A Safe Framework for Quantitative In Vivo Human Evaluation of Image Guidance.

Goal: We present a new framework for in vivo image guidance evaluation and provide a case study on robotic partial nephrectomy. Methods: This framework (called the "bystander protocol") involves two surgeons, one who solely performs the therapeutic process without image guidance, and another who solely periodically collects data to evaluate image guidance. This isolates the evaluation from the therapy, so that in-development image guidance systems can be tested without risk of negatively impacting the standard of care. We provide a case study applying this protocol in clinical cases during robotic partial nephrectomy surgery. Results: The bystander protocol was performed successfully in 6 patient cases. We find average lesion centroid localization error with our IGS system to be 6.5 mm in vivo compared to our prior result of 3.0 mm in phantoms. Conclusions: The bystander protocol is a safe, effective method for testing in-development image guidance systems in human subjects.

Are 3D Image Guidance Systems Ready for Use? A Comparative Analysis of 3D Image Guidance Implementations in Minimally Invasive Partial Nephrectomy.

Introduction: Three-dimensional image-guided surgical (3D-IGS) systems for minimally invasive partial nephrectomy (MIPN) can potentially improve the efficiency and accuracy of intraoperative anatomical localization and tumor resection. This review seeks to analyze the current state of research regarding 3D-IGS, including the evaluation of clinical outcomes, system functionality, and qualitative insights regarding 3D-IGS's impact on surgical procedures. Methods: We have systematically reviewed the clinical literature pertaining to 3D-IGS deployed for MIPN. For inclusion, studies must produce a patient-specific 3D anatomical model from two-dimensional imaging. Data extracted from the studies include clinical results, registration (alignment of the 3D model to the surgical scene) method used, limitations, and data types reported. A subset of studies was qualitatively analyzed through an inductive coding approach to identify major themes and subthemes across the studies. Results: Twenty-five studies were included in the review. Eight (32%) studies reported clinical results that point to 3D-IGS improving multiple surgical outcomes. Manual registration was the most utilized (48%). Soft tissue deformation was the most cited limitation among the included studies. Many studies reported qualitative statements regarding surgeon accuracy improvement, but quantitative surgeon accuracy data were not reported. During the qualitative analysis, six major themes emerged across the nine applicable studies. They are as follows: 3D-IGS is necessary, 3D-IGS improved surgical outcomes, researcher/surgeon confidence in 3D-IGS system, enhanced surgeon ability/accuracy, anatomical explanation for qualitative assessment, and claims without data or reference to support. Conclusions: Currently, clinical outcomes are the main source of quantitative data available to point to 3D-IGS's efficacy. However, the literature qualitatively suggests the benefit of accurate 3D-IGS for robotic partial nephrectomy.

From Consensus to Validation: A Multicenter Study for Design and Development of a Holmium Laser Enucleation of the Prostate Hydrogel Simulation Platform.

Background: Holmium laser enucleation of the prostate (HoLEP) has emerged as a new gold standard for treatment of benign prostatic hyperplasia; however, its steep learning curve hinders generalization of this technique. Therefore, there is a need for a benchtop HoLEP simulator to reduce this learning curve and provide training. We have developed a nonbiohazardous HoLEP simulator using modern education theory and validated it in a multicenter study. Materials and Methods: Six experts established key components for a HoLEP simulator through a Delphi consensus over three rounds including 250 questions. After consensus, a digital design was created and approved by experts, then used to fabricate a physical prototype using three-dimensional printing and hydrogel molding. After a process of iterative prototype testing, experts completed a survey assessing the simulator with a 5-point Likert scale for final approval. The approved model was validated with 56 expert and novice participants at seven institutions using subjective and objective performance metrics. Results: Consensus was reached on 85 of 250 questions, and experts found the physical model to adequately replicate 82.5% of required features. Objective metrics were statistically significant (p < 0.0001) when comparing experts and novices for enucleation time (37.4 ± 8.2 vs 16.7 ± 6.8 minutes), adenoma weight (79.6 ± 20.4 vs 36.2 ± 9.9 g), and complications (6 vs 22), respectively. Conclusion: We have effectively completed a multicenter study to develop and validate a nonbiohazardous benchtop simulator for HoLEP through modern education theory. A training curriculum including this simulator is currently under development.

