Reply by Authors We agree with Diamond that the incidence of bilateral varicoceles in our series is a bit higher than in the literature. However, this increased rate does not reflect the prevalence of bilateral varicocele in adolescents. This finding may only reflect the incidence of bilateral varicocele in adolescents who present to our clinics with symptoms. In a previous study we found that the prevalence of bilateral varicocele is 10.8% at age 11 to 19 years (reference 1 in article). In addition, the incidence of bilateral varicocele is as high as 35% to 48% in adolescent varicocelectomy series in the literature (references 14, 17 and 30 in article).
Editorial Comment This provocative long-term controlled study will add to the controversy surrounding the appropriateness of adolescent varicocele repair. The findings strongly suggest that teenage patients benefit from surgery if there is evidence of testicular growth arrest and/or an abnormal semen analysis. Semen parameters, testosterone levels and paternity all appear improved by microscopic inguinal varicocele ligation.
Editorial Comment This is an important study since it adds to the limited literature regarding the impact of surgical correction of adolescent varicocele on future fertility (references 3 and 16 in article). The authors report on a large number of adolescents (408) deemed to be appropriate candidates for varicocele correction, of whom 70% underwent surgery and 30% declined surgery and served as controls. In the 9 to 10-year mean followup the paternity rates and semen parameters were superior in the surgical group.
Editorial Comment The data in this study are congruent with recommendations from the AUA (American Urological Association)/SUFU (Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction) guideline on nonneurogenic overactive bladder in adults (reference 5 in article). In this study individuals randomized to solifenacin or onabotulinumtoxinA 100 U experienced a reduction in incontinence episodes compared to placebo with the greatest improvement reported among individuals receiving onabotulinumtoxinA.
Editorial Comment In contrast to prior work demonstrating centralization of prostatectomies early in the dissemination of robotic techniques (reference 12 in article), these authors describe decentralization during 2009 to 2011, when the proportion of procedures in hospitals where 1 or more were performed per week increased from 15% to 28%. Unfortunately, as noted in the report, the authors were unable to examine this trend for a longer period due to the substantial change in NIS sampling methodology implemented in 2012.
Reply by Authors We understand the comments on our study and the fact that further research should focus on how the spatial distribution of intralesion targets could be determined. However, we believe that this study has finally started to fill a serious lack in targeted biopsy technique.
Editorial Comment The authors aimed to evaluate the minimum core number for better index tumor detection and characterization in 327 patients. Index lesions were sampled with 4 or 6 cores depending on lesion size (8 or less vs greater than 8 mm) using TRUS/MRI fusion guidance. The major positive core prevalence was observed in the center of targets. Gleason score heterogeneity was observed in 12.6% vs 26.4% of 8 or less vs greater than 8 mm targets. A Gleason 4 or greater pattern was more often observed in the center of lesions.
Editorial Comment The results of Porpiglia et al support the current practice at expert centers and are concordant with international recommendations1 and previous surgical studies (reference 24 in article). In MRI/ultrasound fusion targeted prostate biopsies a minimum of 2 cores must be taken per lesion, sampling the lesion center increases the likelihood of finding the highest Gleason pattern and differences in Gleason scores per core are more frequently found in larger lesions.
Editorial Comment It is critical to determine which men truly harbor indolent disease when deciding which men are suitable candidates for active surveillance for low risk prostate cancer. This is especially important for African American men, who have been shown to present with earlier, aggressive disease and are more likely to experience upgrading and biochemical failure after treatment when initially eligible for active surveillance.1,2 A plethora of serum, urine and tissue based tests add incremental value to the predictive ability of the known risk factors of PSA, Gleason sum and clinical tumor classification.
Editorial Comment Urologists performing PN by any approach face similar challenges, which must be articulated to the patient prior to the operation. Potential adverse events include bleeding, urinary fistula formation, infection and conversion to RN (reference 18 in article) if for technical reasons PN cannot be executed. This group of high volume robotic surgeons reports their RN conversion rate of 3.1% and the patients most likely to require conversion due to worse baseline kidney function, larger tumor size and greater tumor complexity.
Editorial Comment Robotic partial nephrectomy has advanced significantly. Early in its evolution cautious application dictated that complex tumors were avoided. Now with experience there are few, if any, tumors not amenable to RPN when OPN is possible, although not for all surgeons and institutions.
Robotic Intracorporeal Continent Cutaneous Diversion Robotic intra-corporeal urinary diversion has mostly been utilized for ileal conduit or orthotopic neobladder diversion. Herein, we present the initial series, detailed technique and outcomes of robotic intra-corporeal Indiana pouch, with minimum 1-year follow-up.
The Importance of Peer Review Winston Churchill is quoted as saying “Democracy is the worst form of government except all the others.” A similar sentiment about the peer review process for evaluating scientific manuscripts is often expressed by many. However, the fact is no alternative system has been developed which has proven to be superior to peer review, which is considered the backbone of scientific and medical research.
A Pediatric Urology Wish List for Spina Bifida Research The long-term prognosis for children with spina bifida (SB) has greatly improved in the last 50 years.1 Until the latter half of the 20th century children with SB infrequently lived to adolescence. In the early part of the 21st century adults with SB are now so numerous that urologists struggle with how best to cope with a “tidal wave” of patients with SB who have aged out of pediatric clinics.2 In the 1970s ileal conduits represented state-of-the-art urological care for patients with SB. In 2017 incontinent diversions are used only rarely.
