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1.  Increased Incidence of Pathologically Nonorgan Confined Prostate Cancer in African-American Men Eligible for Active Surveillance 
Urology  2013;81(4):831-835.
OBJECTIVE
To compare the clinicopathologic findings of African-American (AA) and White-American (WA) men with prostate cancer (PCa) who were candidates for active surveillance (AS) and underwent radical prostatectomy (RP).
METHODS
Prospectively maintained database of men who underwent RP from 2 academic centers were analyzed retrospectively. Postoperative pathologic characteristics of patients who met the AS inclusion criteria of the University of California, San Francisco (UCSF) and National Comprehensive Cancer Network (NCCN) were evaluated. After RP, the rate of pathological upstaging and Gleason upgrading were compared between AA and WA men.
RESULTS
In the AA cohort, 196 and 124 men met the UCSF and NCCN criteria for AS, respectively. With respect to WA patients, 191 and 148 fulfilled the AS criteria for UCSF and NCCN, respectively. AA men had a higher percentage of maximum biopsy core than WA men (15.3%–20.4% vs 11.5%–15.0%, P <.05, respectively) in both cohorts. In addition, a greater proportion of AA men had multiple positive biopsy cores compared to WA men (45.2% vs 33.1%, P = .046) under the NCCN criteria. A higher proportion of AA men were upstaged (≥pT3) compared to WA men (19.4% vs 10.1%, P = .037). A multivariate regression test revealed that age, preoperative PSA, and number of positive cores were independent predictors of more advanced disease (upstaging and/or upgrading) in AA men.
CONCLUSION
AA men who were candidates for AS criteria had worse clinicopathological features on final surgical pathology thanWA men. These results suggest that a more stringent AS criteria should be considered in AA men with prostate cancer.
doi:10.1016/j.urology.2012.12.046
PMCID: PMC3978180  PMID: 23465143
2.  Screening Rectal Culture to Identify Fluoroquinolone-resistant Organisms Before Transrectal Prostate Biopsy: Do the Culture Results Between Office Visit and Biopsy Correlate? 
Urology  2013;82(1):67-71.
OBJECTIVE
To investigate the performance of screening rectal cultures obtained 2 weeks before transrectal prostate biopsy to detect fluoroquinolone-resistant organisms and again at transrectal prostate biopsy.
MATERIALS AND METHODS
After institutional review board approval for observational study, we obtained a rectal culture on patients identified for a prostate biopsy but before antibiotic prophylaxis from September 12, 2011 to April 23, 2012. The specimen was cultured onto MacConkey agar with and without 1 µg/mL ciprofloxacin. We then obtained a second rectal culture immediately before prostate biopsy after 24 hours of ciprofloxacin prophylaxis. All cultures were blinded to the practitioner until the end of the study.
RESULTS
Of 108 patients enrolled, 58 patients had both rectal cultures for comparison. The median time duration between cultures was 14 (6–119) days. There were 54 of 58 concordant pairs (93%), which included 47 negative cultures and 7 positive cultures; 2 patients (3%) who were culture negative from the first screening culture became positive at biopsy. Sensitivity, specificity, negative, positive predictive values, and area under the operator curve were 95.9%, 77.8%, 95.9%, 77.8%, and 0.868, respectively. When Pseudomonas spp. are removed from the analysis, the area under the curve is increased to 0.927.
CONCLUSION
Screening rectal cultures 2 weeks before prostate biopsy has favorable test performance, suggesting screening cultures give an accurate estimate of fluoroquinolone-resistant colonization.
doi:10.1016/j.urology.2013.02.068
PMCID: PMC3952011  PMID: 23806391
3.  Preventing Perioperative Complications of Robotic-assisted Radical Prostatectomy 
Urology  2013;81(2):319-323.
OBJECTIVE
To report the change in complication rates after the identification and modification of technique to reduce their incidence during robot-assisted radical prostatectomy (RARP).
METHODS
This study retrospectively reviewed 1000 consecutive patients who underwent RARP from June 2002 to June 2011. A number of technical changes were made after complications were noted and changes in technique were documented. The Fisher exact test and multivariate analysis were used for comparison of techniques, and values of P <.05 were considered significant.
RESULTS
The overall rate of major and minor complications was 10.8% (108 of 1000). The complication rates of lymphoceles (0.4%), ileus (0.4%), and wound infection (0.4%) were low and did not require technical changes. There were no significant changes in rates of femoral nerve palsies, rectal injuries, or bladder neck contractures. There was statistically significant change in corneal abrasions (P = .03), fossa navicularis strictures (P = .03), and camera-site hernias (P <.001) after a directed intervention adjusted for age, body mass index, and learning curve. Clavien 3 and 4 complications all significantly decreased to ≤0.6%, with the most occurring in the first 200 cases.