Patient-Reported Financial Toxicity Associated With Management of Nephrolithiasis.

OBJECTIVE: To characterize stone-related financial burden among adults with nephrolithiasis through validated questionnaires for financial toxicity. METHODS: We performed a cross-sectional survey of adults with history of nephrolithiasis at an outpatient clinic. The survey contained a measure of stone-related financial toxicity (COST score), and assessed demographics, stone event history, and burden of overall, ancillary, preventative, and insurance costs. A COST score ≤21 was classified as high financial toxicity. Multivariable logistic regression was used to evaluate associations with demographic variables and stone event history. RESULTS: One hundred patients completed the survey (median age 57, IQR, 48-64). The median COST score was 30 (IQR, 23-37), and 19% reported high financial toxicity. Insurance status, household income, stone surgeries during lifetime and within the last 3 years were associated with financial toxicity on univariable analysis (P <.05). Burden of costs was significantly higher in all categories within the high financial toxicity cohort (each P <.05). On multivariable logistic regression, only income >$75,000 remained significant within the second model (OR: 0.22, 95% CI, 0.05-0.77, P = .02), however, this relationship did not persist on the final model. When asked whether providers should be mindful of their financial situation prior to making treatment recommendations, 39% responded "quite a bit" or "very much." CONCLUSION: One in 5 patients seeking care for nephrolithiasis meet criteria for high financial toxicity. Financial toxicity was associated with household income, insurance, education, and frequency of stone events. Thirty-nine percent reported that their provider should be mindful of their financial situation when making recommendations.

Computer Vision Enabled Segmentation of Kidney Stones During Ureteroscopy and Laser Lithotripsy.

Objective: To evaluate the performance of computer vision models for automated kidney stone segmentation during flexible ureteroscopy and laser lithotripsy. Materials and Methods: We collected 20 ureteroscopy videos of intrarenal kidney stone treatment and extracted frames (N = 578) from these videos. We manually annotated kidney stones on each frame. Eighty percent of the data were used to train three standard computer vision models (U-Net, U-Net++, and DenseNet) for automatic stone segmentation during flexible ureteroscopy. The remaining data (20%) were used to compare performance of the three models after optimization through Dice coefficients and binary cross entropy. We identified the highest performing model and evaluated automatic segmentation performance during ureteroscopy for both stone localization and treatment using a separate set of endoscopic videos. We evaluated performance of the pixel-based analysis using area under the receiver operating characteristic curve (AUC-ROC), accuracy, sensitivity, and positive predictive value both in previously recorded videos and in real time. Results: A computer vision model (U-Net++) was evaluated, trained, and optimized for kidney stone segmentation during ureteroscopy using 20 surgical videos (mean video duration of 22 seconds, standard deviation ±13 seconds). The model showed good performance for stone localization with both digital ureteroscopes (AUC-ROC: 0.98) and fiberoptic ureteroscopes (AUC-ROC: 0.93). Furthermore, the model was able to accurately segment stones and stone fragments <270 µm in diameter during laser fragmentation (AUC-ROC: 0.87) and dusting (AUC-ROC: 0.77). The model automatically annotated videos intraoperatively in three cases and could do so in real time at 30 frames per second (FPS). Conclusion: Computer vision models demonstrate strong performance for automatic stone segmentation during ureteroscopy. Automatically annotating new videos at 30 FPS demonstrate the feasibility of real-time application during surgery, which could facilitate tracking tools for stone treatment.

Assessing the diagnostic performance of systematic freehand PrecisionPoint transperineal prostate biopsy: Comparison of observed outcomes to PBCG nomogram predictions.