Robot-Assisted Laparoscopic Extravesical Ureteral Reimplantation for Primary Vesicoureteral Reflux in Children The study by Boysen et al in this issue of The Journal represents a great step in helping us answer lingering questions regarding the current efficacy and safety of robot-assisted laparoscopic extravesical ureteral reimplantation (RALUR-EV) for the treatment of vesicoureteral reflux (VUR) in children.1 We praise the many contributors who embarked on this multi-institutional study with good intentions. It is imperative that we examine competitive surgical options concerning “QCCC” yield, ie quality (success and complication rate), convalescence (with associated pain medication requirements), cost and cosmesis.
2016 Journal of Urology Peer Reviewers Below is the list of peer reviewers who reviewed manuscripts for The Journal of Urology® in 2016 and who submitted their reviews on time. Our peer reviewers give their time, expertise and advice generously and objectively to the editors and authors. All participants in the process benefit from this interchange, and the readers benefit from the improved communications that result. We all owe these individuals a debt and our thanks.
This Month in Pediatric Urology There has been a great deal of interest in the potential benefit of in utero myelomeningocele closure since the MOMS (Management of Myelomeningocele Study) trial was published in 2011. This prospective trial demonstrated a significant reduction in the need for ventriculoperitoneal shunting and improved motor skills for patients who had undergone prenatal closure. Unfortunately there has not been equivalent improvement in the urological outcome for these children.
Choosing the Right Intervention for Treatment of Lower Urinary Tract Symptoms in Men Without ever being subjected to the scrutiny that has been expected of subsequent treatment innovations, transurethral resection of the prostate (TURP) came to be regarded as the gold standard surgical treatment for benign prostatic hyperplasia (BPH). The only randomized controlled trials that have properly scrutinized TURP have been those in which TURP was the control rather than the experimental arm of the study.
Editorial Comment This comparison paper of urine biomarkers between sacral neuromodulation and botulinum toxin injection for refractory OAB, which is based on another excellent study,1 has several stimulating findings that I like to highlight.
Editorial Comment Previously we have enthusiastically searched for urinary proteins to diagnose functional disorders of the bladder. To date no 1 biomarker has proved superior to the cardinal symptoms of the disease. The wide variability of urinary protein concentrations might result from different investigating methodology, urine collection and most likely the heterogeneity of the disease. OAB is a dynamic disorder and the symptoms may change with time.1 Previous studies have shown that functional alterations in urothelium, detrusor, sensory afferents or central nervous system, or inflammation might contribute to the development of OAB.
Re: Mortality among Men with Advanced Prostate Cancer Excluded from the ProtecT Trial T. J. Johnston, G. L. Shaw, A. D. Lamb, D. Parashar, D. Greenberg, T. Xiong, A. L. Edwards, V. Gnanapragasam, P. Holding, P. Herbert, M. Davis, E. Mizielinsk, J. A. Lane, J. Oxley, M. Robinson, M. Mason, J. Staffurth, P. Bollina, J. Catto, A. Doble, A. Doherty, D. Gillatt, R. Kockelbergh, H. Kynaston, S. Prescott, A. Paul, P. Powell, D. Rosario, E. Rowe, J. L. Donovan, F. C. Hamdy and D. E. Neal; ProtecT Study Group
Organ Sparing Surgery in Penile Cancer: A Systematic Review Although penile cancer (PC) only represents 1% of all male cancers, the traditional treatment of total or subtotal penectomy carries devastating psychological and functional outcomes. Organ sparing surgery (OSS) in PC is an attractive option if it can provide satisfactory cancer control equivocal or near equivocal to standard techniques. In fact, these techniques are meeting increasing acceptance. Accordingly, the need to evaluate these options objectively is crucial in a comprehensive review is timely in order to increase awareness of these procedures, their applicability and provide guidance to the practicing urologist.
Penile Allotransplantation for Complex Genitourinary Reconstruction Reconstruction of complex functional structures is increasingly being performed with vascularized composite allo-transplantation (VCA). Penile transplantation is a novel VCA treatment option for severe penile tissue loss and disfigurement. Three allogeneic human penile transplantations have been reported. We review these cases as well as penile transplant indications, pre-clinical models, and immunosuppression therapy.
Cytoreductive Nephrectomy Renal Cell Carcinoma Patients with Venous Tumor Thrombus Careful selection is critical to identify metastatic renal cell carcinoma (mRCC) patients who are most likely to benefit from cytoreductive nephrectomy (CN). Surgery for mRCC patients with tumor thrombus is complex and may not benefit some patients with very poor overall survival (OS). The objective of this study was to evaluate whether preoperative variables or risk stratification systems could predict OS following CN.
Editorial Comment The authors use an innovative predictive tool, the VURx, which has been demonstrated to predict the likelihood of reflux resolution in a younger cohort. They present a retrospective review of patients diagnosed with VUR at ages 2 to 18 years. The VURx is a weighted system that includes female gender, ureteral anomalies, higher grades of VUR and reflux during earlier filling. In the current study resolution/improvement and timing correlated with lower VURx scores but resolution beyond age 24 months did not.
Editorial Comment There are clear but controversial guidelines for diagnosing and treating vesicoureteral reflux in children who present at ages 2 to 24 months (reference 11 in article).1 Recommendations are less straightforward in older children. The VURx is a simple validated tool that has been shown to predict spontaneous resolution/improvement in children diagnosed before age 24 months (reference 4 in article). In this study the authors found that the VURx also reliably predicts spontaneous resolution/improvement in older children.
Evidence-Based versus Personalized Medicine in Pediatric Urology We live in an age awash in data, much of which are electronically recorded and accessible. “Big data” and their analysis are said to provide answers unobtainable by small scale observation and anecdote, which can then guide appropriate decision making for the individual patient. However, is such evidence-based medicine always true? Or perhaps not all data are equivalent so that the combination of data points is inappropriate at times, resulting in conclusions that are not only inaccurate, but the opposite of truth.
