignificant disease until intervention is warranted - were developed in response to this issue. The success of this approach is critically dependent on the accurate selection of patients who are predicted to be at the lowest risk of prostate cancer mortality. The Epstein criteria for clinically insignificant prostate cancer were first published in 1994 and have been repeatedly validated for risk-stratification and selection for active surveillance over the past few decades. Current active surveillance programmes use modified criteria with 30-50% of patients receiving treatment at 10 years. Nonetheless, tools for prostate cancer diagnosis have continued to evolve with improvements in biopsy format and targeting, advances in imaging technologies such as multiparametric MRI, and the identification of serum-, tissue- and urine-based biomarkers. These advances have the potential to further improve the identification of men with low-risk disease who can be appropriately managed using active surveillance.
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http://dx.doi.org/10.1038/s41585-021-00432-wDOI Listing
April 2021

Emergency department and hospital revisits after ambulatory surgery for kidney stones: an analysis of the Healthcare Cost and Utilization Project.

Urolithiasis 2021 Feb 17. Epub 2021 Feb 17.

Division of Urology, Hospital of the University of Pennsylvania, Perelman School of Medicine, University of Pennsylvania, 3 West Perelman Center for Advanced Medicine, 3400 Civic Center Boulevard, Philadelphia, PA, USA.

Our objective was to identify the rate of revisit to either emergency department (ED) or inpatient (IP) following surgical stone removal in the ambulatory setting, and to identify factors predictive of such revisits. To this end, the AHRQ HCUP ambulatory, IP, and ED databases for NY and FL from 2010 to 2014 were linked. Cases were selected by primary CPT for shock-wave lithotripsy (SWL), ureteroscopy (URS), and percutaneous nephrolithotomy (PNL) with accompanying ICD-9 for nephrolithiasis. Cystoscopy (CYS) was selected as a comparison group. The risk of revisit was explored using multivariate models. The overall unplanned revisit rate following stone removal was 6.4% (4.2% ED and 2.2% IP). The unadjusted revisit rates for SWL, URS, and PNL are 5.9%, 6.8%, and 9.0%, respectively. The adjusted odds of revisit following SWL, URS, and PNL are 1.93, 2.25, and 2.70 times higher, respectively, than cystoscopy. The majority of revisits occurred within the first two weeks of the index procedure, and the most common reasons for revisit were due to pain or infection. Younger age, female sex, lower income, Medicare or Medicaid insurance, a higher number of chronic medical conditions, and hospital-owned surgery centers were all associated with an increased odds of any revisit. The most important conclusions were that ambulatory stone removal has a low rate of post-operative revisits to either the ED or IP, there is a higher risk of revisit following stone removal as compared to urological procedures that involve only the lower urinary tract, and demographic factors appear to have a moderate influence on the odds of revisit.
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http://dx.doi.org/10.1007/s00240-021-01252-8DOI Listing
February 2021

Cytoreductive Nephrectomy for Synchronous Metastatic Renal Cell Carcinoma-Are There Any Favorable Risk Patients?

J Urol 2021 Feb 9:101097JU0000000000001656. Epub 2021 Feb 9.

Department of Urology, Loyola University Medical Center, Maywood, Illinois.

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http://dx.doi.org/10.1097/JU.0000000000001656DOI Listing
February 2021

Effect of Erythropoietin on Erectile Function after Radical Prostatectomy: The ERECT Randomized Clinical Trial.

J Urol 2021 Feb 3:101097JU0000000000001586. Epub 2021 Feb 3.

The Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland.

Purpose: Erectile dysfunction significantly impacts quality of life for men undergoing radical prostatectomy for prostate cancer. Erythropoietin is a promising neurotrophic factor for neurogenic erectile dysfunction based on preclinical and retrospective data.

Materials And Methods: ERECT (NCT00737893) is a phase 2, double-blinded, randomized, placebo-controlled trial (July 2017-December 2019) evaluating the impact of perioperative erythropoietin on recovery of erectile function and other patient-reported, health-related quality of life outcomes after bilateral nerve-sparing radical prostatectomy (3, 6, 9, and 12 months). Erythropoietin (20,000 units) or saline placebo was injected subcutaneously the day before, day of, and day after surgery for 3 total doses.

Results: Of 63 patients assessed for eligibility, 56 patients were randomized. Arms (29 erythropoietin, 27 placebo) were well balanced (89.3% robotic, median age 55.5 years). International Index of Erectile Function-Erectile Function Domain (IIEF-EF) scores increased from median 12.5 at 3 months to 24.5 at 12 months. Median 2-week serum hemoglobin was higher for the erythropoietin arm compared to placebo (14.7 vs 13.6, p=0.02). There was no statistically significant difference in IIEF-EF scores at 6 months comparing erythropoietin to placebo (p=0.50) or at other time points (mixed model regression coefficient: -1.7, 95% CI -6.1-2.7, p=0.45). Excellent nerve-sparing rating (10/10) was associated with improved IIEF-EF recovery (+5.2, p=0.022). Other patient-reported, health-related quality of life domains as well as oncologic outcome and complications were similar between arms during followup.

Conclusions: In the context of brief perioperative dosing, erythropoietin did not improve recovery of erectile function for men undergoing radical prostatectomy for prostate cancer compared to placebo. Further research to identify effective adjuncts to improve health-related quality of life for these men is needed.
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http://dx.doi.org/10.1097/JU.0000000000001586DOI Listing
February 2021

Outcomes of Active Surveillance for Young Patients with Small Renal Masses: Prospective Data from the DISSRM Registry.

J Urol 2021 May 24;205(5):1286-1293. Epub 2020 Dec 24.

The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Purpose: A paradigm shift in the management of small renal masses has increased utilization of active surveillance. However, questions remain regarding safety and durability in younger patients.

Materials And Methods: Patients aged 60 or younger at diagnosis were identified from the Delayed Intervention and Surveillance for Small Renal Masses registry. The active surveillance, primary intervention, and delayed intervention groups were evaluated using ANOVA with Bonferroni correction, χ and Fisher's exact tests, and Kruskal-Wallis and Wilcoxon signed-rank tests. Survival outcomes were calculated using the Kaplan-Meier method and compared with the log-rank test.