OBJECTIVE: We assessed the diagnostic performance of freehand systematic transperineal biopsy (fTPb) by using the Prostate Biopsy Collaborative Group (PBCG) nomogram, which is a contemporary update to the PCPT nomogram. METHODS: From 1/2012 to 12/2018, fTPb was performed on consecutive men with clinical suspicion of prostate cancer. Patients included in this study had no previous diagnosis of prostate cancer, PSA between 2.5 ng/ml and 20 ng/ml, and underwent at least 12 core biopsies. In addition, those men who underwent pre-biopsy multiparametric magnetic resonance imaging of the prostate were considered separately from those without prebiopsy imaging. Biopsies were performed by a single urologist who developed the needle guidance device used in the procedure. Clinical and pathological data were collected retrospectively. We compared observed biopsy outcomes with those predicted by PBCG nomogram utilizing chi-square statistical analysis. RESULTS: Systematic fTPb (without pre-biopsy MRI) was performed in 301 men (median age 67, mean PSA 6.9 ng/mL). These men had a median of 20 biopsy cores. Clinically significant cancer (ISUP 2 or greater) was found in 33.9% of men. In men without pre-biopsy MRI, using PBCG Nomogram, we found no significant difference between the expected and observed number of clinically significant cancer (96 vs. 102; P = 0.09). An additional 73 men (median age 67, mean PSA 7.8 ng/ml) underwent pre-biopsy MRI imaging. The addition of MRI targets to systematic sampling resulted in a median of 25 cores. Clinically significant cancer was found in 49.3%. Using the PBCG Nomogram, in the men with pre-biopsy MRI we found clinically significant cancer in significantly more men than was expected by PBCG nomogram predictions (36 vs. 20; P = <0.01). There were no biopsy-related infectious complications. CONCLUSION: The fTPb technique is a promising method to sample the prostate which provides cancer detection that is comparable to that expected from systematic TRUS biopsy. We found that pre-biopsy mpMRI resulted in greater than expected detection of clinically significant cancer when utilizing this technique.

Outcomes of freehand transperineal prostate biopsy with omission of antibiotic prophylaxis.

OBJECTIVE: To assess the utility of antimicrobial prophylaxis when performing freehand systematic transperineal (TP) biopsy. PATIENTS AND METHODS: From January 2012 to February 2020, freehand TP prostate biopsy via angiocatheters or the PrecisionPoint Transperineal Access System was performed on consecutive men with clinical suspicion of prostate cancer (PCa) or confirmed PCa. Biopsies were performed by a single urologist (developer of the PrecisionPoint system). Clinical data were collected retrospectively. Pre-procedural antibiotics were given to all patients up until 6 September 2016. After this date, antibiotics were omitted from those without risk factors (chronic catherization, concurrent endoscopic procedure, history of sepsis after transrectal [TR] biopsy, history of TR biopsy within the last year, prosthetic joints/heart valves). Patients were assessed 1 week after biopsy for symptoms, emergency department visits, and hospital admissions. Patients who received antimicrobial prophylaxis were compared with those who did not, and infectious complications were analysed. Additionally, oncological outcomes were reported. RESULTS: A total of 988 biopsies (median prostate-specific antigen level 7.7 ng/mL) were included in the analysis on 756 patients. Prophylaxis was given in 538 of the biopsies (54.4%) and in 450 (48.6%) it was not. There was a statistical difference in median age (67 vs 69 years; P < 0.001), abnormal digital rectal examination (13% vs 5%; P < 0.001), and history of multiparametic magnetic resonance imaging (15% vs 31%; P < 0.001) between the prophylaxis and no-prophylaxis cohorts, respectively. There were no documented complications in those who received antibiotics. Within the no-prophylaxis cohort, there were three (0.66%) complications (P = 0.09). Two patients (0.44%) had urinary tract infections and one patient (0.22%) experienced post-procedural urinary retention. No patient required hospital admission or an emergency department visit. Clinically significant cancer was detected in 152 (40.0%) and 64 patients (39.0%) on initial biopsy and prior negative biopsy, respectively. CONCLUSIONS: These data suggest that antimicrobial prophylaxis may be safely omitted in selected patients when using the freehand TP approach.