CONCLUSION
Identification and correction of perioperative complications in patients undergoing robotic prostatectomy has decreased the incidence of major and minor complications adjusted for learning curve. The conscientious monitoring of adverse events can provide targeted change in technique to decrease complications and provide information to those early in learning robotic-assisted radical prostatectomy.
doi:10.1016/j.urology.2012.09.033
PMCID: PMC3952012  PMID: 23374792
4.  Determination of Ureter Stent Appearance on Dual-energy Computed Tomography Scan 
Urology  2012;80(5):986-989.
OBJECTIVE
To examine the dual-energy computed tomography (DECT) properties of 7 commonly used ureteral stents to optimize stent selection for calculi monitored using DECT. The use of DECT to evaluate renal and ureteral calculi has recently increased.
METHODS
Seven stents were individually placed in a fish bowl phantom and imaged using a Siemens Somatom Definition Flash CT scanner. DECT peak tube potentials of 80 and 140 kVp and 100 and 140 kVp were used, reflecting our current dual-energy protocols. These were compared to 31 in vivo stents of known composition. The data were reconstructed on a multimodality Work-Place (Siemens) using CT syngo Post-Processing Suite software.
RESULTS
The average patient age was 64 years (range 27–90). The average body mass index was 31.9 kg/m2 (range 24–51.6). Of the 27 patients, 4 had uric acid stones and 22 had calcium-based stones; 1 patient had undergone renal transplantation. No difference was seen in the dual-energy characterization of stents from the same manufacturer. All imaged Cook and Bard stents had a dual-energy characterization that approached that of calcium stones (blue). All Boston Scientific and Gyrus ACMI stents had a dual-energy characterization resembling that of uric acid stones (red).
CONCLUSION
The present study evaluated the stent appearance on DECT for various stent manufacturers. This information will aid in the optimal stent selection for patients undergoing treatment of renal calculi and followed up with DECT.
doi:10.1016/j.urology.2012.07.005
PMCID: PMC3939716  PMID: 22921702
5.  PDE5 Expression and Function in the Lower Urinary Tract: A Critical Review 
Urology  2013;81(3):480-487.
doi:10.1016/j.urology.2012.11.028
PMCID: PMC3839665  PMID: 23333001
PDE5; Bladder; Prostate; Urethra
7.  Editorial Comment 
Urology  2012;80(6):1373-1374.
doi:10.1016/j.urology.2012.07.061
PMCID: PMC3915868  PMID: 23206788
8.  Struvite Urolithiasis and Chronic Urinary Tract Infection in a Murine Model of Urinary Diversion 
Urology  2013;81(5):943-948.
OBJECTIVES
To characterize the clinical course following cutaneous vesicostomy (CV) in megabladder (mgb−/−) mice with functional urinary bladder obstruction.
MATERIALS AND METHODS
Forty-five mgb−/− males underwent CV at a median age of 25 days. The 34 animals that survived longer than 3 days after CV were evaluated by serial observation and renal ultrasound. Moribund animals were euthanized. Urinary bladders and kidneys were analyzed by histopathology, and urine biochemical studies were performed.
RESULTS
At a median of 11 weeks after CV, 35% (12/34) of mgb−/− males became moribund with pelvic masses, which were identified as bladder stones at necropsy. Urine pH was alkaline and microscopy demonstrated struvite crystals. Urine contained Gram-positive cocci, while urine cultures were polymicrobial. Stone composition was chiefly struvite (88–94%) admixed with calcium phosphate. In 40% (2/5) of cases, retained intravesical polypropylene suture was identified as the presumed nidus. No stones were detected in over 100 males prior to CV or in 25 cases when CV was performed using polydioxanone suture. Kidneys from 33% (4/12) of animals with bladder stones contained staghorn calculi. Histopathology from animals with struvite stones demonstrated active cystitis, pyelitis, and chronic pyelonephritis.
CONCLUSIONS
These findings attest to the importance of the nidus in lithogenesis and provide a novel murine model for struvite urolithiasis and chronic infection of the diverted urinary tract.
doi:10.1016/j.urology.2013.02.003
PMCID: PMC3916187  PMID: 23523293
urinary tract infection; pyelonephritis; urinary diversion; struvite; urolithiasis; mouse model
9.  The selective rho-kinase inhibitor Azaindole-1 has long lasting erectile activity in the rat 
Urology  2013;81(2):465.e7-465.e14.
Objectives
To investigate the effects of the selective Rho-kinase (ROCK) inhibitor azaindole-1 on erectile function under physiologic and pathophysiologic conditions in the rat.
Methods
The effect of intracavernosal (i.c.) injections of azaindole-1 on change in ICP, ICP/MAP, AUC, and response duration were investigated in the anesthetized rat under control conditions and when NANC neurotransmission and cholinergic function or sGC were inhibited or after cavernosal nerve crush injury.