Results: Of 224 patients with median followup of 4.9 years 30.4% chose surveillance. There were 20 (29.4%) surveillance progression events, including 4 elective crossovers, and 13 (19.1%) patients underwent delayed intervention. Among patients with initial tumor size ≤2 cm, 15.1% crossed over, compared to 33.3% with initial tumor size 2-4 cm. Overall survival was similar in primary intervention and surveillance at 7 years (94.0% vs 90.8%, log-rank p=0.2). Cancer-specific survival remained at 100% for both groups. There were no significant differences between primary and delayed intervention with respect to minimally invasive or nephron-sparing interventions. Recurrence-free survival at 5 years was 96.0% and 100% for primary and delayed intervention, respectively (log-rank p=0.6).

Conclusions: Active surveillance is a safe initial strategy in younger patients and can avoid unnecessary intervention in a subset for whom it is durable. Crucially, no patient developed metastatic disease on surveillance or recurrence after delayed intervention. This study confirms active surveillance principles can effectively be applied to younger patients.
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http://dx.doi.org/10.1097/JU.0000000000001575DOI Listing
May 2021

Clinical utility of the AJCC 8 edition pT1 subclassification and impact on practice patterns in stage I seminoma.

Urol Oncol 2021 02 19;39(2):136.e19-136.e25. Epub 2021 Jan 19.

Department of Urology, University of Texas Southwestern, Dallas, TX. Electronic address:

Background: The American Joint Committee on Cancer 8 edition staging guidelines for testicular cancer established a 3 cm cutoff to subclassify stage T1 seminomas (<3 cm = pT1a and ≥3 cm = pT1b). The efficacy of this cutoff in predicting metastatic disease and impact on treatment patterns have not been studied.

Methods: We retrospectively reviewed patients with pT1 testicular seminoma in the National Cancer Database from 2004 to 2016. Receiver operating curves were used to determine the efficacy of the 3 cm tumor cutoff in identifying metastatic disease, and multivariable regression was used to compute the effect of tumor size on the rate of adjuvant therapy among Stage I patients.

Results: A total of 10,134 patients with pT1 seminoma were evaluated. The current size cutoff of 3 cm for subclassification did not exhibit high discrimination in identifying metastatic disease (area under receiver operating curve: 0.546). Surveillance has grown as the preferred treatment after orchiectomy -32.1% in 2004 to 81.2% in 2015. However, the rate of adjuvant therapy for pT1, Stage I seminomas associated positively with tumor size even with adjustment for year of diagnosis. For tumors above 3 cm, the odds ratio stabilized around 1.9. By using the 3 cm cutoff to guide adjuvant therapy, up to 85% of T1b patients may be overtreated.

Conclusion: The 3 cm cutoff for subclassification of Stage I seminoma does not predict metastatic recurrence but is associated with increased receipt of adjuvant therapy. A 3 cm cutoff and the pT1a/b classification may therefore contribute to overtreatment in many young patients with a long life expectancy for whom minimizing adverse effects should be prioritized.
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http://dx.doi.org/10.1016/j.urolonc.2020.11.039DOI Listing
February 2021

Delaying surgery for clinical T1b-T2bN0M0 renal cell carcinoma: Oncologic implications in the COVID-19 era and beyond.

Urol Oncol 2020 Oct 20. Epub 2020 Oct 20.

Section of Urologic Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ. Electronic address:

Purpose: During COVID-19, many operating rooms were reserved exclusively for emergent cases. As a result, many elective surgeries for renal cell carcinoma (RCC) were deferred, with an unknown impact on outcomes. Since surveillance is commonplace for small renal masses, we focused on larger, organ-confined RCCs. Our primary endpoint was pT3a upstaging and our secondary endpoint was overall survival.

Materials And Methods: We retrospectively abstracted cT1b-T2bN0M0 RCC patients from the National Cancer Database, stratifying them by clinical stage and time from diagnosis to surgery. We selected only those patients who underwent surgery. Patients were grouped by having surgery within 1 month, 1-3 months, or >3 months after diagnosis. Logistic regression models measured pT3a upstaging risk. Kaplan Meier curves and Cox proportional hazards models assessed overall survival.

Results: A total of 29,746 patients underwent partial or radical nephrectomy. Delaying surgery >3 months after diagnosis did not confer pT3a upstaging risk among cT1b (OR = 0.90; 95% CI: 0.77-1.05, P = 0.170), cT2a (OR = 0.90; 95% CI: 0.69-1.19, P = 0.454), or cT2b (OR = 0.96; 95% CI: 0.62-1.51, P = 0.873). In all clinical stage strata, nonclear cell RCCs were significantly less likely to be upstaged (P <0.001). A sensitivity analysis, performed for delays of <1, 1-3, 3-6, and >6 months, also showed no increase in upstaging risk.

Conclusion: Delaying surgery up to, and even beyond, 3 months does not significantly increase risk of tumor progression in clinically localized RCC. However, if deciding to delay surgery due to COVID-19, tumor histology, growth kinetics, patient comorbidities, and hospital capacity/resources, should be considered.
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http://dx.doi.org/10.1016/j.urolonc.2020.10.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7574787PMC
October 2020

Detection of a Meckel's diverticulum on PSMA PET/CT: A case report.

Urol Case Rep 2020 Nov 16;33:101306. Epub 2020 Jun 16.

The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Meckel's diverticulum is the most common congenital malformation of the gastrointestinal tract. In this report, we present a patient with a Meckel's diverticulum that was incidentally discovered on prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) imaging performed for prostate cancer staging. We discuss hypotheses for why the Meckel's diverticulum showed high uptake of PSMA-targeted radiotracer and the clinical implications of this finding.
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http://dx.doi.org/10.1016/j.eucr.2020.101306DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7573858PMC
November 2020

Site of metastatic recurrence impacts prognosis in patients with high-grade upper tract urothelial carcinoma.

Urol Oncol 2021 01 15;39(1):74.e9-74.e16. Epub 2020 Oct 15.

Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD.

Purpose: Metastatic recurrence occurs in over 25% of upper tract urothelial carcinoma patients treated with radical nephroureterectomy. While metastatic recurrence suggests poor prognosis, the impact of the specific site of recurrence on prognosis is not well documented.