The Use of Serum Procalcitonin in the Setting of Infected Ureteral Stones: A Prospective Observational Study.

Introduction: Infected ureteral stones are a urologic emergency and require urgent decompression. We set out to determine whether serum procalcitonin (PCT) could aid in the diagnosis of infected ureteral stones. Methods: All consecutive patients presenting to the emergency room from November 9, 2016, to November 10, 2018, with an obstructing ureteral stone were included. All patients had complete blood count, urinalysis (UA), PCT, and urine culture (UCx). Subgroup analysis was performed in a "clinically equivocal" cohort of afebrile patients defined as a leukocytosis >104/µL and UA with <50 white blood cells (WBCs) per high powered field (hpf). Patients with positive and negative UCx were compared. Results: A total of 231 patients were included, of whom 56 had a positive UCx. Of all covariates, UA WBCs with a cutoff of 9 per hpf performed best at predicting positive UCx with an area under the curve (AUC) of 0.87. PCT did not perform as well with an ideal cutoff of 0.08 ng/mL, having an AUC of 0.77, sensitivity 70.6%, specificity 73.9%, positive predictive value (PPV) 34.3%, and negative predictive value (NPV) 92.9%. When looking at the clinically equivocal cohort, UA WBCs with a cutoff of 6 per hpf appeared to perform best at predicting a positive UCx with an AUC of 0.72. PCT was less predictive in this cohort with an ideal cutoff of 0.3 ng/mL, having an AUC of 0.32, sensitivity 47.1%, specificity 85.2%, PPV 38.1%, and NPV 89.3%. Conclusion: PCT does not appear to be a superior marker for diagnosing urinary tract infection in the setting of obstructing ureterolithiasis when compared with components of the standard work-up.

Renal Forniceal Rupture in the Setting of Obstructing Ureteral Stones: An Analysis of Stone Characterization and Urologic Intervention Pattern.

Introduction and Objective: Forniceal rupture due to obstructing ureterolithiasis (FROU) is a seldom encountered radiographic finding, but the impact of this diagnosis and influence on stone management has not been well studied in the literature. The purpose of the study is to examine stone characteristics and intervention patterns of patients with radiographic evidence of FROU. Materials and Methods: A retrospective analysis of all patients with radiographic evidence of FROU was compared with patients with obstructing ureteral stones without forniceal ruptures (noFROU). All patients presented to our Emergency Department from January 2015 until December 2018. Data analyzed included patient demographics, clinical presentation, stone characteristics, and management pattern. Primary outcome was need for hospital admission and surgical intervention. Results: Thirty-two patients with FROU (mean age = 45) were compared with 50 patients with noFROU (mean age = 57). Univariate analysis revealed that age, history of diabetes mellitus, history of hypertension, days of symptoms, degree of hydronephrosis, and degree of perinephric stranding were associated with forniceal rupture (p ≤ 0.05). On multivariate analysis, only degree of perinephric stranding remained significant (p ≤ 0.05). Average maximum axial stone diameter in the FROU group was 5.1 mm vs 4.7 mm in the noFROU group (p = 0.66). Overall, 68.8% of stones were located within the distal ureter in the FROU group vs 48.8% in the noFROU group (p = 0.09). There was no difference in hospital admission (FROU 37.5% vs noFROU 44%, p = 0.56) and need for surgical intervention (FROU 50% vs noFROU 48%, p = 0.86). There were no 30-day complications in patients with FROU. Conclusions: Ureteral stone location and size does not seem to impact the presence of FROU. FROU may be an alarming reported finding but its presence does not appear to impact clinical outcomes or affect urological management, including admission or need for urologic intervention.

The Surgical Treatment of Peyronie's Disease in the Older Man: Patient Characteristics and Surgical Outcomes in Men 65 and Older.

