Poster Session 4 - Sexual Medicine/Testis Cancer/Urothelial Cancer (On Demand Viewing - No Formal Session) 2:30 - 3:00Pm Thursday, 29Th October, 2020

Home , Semen analysis, Vasectomy reversal

Poster Session 4 - Sexual Medicine/Testis Cancer/Urothelial Cancer (On Demand Viewing - No Formal Session) 2:30 - 3:00pm Thursday, 29th October, 2020

38 Peyronie’s Disease: What About the Female Sexual Partner?

Tyler Kern MD1, Nancy Ye MD1, George Abdelsayed MD2 1Kaiser, Los Angeles, CA, USA. 2Kaiser, Orange County, CA, USA

Abstract

Introduction: Peyronie’s disease (PD) is an acquired wound healing disorder of the penis involving fibrosis and tunical scar formation that can lead to various penile deformities resulting in penile pain, sexual dysfunction, low self-esteem, and emotional distress. While many studies highlight the psychosocial impact of PD on the patient, little is known about the partner’s experience regarding PD management, interventions, and outcomes.

Objective: To evaluate and summarize the available clinical data available on the effects of the disease and its management on female sexual partners.

Methods: We performed a structured literature review of studies focused on patients with PD and direct evaluation of their partners. A search of the medical literature using the MEDLINE and PubMed databases was performed. The queried terms included: Peyronie’s disease, partner, female, dyspareunia, relationship, satisfaction, survey, and outcome.

Results: The majority of female partners of men with PD reported improvement in their relationship, decrease in sexual dysfunction and overall satisfaction with treatment.

Conclusion: PD can be emotionally debilitating for patients and their female partners. It has been associated with depression, social stigmatization, isolation, diminished self-worth, and avoidance of intimacy. The female partner’s experience with PD, as well as its management and outcomes, is an understudied entity that warrants further investigation and may be useful in guiding future care. 61 Efficacy and Safety of a New Oral Testosterone (TU) Formulation in Hypogonadal Men: Results from the 'inTUne' Trial

Ronald Swerdloff MD1, Jed Kaminetsky MD2, Marc Gittelman MD3, James Longstreth PhD4, Christina Wang MD1, Robert Dudley PhD5 1Lundquist Institute at Harbor-UCLA, Torrance, CA, USA. 2University Urology Associates, New York, NY, USA. 3South Florida Medical Research, Aventura, FL, USA. 4Longstreth & Associates, Mundelein, IL, USA. 5Clarus Therapeutics, Northbrook, IL, USA

Abstract

Introduction: Oral delivery of testosterone (T) replacement therapy (TRT) has several potential advantages over currently available options. A novel formulation of oral TU was studied in two prior Phase 3 trials that demonstrated safety and efficacy. However, to further improve pharmacokinetic (PK) efficacy, a new dose titration algorithm was evaluated. Methods: Hypogonadal men (diagnosed consistent with the Endocrine Society guideline of two morning serum T < 300 ng/dL and signs/symptoms consistent with hypogonadism), age 18 – 65 y/o, were recruited into a 105 day, randomized, open-label, multicenter, dose-titration trial. Patients were randomized 3:1 to oral TU, BID (JATENZO®; n=166) or a topical T product QD (Axiron®; n=56). Dose titration was based on average T levels (Cavg) calculated from serial pharmacokinetic (PK) samples. T was assayed by LC-MS/MS. Patients had two dose adjustment opportunities, which was based on plasma T levels (Cavg) calculated from multiple PK samples, prior to final PK visit. Safety was assessed by standard clinical measures, including ambulatory BP. Results: 87% of patients in both groups achieved mean T Cavg in the eugonadal range. NaF-EDTA plasma T Cavg for oral TU group was 403 ± 128 ng/dL (~14 ± 4 nmol/L; mean ± SD) [serum T equivalent ~ 489 ± 155 ng/dL (17 ± 5 nmol/L)] and for topical T (Axiron®) was 391 ± 140 ng/dL (~14 ± 5 nmol/L). The overall safety profile of TU was similar to topical T. There were no deaths or T-related serious adverse events. Mean changes in HCT and PSA were similar in both treatment arms with HCT increase of 2-3% (absolute increase) and PSA increase of 0.2-0.3 ng/mL with no PSA values > 4 ng/mL. Final subject mean increase in systolic BP by cuff in the oral TU and topical T groups was 2.8 (± 11.84) and 1.8 (± 10.76), respectively. Conclusion: A new oral TU formulation restored T to mid-eugonadal levels in hypogonadal patients. Both groups showed a modest change in HCT and PSA.