Results
The i.c. injections of azaindole-1 produced dose-related increases in ICP/MAP and AUC that were long lasting at the highest doses studied when compared with the prototypical ROCK-inhibitor fasudil. Erectile responses were not altered by 7-NI and atropine in doses that reduced the response to cavernosal nerve stimulation by 86%, indicating that they were independent of NO release by cavernosal nerves or activation of muscarinic receptors in the corpora cavernosa. Erectile responses to azaindole-1 were not altered by the sGC inhibitor ODQ in a dose that attenuated responses to the NO donor SNP indicating that they were independent of an action on sGC. The erectile response to ic injections of azaindole-1 or Y-27632 which was reported to be NO/cGMP- dependent were not attenuated after cavernosal nerve crush injury.
Conclusions
The present studies indicate azaindole-1 has long lasting erectile activity that is independent of NO release, muscarinic receptor, or sGC activation or the integrity of the cavernosal nerves.
doi:10.1016/j.urology.2012.10.039
PMCID: PMC3564057  PMID: 23374844
Azaindole-1; selective Rho-kinase inhibitor; erectile dysfunction; oxidative stress; impaired cavernosal nerve function
10.  Quality Assessment Of Economic Analyses in Pediatric Urology 
Urology  2013;81(2):263-268.
Objective
To describe and evaluate economic analyses or economic evaluations in pediatric urological literature including study types such as cost-effectiveness analysis, are increasingly common in the medical literature.
Methods
We performed a systematic literature review of the MEDLINE, EMBASE, and Cochrane databases (1990–2011) to identify economic analyses of pediatric urologic topics. Studies were evaluated using published quality metrics. We examined the analysis type, data sources, perspective, methodology, sensitivity analyses, and the reporting of methods, results, limitations, and conclusions.
Results
We identified 2,945 non-duplicated studies, 60 of which met inclusion criteria. Economic analyses of pediatric urologic topics increased in number during the study period, from 1 study (2%) in 1990 to 7 (12%) in 2010 (p<0.0001 for trend). The most common types of analyses were cost-effectiveness and cost-minimization (22 each, 37%), typically performed from the payer perspective (26, 43%). Although 44 (73%) correctly identified the analysis type, only 21 (35%) correctly identified the study perspective. Optimal data sources were used in 7 studies (11%). Appropriate inflationary discounting was used in 32% (17/53). Sensitivity analyses were not reported in 58% (31/53). The descriptions of study methods were adequate in 43 (72%); assumptions were adequately reported in 42 studies (70%). Most (37, 62%) adequately discussed limitations.
Conclusions
Although economic analyses are increasing in the pediatric urologic literature, there is a need for standardization in methods and reporting. Future investigations should attempt to follow standardized reporting guidelines and should pay particular attention to reporting of methods and results, including a comprehensive discussion of limitations.
doi:10.1016/j.urology.2012.08.071
PMCID: PMC3594685  PMID: 23374775
Cost Effectiveness; Cost Analysis; Pediatrics; Urology; Systematic Review
11.  Defining and Managing Overactive Bladder: Disagreement among the Experts 
Urology  2013;81(2):257-262.
Objectives
To better understand experts’ perceptions of the definition of overactive bladder (OAB), the evaluation of OAB, and treatment of OAB. OAB is defined by the International Continence Society as “urinary urgency, with or without urge urinary incontinence, usually with frequency and nocturia.” Under the current definition, people with very different clinical conditions fall under the OAB umbrella. With the goal of improving the care for women with OAB, we sought to better understand experts’ perceptions of OAB as it is presently defined.
Methods
Twelve interviews with leading urologic, gynecologic, and geriatric practitioners in urinary incontinence and OAB were performed. Questions were asked about their perception and agreement with the current definition of OAB. Interviews were audiotaped and transcribed verbatim. Grounded theory methodology was used to analyze the data.
Results
Overall, there was a great deal of variability in defining and managing OAB. Four categories of definitions were derived from the qualitative analysis: current definition is adequate, OAB is a constellation of symptoms, should include the fear of leakage, and OAB is a marketing term. While there is some consensus on evaluation, several areas demonstrate disagreement over elements of the evaluation. Experts also felt that OAB is a chronic condition, with variability of symptoms, and it has no cure. Managing patient expectation is essential, as OAB is challenging to treat. A focus was placed on behavioral therapy.
Conclusions
There was disagreement among experts over the definition and work-up of OAB. However, experts agree that OAB is a chronic condition with a low likelihood of cure.
doi:10.1016/j.urology.2012.09.028
PMCID: PMC3890251  PMID: 23374774
overactive bladder; urgency; urge incontinence; diagnosis; evaluation; management; definition
12.  Phase II Trial of Capecitabine and Weekly Docetaxel in Metastatic Renal Cell Carcinoma 
Urology  2008;72(4):10.1016/j.urology.2008.05.032.