INTRODUCTION: Surgery remains the gold standard for the correction of penile deformities secondary to Peyronie's disease (PD). Nevertheless, there is no published data on the surgical treatment of PD in older men. AIM: Considering the aging national and international population, we sought to evaluate the pre-operative characteristics and surgical outcomes of men aged 65 or older who underwent surgical treatment for PD at our tertiary care institution. METHODS: We retrospectively reviewed the charts of all men 65 years or older who underwent surgery for PD from January 2010 to September 2017. We compared men who underwent penile prosthesis implantation with straightening maneuvers (PP+SMs), tunica albuginea plication (TAP), and plaque partial excision with grafting (PEG). MAIN OUTCOME MEASURE: The main objective of this study was to find the baseline pre-operative patient characteristics and postoperative patient-reported outcomes. RESULTS: A total of 86 men with a median age of 68 years underwent surgery during the study period. 39 men underwent PP+SM (45%), 25 men a TAP (29%), and 22 men a PEG (26%). The mean curvature for all men was 59.9 ± 22.0° (range 0-105°). Those who underwent a PEG had a mean ± SD degree of curvature of 78.6 ± 16.6°, significantly higher than those who underwent PP+SM or TAP (49.1 ± 20.2° and 61.4 ± 17.4°, respectively; P < .001). Moreover, men who underwent a PEG had significantly more complex penile deformities (eg, narrowing with hinge effect) and better reported baseline erectile function compared with men who underwent PP+SM or TAP. Overall, 95% of all men reported having a functionally straight penis postoperatively with 94% engaging in penetrative intercourse at last follow-up. Overall, patient-reported satisfaction was 85% with a median follow-up of 43.5 months. CLINICAL IMPLICATIONS: Our findings suggest that the surgical treatment of PD in older men is safe, effective, and associated with high patient satisfaction. Although this represents a surgical series susceptible to selection bias, it underscores the importance of patient selection and counseling in achieving good surgical outcomes. STRENGTHS & LIMITATIONS: Our study is the first to report on outcomes of surgical treatment of PD in an elderly patient population with relatively long-term follow-up. Our limitations include a small sample size, single operating surgeon, and the lack of a younger comparison group. CONCLUSION: Despite an aging global population, surgery remains a viable and reliable option for the properly selected and counseled older men with PD. Abdelsayed GA, Setia SA, Levine LA. The Surgical Treatment of Peyronie's Disease in the Older Man: Patient Characteristics and Surgical Outcomes in Men 65 and Older. J Sex Med 2019;16:1820-1826.

Urology Residents' Experience With Simulation: Initial Evaluation of MRI/US Fusion Biopsy Workshop.

OBJECTIVE: To evaluate our initial experience with a multi-institutional workshop model of MRI/US fusion biopsy simulation for resident education. METHODS: Residents from 6 Chicago area urology programs participated in a MRI/US fusion biopsy workshop, which incorporated a 30 minute didactic session followed by hands-on simulation. The workshop was facilitated by fellowship-trained university faculty members and company representatives of MRI/US fusion technologies who provided teaching assistance and verbal feedback. Participants completed pre- and post-test nonvalidated 4-item questionnaires graded on a Likert scale. Information on resident prior experience with TRUS and MRI/US fusion biopsies was also collected. Pre-and postquestionnaires were compared with paired t tests for each survey domain (P <.05 were considered significant). RESULTS: Thirty-three residents (PGY 1-6, median PGY 3) participated in the workshop. 13 (40.6%) residents reported performing between 51 and 100 TRUS biopsies previously. Twenty-one (65.6%) reported being familiar with PIRADS v2 interpretation of prostate MR imaging, however 17 (53.1%) had never previously performed a MRI/US fusion biopsy. Analysis of pre- and post-test questionnaires showed significant increases in all 4 survey domains (P <.05). Residents demonstrated increased familiarity with indications for fusion biopsy (mean difference = +0.59), preparation for fusion biopsy (mean difference = +1.16), methods of MRI to TRUS image registration (mean difference = +1.38), and the advantages/disadvantages of perineal vs TRUS fusion biopsy (mean difference = +1.25). CONCLUSION: This workshop model which combines didactics followed by hands-on simulation training is an effective method for increasing the knowledge and familiarity with MRI/US fusion biopsy of trainees.