Materials And Methods: We retrospectively analyzed 188 patients who underwent radical nephroureterectomy for high-grade, node-negative upper tract urothelial carcinoma at our institution from 2003 to 2018 without receiving neoadjuvant or adjuvant chemotherapy. Competing-risks survival analysis was performed to evaluate the cumulative incidence and predictors of metastatic recurrence. The Kaplan-Meier method and log-rank test were used to estimate and compare recurrence site-specific survival probabilities following metastatic recurrence. Cox regression analyses were performed to assess site-specific prognoses.

Results: Of the 188 patients, 47 (25%) developed metastatic recurrence over a median follow-up of 30 months (interquartile range: 10.5-58.5 months). The 1- and 2-year cumulative incidences of metastatic recurrence were 13.6% and 23.6%, respectively. On multivariable analysis, lymphovascular invasion was significantly predictive of metastatic recurrence (subhazard ratio: 2.6, P = 0.01). Of the 47 patients who developed recurrence, 38 (80.9%) died over a median follow-up of 10 months (interquartile range: 5-20 months). Metastatic recurrence was most common in the lungs (n= 13, 28%) and at multiple sites (n= 14, 30%). Median time to recurrence was shorter for recurrences at multiple sites (6.5 months) and those in the liver (13 months) and bone (18 months) compared to other sites. Patients who recurred in the liver (hazard ratio: 6.3, P = 0.007), bone (hazard ratio: 4.9, P = 0.02), and multiple sites (hazard ratio: 4.6, P = 0.01) had significantly worse prognosis compared to those who recurred in lymph nodes. Statistical significance persisted after adjusting for treatment with salvage therapy.

Conclusions: A significant proportion of high-grade upper tract urothelial carcinoma patients recur systemically after radical nephroureterectomy. Lymphovascular invasion is a predictor of metastatic recurrence and may inform decisions regarding perioperative chemotherapy. Hepatic and osseous recurrences have relatively quicker onset and less favorable prognosis compared to other sites. These findings may benefit future efforts to develop recurrence site-specific treatment plans and highlight the necessity of subsequent endeavors to explore the genetic associations of recurrence in upper tract urothelial carcinoma.
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http://dx.doi.org/10.1016/j.urolonc.2020.09.029DOI Listing
January 2021

Contemporary Trends in Presentation and Management of Spermatocytic Seminoma.

Urology 2020 Dec 10;146:177-182. Epub 2020 Oct 10.

Department of Urology, Loyola University Medical Center, Maywood, IL.

Objective: To characterize the presentation and management of spermatocytic seminoma (SS) compared to classic seminoma in adults utilizing a large cancer registry.

Methods: Patients >18 years of age in the National Cancer Database from 2006 to 2016 who underwent orchiectomy for testicular tumors were identified. Demographics, oncologic characteristics, and treatment patterns were compared between patients with SS and classic seminoma.

Results: Of 53,481 adults receiving orchiectomy, 29,208 were diagnosed with classic seminoma and 299 (1%) with SS. Compared to patients with classic seminoma, SS patients were older (57 vs 39 years) and more likely to be African-American (odds ratio (OR) 1.8) and insured by Medicare (OR 2.0; all P <.05). SS patients had larger tumors on presentation (3-6 cm: OR 1.8; >6 cm: OR 1.8), but were less likely to have ≥pT2 stage (OR 0.5), regional nodal involvement (Clinical Stage II: OR 0.3), or distant metastatic disease (Clinical Stage III: OR 0.1; all P <.01). For postorchiectomy management, 73.6% of SS patients underwent surveillance while 24.5% had active treatment (retroperitoneal lymph node dissection, chemotherapy, radiation, or a combination). When stratified by year, there was an increasing trend toward surveillance compared to active treatment.

Conclusion: SS is a rare germ cell tumor that typically presents as a larger tumor in older patients. Although these tumors are less likely to be characterized by advanced disease compared to classic seminoma, many patients have undergone aggressive postorchiectomy treatment in the past. Importantly, treatment trends have shifted toward surveillance in recent years with adjuvant therapy limited primarily to higher stage tumors.
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http://dx.doi.org/10.1016/j.urology.2020.10.002DOI Listing
December 2020

Inflatable penile prosthesis outcomes after pelvic radiation.

Can J Urol 2020 10;27(5):10382-10387

Johns Hopkins University School of Medicine, Brady Urological Institute, Baltimore, Maryland, USA.

INTRODUCTION Few studies have compared surgical outcomes after 3-piece inflatable penile prosthesis (IPP) surgery in patients exposed to pelvic radiation therapy (RT) compared to a radiation naïve control group.

Materials And Methods: A total of 715 consecutive patients underwent 3-piece IPP placement between 2007-2018. There were 101 men exposed to pelvic RT before or after IPP for a variety of malignancies and 153 men met inclusion criteria for the control group, which included men undergoing IPP surgery with a history of radical prostatectomy but no exposure to pelvic RT.

Results: Patients in the RT group had a higher body mass index (kg/m²) (28.7 versus 27.8, p = 0.003) and higher Charlson co-morbidity index score (6 versus 5; p < 0.001). At a median follow up of 5 years (IQR 2-8 years), there was an 18.4% surgical complication rate in the radiation group compared to 11.5% in the control group, though this was not statistically significant (p = 0.141). Timing of radiation, prior artificial urinary sphincter (AUS) status, co-implantation of an AUS, and brand of prosthesis were not associated with increased rate of complications. On multivariable logistic regression analysis, exposure to RT was not significantly associated with increased risks of complications (OR: 1.31; CI 0.55-3.12).

Conclusions: This study shows no significant increase in risk of surgical complication in patients exposed to pelvic RT and supports the use of IPP in men with a history of RT and refractory erectile dysfunction.
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October 2020

Delaying primary closure of classic bladder exstrophy: When is it too late?

J Pediatr Urol 2020 Dec 10;16(6):834.e1-834.e7. Epub 2020 Sep 10.