If funding provided, type in source company / entity name(s):

Clarus Therapeutics 81 Novel classification of urethral complications in female to male gender affirming surgery

Virginia Y Li MD1, Wai Gin Lee Md2, David Ralph MD2, Christopher Nim MD2 1Kaiser Permanente, Los Angeles, CA, USA. 2University College London Hospitals NHS Foundation Trust, London, CA, United Kingdom

Abstract

Introduction & Objectives:

Phalloplasty is the most complete genital transformation available and can decrease the psychological distress commonly experienced by transgender men. The surgery is technically challenging with urethral complications occurring in up to 75% of patients. Advances in surgical technique with “tube-in-tube” urethra have improved outcomes but there is no universally accepted gold standard. Debate continues on immediate compared to staged urethral lengthening and join-up. We aim to develop a classification system for urethral complications to improve outcome reporting.

Methods: All men undergoing gender affirming surgery at the national centre in London, United Kingdom over three consecutive years (2014 – 2016) were included. Patient data were extracted retrospectively following urethral construction by radial forearm free flap urethroplasty, or radial forearm, anterolateral thigh free, or pedicled flap phalloplasty with “tube-in-tube” urethra. Phalloplasty was staged as the following: 1) construction of a phallus with neourethra, 2) glansplasty and urethral lengthening (anastomosis of the phallic urethra to the native urethra) with or without hysterectomy and vaginectomy, 3) insertion of an erectile device and testicular prosthesis. The rate, timing and management of urethral complications were reported.

Results: One hundred and ninety-four men with median follow-up of 3.9 years (range 2.8 – 5.7 years) were included. Almost half of all patients (45.9%) developed a urethral complication. Complications were classified as a fistula, stricture, urethral stone or chordee of the urethra. Fistulas were the most common complication representing 59.6% of all the complications. Strictures were the second most common complication (22.5%). The most common site of complication was the phallus compared to the perineal urethra after urethral lengthening (90% of strictures and 79.2% of fistulas). Vaginectomy was associated with a higher risk of fistula formation (29.7% vs 13.8%). The majority of urethral complications were repaired during the second stage (69.8%).

Conclusions: The largest series of patients to date suggests that urethral complications continue to be common following phalloplasty. A proposed classification system for urethral complications is presented based on type, location and timing in order to standardise reporting. Staged urethral join-up allows most complications to be repaired during a routine second stage to prevent symptomatic complications in patients.

If funding provided, type in source company / entity name(s): none 93 Opioid Utilization after Gender Affirming Vaginoplasty

Jasper C Bash MD, Chandler Barton BS, Daniel D Dugi MD, Jyoti Chouhan PharmD OHSU, Portland, OR, USA

Abstract

Objective: There is sparse published literature on opioid use after gender affirming vaginoplasty (GAV). With creation of a neovagina and extensive external genital rearrangement, significant post-operative pain and opioid use would not be unexpected. In our study, we aimed to characterize our patients’ opioid utilization after this surgery.

Methods: An IRB-approved, retrospective analysis was conducted in patients having undergone non-robotic GAV by a single surgeon from 7/11/19 to 1/30/20. Those on chronic narcotics were excluded. Patients received a hydromorphone (HM) patient-controlled analgesia pump on the day of surgery, which was transitioned to scheduled acetaminophen (APAP) every 6 hours and as needed (PRN) oxycodone and/or intravenous HM on POD 1-5. We calculated PRN opioid use on POD 2-4 and converted this to morphine milligram equivalents (MME). Upon discharge, our pathway recommended a prescription for oxycodone 5 mg tablets, #50, and scheduled APAP.

Results: 26 patients were included (median age: 45 years; range 20–71). All patients received at least one dose of PRN opioid. See Table 1 for daily opioid utilization. Ten patients never used PRN IV HM. A wide range of total opioid use was noted (40-1,188 MME), equivalent to 5-158 oxycodone 5mg tablets. BMI was not correlated with total MME. On discharge, 69% received the recommended oxycodone quantity. After discharge, 13 patients (50%) required additional narcotic prescriptions, 7 within 2 weeks of surgery.

