When to Biopsy the Seminal Vesicles: A Validated Multiparametric Magnetic Resonance Imaging and Target Driven Model to Detect Seminal Vesicle Invasion of Prostate Cancer.

PURPOSE: Current imaging and biopsy practices offer limited insight into preoperative detection of seminal vesicle invasion despite the implications for treatment decisions and patient prognoses. We identified magnetic resonance imaging features to assess the risk of seminal vesicle invasion and inform the inclusion of seminal vesicle sampling during biopsy. MATERIALS AND METHODS: Patients underwent multiparametric magnetic resonance imaging and fusion targeted biopsy with or without seminal vesicle biopsy. Magnetic resonance imaging suspicion of seminal vesicle invasion, multiparametric magnetic resonance imaging of prostate base lesions of moderate or greater suspicion, extraprostatic extension, anatomical zone and biopsy data were used to generate multivariable logistic regression models. One model without and one with biopsy data were externally validated in a multi-institutional cohort. Decision curve analyses were done to determine net benefit of the 2 models. RESULTS: The training and validation cohorts comprised 564 and 250 patients, respectively. In the training cohort 55 patients (9.8%) had pathologically confirmed seminal vesicle invasion. In the prebiopsy model magnetic resonance imaging suspicion of seminal vesicle invasion (OR 9.5, 95% CI 4.0-22.4, p <0.001), multiparametric magnetic resonance imaging base lesions of moderate or greater suspicion with extraprostatic extension (OR 13.6, 95% CI 4.0-46.5, p <0.001), and a transition and/or central zone location (OR 11.6, 95% CI 3.5-38.3, p <0.001) showed strong correlations. In the post-biopsy model the risk of pathologically confirmed seminal vesicle invasion increased with the base Gleason Group (Gleason Group 5 OR 85.3, 95% CI 11.8-619.1, p <0.001). In the validation cohort the AUC of the prebiopsy and post-biopsy models was 0.84 and 0.93, respectively (p = 0.030). CONCLUSIONS: Magnetic resonance imaging evidence of seminal vesicle invasion or extraprostatic extension at the prostate base transition and/or central zone and high grade prostate cancer from the prostate base are significant features associated with an increased risk of pathologically confirmed seminal vesicle invasion. Our models successfully incorporated these features to predict seminal vesicle invasion and inform when to biopsy the seminal vesicles.

Predicting Gleason Group Progression for Men on Prostate Cancer Active Surveillance: Role of a Negative Confirmatory Magnetic Resonance Imaging-Ultrasound Fusion Biopsy.

PURPOSE: Active surveillance has gained acceptance as an alternative to definitive therapy in many men with prostate cancer. Confirmatory biopsies to assess the appropriateness of active surveillance are routinely performed and negative biopsies are regarded as a favorable prognostic indicator. We sought to determine the prognostic implications of negative multiparametric magnetic resonance imaging-transrectal ultrasound guided fusion biopsy consisting of extended sextant, systematic biopsy plus multiparametric magnetic resonance imaging guided targeted biopsy of suspicious lesions on magnetic resonance imaging. MATERIALS AND METHODS: All patients referred with Gleason Grade Group 1 or 2 prostate cancer based on systematic biopsy performed elsewhere underwent confirmatory fusion biopsy. Patients who continued on active surveillance after a positive or a negative fusion biopsy were followed. The baseline characteristics of the biopsy negative and positive cases were compared. Cox regression analysis was used to determine the prognostic significance of a negative fusion biopsy. Kaplan-Meier survival curves were used to estimate Grade Group progression with time. RESULTS: Of the 542 patients referred with Grade Group 1 (466) or Grade Group 2 (76) cancer 111 (20.5%) had a negative fusion biopsy. A total of 60 vs 122 patients with a negative vs a positive fusion biopsy were followed on active surveillance with a median time to Grade Group progression of 74.3 and 44.6 months, respectively (p <0.01). Negative fusion biopsy was associated with a reduced risk of Grade Group progression (HR 0.41, 95% CI 0.22-0.77, p <0.01). CONCLUSIONS: A negative confirmatory fusion biopsy confers a favorable prognosis for Grade Group progression. These results can be used when counseling patients about the risk of progression and for planning future followup and biopsies in patients on active surveillance.