Objectives
To evaluate the toxicity and efficacy of capecitabine and weekly docetaxel in a phase II clinical trial.
Methods
Eligibility included metastatic renal cancer with a maximum of 2 prior regimens, performance status of 0-2, and adequate renal, hepatic, and bone marrow function. Docetaxel was adminis-tered intravenously at a dose of 36 mg/m2 weekly on days 1, 8, and 15 of a 28- day cycle and capecitabine was administered orally at a dose of 1800 mg/m2 from days 5-18. Toxicity was assessed on days 1, 8, and 15 of each cycle, and response was evaluated every 2 cycles.
Results
Twenty-five patients, 19 white and 6 African American, were enrolled on this phase II trial. The median age was 60 years (range: 39-75 years). Eighteen patients had clear cell histology, 7 had papillary, sarcomatoid, or chromophobe histology. Thirteen had liver/bone metastases and 13 had ≥2 of the Memorial Sloan-Kettering Cancer Center prognostic risk factors. Twelve patients received prior immunotherapy. A total of 93 cycles were administered; median of 3 cycles and range from 0-10 cycles. The therapy was well tolerated. No treatment-related mortality was observed and 2 treatment-related hospitalizations for nausea, diarrhea, and dehydration occurred. Ten patients had stable disease. The median time to progression was 1.7 months and median survival was 11.1 months.
Conclusions
The combination of capecitabine and docetaxel was well tolerated in metastatic renal cancer. Clinical activity was predominantly noted in non-clear cell histology in which chemotherapy would be worthy of future investigation.
doi:10.1016/j.urology.2008.05.032
PMCID: PMC3859296  PMID: 18692873
13.  Labial Ecythma Gangrenosum in an Immunocompromised Infant with Leukemia: Heightening Awareness for the Urologist 
Urology  2012;80(6):1366-1368.
Ecthyma gangrenosum (EG) is a cutaneous infection most commonly associated with Pseudomonas aeruginosa sepsis. EG generally occurs in immunocompromised hosts, such as patients with severe neutropenia. EG presents as erythematous, hemorrhagic, or necrotic macules or plaques most commonly in the perineal or gluteal areas, but can occur elsewhere. EG is a dermatologic emergency in immunocompromised patients and should be included in the differential diagnosis when urologists are asked to evaluate perineal lesions. We describe the case of a highly immunocompromised infant with labial EG to highlight the importance of prompt clinical diagnosis and of multi-disciplinary medical and surgical management.
doi:10.1016/j.urology.2012.08.020
PMCID: PMC3514568  PMID: 23040328
ecthyma gangrenosum; immunocompromised; Pseudomonas
14.  The Effect of 5-Aminolevulinic Acid and its Derivatives on Protoporphyrin IX Accumulation and Apoptotic Cell Death in Castrate-Resistant Prostate Cancer Cells 
Urology  2012;80(6):1391.e1-1391.e7.
Objective
To examine whether pharmacologically relevant zinc-binding agents are capable of depleting XIAP in tumor cells. Our prior work reveals that treatment with zinc chelating agents induces selective down-regulation of the X-linked inhibitor of apoptosis protein (XIAP) in cancer cells of various origins. A precursor of the heme synthetic pathway, 5-aminolevulinic acid (5-ALA), is metabolized to protoporphyrin IX (PPIX), which is highly reactive with zinc. We assessed whether modified versions of 5-ALA with lipophilic side chains can enhance efficacy and selectivity with respect to PPIX accumulation, XIAP depletion, and TNF-related apoptosis-inducing ligand (TRAIL) – mediated apoptosis in human castration resistant prostate cancer (CRPC) cells.
Methods
Seven modified versions of 5-ALA (five esters and two amides) were synthesized. Levels of endogenous PPIX were examined by flow cytometry. XIAP expression was examined by Western blotting. TUNEL assay was used to assess cell apoptosis. Results were compared qualitatively.
Results
Accumulation of endogenous PPIX by CRPC cells was shown to be directly related to the carbon chain length of the esterified 5-ALA derivatives. In fact, treatment with ALA-HE was superior to that achieved by 5-ALA with respect to XIAP down-regulation. 5-ALA and ALA-HE in combination with TRAIL significantly enhanced apoptotic cell death in CRPC cell lines.
Conclusion
Esterified derivatives of 5-ALA alone or in combination with other agents may provide therapeutic opportunities in treatment of CRPC by harnessing apoptotic pathways that are triggered by cellular zinc imbalance.
doi:10.1016/j.urology.2012.07.008
PMCID: PMC3514607  PMID: 22950992
Prostate cancer; 5-Aminolevulinic acid; Protoporphyrin IX; XIAP; Apoptosis
15.  Gas-Containing Renal Stones: Findings from Five Consecutive Patients 
Urology  2012;80(6):1203-1208.