Devices for penile traction: the long and winding road to treating Peyronie's disease.

INTRODUCTION: Penile traction therapy (PTT) is increasingly being recognized as a viable nonsurgical approach to Peyronie's disease (PD). The goal of this article is to review the current literature on PTT with attention to traction protocols, devices, and outcomes. AREAS COVERED: Literature on the pathophysiology of PD, PTT as primary and adjunctive treatment for PD, perioperative use of PTT, and vacuum erection devices are all reviewed. Pertinent literature was obtained from the PubMed database. The key words 'penile traction,' 'mechanotransduction,' and 'Peyronie's disease' were searched and results were narrowed down based on relevance to the review. EXPERT COMMENTARY: PTT appears beneficial but the true magnitude of effect is difficult to discern. Most studies are not randomized, have small sample sizes, lack control arms, or have varying traction protocols. Patient compliance is critical and new devices and traction protocols are needed to maximize the benefit of PTT.

Spatial Tracking of Targeted Prostate Biopsy Locations: Moving Towards Effective Focal Partial Prostate Gland Ablation with Improved Treatment Planning.

The ability to selectively characterize, localize, and predict the specific areas of the prostate gland which harbor the worst biologic behavior is requisite for optimal prostate cancer therapy, especially in the emerging field of partial prostate gland ablation (focal therapy). In this manuscript, we highlight contemporary techniques in target tracking for focal therapy planning. Multiparametric magnetic resonance imaging has emerged as a dominant strategy to localize biopsy sites most likely to contain high-grade lesions. In-bore MRI biopsy and MR/US fusion biopsy using cognitive or software-enhanced co-registration have also become the most common strategy to accomplish this technical challenge. Such advances have led to growing optimism in the field of focal therapy for prostate cancer.

A Comparison of Secondary Polycythemia in Hypogonadal Men Treated with Clomiphene Citrate versus Testosterone Replacement: A Multi-Institutional Study.

PURPOSE: We evaluated the relative prevalence of secondary polycythemia in hypogonadal men treated with clomiphene citrate or testosterone replacement therapy. MATERIALS AND METHODS: In this retrospective, multi-institutional study, we included 188 men who received clomiphene citrate and 175 who received testosterone replacement therapy with symptomatic hypogonadism. The overall prevalence and ORs of secondary polycythemia for clomiphene citrate treatment vs testosterone replacement were primarily measured, as were baseline characteristics. Subset analysis included polycythemia rates for different types of testosterone replacement therapy. RESULTS: Overall, men on testosterone replacement therapy were older than clomiphene citrate treated men (age 51.5 vs 38 years). Men on testosterone replacement had longer treatment duration than clomiphene citrate treated men (19.6 vs 9.2 months). For testosterone replacement therapy and clomiphene citrate the mean change in hematocrit was 3.0% and 0.6%, and the mean change in serum testosterone was 333.1 and 367.6 ng/dl, respectively. The prevalence of polycythemia in men on testosterone replacement was 11.2% vs 1.7% in men on clomiphene citrate (p = 0.0003). This significance remained on logistic regression after correcting for age, site, smoking history and pretreatment hematocrit. CONCLUSIONS: The prevalence of polycythemia in men treated with clomiphene citrate was markedly lower than that in men on testosterone replacement therapy. The improvement in absolute serum testosterone levels was similar to that in men on testosterone replacement. There is no significant risk of polycythemia in men treated with clomiphene citrate for hypogonadism.

Delayed Partial Nephrectomy for Hydronephrosis After Renal Trauma.

Delayed sequelae following conservative management of renal trauma in the pediatric population are uncommon. Reports of delayed operations to manage these sequelae are even less common. Here we present the case of a 16-year-old male patient who had delayed development of upper urinary tract obstruction with recurrent infections following high-grade renal trauma managed conservatively. Ultimately, he required a robotic-assisted partial nephrectomy 2 years after initial nonoperative management. This is unique as no prior studies to our knowledge have described delayed hydronephrosis and delayed partial nephrectomy over a year following renal trauma.