Discussion: While hospitalized, many patients did not use IV PRN medication and, of those who did, half did not use it past POD 2. Though an increase in narcotic use was noted on POD 3 which may be due to the removal of the external dressing. As an outpatient, our discharge quantity may be insufficient in providing adequate pain control as 50% required an additional prescription.

Conclusion: The majority of hospitalized GAV patients rely on PO PRN medication. Our post-operative opioid prescribing may be insufficient and predictive factors are needed to guide appropriate discharge prescribing. 100 Postvasectomy Scrotal Pain and Hematospermia, a Possible Harbinger for Vasectomy Failure and Recanalization: A Case Report

Daniel Artenstein MD, Tyler A Kern MD, Charles E Shapiro MD Kaiser Permanente, Los Angeles, CA, USA

Abstract

Introduction: Vasectomy is the most common and most effective method of achieving permanent male sterility. However, there is a low risk of vasectomy failure. To our knowledge, there is no symptom complex that has been identified and described that is predictive of early recanalization and vasectomy failure. Case presentation: A 44-year-old man underwent a routine bilateral vasectomy without complication. Two months after the procedure, the patient experienced an acute onset of scrotal pain and hematospermia. Several semen analyses were performed during the following months, the results of which demonstrated progressively rising numbers of motile sperm and were indicative of vasal recanalization. The patient underwent repeated vasectomy, during which he was found to have right vasal recanalization leading to vasectomy failure. Figure shows excised portion of the right vasectomy site with a patent lumen, which is demonstrated by accommodation of a lacrimal duct probe.

Discussion: Delayed postvasectomy scrotal pain associated with hematospermia may be a sign of vasal recanalization. We propose that this symptom complex should prompt an investigation for vasal recanalization, during which the patient should be instructed to refrain from intercourse without the use of an additional method of contraception. Conclusion: Consider sending a semen analysis postvasectomy if a patient presents with scrotal pain and hematospermia and this may signal vasal recanalization and possible restoration of fertility. 116 Patients Accessing the Vancouver Prostate Cancer Supportive Care Program's Sexual Health Service (SHS)

Julie Wong B.Eng, MD1, Christine Zarowski RN2, Eugenia Wu BSc, CCRP2, Monita Sundar MA2, Celestia Higano MD, FACP3, Ryan Flannigan MD, FRCSC4 1University of British Columbia, Vancouver, BC, Canada. 2Vancouver Prostate Centre, Vancouver, BC, Canada. 3Fred Hutchinson Cancer Research Centre, University of Washington, Seattle, WA, USA. 4Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada

Abstract

Objectives: Treatment for prostate cancer (PCa) is well-established and has long-lasting impairment to sexual function. All treatment modalities have strong associations with erectile dysfunction and decrease in sexual satisfaction. The Prostate Cancer Supportive Care Program’s Sexual Health Services (SHS) clinic in Vancouver was created in 2013 to optimize sexual recovery for PCa survivors and their partners via a bio-psycho-social approach through group education sessions and clinical appointments with a sexual health clinician. The purpose of this study is to characterize the patient population of the SHS and assess sexual satisfaction outcomes. Materials and Methods: Data was obtained from patient charts from both their urology clinic and the SHS clinic, along with patient-reported outcomes measures from July 2013 – July 1, 2019. Analyses include descriptive statistics and pre-post comparisons via parametric (paired t-tests) tests. Results: Data from 966 patients and 3392 appointments were analyzed. Average age was 62.3 years (SD=7.5, 35-88yrs) and most (82.0%) were partnered. Appointments were mostly attended alone (81.7%). Most patients were treated primarily with surgery for their prostate cancer (88.0%), with other primary treatment modalities including brachytherapy (5.1%), external beam radiation (3.7%), androgen deprivation therapy (1.4%), and mixed modalities. Median time between the end of prostate cancer treatment to first SHS appointment was 265 days (SD=4069.1). For the last year, through promotion of the program, restructuring clinical appointments and documentation, and automatic earlier referrals from urologists, this time was decreased to 175 days (SD=918.7). Over the period of enrollment in the SHS clinic, mean self-reported overall sexual satisfaction (IIEF) significantly increased both with erectile aids from 1.69 (SD=1.52) at baseline to 2.26 (SD=1.66) at last follow up and without erectile aids from 1.72 (SD=1.43) at baseline to 2.34 (SD=1.58) at last follow up, P<0.001 . Conclusions: This study characterizes the patients participating in the biopsychosocial-oriented SHS sexual rehabilitation clinic following PCa treatment. A significant improvement in sexual satisfaction was shown during enrollment in the clinic. This research illustrates the improved sexual satisfaction among PCa survivors while enrolled in the SHS, and provides guidance for further investigation to refine treatment, wait-times, support, and/or resource offerings. 147 Urology Resident Exposure To Male Infertility: What Are The Effects On In- Service Examination Scores And Self-Perceived Competence?