OBJECTIVE
To describe the clinical course, microbiology, and metabolic findings of five patients presenting to our institution with gas-containing renal stones.
MATERIALS & METHODS
Over a 20 month period beginning in 2009, five patients were identified by computed tomography scanning to harbor gas-containing renal calculi. Despite similar imaging and referral practice patterns, no such cases had been seen at our institution in the preceding 20 years. The records of these patients were reviewed to better characterize this unique condition.
RESULTS
All five subjects were premenopausal women. One patient presented with urosepsis while the other four had flank pain. All had urinary tract infections, and Escherichia coli was isolated from a voided urine specimen in three. Stone culture was positive in two and was concordant with the voided specimen in one. Stones were solitary in four and multiple in one. All stones were composed of calcium phosphate. Three were pure, and two had calcium oxalate monohydrate components. Three subjects had diabetes mellitus, three were hypertensive, and one had a history of gout. Two subjects underwent 24 hour urine metabolic testing, and abnormalities were identified in both. All patients were rendered stone free: four with percutaneous nephrostolithotomy and one via robotic pyelolithotomy.
CONCLUSIONS
Gas-containing renal stones are rare but may be increasing in prevalence. The pathophysiology is unknown but is most likely influenced by a combination of metabolic and infectious factors.
doi:10.1016/j.urology.2012.08.035
PMCID: PMC3514638  PMID: 23102439
Calcium; Phosphate; Gas; Nephrolithiasis; Pyelonephritis; Robotics
16.  Out-of-Pocket Expenses and Treatment Choice for Men with Prostate Cancer 
Urology  2012;80(6):1252-1257.
Objective
To describe prostate cancer patients’ knowledge of and attitudes toward out-of-pocket expenses (OOPE) associated with prostate cancer treatment or the influence of OOPE on treatment choices.
Material and Methods
We undertook a qualitative research study in which we recruited patients with clinically localized prostate cancer. Patients answered a series of open-ended questions during a semi-structured interview and completed a questionnaire about the physician’s role in discussing OOPE, the burden of OOPE, the effect of OOPE on treatment decisions, and prior knowledge of OOPE.
Results
Forty-one (26 white, 15 black) eligible patients were enrolled from the urology and radiation oncology practices of the University of Pennsylvania. Qualitative assessment revealed five major themes: (1) “My insurance takes care of it” (2) “Health is more important than cost” (3) “I didn’t look into it” (4) “I can’t afford it but would have chosen the same treatment” (5) “It’s not my doctor’s business.” Most patients (38/41, 93%) reported that they would not have chosen a different treatment even if they had known the actual OOPE of their treatment. Patients who reported feeling burdened by out-of-pocket costs were socioeconomically heterogeneous and their treatment choices remained unaffected. Only two patients said they knew “a lot” about the likely out-of-pocket costs for different prostate cancer treatments before choosing treatment.
Conclusions
Among insured prostate cancer patients treated at a large academic medical center, few had knowledge of OOPE prior to making treatment choices.
doi:10.1016/j.urology.2012.08.027
PMCID: PMC3535177  PMID: 23102446
prostate cancer; out-of-pocket expenses; qualitative research; treatment decision
17.  Managed care and the diffusion of intensity-modulated radiotherapy for prostate cancer 
Urology  2012;80(6):1236-1242.
Objective
To better understand associations between managed care penetration in healthcare markets and intensity-modulated radiotherapy (IMRT) adoption.
Methods
We used Surveillance, Epidemiology, and End Results (SEER)-Medicare data to identify men diagnosed with prostate cancer between 2001 and 2007 who were treated with radiation therapy (n=55,162). We categorized managed care penetration in Health Service Areas (HSAs) as low (<3%), intermediate (3–10%), and high (>10%); and assessed our main outcomes (i.e., probability of IMRT adoption, which is the ability of a healthcare market to deliver IMRT, and IMRT utilization in HSA markets) using a Cox proportional-hazards model and Poisson regression model, respectively.
Results
Compared to markets with low managed care penetration, populations in highly penetrated HSAs were more racially diverse (25% vs. 15% non-white, p<0.01), densely populated (2,110 vs. 145 people/square mile, p<0.01), and wealthier (median income $48,500 vs. $31,900, p<0.01). The probability of IMRT adoption was greatest in markets with the highest managed care penetration (e.g., 0.82 (high) vs. 0.72 (low) in 2007, p=0.05). Among adopting markets, the use of IMRT increased in all HSA categories. However, relative to markets with low managed care penetration, IMRT utilization was constrained in markets with the highest penetration (0.69 (high) vs. 0.76 (low) in 2007, p<0.01).