Use of multiparametric magnetic resonance imaging and fusion-guided biopsies to properly select and follow African-American men on active surveillance.

OBJECTIVES: To determine the rate of Gleason Grade Group (GGG) upgrading in African-American (AA) men with a prior diagnosis of low-grade prostate cancer (GGG 1 or GGG 2) on 12-core systematic biopsy (SB) after multiparametric magnetic resonance imaging (mpMRI) and fusion biopsy (FB); and whether AA men who continued active surveillance (AS) after mpMRI and FB fared differently than a predominantly Caucasian (non-AA) population. PATIENTS AND METHODS: A database of men who had undergone mpMRI and FB was queried to determine rates of upgrading by FB amongst men deemed to be AS candidates based on SB prior to referral. After FB, Kaplan-Meier curves were generated for AA men and non-AA men who then elected AS. The time to GGG upgrading and time continuing AS were compared using the log-rank test. RESULTS: AA men referred with GGG 1 disease on previous SB were upgraded to GGG ≥3 by FB more often than non-AA men, 22.2% vs 12.7% (P = 0.01). A total of 32 AA men and 258 non-AA men then continued AS, with a median (interquartile range) follow-up of 39.19 (24.24-56.41) months. The median time to progression was 59.7 and 60.5 months, respectively (P = 0.26). The median time continuing AS was 61.9 months and not reached, respectively (P = 0.80). CONCLUSIONS: AA men were more likely to be upgraded from GGG 1 on SB to GGG ≥3 on initial FB; however, AA and non-AA men on AS subsequently progressed at similar rates following mpMRI and FB. A greater tendency for SB to underestimate tumour grade in AA men may explain prior studies that have shown AA men to be at higher risk of progression during AS.

Follow-up of negative MRI-targeted prostate biopsies: when are we missing cancer?

INTRODUCTION: Multiparametric magnetic resonance imaging (mpMRI) has improved clinicians' ability to detect clinically significant prostate cancer (csPCa). Combining or fusing these images with the real-time imaging of transrectal ultrasound (TRUS) allows urologists to better sample lesions with a targeted biopsy (Tbx) leading to the detection of greater rates of csPCa and decreased rates of low-risk PCa. In this review, we evaluate the technical aspects of the mpMRI-guided Tbx procedure to identify possible sources of error and provide clinical context to a negative Tbx. METHODS: A literature search was conducted of possible reasons for false-negative TBx. This includes discussion on false-positive mpMRI findings, termed "PCa mimics," that may incorrectly suggest high likelihood of csPCa as well as errors during Tbx resulting in inexact image fusion or biopsy needle placement. RESULTS: Despite the strong negative predictive value associated with Tbx, concerns of missed disease often remain, especially with MR-visible lesions. This raises questions about what to do next after a negative Tbx result. Potential sources of error can arise from each step in the targeted biopsy process ranging from "PCa mimics" or technical errors during mpMRI acquisition to failure to properly register MRI and TRUS images on a fusion biopsy platform to technical or anatomic limits on needle placement accuracy. CONCLUSIONS: A better understanding of these potential pitfalls in the mpMRI-guided Tbx procedure will aid interpretation of a negative Tbx, identify areas for improving technical proficiency, and improve both physician understanding of negative Tbx and patient-management options.

Comparison of Elastic and Rigid Registration during Magnetic Resonance Imaging/Ultrasound Fusion-Guided Prostate Biopsy: A Multi-Operator Phantom Study.