Evidence-Based versus Personalized Medicine in Pediatric Urology Terms such as “evidence-based medicine” (EBM) and “evidence-based clinical guidelines” have occasionally been known to induce grimaces and heartburn (or at least heavy sighs and eye-rolling) among urologists. Unsurprisingly, there has been pushback against EBM in favor of more “personalized” approaches; after all, one of the highlights of urology is a large degree of decision making autonomy.
Reply by Authors After stratification based on molecular status of a previous tumor, the assay combination had a cross-sectional sensitivity of 62%. When we consider the anticipatory effect over the first 12 months after the positive urine test, sensitivity would increase to 69% for the 3-assay combination. In addition, most aggressive recurrences were detected by the combination with a cross-sectional sensitivity of 83% for stage T1 or greater, or grade 3 recurrences.
Editorial Comment The suggestion that this biomarker combination could be used as an alternative to cystoscopy for low grade bladder cancer challenges current practice. AUA (American Urological Association) guidelines suggest that biomarkers should not be used in place of cystoscopy, and patients with low risk tumors need infrequent cystoscopic surveillance and do not require routine biomarker testing.1 The findings of 57% sensitivity and 59% specificity for surveillance of low grade bladder cancer is a modest improvement over a coin toss.
Editorial Comment The search for reliable urine based tests to identify (recurrent) bladder tumors has been a disappointing journey. Different markers have been evaluated with a wide range of sensitivities and specificities, probably based on patient selection and concomitant intravesical treatment. This is the reason why these markers are not included in guidelines and only cytology is mentioned in recommendations.
Re: Can Activities of Daily Living Predict Complications following Percutaneous Nephrolithotomy? Leavitt et al evaluated whether deficits in activities of daily living (ADLs) could predict complications after percutaneous nephrolithotomy, and how this prediction compares to the Charlson comorbidity index (CCI) and American Society of Anesthesiologists (ASA) classification. The authors concluded that ADLs are easily evaluated preoperatively and independently predict complications following percutaneous nephrolithotomy better than CCI or ASA classification.
Reply by Authors In support of the comment, the performance by Cxbladder in a mitomycin treatment setting is comparable with the overall performance of the test. We identified 74 cases in our clinical trial database in which treatment with mitomycin had been prescribed prior to presentation and urine sampling. In this set of patients Cxbladder Monitor had 91.6% sensitivity and 94.4% negative predictive value.
Editorial Comment The authors present an interesting analysis of a noninvasive urine test for monitoring patients with bladder cancer after transurethral resection of the bladder. The goal is to rule out recurrences and potentially reduce the number of cystoscopies. The results seem to be promising, particularly because of high sensitivity for detecting high grade recurrences.
Editorial Comment This collection of RALUR-EV data from 10 surgeons at multiple hospitals is perhaps a better reflection of true success and complication rates of RALUR-EV than previously published series. Unfortunately the 85% success rate of RALUR-EV falls significantly short of the success rates seen in open ureteral reimplantation. In addition, 31 of the ureters operated on (8.6% of total) were reflux grade 0 or I. If those ureters were eliminated from the study, the success rate might be even lower.
Editorial Comment The authors are to be credited for this attempt to benchmark robotic antireflux surgery. This operation has been challenged in its short life with highly variable success rates and nontrivial complications.
Re: Validation of a DNA Methylation-Mutation Urine Assay to Select Patients with Hematuria for Cystoscopy The authors performed a multicenter study of urinary DNA biomarkers to predict the risk of bladder cancer in patients with hematuria. Six DNA mutations and methylation biomarkers (FGFR3, TERT, HRAS, OTX1, ONECUT2 and TWIST1) were combined as a panel to diagnosis. This study provided more evidence regarding the accuracy of the urinary DNA panel combined with patient age in screening for bladder cancer, and cystoscopy was unnecessary for some individuals presenting with hematuria if the DNA detection was negative.
Reply by Authors The commentator correctly points out the main uncertainties involved with this new treatment from a clinical perspective. Importantly, he reminds us that hemostasis remains an issue following creation of the prostatic cavity by aquablation. The technique of hemostasis used in the current global, phase III study (known as the WATER Study), which has just completed enrolment, now involves catheter traction for 2 hours following surgery with the balloon of the Foley catheter inflated to 50% of the original prostate volume and positioned in the fossa under TRUS guidance.
Editorial Comment The use of a transrectal ultrasound guided, high pressure saline jet to ablate prostatic tissue (termed aquablation) is a highly novel approach for men with symptomatic BPH. Gilling et al report promising outcomes in a small multicenter trial of men with a mean prostate volume of 57.2 cc. The attraction of this technology is the speed with which tissue can be ablated with a mean aquablation treatment time of only 5 minutes. The high pressure saline waterjet is nonhemostatic so that the treatment is paired with standard resectoscope techniques for achieving hemostasis.
A 10-Year Retrospective Review of Nephrolithiasis in the Navy and Navy Pilots Little is known about the incidence of nephrolithiasis in the U.S. Navy, and Navy pilots must be kidney stone-free and are often referred for treatment of small asymptomatic stones. The primary objectives of this study were to determine the incidence of nephrolithiasis, CT scans performed, proportion undergoing treatment, and incidence of stone-related mishaps of Navy pilots compared with other Navy personnel.