Conclusion
Markets with higher managed care penetration demonstrated a greater propensity for acquiring IMRT technology. However, after adopting IMRT, more highly penetrated markets had roughly 7% slower growth in utilization over the study period. These findings provide insight into the implications of delivery system reforms for cancer-related technologies.
doi:10.1016/j.urology.2012.09.006
PMCID: PMC3514877  PMID: 23206767
intensity-modulated radiotherapy; managed care; health service area
18.  Temporal Ordering of Interstitial Cystitis/Bladder Pain Syndrome and Non-bladder Conditions 
Urology  2012;80(6):1227-1231.
Objective
To examine the prevalence and timing of nonbladder conditions in a community cohort of women with symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS).
Methods
As part of the Rand Interstitial Cystitis Epidemiology (RICE) study, we identified 3397 community women who met a validated case definition for IC/BPS symptoms. Each completed a survey asking if they had a physician diagnose them as having irritable bowel syndrome, fibromyalgia, chronic fatigue syndrome, migraines, panic attacks, or depression. If a positive response was received, subjects were asked to provide the age of symptom onset. All subjects were also asked to provide the date of IC/BPS symptom onset.
Results
A total of 2185 women reported a diagnosis of at least one of the nonbladder conditions. Onset of bladder symptoms was not consistently earlier or later than the onset of nonbladder symptoms. Depression tended to occur earlier (P < .05), whereas fibromyalgia generally occurred later (P < .05). Mean age of onset was lowest for migraine symptoms, depression symptoms, and panic attacks symptoms, and greatest for fibromyalgia and chronic fatigue syndrome symptoms. Mean age of irritable bowel syndrome and IC/BPS symptom onset was between these other conditions.
Conclusion
These findings confirm the common co-occurrence of IC/BPS with chronic nonbladder conditions. In women with IC/BPS symptoms and coexistent nonbladder conditions, bladder symptoms do not uniformly predate the nonbladder symptoms. These observations suggest that phenotypic progression from isolated bladder symptoms to regional/systemic symptoms is not a predominant pattern in IC/BPS, although such a pattern may occur in a subset of individuals.
doi:10.1016/j.urology.2012.06.059
PMCID: PMC3804419  PMID: 23206765
19.  Inhibitory Effect of the Somatostatin Receptor Subtype-4 Agonist NNC 26-9100 on the Micturition Reflex in Rats 
Urology  2012;80(6):10.1016/j.urology.2012.07.007.
Objective
To investigate the effects of activation of sst4 on the micturition reflex in rats.
Methods
Continuous cystometrograms (0.04 ml/min infusion rate) were performed in female Sprague-Dawley rats (242-265 g) under urethane anesthesia. After stable micturition cycles were established, a selective sst4 receptor agonist, NNC 26-9100, was administered intravenously in normal rats or rats pretreated with capsaicin 4 days before the experiments. Micturition parameters were recorded and compared before and after drug administration.
Results
Intravenous administration of NNC 26-9100 (10 to 300 μg/kg) significantly increased intercontraction interval in dose dependent fashion. Intravenous administration of NNC 26-9100 (10 to 300 μg/kg) also significantly increased pressure threshold in dose dependent fashion. There were no significant changes in baseline pressure, maximum voiding pressure or post-void residual volume. However, NNC 26-9100-induced increases in intercontraction intervals and pressure threshold were not seen in rats with C-fiber desensitization induced by capsaicin pretreatment.
Conclusion
These results indicate that in urethane-anesthetized rats activation of sst4 receptor can inhibit the micturition reflex via suppression of capsaicin sensitive C-fiber afferent pathways. Thus sst4 receptor could be a potential target for the treatment of C-fiber afferent mediated bladder dysfunctions.
doi:10.1016/j.urology.2012.07.007
PMCID: PMC3829683  PMID: 22951005
bladder; somatostatin; capsaicin; cystometry; rats
20.  TEN-YEAR FOLLOW-UP OF NEOADJUVANT THERAPY WITH GOSERELIN ACETATE AND FLUTAMIDE PRIOR TO RADICAL PROSTATECTOMY FOR CLINICAL T3 AND T4 PROSTATE CANCER: UPDATE ON SOUTHWEST ONCOLOGY GROUP STUDY 9109 
Urology  2012;79(3):10.1016/j.urology.2011.11.019.
Purpose
The optimal management for clinical stage T3 and T4 (N0, M0) prostate cancer is uncertain. Herein we update the results with ten-year data of a phase II prospective trial of neoadjuvant hormonal therapy with goserelin acetate and flutamide followed by radical prostatectomy for locally-advanced prostate cancer (SWOG 9109).