PURPOSE: The relative value of rigid or elastic registration during magnetic resonance imaging/ultrasound fusion guided prostate biopsy has been poorly studied. We compared registration errors (the distance between a region of interest and fiducial markers) between rigid and elastic registration during fusion guided prostate biopsy using a prostate phantom model. MATERIALS AND METHODS: Four gold fiducial markers visible on magnetic resonance imaging and ultrasound were placed throughout 1 phantom prostate model. The phantom underwent magnetic resonance imaging and the fiducial markers were labeled as regions of interest. An experienced user and a novice user of fusion guided prostate biopsy targeted regions of interest and then the corresponding fiducial markers on ultrasound after rigid and then elastic registration. Registration errors were compared. RESULTS: A total of 224 registration error measurements were recorded. Overall elastic registration did not provide significantly improved registration error over rigid registration (mean ± SD 4.87 ± 3.50 vs 4.11 ± 2.09 mm, p = 0.05). However, lesions near the edge of the phantom showed increased registration errors when using elastic registration (5.70 ± 3.43 vs 3.23 ± 1.68 mm, p = 0.03). Compared to the novice user the experienced user reported decreased registration error with rigid registration (3.25 ± 1.49 vs 4.98 ± 2.10 mm, p <0.01) and elastic registration (3.94 ± 2.61 vs 6.07 ± 4.16 mm, p <0.01). CONCLUSIONS: We found no difference in registration errors between rigid and elastic registration overall but rigid registration decreased the registration error of targets near the prostate edge. Additionally, operator experience reduced registration errors regardless of the registration method. Therefore, elastic registration algorithms cannot serve as a replacement for attention to detail during the registration process and anatomical landmarks indicating accurate registration when beginning the procedure and before targeting each region of interest.

Added Value of Multiparametric Magnetic Resonance Imaging to Clinical Nomograms for Predicting Adverse Pathology in Prostate Cancer.

PURPOSE: We examined the additional value of preoperative prostate multiparametric magnetic resonance imaging and transrectal ultrasound/multiparametric magnetic resonance imaging fusion guided targeted biopsy when performed in combination with clinical nomograms to predict adverse pathology at radical prostatectomy. MATERIALS AND METHODS: We identified all patients who underwent 3 Tesla multiparametric magnetic resonance imaging prior to fusion biopsy and radical prostatectomy. The Partin and the MSKCC (Memorial Sloan Kettering Cancer Center) preradical prostatectomy nomograms were applied to estimate the probability of organ confined disease, extraprostatic extension, seminal vesicle invasion and lymph node involvement using transrectal ultrasound guided systematic biopsy and transrectal ultrasound/multiparametric magnetic resonance imaging fusion guided targeted biopsy Gleason scores. With radical prostatectomy pathology as the gold standard we developed multivariable logistic regression models based on these nomograms before and after adding multiparametric magnetic resonance imaging to assess any additional predictive ability. RESULTS: A total of 532 patients were included in study. When multiparametric magnetic resonance imaging findings were added to the systematic biopsy based MSKCC nomogram, the AUC increased by 0.10 for organ confined disease (p <0.001), 0.10 for extraprostatic extension (p = 0.003), 0.09 for seminal vesicle invasion (p = 0.011) and 0.06 for lymph node involvement (p = 0.120). Using Gleason scores derived from targeted biopsy compared to systematic biopsy provided an additional predictive value of organ confined disease (Δ AUC 0.07, p = 0.003) and extraprostatic extension (Δ AUC 0.07, p = 0.048) at radical prostatectomy with the MSKCC nomogram. Similar results were obtained using the Partin nomogram. CONCLUSIONS: Magnetic resonance imaging alone or in addition to standard clinical nomograms provides significant additional predictive ability of adverse pathology at the time of radical prostatectomy. This information can be greatly beneficial to urologists for preoperative planning and for counseling patients regarding the risks of future therapy.

Targeted biopsy: benefits and limitations.

PURPOSE OF REVIEW: To review the current literature regarding the role of multiparametric MRI and fusion-guided biopsies in urologic practice. RECENT FINDINGS: Fusion biopsies consistently show an increase in the detection of clinically significant cancers and decrease in low-risk disease that may be more suitable for active surveillance. Although, when to incorporate multiparametric MRI into workup is not clearly agreed upon, studies have shown a clear benefit in both biopsy naïve and those with prior negative biopsies in determining the appropriate treatment strategy. More recently, cost-analysis models have been published that show that upfront MRIs are more cost-effective when considering missed cancers and treatment courses. SUMMARY: With improved accuracy over systematic biopsies, fusion biopsies are a superior method for detection of the true grade of cancer for both biopsy naïve and patients with prior negative biopsies, choosing appropriate candidates for active surveillance, and monitoring progression on active surveillance.