Robert D. Jeffs Division of Pediatric Urology, Brady Urological Institute, The Johns Hopkins Medical Institutions, Baltimore, MD, USA. Electronic address:

Introduction: With current trends towards delaying the closure of classic bladder exstrophy (CBE), bladder growth rate or ultimate capacity may be impacted.

Objective: To examine consecutive bladder capacities in CBE patients who had primary closures at differing ages and determine whether there is an optimal age for closure, with reference to bladder capacity.

Study Design: A retrospective review was performed using an institutional database.

Inclusion Criteria: CBE, successful neonatal (i.e. ≤28 days old) or delayed (i.e. >28 days old) primary closure, at least three consecutive bladder capacities or two measures taken 18 months apart, and first bladder capacity measured ≥3 months after closure. Only capacities prior to continence surgery and before 14 years of age were considered. Two cohorts were created: neonatal and delayed closure. To account for repeated measurements per patient, a linear mixed model evaluated effects of age and length of delay on bladder capacity based on closure cohort. Individuals in the delayed closure group were further stratified into quartiles to assess for detriment to the bladder based on length of delay.

Results: The cohort included 128 neonatal and 38 delayed patients. Median age at closure for the delayed group was 193 days (IQR 128-299). Based on univariate analysis, for the first three capacity measurements, the delayed group had significantly lower capacities despite having a similar median age when the measurements were taken. Linear mixed effects model showed significantly decreased total bladder capacity in delayed closure compared to neonates. The 2nd and 4th quartile groups had the most significant decreases in capacity.

Discussion: Time points for the most significant decline appear after the 2nd and 4th quartiles, representing 4-6 months and beyond 9 months, respectively. From this, the authors theorize that the appropriate time to close an exstrophy patient is as early as possible (1st quartile), or, if a delay is needed for growth of a bladder template, then between 6 and 9 months (3rd quartile). There may be a detriment to growth rate, however, statistical power may be lacking to discern this. Study limitations include the single-centered, retrospective design. However, results described here fill an important deficit in the knowledge of managing CBE.

Conclusions: All patients in the delayed bladder closure group demonstrated a decline in bladder capacity compared to the control neonatal closure group, with significant differences in the 2nd and 4th quartiles. Thus, closing the bladder prior to nine months of age is recommended.
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http://dx.doi.org/10.1016/j.jpurol.2020.09.003DOI Listing
December 2020

Editorial Comment.

J Urol 2020 12 24;204(6):1165. Epub 2020 Sep 24.

Department of Urology, Loyola University Medical Center, Maywood, Illinois.

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http://dx.doi.org/10.1097/JU.0000000000001238.01DOI Listing
December 2020

A prospective comparative study of routine versus deferred pelvic drain placement after radical prostatectomy: impact on complications and opioid use.

World J Urol 2020 Sep 14. Epub 2020 Sep 14.

Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Park 213, Baltimore, MD, 21287, USA.

Purpose: To evaluate the association of post-RP drain placement with post-operative complications and opioid use at a high-volume institution.

Methods: A prospective, comparative cohort study of patients undergoing robot-assisted or open RP was conducted. Patients for two surgeons did not routinely receive pelvic drains ("No Drain" arm), while the remainder routinely placed drains ("Drain" arm). Outcomes were evaluated at 30 days including Clavien-Dindo complications and opioid use. Intention-to-treat primary analysis and additional secondary analyses were performed using appropriate statistical tests and logistic regression.

Results: Of 498 total patients, 144 (28.9%) were in the No Drain arm (all robot-assisted) and 354 (71.1%) in the Drain arm. In the No Drain arm, 19 (13.2%) intraoperatively were chosen to receive drains. There was no difference in overall or major (Clavien ≥ 3) complications between groups (p = 0.2 and 0.4, respectively). Drain deferral did not predict complications on multivariable analysis adjusted for age, BMI, comorbidities, clinical risk, surgical approach, operating time, lymphadenectomy, and number of nodes removed [OR 0.61, 95% CI 0.34-1.11, p = 0.10]; nor did it predict symptomatic fluid collection, adjusting for lymphadenectomy and nodes removed [OR 1.14, 95% CI 0.43-3.60, p = 0.8]. Drain deferral did not decrease opioid use (p = 0.5). Per protocol analysis and restriction to robot-assisted cases demonstrated similar results.

Conclusion: There was no difference in adverse events, complications, symptomatic collections, or opioid use with deferral of routine drain placement after RP. Experienced surgeons may safely defer drain placement in the majority of robot-assisted RP cases.
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http://dx.doi.org/10.1007/s00345-020-03439-xDOI Listing
September 2020

Comparative Effectiveness of Surveillance, Primary Chemotherapy, Radiotherapy and Retroperitoneal Lymph Node Dissection for the Management of Early Stage Testicular Germ Cell Tumors: A Systematic Review.

J Urol 2021 02 11;205(2):370-382. Epub 2020 Sep 11.

The Johns Hopkins Evidence-Based Practice Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

Purpose: Cancer specific survival for men with early stage (I to IIB) testicular germ cell tumors is greater than 90% with any management strategy. The data regarding the comparative effectiveness of surveillance, primary chemotherapy, radiotherapy and retroperitoneal lymph node dissection were synthesized with a focus on oncologic outcomes, patient reported outcomes, and short and long-term toxicities.

Materials And Methods: PubMed®, Embase® and the Cochrane Central Register of Controlled Trials were searched from 1980 to 2018 for studies addressing the effectiveness of surveillance, chemotherapy, radiotherapy and retroperitoneal lymph node dissection, according to pathology and clinical stage, for men with an early stage testicular germ cell tumor.