Materials and Methods
62 patients with clinical stage T3 and T4 (N0, M0) prostate cancer were enrolled. Cases were classified by stage T3 versus T4 and by volume of disease (bulky > 4 cm and non-bulky ≤ 4 cm).
Results
A total of 55 of 61 eligible patients completed the trial with radical prostatectomy after neoadjuvant androgen deprivation therapy (ADT). The median pre-operative PSA value was 19.8 ng/ml, and 67% of patients had a Gleason score of 7 or higher. Among 41 patients last known to be alive, median follow-up is 10.6 years (range 5.1–12.6 years). In all, 38 patients have had disease progression (30/55, 55%) or died without progression (8/55, 15%) for a ten-year PFS estimate of 40% (95% CI, 27–53%). Median progression-free survival (PFS) was 7.5 years, and median survival has not been reached. The ten-year overall survival (OS) estimate is 68% (95% CI, 56–80%).
Conclusions
In this small, prospective phase II study, neoadjuvant hormonal therapy with goserelin acetate and flutamide followed by radical prostatectomy achieves long-term PFS and OS comparable to alternative treatments. This approach is feasible and may be an alternative to a strategy of combined radiation and ADT.
doi:10.1016/j.urology.2011.11.019
PMCID: PMC3839235  PMID: 22386416
prostate cancer; PSA; radical prostatectomy; survival; locally-advanced
21.  Canary Prostate Active Surveillance Study (PASS); Design of a Multi-institutional Active Surveillance Cohort and Biorepository 
Urology  2009;75(2):10.1016/j.urology.2009.05.050.
Active surveillance is a management plan for localized prostate cancer that offers selective delayed intervention upon indication of disease progression, allowing patients to delay or avoid treatment and associated side-effects. Outcomes from centers that promote active surveillance are favorable, with high rates of disease-specific survival. However, there remains a need for prognostic variables or biomarkers that distinguish with high specificity the aggressive cancers that progress on surveillance from the indolent cancers. The Canary Prostate Active Surveillance Study(PASS) is a multicenter study and biorepository that will discover and confirm biomarkers of aggressive disease as defined by histologic, PSA, or clinical criteria.
doi:10.1016/j.urology.2009.05.050
PMCID: PMC3827723  PMID: 19758683
Prostate cancer; Active Surveillance; Clinical Trial
22.  Certificate of need regulations and the diffusion of intensity-modulated radiotherapy 
Urology  2012;80(5):1015-1020.
Objective
To better understand the associations between certificate of need regulations and intensity-modulated radiotherapy (IMRT) dissemination.
Methods
Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, we identified men (66 years or older) treated with radiotherapy for prostate cancer diagnosed between 2001 and 2007. Based on data from the American Health Planning Association, we sorted Health Service Areas (HSAs) according to the stringency of certificate of need regulations (low vs. high) in that market. We assessed our outcomes (i.e., the probability of IMRT adoption and IMRT utilization in HSAs) using Cox proportional-hazards and Poisson regression models, respectively.
Results
Low and high stringency markets were similar in terms of racial composition (80% vs. 85% white, p=0.08), population density (1,085 vs. 558 people/square mile, p=0.08), and income (median: $38,683 vs. 40,309, p=0.44), but low stringency markets had more patients with stage T1 disease (45% vs. 36%, p<0.01). The probability of IMRT adoption across the two groups of HSAs was similar (p=0.65). However, among adopting HSAs, those with high stringency consistently had greater use of IMRT (p<0.01).
Conclusions
Certificate of need regulations fail to create significant barriers to entry for IMRT. Among HSAs that acquire IMRT, high stringency markets demonstrate a greater propensity for using IMRT. These findings raise questions regarding the ability of certificate of need regulations to control technology dissemination.
doi:10.1016/j.urology.2012.07.042
PMCID: PMC3505690  PMID: 22999447
intensity-modulated radiotherapy; certificate of need; adoption; utilization; health service area
23.  Timing of Orchiopexy in the United States: A Quality-of-Care Indicator 
Urology  2012;80(5):1121-1126.
Objective
To investigate whether orchiopexies are occurring later than recommended by American Academy of Pediatrics 1996 guidelines (around age one). Adherence to guidelines is poorly studied.