Risk of adverse pathology at prostatectomy in the era of MRI and targeted biopsies; rethinking active surveillance for intermediate risk prostate cancer patients.

PURPOSE: Men with intermediate risk (IR) prostate cancer (CaP) are often excluded from active surveillance (AS) due to higher rates of adverse pathology (AP). We determined our rate of AP in men who underwent multiparametric MRI (MpMRI) with combined biopsy (CB) consisting of targeted biopsy (TB) and systematic biopsy (SB) prior to radical prostatectomy (RP). METHODS: A retrospective review was conducted of men with Gleason Grade Group (GG) 2 disease who underwent RP after SB alone or after preoperative MRI with CB. AP was defined as either pathologic stage T3a (AP ≥ T3a) or pathologic stage T3b (AP ≥ T3b) and/or GG upgrading. Rates of AP were determined for both groups and those who fit the National Comprehensive Cancer Network (NCCN) definition of favorable IR (FIR) or the low volume IR (LVIR) criteria. Multivariable logistic regression was used to determine predictive factors. RESULTS: The overall rate of AP ≥ T3b was 21.2% in the SB group vs. 8.6% in the MRI with CB group, P = 0.006. This rate was lowered to 6.8% and 5.6% when men met the definition of NCCN FIR or LVIR, respectively. Suspicion for extraprostatic extension (EPE) (OR 7.65, 95% CI 1.77-33.09, P = 0.006) and positive cores of GG 2 on SB (OR 1.43, 95% CI 1.05-1.96, P = 0.023) were significant for predicting AP ≥ T3b. CONCLUSIONS: Rates of AP at RP after MRI with CB are lower than studies prior to the adoption of this technology, suggesting that more men with IR disease may be considered for AS. However, increasing cores positive on SB and MRI findings suggestive of EPE remain unsafe.

Comparison of cross-sectional imaging techniques for the detection of prostate cancer lymph node metastasis: a critical review.

Conventional staging for prostate cancer (PCa) is performed for men diagnosed with unfavorable-intermediate or higher risk disease. Computed tomography (CT) of the abdomen and pelvis and whole body bone scan remains the standard of care for the detection of visceral, nodal, and bone metastasis. The implementation of the 2012 United States Preventive Services Task Force recommendation against routine prostate specific antigen (PSA) screening resulted in a rise of metastatic PCa at the time of diagnosis, emphasizing the importance of effective imaging modalities for evaluating metastatic disease. CT plays a major role in clinical staging at the time of PCa diagnosis, but multi-parametric magnetic resonance imaging (MRI) is now integrated into many prostate biopsy protocols for the detection of primary PCa, and may be a surrogate for CT for nodal staging. Current guidelines incorporate both CT and MRI as appropriate cross-sectional imaging modalities for the identification of nodal metastasis in indicated patients. There is an ongoing debate about the utility of traditional cross-sectional imaging modalities as well as advanced imaging modalities in detection of both organ-confined PCa detection and nodal involvement.

Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database.