Results: Cancer specific survival ranged from 94% to 100% for patients with early stage testicular germ cell tumors regardless of tumor histology and initial management strategy. For men with seminoma the median cancer specific survival was 99.7% (range 97% to 100%), 99.5% (96.8% to 100%) and 100% (100% to 100%) among those managed by surveillance, radiotherapy and chemotherapy, respectively. Median cancer specific survival for men with nonseminomatous testicular germ cell tumors was 100% (range 98.6% to 100%), 100% (96.9% to 100%) and 100% (94% to 100%) when managed by surveillance, retroperitoneal lymph node dissection and chemotherapy, respectively. Recurrence rates and toxicities varied by management strategy. For men with seminoma surveillance, chemotherapy and radiotherapy were associated with median recurrence rates of 15%, 2% and 3.7%, respectively. For men with nonseminomatous testicular germ cell tumors the median recurrence rates were 20.5%, 3.3% and 11.1% for surveillance, chemotherapy and retroperitoneal lymph node dissection, respectively. Surveillance was associated with minimal toxicities compared to other approaches. Primary chemotherapy had the highest rate of short-term toxicities and was associated with long-term risks of metabolic syndrome, hypogonadism, renal impairment, neuropathy, infertility and secondary malignancies. Toxicities with radiotherapy included acute dermatitis and long-term gastrointestinal complications, infertility and high rates of secondary malignancies (2% to 3%). Patients undergoing retroperitoneal lymph node dissection had significant risk of toxicity perioperatively and long-term infertility in men with anejaculation. Transient detriments in patient reported outcomes and quality of life were noted with all management options.

Conclusions: Men with early stage testicular germ cell tumors experience excellent cancer specific survival regardless of management strategy. Management options, however, differ in terms of associated recurrence rates, short and long-term toxicities, and patient reported outcomes. The profile for each approach should be clearly communicated to patients and matched with patient preferences to offer the best individual outcome.
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http://dx.doi.org/10.1097/JU.0000000000001364DOI Listing
February 2021

Comparison of Perioperative and Pathologic Outcomes Between Single-port and Standard Robot-assisted Radical Prostatectomy: An Analysis of a High-volume Center and the Pooled World Experience.

Urology 2021 Jan 5;147:223-229. Epub 2020 Sep 5.

The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD.

Objective: To perform an early comparative study of outcomes between single-port and robot-assisted laparoscopic radical prostatectomy (SP-RALRP) and standard RALRP at our institution and pooled analysis of series to date.

Patients And Methods: Patients with organ-confined prostate cancer undergoing SP-RALRP at a high-volume institution were identified retrospectively along with reported SP-RALRP series to date. Data were compared to a contemporary prospective cohort of men undergoing standard RALRP. Patient demographics, perioperative and postoperative data, and complications categorized by the Clavien-Dindo system were compared for the institutional and pooled SP-RALRP cohorts to standard RALRP.

Results: A total of 208 SP-RALRP cases were identified (26 from our institution) and compared to 376 standard RALRP cases. In the institutional analysis, there was no difference in operative time, length of stay, overall complications (15.4% vs 17.3%, P= 1.0), major (Clavien ≥III) complications (3.8% vs 3.7%, P = .6), inpatient opioid use, or patient-reported pain scores; median estimated blood loss (100 mL vs 150 mL, P = .02) and number of lymph nodes removed (5.5 vs 9, P = .002) were lower for SP-RALRP. In the pooled analysis, 208 patients receiving SP-RALRP had similar estimated blood loss and complication rates but fewer lymph nodes removed (P = .02) and marginally longer operating time (+16 minutes, P = .01) compared to standard RALRP. The difference in rate of positive surgical margins was not statistically significant (31.3% vs 24.5%, P = .08).

Conclusion: Based on an early experience with SP-RALRP at a high-volume center and a pooled analysis of SP series to date, perioperative and pathologic outcomes appear nearly equivalent compared to standard RALRP.
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http://dx.doi.org/10.1016/j.urology.2020.08.046DOI Listing
January 2021

Gender Differences in the Clinical Management of clinical T1a Renal Cell Carcinoma.

Urology 2020 Sep 2. Epub 2020 Sep 2.

The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD.

Objective: To evaluate gender differences in the management of clinical T1a (cT1a) renal cell carcinoma (RCC) before and after release of the AUA guidelines for management in 2009, which prioritized nephron-sparing approaches.

Methods: Patients aged ≥66 years diagnosed with cT1a RCC from 2004 to 2013 in Surveillance, Epidemiology, and End Results-Medicare were analyzed. Multivariable mixed-effects logistic regression models were used to evaluate factors associated with radical nephrectomy (RN) for cT1a RCC before (2004 to 2009) and after (2010 to 2013) guidelines release. Predictors of pathologic T3 upstaging and high grade pathology in the postguidelines period were examined using multivariable logistic regression among patients who underwent RN or partial nephrectomy.

Results: Twelve thousand four hundred and two patients with cT1a RCC were identified, 42% of whom were women. Overall, the likelihood of RN decreased postguidelines (odds ratio [OR] = 0.44, P <.001), but women were at increased odds of undergoing RN both before and after guideline release (OR = 1.27, P <.001 and OR = 1.37, P <.001, respectively) upon multivariable mixed-effects logistic regression. Tumor size >2 cm was also associated with increased likelihood of RN before and after guidelines (OR = 2.61, P <.001 and OR = 2.51, P <.001, respectively). In the postguidelines period, women had significantly lower odds of pathologic upstaging (OR = 0.75, P = .024) and harboring high grade pathology (OR = 0.71, P <.001) compared to men.

Conclusion: Gender differences persist in the management of cT1a RCC, with women having higher odds of undergoing RN, even after release of AUA guidelines and despite having lower odds of pathologic upstaging and high-grade disease.
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http://dx.doi.org/10.1016/j.urology.2020.08.041DOI Listing
September 2020

Re-establishing the Role of Robot-assisted Radical Cystectomy After the 2020 EAU Muscle-invasive and Metastatic Bladder Cancer Guideline Panel Recommendations.

Eur Urol 2020 10 28;78(4):489-491. Epub 2020 Jul 28.

Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium; ORSI Academy, Melle, Belgium.

The EAU guidelines panel on muscle-invasive and metastatic bladder cancer (MIBC) recently recommended open radical cystectomy (ORC) as the best surgical approach for MIBC patients. We critically re-examine the indications for considering ORC as the first choice over robot-assisted radical cystectomy. To the best of our knowledge, this is not supported by trials or meta-analyses.
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http://dx.doi.org/10.1016/j.eururo.2020.06.035DOI Listing
October 2020

A Comparative Analysis of Surgical Scar Cosmesis Based on Operative Approach for Radical Prostatectomy.

J Endourol 2021 Feb 15;35(2):138-143. Epub 2020 Sep 15.