Methods
Main Cohort: 4,103 boys insured from birth (Innovus i3, insurance claims database) Complementary cohort: 17,010 insured and non-insured boys (Pediatric Health Information System, PHIS)
Inclusion criteria: age ≤5 years at time of ICD-9-defined cryptorchidism diagnosis Primary outcome: timely surgery (orchiopexy by age 18 months)
Results
In Innovus, 87% of boys who underwent an orchiopexy had a timely orchiopexy. Of those who did not undergo surgery (n=2738), 90% had at least one subsequent well-care visit. Those who underwent timely surgery were referred to a surgeon at a younger age compared with those who underwent late surgery (4.1 months vs. 16.1 months, p<.00005). Predictors of timely surgery were number of well-care visits (OR 1.5, 95% CI 1.3–1.7), continuity of primary care (OR 1.9, 95% CI 1.3–2.7), and use of laparoscopy (OR 4.5, 95% CI 1.4–14.9). Family/internal medicine as referring provider was predictive of delayed surgery (OR 0.5, 95% CI 0.3–0.8). In PHIS, 61% of those with private insurance had timely surgery compared with 54% of those without private insurance (p< 0.0001).
Conclusions
We found an unexpectedly high adherence to guidelines in our continuously insured since birth Innovus population. Primary care continuity and well-care visits were associated with timely surgery. Further studies can confirm these findings in non-privately insured patients with the ultimate goal of instituting quality improvement initiatives.
doi:10.1016/j.urology.2012.08.008
PMCID: PMC3753094  PMID: 23107402
cryptorchidism; health services research; orchiopexy; pediatrics; quality indicators; healthcare
24.  Durability of anti-reflux effect of ureteral reimplantation for primary vesicoureteral reflux: findings on long-term cystography 
Urology  2012;79(3):675-679.
Objectives
Ureteral reimplantation (UR) is the gold standard for the surgical treatment of vesicoureteral reflux (VUR) but few studies have documented its long-term results. We reviewed late cystography (LC) results following successful UR.
Methods
We performed a retrospective chart review of all children with primary VUR who underwent successful open UR (grade 0 VUR into the reimplanted ureter(s) on initial cystogram) at our institution from January 1990 – December 2002. We identified successful UR patients who underwent LC ≥ 1 year after UR and reviewed the results for the presence of recurrent VUR into the reimplanted ureter(s).
Results
794 patients underwent successful open UR for primary VUR, of whom 60 (7.6%) had a subsequent LC. Preoperative VUR grade was ≤II in 20 (34.5%), ≥III in 38 (65.5%). Median age at UR was 3.5 years (IQR: 1.3–6.2 years); 51 (85%) were female. UR was intravesical in 45 (75%) and bilateral in 19 (32%). LC was performed at a median of 38.7 months after UR (IQR: 19.6–66.1 months). Indication for LC was febrile UTI in 16 (27%), non-febrile UTI’s in 15 (25%), follow-up of contralateral VUR in 16 (27%) and other clinical indications in 13 (21%). The recurrence rate was 0%; of the 79 reimplanted ureters, 100% (95% CI: 95.4–100) had no VUR (grade 0).
Conclusions
Among children who underwent successful open UR for primary VUR, there was no VUR recurrence on extended follow-up. This suggests that the late durability of open anti-reflux surgery is excellent.
doi:10.1016/j.urology.2011.11.005
PMCID: PMC3792793  PMID: 22245304
Vesico-ureteral reflux; Surgical Procedures; Operative; Follow-up Studies; Urinary Tract Infections
25.  Differences in the frequency of ERG oncoprotein expression between index tumors of Caucasian American and African American prostate cancer patients 
Urology  2012;80(4):749-753.
OBJECTIVE
Tosystematically evaluate ERG alterations in the multifocal tumor context by using whole-mount prostatectomy specimens of African American and Caucasian American patients matched for age, pathologic grade and stage. Oncogenic activation of the ETS-Related Gene (ERG) is the most common early genomic alteration in prostate cancer patients in Western countries. However, ERG alterations have not been systematically examined in African American patients with known higher risk of prostate cancer incidence and mortality.
METHODS
ERG oncoprotein expression was analyzed in 91 Caucasian American and 91 African American prostate cancer patients matched for age, Gleason score and pathologic stage. A unique aspect of this study was the evaluation of ERG in whole-mount prostatectomy sections, minimizing sampling bias and allowing the careful assessment of ERG in the multifocal tumor context of prostate cancer.
RESULTS
The frequency of ERG positive prostate tumors was significantly greater among Caucasian Americans vs. African Americans when assessed in all tumor foci (41.9% vs. 23.9%, p<0.0001). Markedly higher frequency of the ERG oncoprotein expression was noted between the index tumors of Caucasian Americans (63.3%) and African Americans (28.6%). Of note, in African American patients the higher grade index tumors were predominantly ERG negative.
CONCLUSIONS
ERG typing of prostate tumors establishes a major difference between the index tumors of Caucasian and African American patients. ERG negative index tumors may indicate less favorable outcome in African American patients. This study underscores that typing of prostate tumors for ERG may enhance our understanding of biological differences between the examined ethnic groups.
doi:10.1016/j.urology.2012.07.001
PMCID: PMC3462242  PMID: 22950997

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