Introduction and Objectives: Multiple surgical therapies for benign prostatic hyperplasia (BPH) have been developed to decrease complications and increase provider efficiency. We investigated contemporary BPH treatment device-related adverse events by searching a publicly available database. Materials and Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for contemporary BPH treatments. All devices were evaluated for malfunction, patient complications, and manufacturer review. The MAUDE adverse event classification system was used to standardize complications. Univariate analysis was performed to identify associations between BPH devices and adverse events. Results: A total of 2567 reports were identified: transurethral resection of the prostate (TURP) 197 (7.67%), holmium laser enucleation of the prostate (HoLEP) 39 (1.52%), GreenLight™ 2315 (90.2%), and UroLift® 16 (0.62%). The most common deviations for each modality included cutting loop detachment during TURP 116 (58.9%), morcellator dysfunction for HoLEP 23 (58.9%), tip fracture/detachment for GreenLight (68.8%), and failure to deploy during UroLift 10 (62.5%). Only 18 (0.7%) patients required medical/surgical management (MAUDE II-IV) due to a device complication. No significant relationship was seen between each modality and complications; however, morcellator use (27.8%) was observed in higher grade complications. Manufacturer review occurred in 61.7% of cases, with 41.3% of reviewed cases finding the operator the cause of the malfunction. Conclusion: Each BPH modality investigated had minimal patient harm with over 99% of patients experiencing no complication after device malfunction. Of note, great care should be taken with morcellator use during HoLEP as it had the greatest number of MAUDE II to IV complications among all devices. Manufacturer review revealed that over 40% of cases were due to misuse by the user. Therefore, urologists should select the modalities they are most familiar with to decrease patient harm and prevent device malfunctions.

Contemporary Trends in Percutaneous Nephrolithomy Across New York State: A Review of the Statewide Planning and Research Cooperative System.

Introduction and Objectives: Percutaneous nephrolithotomy (PCNL) is a complex multistep surgery that has shown a steady increase in use for the past decade in the United States. We sought to evaluate the trends and factors associated with PCNL usage across New York State (NYS). Our goal was to characterize patient demographics and socioeconomic factors across high-, medium-, and low-volume institutions. Materials and Methods: We searched the NYS, Statewide Planning and Research Cooperative System (SPARCS) database from 2006 to 2014 using ICD-9 Procedure Codes 55.04 (percutaneous nephrostomy with fragmentation) for all hospital discharges. Patient demographics including age, gender, race, insurance status, and length of hospital stay were obtained. We characterized each hospital as a low-, medium-, or high-volume center by year. Patient and hospital demographics were compared and reported using chi-square analysis and Student's t-test for categorical and continuous variables, respectively, with statistical significance as a p-value of <0.05. Results: We identified a total of 4576 procedures performed from 2006 to 2014 at a total of 77 hospitals in NYS (Table 1). Total PCNL volume performed across all NYS hospitals increased in the past decade, with the greatest number of procedures performed in 2012 to 2013. Low-volume institutions were more likely to provide care to minority populations (21.4% vs 17.3%, p < 0.001) and those with Medicaid (25.5% vs 21.5%, p < 0.001). High-volume institutions provided care to patients with private insurance (42.1% vs 34.0%, p < 0.001) and had a shorter length of stay (3.3 days vs 4.1 days, p < 0.001). Conclusion: Our data provide insight into the patient demographics of those treated at high-, medium-, and low-volume hospitals for PCNL across NYS. Significant differences in race, insurance status, and length of stay were noted between low- and high-volume institutions, indicating that racial and socioeconomic factors play a role in access to care at high-volume centers.

mpMRI preoperative staging in men treated with antiandrogen and androgen deprivation therapy before robotic prostatectomy.

INTRODUCTION: Using multiparametric magnetic resonance imaging (mpMRI), we sought to preoperatively characterize prostate cancer (PCa) in the setting of antiandrogen plus androgen deprivation therapy (AA-ADT) prior to robotic-assisted radical prostatectomy (RARP). We present our preliminary findings regarding mpMRI depiction of changes of disease staging features and lesion appearance in treated prostate. METHODS: Prior to RARP, men received 6 months of enzalutamide and goserelin. mpMRI consisting of T2 weighted, b = 2,000 diffusion weighted imaging, apparent diffusion coefficient mapping, and dynamic contrast enhancement sequences was acquired before and after neoadjuvant therapy. Custom MRI-based prostate molds were printed to directly compare mpMRI findings to H&E whole-mount pathology as part of a phase II clinical trial (NCT02430480). RESULTS: Twenty men underwent imaging and RARP after a regimen of AA-ADT. Positive predictive values for post-AA-ADT mpMRI diagnosis of extraprostatic extension, seminal vesicle invasion, organ-confined disease, and biopsy-confirmed PCa lesions were 71%, 80%, 80%, and 85%, respectively. Post-treatment mpMRI correctly staged disease in 15/20 (75%) cases with 17/20 (85%) correctly identified as organ-confined or not. Of those incorrectly staged, 2 were falsely positive for higher stage features and 1 was falsely negative. Post-AA-ADT T2 weighted sequences best depicted presence of PCa lesions as compared to diffusion weighted imaging and dynamic contrast enhancement sequences. CONCLUSION: mpMRI proved reliable in detecting lesion changes after antiandrogen therapy corresponding to PCa pathology. Therefore, mpMRI of treated prostates may be helpful for assessing men for surgical planning and staging.