The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Recent developments in minimally invasive approaches to radical prostatectomy (RP) for localized prostate cancer have improved oncological outcomes, but may also affect surgical scar cosmesis, an important component of survivorship and patient quality of life. Our aim was to evaluate surgical scar appearance based on operative approach to RP using a validated tool for evaluating psychosocial impact of scar appearance. Men between the ages of 45 and 80 were surveyed on an online crowdsourcing platform. Well-healed surgical scars after open, multiport (MP) robotic (transperitoneal and extraperitoneal), and single-port (SP) robotic RP were digitally rendered on stock photos to control for patient appearance. Respondents evaluated images using the SCAR-Q© psychosocial impact domain. Additionally, different RP scars were ranked by appearance and assigned 10-point appearance scores. Two hundred thirty-four surveys were included for analysis (completion rate 84.2%). The median age was 54 (IQR: 49-61) and 35% (85/234) had previous abdominal surgery, of which 45% (38/85) was robotic or laparoscopic. SP scars had better psychosocial impact scores (median 100 out of 100 69 and 58) than MP and open, respectively (both  < 0.001). SP scars were consistently ranked higher by appearance (median rank 1, IQR: 1-1) than MP (2, IQR: 2-3) and open (3, IQR: 3-4) ( < 0.001). SP without assistant port had the highest appearance score (median 9, IQR: 7-9) among all scars ( < 0.001). SP scars scored highest on psychosocial impact and were consistently ranked highest in appearance. These findings may be informative for optimizing both cosmetic appearance and quality of life for patients undergoing RP.
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http://dx.doi.org/10.1089/end.2020.0649DOI Listing
February 2021

Complications after open and robot-assisted radical prostatectomy and association with postoperative opioid use: an analysis of data from the PREVENTER trial.

BJU Int 2021 02 17;127(2):190-197. Epub 2020 Aug 17.

Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Objective: To evaluate perioperative complications for open radical prostatectomy (ORP) and robot-assisted RP (RARP) for patients enrolled in the PREvention of VENous ThromboEmbolism Following Radical Prostatectomy (PREVENTER; ClinicalTrials.gov Identifier: NCT03006562) trial, to determine predictors and impact on opioid consumption.

Patients And Methods: A prospective cohort of 500 patients undergoing ORP and RARP was followed to determine rates of complications and opioid use. Complications were classified 30 days after RP using the Clavien-Dindo system. Patient characteristics and outcomes were compared using appropriate statistical tests. Logistic and linear regressions were performed to identify predictors of complications and evaluate the relationship between complications and postoperative opioid use.

Results: A total of 124 (24.8%) men underwent ORP and 376 (75.2%) RARP, with 418 (83.6%) receiving pelvic lymph node dissection (PLND). While 83 patients (16.6%) had complications, only 19 (3.8%) were major (Clavien-Dindo Grade ≥III), with no differences by surgical approach. PLND (odds ratio [OR] 2.96, 95% confidence interval [CI] 1.25-8.71; P = 0.03) and Stage pT3b (OR 2.76, 95% CI 1.23-6.00;P = 0.01) were the only predictors of complications after controlling for potential confounders. Patients who had complications had greater inpatient (P = 0.02) and outpatient (P = 0.005) opioid use, which persisted after controlling for patient-reported pain, attending surgeon variation, surgical approach, and undergoing PLND (inpatient β:77.2, 95% CI 17.9-136.5,P = 0.03; and outpatient β:21.9, 95% CI 4.7-39.1,P = 0.01).

Conclusion: In an analysis of prospectively collected data, overall and major complications rates did not differ by surgical approach. Patients receiving PLND and with Stage pT3b disease had more complications. Complications were independently associated with higher inpatient and outpatient postoperative opioid use.
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http://dx.doi.org/10.1111/bju.15172DOI Listing
February 2021

Cost-effectiveness Analysis of Non-risk-adapted Active Surveillance for Postorchiectomy Management of Clinical Stage I Seminoma.

Eur Urol Focus 2020 Jul 6. Epub 2020 Jul 6.

The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Background: Cancer-specific survival for men with clinical stage I (CSI) seminoma approaches 100%, regardless of the management approach chosen after orchiectomy. Given the young age and high survival rate of these patients, there has been a shift toward minimizing treatment-related morbidity and cost. In this context, non-risk-adapted active surveillance (NRAS) has emerged as a desirable management strategy.

Objective: To evaluate the clinical, quality of life, and economic values of postorchiectomy NRAS for CSI seminoma.

Design, Setting, And Participants: We developed a decision analytic Markov model to estimate the costs and health outcomes of competing postorchiectomy management strategies for otherwise healthy 30-yr-old men with CSI seminoma.

Intervention: Real-world current practice, comprising active surveillance and adjuvant therapies (reference arm), was compared with empiric adjuvant radiotherapy (option 1), empiric adjuvant chemotherapy (option 2), risk-adapted active surveillance (RAAS; option 3), and NRAS (option 4).

Outcome Measurements And Statistical Analysis: Quality-adjusted life-years (QALYs), medical costs, incremental cost-effectiveness ratio, mortality, and unnecessary treatment avoidance were estimated over a 10-yr period. Uncertainties in model input values were accounted for using univariate, scenario, and probabilistic sensitivity analyses.

Results And Limitations: NRAS dominated all other management options, offering the lowest per-patient health care cost ($3839) and the highest QALYs gained (7.74) over 10 yr. On probabilistic sensitivity analysis, NRAS had the highest chance of being most cost effective. Although NRAS resulted in the highest rate of salvage chemotherapy (20% vs 6% radiotherapy, 6% chemotherapy, 15% current practice, and 16% RAAS), it had the same mortality rate compared to current practice (2.5%). NRAS also allowed 80% of patients to avoid unnecessary treatment compared with 46% for current practice and 52% for RAAS. Study limitations included model simplifications, model parameter assumptions, as well as the absence of patient preference as a decision factor.

Conclusions: NRAS maintains high cure rates for CSI seminoma, minimizes unnecessary treatment, and is cost effective compared with other management strategies.