Editorial Comment Although it is perhaps a forgotten entity, percussion has been shown to facilitate the passage of stone fragments (reference 13 in article). These authors report a novel percussion machine that creates vibrations to “shake up” stone fragments to improve passage. Similar in concept but using different technology, ultrasonic propulsion has been described to use focused ultrasound to move stones to facilitate passage and potentially relieve obstruction (reference 17 in article).1
This Month in Adult Urology From the earliest descriptions of medical procedures, management of lower urinary tract symptoms (LUTS) from benign prostate enlargement has been an area of controversy. This issue of The Journal of Urology® includes articles on the significant advances in the treatment of LUTS which have been made as well as a variety of available options. There are many ways to eliminate obstructing prostate tissue and which is best depends on a number of factors, including equipment availability, and surgeon preference and experience.
The Role of Intermittent Androgen Deprivation Therapy for Prostate Cancer The rationale for comparing intermittent (IAD) to continuous androgen deprivation (CAD) therapy was based on preclinical data that showed intermittent exposure to testosterone delayed time to castration resistance compared to CAD.1 As originally observed by Klotz et al, an additional benefit of IAD was the return of sexual function during the off treatment periods.2 The 2 largest phase 3 trials, S9346 (NCT00002651) in metastatic disease and NCIC JPR-7 (NCT00003653) in nonmetastatic disease, were based on the hypothesis that overall survival with IAD might at least be noninferior to that of CAD as a result of delaying time to castration resistance and that quality of life (QoL) would be better on IAD.
This Month in Pediatric Urology The pediatric articles in this issue of The Journal are about stone disease and surgical oncology. Like adults, children are now troubled frequently with urinary stones, and a common set of predisposing causes are dietary (hydration and sodium intake). Fortunately, unlike adults, children are not replicating the pattern of urology oncology but for those who do need urology oncology services, we have the results of a survey of the state of affairs in North America.
Outcomes of prostate cancer screening by 5-alpha reductase inhibitor usage Prostate cancer (PCa) screening with prostate-specific antigen (PSA) reduces PCa mortality, but leads to overdiagnosis of indolent PCa. Use of 5-alpha reductase inhibitors (5-ARIs) lowers PSA and in theory could affect performance of PSA-based screening. We evaluated outcomes of PCa screening among 5-ARI users.
Zinc as a Contributing Factor in Lithogenesis: Not Yet Ready for the Clinic Kidney stones are increasingly prevalent in children and adults, with associated estimated yearly health care costs in the United States exceeding $5 billion.1 Environmental and particularly dietary factors have a role in the risk of kidney stones. There is substantial evidence that decreased fluid, calcium and potassium intakes are major contributors to stone formation. On the other hand, evidence regarding the role of trace minerals such as zinc is quite scarce. In rats zinc has been shown to affect mineral metabolism and potentially stone formation by reducing deposition of calcium salts in the renal papillae.
News and Announcements President – Dr. Richard K. Babayan, 725 Albany St., Ste 3 B, Boston, Massachusetts 02118
Bladder capacity is a biomarker for a bladder-centric versus systemic manifestation in interstitial cystitis/bladder pain syndrome Interstitial cystitis/bladder pain syndrome (IC/BPS) presents a significant clinical challenge due to symptom heterogeneity and the myriad associated comorbid medical conditions. We recently reported that diminished bladder capacity (BC) may represent a specific IC/BPS sub-phenotype. The objective of this study is to investigate the relationship between anesthetic bladder capacity and clinical findings (urologic and non-urologic) in a cohort of IC/BPS patients who had undergone therapeutic urinary bladder hydrodistention.
Editorial Comment Because data supporting the use of AS have been derived from predominantly Caucasian cohorts, the appropriateness of AS in the African American population remains a subject of debate.1 These authors present outcomes in 234 men treated with AS in the French West Indies, where more than 90% of the population is of African descent. In a population in which 81% of individuals are at very low risk, the authors observed extremely low rates of metastasis (0.4%) and PCa mortality (0%) over a median followup of 4 years, consistent with findings in Caucasian men at similar risk (reference 5 in article).
Editorial Comment Ethnic disparity in men with newly diagnosed PCa is an increasingly important issue in the United States. These authors studied a cohort of mostly nonHispanic African Guadaloupian men, of whom 81.2% qualified for very stringent AS criteria composed of a hybrid of original Epstein and NCCN definitions of very low risk PCa. PSA density was the only finding that strongly predicted AS termination but it was not part of the AS selection criteria.
Editorial Comment Tan et al provide an interesting contribution to the urological health services literature on functional status and kidney cancer surgery. Using SEER-Medicare data, they found that poor functional status is independently associated with increased medical and geriatric complications but not with surgical complications after surgery. Resource utilization is higher in patients with worse functional status.
Editorial Comment In this article Tan et al provide a perspective on frailty as a determinant of value in treatment for renal cell cancer. Given the recent growth of advanced treatment modalities such focal therapy and robotic surgery, and more conservative approaches like active surveillance, there is a need to account for the value of renal cancer care. This will be especially important in coming years when alternative payment models such as bundled payments may make urologists accountable for outcomes and costs.
Re: Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer Data are lacking for patient reported outcome measures comparing treatments for clinically localized prostate cancer. These authors compared patient reported outcomes in 1,643 men in the ProtecT trial, who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and yearly thereafter. Patients completed validated measures that assessed urinary, bowel and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer related quality of life was assessed at 5 years.