Detection of lymph node metastases in penile cancer.

Penile cancer (PC) is a relatively rare malignancy in the United States (US) but a greater concern in developing nations. Lymph node imaging remains critical to the staging and treatment of this disease as metastases develop in a predictable, anatomic fashion. Early surgical intervention remains a mainstay in treatment and imaging often aids in decision making. This review highlights the indications for imaging in both low-stage and advanced disease. Furthermore, we discuss the benefits and limitations of currently available imaging for staging of inguinal and pelvic lymph nodes in PC and novel modalities in development.

Lymph node imaging in testicular cancer.

Testicular cancer is a rare malignancy mainly affecting young men. Survival for testicular cancer remains high due to the effectiveness of multimodal treatment options. Accurate imaging is imperative to both treatment and follow-up. Both computed tomography (CT) and magnetic resonance imaging (MRI) suffer from size cut-offs as the only distinguishing characteristic of benign vs. malignant lymph nodes and may miss up to 30% of micro-metastatic disease. While functional [positron emission tomography (PET)] imaging may rule out disease in patients with seminoma who have undergone chemotherapy, there is insufficient evidence to recommend its use in other settings. This review highlights the uses and pitfalls of conventional imaging during staging, active surveillance, and post-treatment phases of both seminomatous and non-seminomatous germ cell tumors (NSGCT).

Percutaneous and Endoscopic Management of Nephrolithiasis in a Patient with Five Native Ureters (Trifid Right and Bifid Left Collecting System).

Triplication of the ureter is a rare urologic finding that has been well described in the literature. Patients can present with urinary tract infections, incontinence, and calculi. We present the case of a patient with extensive stone burden with right trifid and left bifid collecting systems. Stone management was performed with a multimodal approach using a combination of endoscopic and percutaneous approaches. Our systematic and staged approach highlights a method for efficacious stone treatment in a complex endourologic case.

"Super-active surveillance": MRI ultrasound fusion biopsy and ablation for less invasive management of prostate cancer.

Multiparametric magnetic resonance imaging (mpMRI) of the prostate has allowed clinicians to better visualize and target suspicious lesions during biopsy. Targeted prostate biopsies give a more accurate representation of the true cancer volume and stage so that appropriate treatment or active surveillance can be selected. Advances in technology have led to the development of MRI and ultrasound fusion platforms used for targeted biopsies, monitoring cancer progression, and more recently for the application of focal therapy. Lesions visualized on mpMRI can be targeted for ablation with a variety of energy sources employed under both local and general anesthesia. Focal ablation may offer an alternative option for treating prostate cancer as compared to the well-established interventions of whole-gland radiation or prostatectomy. Focal ablation may also be an option for patients on active surveillance who wish to be even more "active" in their surveillance. In this review, we describe the advancements and development of fusion biopsies, the rationale behind focal therapy, and introduce focal ablative techniques for indolent prostate cancers ("super-active surveillance"), including cryoablation and focal laser ablation (FLA) and the subsequent MRI/biopsy surveillance.

Incidental bladder cancers found on multiparametric MRI of the prostate gland: a single center experience.