Patient Summary: Clinical stage I (CSI) seminoma is one of the most common forms of testicular cancer. Surgery is the first step in the treatment of men with this disease, and some men may receive additional treatment with radiation or chemotherapy afterward. As most men are cured with surgery alone, non-risk-adapted active surveillance (NRAS), which involves routine monitoring with imaging and blood tests for disease recurrence after surgery, has become a desirable treatment option. Our study shows that in addition to maintaining high survival rates and avoiding unnecessary radiation and chemotherapy, NRAS is cost effective for the health care system.
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http://dx.doi.org/10.1016/j.euf.2020.06.012DOI Listing
July 2020

Cytoreductive Nephrectomy in the Era of Tyrosine Kinase and Immuno-Oncology Checkpoint Inhibitors.

Urol Clin North Am 2020 Aug 11;47(3):359-370. Epub 2020 Jun 11.

James Buchanan Brady Urological Institute, The Johns Hopkins Medical Institutions, 600 N. Wolfe Street / Marburg 144, Baltimore, MD 21287, USA.

The role for cytoreductive nephrectomy (CN) in the treatment of metastatic renal cell carcinoma (mRCC) has evolved with advancements in systemic therapy. During the cytokine-based immunotherapy era, CN provided a clear survival benefit and was considered standard of care in management of mRCC. The development of targeted systemic therapy directed at the vascular endothelial growth factor pathway altered the treatment paradigm and accentuated the importance of risk stratification in treatment selection. This article reviews the literature evaluating the benefit of CN during the evolution of systemic therapy and provides clinical recommendations for current utilization of CN in patients with mRCC.
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http://dx.doi.org/10.1016/j.ucl.2020.04.009DOI Listing
August 2020

Effect of Pharmacologic Prophylaxis on Venous Thromboembolism After Radical Prostatectomy: The PREVENTER Randomized Clinical Trial.

Eur Urol 2020 09 19;78(3):360-368. Epub 2020 May 19.

The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Background: Direct high-quality evidence is lacking evaluating perioperative pharmacologic prophylaxis (PP) after radical prostatectomy (RP) to prevent venous thromboembolism (VTE) leading to significant practice variation.

Objective: To study the impact of in-hospital PP on symptomatic VTE incidence and adverse events after RP at 30 d, with the secondary objective of evaluating overall VTE in a screening subcohort.

Design, Setting, And Participants: A prospective, phase 4, single-center, randomized trial of men with prostate cancer undergoing open or robotic-assisted laparoscopic RP was conducted (July 2017-November 2018).

Intervention: PP (subcutaneous heparin) plus routine care versus routine care alone. The screening subcohort was offered lower extremity duplex ultrasound at 30 d.

Outcomes Measurements And Statistical Analysis: The primary efficacy outcome was symptomatic VTE incidence (pulmonary embolism [PE] or deep venous thrombosis [DVT]). Primary safety outcomes included the incidence of symptomatic lymphocele, hematoma, or bleeding after surgery. Secondary outcomes were overall VTE, estimated blood loss, total surgical drain output, complications, and surveillance imaging bias. Fisher's exact test and modified Poisson regression were performed.

Results And Limitations: A total of 501 patients (75% robotic) were randomized and >99% (500/501) completed follow-up. At second interim analysis (N = 445), the symptomatic VTE rate was 2.3% (four PE + DVT and one DVT) for routine care versus 0.9% (one PE + DVT and one DVT) for PP (relative risk 0.40 [95% confidence interval 0.08-2.03], p = 0.3) meeting a futility threshold for early stopping. In the screening subcohort, the overall VTE rate was 3.3% versus 2.4% (p = 0.7). Results were similar at the final analysis (symptomatic VTE: 2.0% vs 0.8%, p = 0.3; overall VTE: 2.9% vs 2.8%, p = 1). No differences were observed in safety or secondary outcomes. All VTE events (seven symptomatic and three asymptomatic) occurred in patients undergoing pelvic lymph node dissection.

Conclusions: This study was not able to demonstrate a statistically significant reduction in symptomatic VTE associated with PP. There was no increase in the development of symptomatic lymphoceles, bleeding, or other adverse events. Given that the event rate was lower than powered for, further research is needed among high-risk patients (Caprini score ≥8) or patients receiving pelvic lymph node dissection.

Patient Summary: In this report, we randomized patients undergoing radical prostatectomy to perioperative pharmacologic prophylaxis or routine care alone. We found that pharmacologic prophylaxis did not reduce postoperative symptomatic venous thromboembolism significantly for men at routine risk. Importantly, pharmacologic prophylaxis did not increase adverse events, such as formation of lymphoceles or bleeding, and can safely be implemented when indicated for patients with risk factors undergoing radical prostatectomy.
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http://dx.doi.org/10.1016/j.eururo.2020.05.001DOI Listing
September 2020

Delaying reclosure of bladder exstrophy leads to gradual decline in bladder capacity.

J Pediatr Urol 2020 06 29;16(3):355.e1-355.e5. Epub 2020 Mar 29.

Robert D. Jeffs Division of Pediatric Urology, Brady Urological Institute, The Johns Hopkins Medical Institutions, Baltimore, MD, USA. Electronic address:

Introduction: After unsuccessful repair of bladder exstrophy, when to repeat surgical intervention is unclear. One must balance time required for tissue healing with the damaging effects of an exposed urothelium to the environment.

Objective: The authors aim to study whether a relationship exists between bladder growth/capacity and time till eventual successful closure.

Study Design: An institutional database of exstrophy-epispadias complex patients was queried for failed exstrophy closure with successful repeat reconstruction, at least three consecutive bladder capacity measurements, and measurements obtained at least three months following successful closure. Patients closed successfully in the neonatal period were used as a comparative group. Linear mixed effects models were used to study the effect of time and age on bladder capacity.

Results: Forty-seven patients requiring reclosure and 117 who had successful neonatal closures were included. Two models were created. The first linear mixed effects model found that for a given age, the bladder capacity declined approximately 9.6 mL per year (p = 0.016). The second model found that when time to successful closure was grouped by quartiles, compared to neonates, those in the fourth quartile had significantly decreased bladder capacity of 28.8 cc (p = 0.042). An interaction model comparing neonates and those requiring reclosure did not demonstrate a significant change in bladder growth rate (p = 0.098). A model stratified by quartiles similarly did not find any significant impact to bladder growth rate.