Re: Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer J. L. Donovan, F. C. Hamdy, J. A. Lane, M. Mason, C. Metcalfe, E. Walsh, J. M. Blazeby, T. J. Peters, P. Holding, S. Bonnington, T. Lennon, L. Bradshaw, D. Cooper, P. Herbert, J. Howson, A. Jones, N. Lyons, E. Salter, P. Thompson, S. Tidball, J. Blaikie, C. Gray, P. Bollina, J. Catto, A. Doble, A. Doherty, D. Gillatt, R. Kockelbergh, H Kynaston, A. Paul, P. Powell, S. Prescott, D. J. Rosario, E. Rowe, M. Davis, E. L. Turner, R. M. Martin and D. E. Neal; ProtecT Study Group
Reply by Authors This study was part of a larger evaluation that included a controlled assessment of bowel functional outcomes in patients with ARMs treated with modern repairs.1–4 A high response rate was one of the strengths of this study, for which we can only thank our patients. Regarding choice of survey for erectile function, the Erection Hardness Score has been validated,5 and yields similar information to IIEF-5. Importantly we ascertained that erectile function sufficient for penetration was preserved in patients even with the most severe type of ARM (RUF) after posterior sagittal anorectoplasty.
Reply by Authors Ramos and Yu highlight the importance of a more targeted approach to thromboembolism prophylaxis in patients with bladder cancer. Bladder cancer is the second most common malignancy (after esophageal cancer) associated with high rates of postoperative TEEs.1 In our study additional risk of TEEs was posed in these patients by the application of platinum based neoadjuvant chemotherapy. Extended period thromboembolism prophylaxis following abdominopelvic cancer surgeries has been observed to reduce the incidence of venographically demonstrated thrombosis,2 and there are indications that extended VTE prophylaxis following radical cystectomy is warranted.
Editorial Comment Is a competitive spirit enough to improve one’s surgical outcomes? Does the Hawthorne effect truly impact surgical technique? In this innovative study, the authors implemented a CQPR strategy (reference 1 in article), a method that drives improved clinical performance by informing clinicians of their outcomes and those of their colleagues. Using 2 oncologic quality indicators, the investigators compiled surgeon score cards including 2 years of radical prostatectomy risk adjusted outcome data for each surgeon in the study.
Re: Multilocular Cystic Renal Cell Carcinoma: Pathological T Staging Makes No Difference to Favorable Outcomes and Should be Reclassified We studied in detail this publication describing 168 cases of renal tumor excision with long followup. The authors group these cases together based on the cystic architecture, referring to them as cystic renal cell carcinoma (RCC), and suggest that pathological tumor stage does not influence outcome in multilocular cystic (mc) RCC and needs to be reclassified. Although we support their observation regarding favorable prognosis with multilocular cystic renal neoplasm of low malignant potential (MCRNLMP, formerly mcRCC),1 we must comment on some aspects of the study from a pathology standpoint.
Trends in imaging use for the evaluation and follow-up of kidney stone disease: A single center experience Recent reports support the use of renal ultrasonography (US) as the initial imaging study for the evaluation of patients with suspected renal colic. Urologists, however, often advocate for computed tomography (CT) to better define stone size and location, especially prior to proceeding with endourologic intervention. One concern with using US as the initial imaging study is that CT may be required at a later time, obviating the reduction in costs and radiation gained by using US.
Editorial Comment The authors have assembled data supporting a hypothesis, and a widely held perception among pediatric urologists, that the volume of oncologic surgeries being done by pediatric urologists is quite low. This finding is not a surprise. There are a lot of surgeons and not many tumors. The cited studies (references 3 to 5 in article), along with a more recent report,1 suggest that there are at most small differences in outcomes between high and low volume hospitals. There do appear to be significant differences in outcomes between Children’s Oncology Group and nonChildren’s Oncology Group affiliated hospitals.
Editorial Comment In 2014 the Pediatric Urologic Oncology Working Group emailed a survey to Society for Pediatric Urology members concerning participation in oncology care. Of 200 responding pediatric urologists 22% denied performing cancer surgeries, in contrast to the 53.4% noted in the present study. While 25% of survey respondents claimed more than 6 surgeries, this study found that 4 cases comprise the 95th percentile for oncology volume.1 This discrepancy suggests recall bias by survey participants or sample biases within the case logs.
Reply by Authors Stepwise modular learning has been used to teach robot-assisted radical prostatectomy. The main challenge for establishing the reliability of some technically challenging steps is that the opportunity to perform these steps is given to trainees only when their surgical skills are almost at par to faculty performance. This difference was not noticeable in our study, probably due to small sample size. Crowd scoring is ineffective to assess the key technical nuances of any advanced surgical technique, although it may be effective to assess basic robot-assisted surgical skills.
Editorial Comment The methodology for the development of this procedure specific, objective tool to assess surgical skills for RARP should be commended despite some limitations to this study. During construct validation, only 4 of the 7 steps were significantly different between trainees and attending surgeons. A larger multi-institutional study should help with further validation of this tool. The potential to use this tool for milestones during residency training is appealing.
Editorial Comment Critical to the development of any surgical training program is the ability to objectively and reliably measure performance.1 These authors present the development of a procedure specific assessment tool for use during robotic prostatectomy. They provide a robust framework for iterative consensus development using Delphi methodology. The preliminary data on validity and reliability appear promising. However, external validation across a wider range of skill levels is needed to confirm its utility.
This Month in Adult Urology Physicians in general and surgeons in particular are noted for being independent and resistant to being told what to do. Increasingly, though, third party payers and regulatory agencies are using measurements of physician practice patterns and results to provide financial rewards and, sometimes, punitive actions. Beyond any incentive based programs is the potential influence of the observer effect. Sometimes called the “Hawthorne effect,” this principle contends that individuals may modify their behavior, potentially in a positive manner, simply because they are aware that they or their results are being observed.
Penile Cancer: Contemporary Lymph Node Management In penile cancer, the optimal diagnostics and management of metastatic lymph nodes are not clear. Advances in minimally invasive staging, including dynamic sentinel lymph node biopsy, have widened the diagnostic repertoire of the urologist. We aimed to provide an objective update of the recent trends in the management of penile squamous cell carcinoma, and inguinal and pelvic lymph node metastases.