PURPOSE: In the era of multiparametric magnetic resonance imaging (mpMRI) of the prostate gland, incidental findings are occasionally discovered on imaging. We aimed to report our experience of detecting incidental bladder cancers on mpMRI of the prostate in asymptomatic patients without irritative voiding symptoms or microscopic or gross hematuria. METHODS: A retrospective review was performed on a prospectively maintained database of all men who underwent prostate mpMRI at our institution from 2012 to 2018. Patients who were found to have incidental bladder lesions were identified and baseline demographics, imaging and histopathologic data were recorded. All patients with incidental bladder lesion detection on mpMRI, not attributable to extension of prostate cancer, underwent cystoscopy in addition to a biopsy and/or transurethral resection of bladder tumor (TURBT) if warranted on cystoscopy. RESULTS: There were 3147 prostate mpMRIs performed during this period and 25 cases (0.8%) of incidental bladder lesions were detected. These patients did not have any presenting symptoms such as gross or microscopic hematuria to prompt bladder lesion workup. The largest diameter of incidentally discovered bladder lesions ranged from 0.4 cm to 1.7 cm. Of the 25 cases of incidental bladder lesions, five were suspected to be due to prostate cancer invasion into the bladder. Only two of these five patients underwent biopsy, which confirmed prostate adenocarcinoma in both cases. Of the 20 patients without suspected prostate cancer invasion of the bladder, four had no suspicious lesions on cystoscopy to warrant a biopsy. The remaining 16 patients had bladder lesions seen on cystoscopy and underwent a biopsy and/or TURBT. Three of these patients had benign features on pathology (urachal remnant, amyloidosis and inflammation) and the remaining 13 had stage Ta urothelial carcinoma. Seven of these patients had low-grade Ta tumors and six had high-grade Ta tumors. All patients were treated with standard management of TURBT with or without intravesical BCG. There have been no reported cases of recurrence or progression in any of the patients in our cohort at the median follow-up of 26 months (interquartile range,19-40 months). CONCLUSION: mpMRI of the prostate may yield incidental findings, such as small bladder tumors. Awareness of the possibility of incidental bladder lesions is important as 65% of lesions reported in the bladder, not attributable to extension of prostate cancer, proved to be bladder cancer. This may allow for early intervention for asymptomatic patients with undetected bladder cancer prior to disease progression.

Device-Related Adverse Events During Percutaneous Nephrolithotomy: Review of the Manufacturer and User Facility Device Experience Database.

INTRODUCTION AND OBJECTIVES: Percutaneous nephrolithotomy (PCNL) is an established technique for removal of large stones from the upper urinary tract. It is a complex multistep procedure requiring several classes of instruments that are subject to operator misuse and device malfunction. We report device-related adverse events during PCNL from the Manufacturer and User Facility Device Experience (MAUDE) database using a recently developed standardized classification system. MATERIALS AND METHODS: The MAUDE database was queried for "percutaneous nephrolithotomy" from 2006 to 2016. The circumstances and patient complications associated with classes of devices used during PCNL were identified. We then utilized a novel MAUDE classification system to categorize clinical events. Logistic regression analysis was performed to identify associations between device classes and severe adverse events. RESULTS: A total of 218 device-related events were reported. The most common classes included: lithotripter 53 (24.3%), wires 43 (19.7%), balloon dilators 30 (13.8%), and occlusion balloons 28 (12.8%). Reported patient complications included need for a second procedure 12 (28.6%), bleeding 8 (19.0%), retained fragments 7 (16.7%), prolonged procedure 4 (9.5%), ureteral injury 2 (4.8%), and conversion to an open procedure 3 (7.1%). Using a MAUDE classification system, 176 complications (81%) were Level I (mild/none), 26 (12%) were Level II (moderate), 15 (7%) were Level III (severe), and 1 (0.5%) was Level IV (life threatening). On univariate analysis, balloon dilators had the highest risk of Level II-IV complications compared with the other device classes [odds ratio: 4.33, confidence interval: 1.978, 9.493, p < 0.001]. The device was evaluated by the manufacturer in 93 (42.7%) cases, with 54.8% of reviewed cases listing the source of malfunction as misuse by the operator. CONCLUSIONS: PCNL is subject to a wide range of device-related adverse events. A MAUDE classification system is useful for standardized, clinically-relevant reporting of events. Our findings highlight the importance of proper surgeon training with devices to maximize efficiency and decrease harm.