Discussion: From the general linear mixed effects models, the authors conclude when compared to neonates, (1) there was an approximate 9.6 cc loss of total bladder capacity per year taken until successful closure, and that (2) those who were delayed the longest had the most significant difference in bladder capacity. This study required stricter inclusion criteria compared to previous publications, and therefore the conclusions that can be drawn regarding bladder growth rates may be more reliable. Future studies will examine the effects of delayed closure on the bladder at the cellular level.

Conclusions: There is a demonstrable significant impact on overall bladder capacity with increasing delay to successful reclosure. One should be cautious when prolonging reconstruction of the bladder as these data demonstrate a time dependent decline in overall capacity.
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http://dx.doi.org/10.1016/j.jpurol.2020.03.019DOI Listing
June 2020

The association of broadband internet access with dermatology practitioners: An ecologic study.

J Am Acad Dermatol 2020 Dec 31;83(6):1767-1770. Epub 2020 Mar 31.

Department of Dermatology, Loma Linda University Health, Loma Linda, California.

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http://dx.doi.org/10.1016/j.jaad.2020.03.065DOI Listing
December 2020

Testis-sparing surgery and scrotal violation for testicular masses suspicious for malignancy: A systematic review and meta-analysis.

Urol Oncol 2020 05 17;38(5):344-353. Epub 2020 Mar 17.

Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD.

Radical inguinal orchiectomy is the standard of care for men diagnosed with a testicular mass suspicious for germ cell tumor (TGCT). Nontraditional approaches to management, including testis-sparing surgery (TSS) and scrotal orchiectomy, occur in clinical practice. We systematically reviewed studies evaluating outcomes after TSS and scrotal violation for the management of a suspected TGCT. We used PubMed, Embase, and the Cochrane Central Register of Controlled Trials (January 1980-December 2018) to search for studies addressing morbidity and oncologic outcomes after TSS or scrotal violation for testicular masses concerning for TGCT. Paired reviewers independently screened abstracts for inclusion, sequentially extracted data, and assessed study quality. Twenty-one studies were included (10 TSS, 11 scrotal violation). Risk of local recurrence after TSS on meta-analysis was 7.5% after 3 to 5 years (absolute proportion reported in studies: 10.9%). Aggregated rates of positive margins (1.4%) and testicular atrophy (2.8%) across studies were low with 7.1% of patients requiring subsequent androgen therapy. Scrotal violation led to a higher aggregate risk of local recurrence compared to no scrotal violation (2.5% vs. 0.0%, P < 0.001) but did not appear to impact subsequent metastasis and survival in the short term (3-5 years). Most patients received adjuvant therapy after scrotal violation with 9.3% found to harbor residual primary tumor after scrotal scar excision. TSS carries a quantifiable risk of local recurrence after 3 to 5 years despite the majority receiving adjuvant radiation or chemotherapy. Scrotal violation carries a risk of local recurrence but does not appear to impact subsequent metastasis and survival in the short term.
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http://dx.doi.org/10.1016/j.urolonc.2020.02.023DOI Listing
May 2020

Cost-effectiveness Analysis of Tc-sestamibi SPECT/CT to Guide Management of Small Renal Masses.

Eur Urol Focus 2020 Feb 27. Epub 2020 Feb 27.

The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address:

Background: Incidentally detected small renal masses (SRMs) may be one of several benign or malignant tumor histologies, and are heterogeneous in oncologic potential. Renal mass biopsy can be used to determine the histology of SRMs. However, this invasive approach has significant limitations. Technetium-99m sestamibi single photon emission computed tomography/computed tomography (Tc-sestamibi SPECT/CT) is a promising imaging tool that can aid in identifying benign renal oncocytomas and hybrid oncocytic/chromophobe tumors.

Objective: To evaluate the clinical and economic value of Tc-sestamibi SPECT/CT in guiding the management of SRMs.

Design, Setting, And Participants: We developed a decision analysis model to estimate the costs and health outcomes of competing management strategies for a healthy 65-yr-old patient with an asymptomatic SRM.

Intervention: Empiric surgery (reference); real-world clinical practice (RWCP) consisting of empiric surgery, thermal ablation, and active surveillance (alternative reference); renal mass biopsy (option 1); Tc-sestamibi SPECT/CT (option 2); and Tc-sestamibi SPECT/CT followed by biopsy to confirm benign SRMs (option 3).

Outcome Measurements And Statistical Analysis: We assessed lifetime health utilities, measured in quality-adjusted life years (QALYs), and direct medical costs from a health payer perspective. We calculated the incremental cost-effectiveness ratio (ICER) for options 1-3 versus the reference and alternative reference arms, with a willingness-to-pay threshold of $50 000/QALY. Univariate, multivariate, and probabilistic sensitivity analyses were performed.

Results And Limitations: Option 3 had a very low risk of untreated malignant tumors (0.2%, vs 2.1% for option 1, 4.2% for option 2, and 0% for empiric surgery) and the highest probability of leaving benign tumors untreated (84.4%, vs 53.9% for option 1, 51.7% for option 2, and 0% for empiric surgery). Option 3 dominated empiric surgery and options 1 and 2 (ie, lower costs and higher QALYs). Compared with RWCP, options 1-3 were all cost effective; option 3 had the lowest ICER of $18 821/QALY. These findings were robust to alternative input values. Study limitations included data uncertainties and a limited number of centers from which Tc-sestamibi SPECT/CT performance data were collected.

Conclusions: Tc-sestamibi SPECT/CT followed by confirmatory biopsy helps avoid surgery for benign SRMs, minimizes untreated malignant SRMs, and is cost effective compared with existing strategies.

Patient Summary: Our research suggests that by using a noninvasive imaging test, known as technetium-99m sestamibi single photon emission computed tomography/computed tomography, to diagnose small renal masses, urologists may avoid unnecessary surgery for benign tumors and minimize the risk of leaving a malignant tumor untreated. Moreover, the use of this strategy to diagnose small renal masses is cost effective for the health care system.
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http://dx.doi.org/10.1016/j.euf.2020.02.010DOI Listing
February 2020