Surgical Options for the Enlarged, Obstructing, Benign Prostate Medication is the first line of treatment for most men with lower urinary tract symptoms and other manifestations of bladder outlet obstruction resulting from benign prostatic hyperplasia (BPH). Nevertheless, surgery remains a robust, safe and definitive alternative. Medications control symptoms and prevent adverse clinical events, including acute urinary retention, but they are not curative. Substantial percentages of men on oral therapy will experience clinical progression within 5 to 10 years.
When is a Negative Prostate Biopsy Really Negative? Repeat Biopsies in Detection and Active Surveillance Repeat biopsies are commonly performed in the diagnostic setting and increasingly for men on active surveillance. A prior study using SEER (Surveillance, Epidemiology, and End Results)-Medicare data reported that 11.8% of men with a negative prostate biopsy underwent repeat biopsy within 1 year and 38% did so within 5 years.1 A major problem is the significant sampling error with the traditional random systematic biopsy and the resulting lack of confidence that a negative biopsy is really negative.
The Current Status of Clinical Drug Trials in Pediatric Urology The development of a compound to a specific therapy is a long process, often taking years and in some cases even decades. This process, although time consuming and costly, is necessary for safety and efficacy reasons. For children these concerns may become magnified due to the shifting and evolving physiology that fragment pediatric subjects into as many as 5 different test groups, ie premature babies, infants, young children, peripubertal adolescents and postpubertal adolescents who are not yet legally adults.
This Month in Pediatric Urology Bladder exstrophy remains one of the more complex reconstructive problems that pediatric urologists face. Multiple advances have been proposed, one being the addition of pelvic osteotomy to ensure a secure bladder closure in the neonate and older child. Sirisreetreerux et al (page 1138) from Baltimore, Maryland present their extensive experience using osteotomies in this patient population, in an effort to define factors that may contribute to failure of bladder exstrophy despite the addition of standard osteotomy.
Reply by Authors Our study includes the survival outcome of surgical patients with GS 6 or 7 disease in whom prostate cancer specific mortality was relatively uncommon. In our study, downgrading was associated with an elevated HR for prostate cancer specific mortality but it did not reach statistical significance. This may reflect low power associated with the small number of events. However, recurrence was significantly more common in those with downgrading or GS 7 disease compared to men with GS 6 at Bx and RP.
Editorial Comment The authors make the important observation that downgrading from Gleason 3 + 4 to 3 + 3 usually does not correct initial over grading. Rather, it is more likely that these patients simply have small volume pattern 4 disease that is not identified on final pathology. However, the statement that these data support the concept that men with GS 7 may not be appropriate candidates for active surveillance is not my interpretation of the data.
Editorial Comment Metformin, a therapy for type II diabetes, is increasingly considered a potential antineoplastic agent in prostate cancer. Docetaxel is standard of care therapy of both castration sensitive, metastatic prostate cancer and CRPC, and chemosensitization is an attractive area of investigation to improve the therapeutic ratio of docetaxel, given the low toxicity of metformin.
Editorial Comment Mayer et al studied the impact of metformin in diabetic patients receiving docetaxel for castrate resistant prostate cancer and found no improvement in prostate cancer specific or overall survival. While this well done, retrospective cohort study of men older than 65 years indicated no benefit, the limitations of study design, exposure (dose, intensity of use and misclassification), diabetic severity and the short 1-year median followup persist.
Reply by Authors In our study, all 11 multilocular cystic RCCS were classified as cystic RCC and none of them showed metastasis or recurrence. Therefore, the incidence of cystic RCC was increased and the favorable prognosis of cystic RCC might be overstated by including multilocular cystic RCCs. However, multilocular cystic RCC cannot be completely differentiated from RCC with cystic changes by imaging features because both of them usually present as Bosniak category III or IV cysts on CT.1 Furthermore, a recent study reported that it is a subtype of clear cell RCC according to the result of chromosomal analysis.
Editorial Comment The authors provide an insightful analysis of outcomes after surgical management of radiologically defined cystic RCC. Up to 15% of all RCCs exhibit cystic change. As a growing body of evidence points out, this might be indicative of a favorable oncological outcome (references 9 and 10 in article).
Editorial Comment This study adds to the growing body of evidence that clinically useful information about the aggressiveness of prostate cancer can be obtained from needle biopsies despite known issues with sampling error and genetic heterogeneity. As such, we are on the threshold of being able to exploit biological information beyond that contained in the classic triad of grade, stage and PSA to allow for a tailored management approach for newly diagnosed patients, including who to put on active surveillance, who is likely to respond to radiation1 or androgen deprivation and the choice of specific drugs for individual patients.
Re: Comprehensive Transcriptional Analysis of Early-Stage Urothelial Carcinoma J. Hedegaard, P. Lamy, I. Nordentoft, F. Algaba, S. Høyer, B. P. Ulhøi, S. Vang, T. Reinert, G. G. Hermann, K. Mogensen, M. B. Thomsen, M. M. Nielsen, M. Marquez, U. Segersten, M. Aine, M. Höglund, K. Birkenkamp-Demtröder, N. Fristrup, M. Borre, A. Hartmann, R. Stöhr, S. Wach, B. Keck, A. K. Seitz, R. Nawroth, T. Maurer, C. Tulic, T. Simic, K. Junker, M. Horstmann, N. Harving, A. C. Petersen, M. L. Calle, E. W. Steyerberg, W. Beukers, K. E. van Kessel, J. B. Jensen, J. S. Pedersen, P. U. Malmström, N.
Re: A miR-192-EGR1-HOXB9 Regulatory Network Controls the Angiogenic Switch in Cancer S. Y. Wu, R. Rupaimoole, F. Shen, S. Pradeep, C. V. Pecot, C. Ivan, A. S. Nagaraja, K. M. Gharpure, E. Pham, H. Hatakeyama, M. H. McGuire, M. Haemmerle, V. Vidal-Anaya, C. Olsen, C. Rodriguez-Aguayo, J. Filant, E. A. Ehsanipour, S. M. Herbrich, S. N. Maiti, L. Huang, J. H. Kim, X. Zhang, H. D. Han, G. N. Armaiz-Pena, E. G. Seviour, S. Tucker, M. Zhang, D. Yang, L. J. Cooper, R. Ali-Fehmi, M. Bar-Eli, J. S. Lee, P. T. Ram, K. A. Baggerly, G. Lopez-Berestein, M. C. Hung and A. K. Sood
Reply by Authors Referring to the Editorial Comment, the outcome parameters in this series “are more than competitive with modern laser vaporization.”
Reply by Authors The perspective of the commentator is what precisely motivated our effort to challenge how we prescribe and interpret the 24-hour urine collection. Our intention was not to focus on whether performing 1 or 2 collections is better or which day of the week is optimal to perform this test. Rather, as a starting point, our intention was to generate a discussion on how we can better define and refine who should receive testing.
Editorial Comment The value of 24-hour urine collection is put under suspicion for urolithiasis diagnosis and recurrence. Parks et al noted that a single 24-hour urine collection is not enough.1 This analysis has limitations, including more than 1 biochemical abnormality present, borderline values and weekend collection which could vary the diet. However, 2 consecutive collections decrease variability and make results trustworthy. Weekend diet differences are the same for stone formers compared to nonformers with a genetic component in the latter (forming stones is not a wish but a capacity).
Editorial Comment The learning curve for HoLEP is highly dependent upon the way that the procedure is acquired with estimates ranging from 20 cases when mentored,1 to more than 50 when self-taught.2 In this article Elshal et al take a structured look at the process, comparing 2 mentored surgeons with a nonmentored one. Both operative and enucleation efficiency plateaued after 40 cases in their series. This number was also found to be associated with the lowest rates of transient incontinence and their designated “safety measures,” including capsular perforation and intraoperative bleeding.
Editorial Comment Although data from observational studies and randomized trials suggest that in men with Gleason score 6 (3 + 3) localized prostate cancer who are on active surveillance 5-ARI use diminishes disease progression, little is known about the effect of 5-ARI on tumor size (reference 3 in article).1 In the MAPPED study, Moore et al convincingly found that during 6 months MRI visible tumors shrank in men on active surveillance randomized to dutasteride vs placebo (36% shrinkage vs 12% growth). The sequential images of tumor containment and reduction support the presumed biological activity of 5-ARIs.
Reply by Authors We completely agree that calculus based CSA is limited to renal tumors with spherical shapes. For tumors with irregular shapes software based calculation may be more accurate to estimate CSA, provided a precise and meticulous algorithm is applied (reference 1 in letter). Nevertheless, the cost and availability of the image processing software are of great concern, so it is difficult to use this method worldwide.
Reply by Authors The main aim of our study was to highlight the morbidities associated with traumatic urethral catheterization as data on urethral catheter related injuries are sparse. The 6-month followup period is relatively short and we agree that some patients sustaining urethral trauma may be at risk for urethral stricture disease at a later date. For this reason we are continuing to monitor this patient cohort prospectively in an outpatient setting and aim to publish our long-term results on additional costs and incidence of urethral stricture disease at a later date.
Reply by Authors Shenoy et al first comment on the way in which we presented our recurrence rates at each of the 3 surveillance time points (3 months, 1 year and 2 years). The method of reporting is that of “conditional recurrence,” ie the disease-free rates of 86% at 1 year and 93% at 2 years refer to patients who have not previously had recurrence. Stated otherwise, “Of those who were disease-free, this percentage remains disease-free.” It is a legitimate method of presenting data, and the methodology is clearly stated throughout the article, particularly in figure 2.
Re: Treatment for T1a Renal Cancer Substratified by Size: “Less is More” We read with interest this study showing that black and Hispanic patients with small (less than 3 cm) localized renal cell cancers (RCCs) had an increased chance of undergoing radical nephrectomy (RN) rather than partial nephrectomy compared to white patients. In this SEER (Surveillance, Epidemiology and End Results) Program cohort of 17,716 patients with small RCCs diagnosed from 2005 to 2010 the researchers describe increased relative rates of 63% and 28% for black and Hispanic patients, respectively, to have undergone RN compared to white patients.
Re: A Mathematical Method to Calculate Tumor Contact Surface Area: An Effective Parameter to Predict Renal Function after Partial Nephrectomy The primary purpose of nephrometry scoring should be to standardize anatomical description of renal mass complexity and thereby standardize outcome reporting for nephron sparing surgery. Renal tumor contact surface area (CSA), which numerically combines tumor size and percent endophytic component, was initially conceived by us as a novel, readily measurable adjunct to be ideally incorporated into future nephrometry scoring systems.1 We described a software based, internally validated method for calculating CSA and found it to correlate with partial nephrectomy outcomes.
Re: Incidence, Cost, Complications and Clinical Outcomes of Iatrogenic Urethral Catheterization Injuries: A Prospective Multi-Institutional Study This article tries to shine a light on an important factor for urethral stricture disease. However, there are limiting factors to the reporting of the incidence of urethral trauma or stricture. The 6-month time frame is short as stricture can develop in many of these patients sometime later than 6 months. In addition, the inclusion criteria consisted of referral to the urologist for difficult/failed catheter with at least 1 of the conditions of hematuria, blood at the meatus, perineal/urethral pain, cystoscopic evidence of urethral trauma and retrograde/antegrade urethrogram demonstrating urethral trauma.
Editorial Comment Around 20% of the patients who need surgery for BPH at most institutions have a prostate larger than 100 gm and it is becoming increasingly clear that some form of enucleation is the best form of treatment.1 The article by Umari et al is an important clarification in this regard from a team experienced with and adept at the 2 most compelling enucleation techniques, namely HoLEP and robotic assisted simple prostatectomy.
Reply by Authors Besides undergoing Buck traction to immobilize the lower extremities, all patients with an osteotomy have an external fixator and intrafragmentary pins placed to better immobilize and protect the pelvic closure. This approach adds to the safety of a closure over that of a spica cast.1 Some surgeons are reticent to do an osteotomy in the newborn period but our long-term results reveal that it is safe and effective.2 However, as Canning clearly indicates, without good postoperative pain and movement control an osteotomy will not save either a poorly done or a well-done closure, and does not itself guarantee success.
Editorial Comment These authors, from a premier program of exstrophy care, have previously demonstrated that osteotomy is essential to a successful first closure. While other experienced teams have found that the spica cast can be used with good results (reference 17 in article),1 in this series the authors observed that patients immobilized with Buck traction and those immobilized longer than 4 weeks had fewer failed closures. These findings may actually reflect the experience and overall better results the Hopkins team enjoys along with their commitment to Buck traction rather than an inherent problem with the spica cast.
This Month in Adult Urology In patients with large prostates excellent results have been reported for the treatment of bladder outlet obstruction with holmium laser enucleation of the prostate and robotic assisted simple prostatectomy. Umari et al (page 1108) compared retrospectively the results of each operation performed at a single tertiary referral center.1 Both procedures demonstrated comparable and statistically significant improvement in subjective and objective outcome parameters. The median operating time was equivalent as was the decrease in serum hemoglobin.
Patient Function and the Value of Surgical Care for Kidney Cancer Frailty and functional status have emerged as significant predictors of morbidity and mortality for patients undergoing cancer surgery. To articulate the impact on value (ie quality per cost), we compared perioperative outcomes and expenditures according to patient function for older adults undergoing kidney cancer surgery.
Dual Therapy for Refractory Overactive Bladder in Children: A Prospective Open-Label Study Mirabegron (β3 adrenoreceptor agonist) is a new molecule with a mechanism of action distinct from antimuscarinics. Combination therapy with solifenacin was recently studied in an adult population. We evaluated the efficacy and safety of mirabegron as add-on therapy to treat urinary incontinence in children with idiopathic overactive bladder refractory/intolerant to antimuscarinics.
Pulsed Magnetic Stimulation for Stress Urinary Incontinence: 1-Year Followup Results Despite significant differences in success rates between surgical and nonsurgical treatments for female stress urinary incontinence, a few cross-sectional surveys showed that most patients still prefer the latter. We evaluated the efficacy of the under studied nonsurgical treatment using pulsed magnetic stimulation for female stress urinary incontinence.
The Cardiovascular Safety of Dutasteride Randomized controlled trials suggest an increased risk of heart failure with dutasteride, which inhibits both the type 1 and type 2 isoforms of 5α-reductase. In contrast, no such association has been suggested for finasteride, which selectively inhibits the type 2 isoform. We investigated the risk of cardiovascular events among patients receiving dutasteride relative to finasteride.
The Role of the 24-Hour Urine Collection in the Prevention of Kidney Stone Recurrence Kidney stone prevention relies on the 24-hour urine collection to diagnose metabolic abnormalities and direct dietary and pharmacological therapy. While its use is guideline supported for high risk and interested patients, evidence that the test can accurately predict recurrence or treatment response is limited. We sought to critically reassess the role of the 24-hour urine collection in stone prevention.
Biopsy Based Proteomic Assay Predicts Risk of Biochemical Recurrence after Radical Prostatectomy Current clinicopathological parameters are insufficient to predict the likelihood of biochemical recurrence in patients with prostate cancer after radical prostatectomy. Such information may help identify patients who would likely benefit from adjuvant radiotherapy rather than active surveillance. A multiplex proteomic assay, previously tested on biopsies and found to be predictive of favorable or unfavorable pathology at radical prostatectomy, was assessed for its predictive value to identify patients at higher risk for biochemical relapse.
PTEN Loss in Gleason Score 3 + 4 = 7 Prostate Biopsies is Associated with Nonorgan Confined Disease at Radical Prostatectomy Men with intermediate risk prostate cancer have widely variable outcomes. Some suggest that active surveillance or less invasive therapies (brachytherapy or focal therapy) may be appropriate for some men with Gleason score 3 + 4 = 7 disease. Molecular markers may help further distinguish prostate cancers with aggressive behavior. We tested whether loss of the PTEN (phosphatase and tensin homolog) tumor suppressor in 3 + 4 = 7 tumor biopsies is associated with adverse pathology at prostatectomy.
Editorial Comment This is an interesting article addressing a not too uncommon scenario in which a patient on required antiplatelet therapy is in need of surgical resection of a suspicious renal mass. While it makes complete sense intuitively that patients on clopidogrel can potentially have more bleeding complications, only 8 patients were on continued clopidogrel therapy. Therefore, some observations have to be viewed with caution. For example, the fact that those patients who remained on clopidogrel had longer operative times could be an incidental finding unless the operative notes dictated state that the increased operative time was due to intraoperative bleeding.
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