Kian Asanad M.D., David J Nusbaum M.D., Mary K Samplaski M.D. University of Southern California, Institute of Urology, Los Angeles, California, USA

Abstract

Objectives: We sought to better understand the training experience in male infertility of current urology residents in the United States (US). We aimed to determine the impact of having an Andrology faculty on urology residents’ 2019 in-service examination scores as well as self-perceived competence and confidence in clinical and surgical management of male infertility patients.

Methods: A cross-sectional survey of urology residents at accredited US urology residencies was administered between March 2020 – May 2020. Survey results were aggregated and summarized. Categorical data are presented as percentages and continuous data are reported as medians with inter-quartile ranges. The chi-squared and Kruskal-Wallis tests were used to detect associations between survey responses and outcomes of interest. Linear and logistic regression analyses were performed to understand the relationship between key survey questions and outcomes.

Results: A total of 72 surveys were completed. The majority of respondents (77.8%) reported having a fellowship- trained reproductive urologist on faculty at their program with 18.6% of these having an andrology fellow. Less than half of respondents reported observing or performing a vasectomy reversal or testicular sperm extraction. 75% of respondents described £10% of residents’ training comprising male infertility. Having formal microsurgical experience was significantly associated with a good/excellent fund of knowledge in management of nonobstructive azoospermia (p=0.004), good/excellent global understanding of male infertility (p<0.001), and self-perceived competence in male infertility procedures (p<0.001). On linear regression analysis, a poor fund of knowledge in nonobstructive azoospermia (b -29, 95% CI –[54, -3], p=0.027) and an awful global understanding of male infertility (b -50, 95% CI –[78, -21], p=0.001) was a significant predictor of lower in- service examination scores. Self-perceived competence and planning to perform male infertility procedures was not associated with in-service examination scores.

Conclusions: Clinical and surgical exposure of male infertility is lacking in US urology residency programs. The absence of any formal microsurgical experience in nearly half of all urology residents was associated with a lower global understanding of male infertility and self-perceived competence in performing male infertility procedures. Integrating a formal reproductive urology curriculum may help bridge this gap and ultimately improve in- service examination scores.

Source of Funding: None 165 Regenerative Medicine Approach Using Novel Therapies to Promote Sexual Function Recovery Following Pelvic Injury

Theodore Crisostomo-Wynne MD, Timothy Brand MD, Shashikumar Salgar PhD Madigan Army Medical Center, Tacoma, WA, United States Minor Outlying Islands

Abstract

Background: Trauma-related ED is notoriously difficult to treat with traditional therapies. Low-energy shockwave therapy (LESWT) has shown promise in the recovery of erectile function (EF) by tissue regeneration. Mesenchymal Stem cells (MSCs) produce paracrine factors that can promote healing. Platelet Rich Plasma (PRP) and Granulocyte Colony Stimulating Factor (G-CSF) have been shown to promote tissue regeneration. All-natural herbal product COMP4 has been shown to improve EF recovery. This study aimed to determine whether these agents would result in improved EF after pelvic neurovascular injury.

Methods: Lewis rats aged 10-12 weeks were used. Experimental design included 10 groups (n=8/group): 1) Sham, 2) Injury control, 3) COMP4, 4) COMP4+LESWT, 5) PRP, 6) PRP+MSC, 7) MSC+G-CSF, 8) 2-week Sham, 9) 2-week Injury Control, and 10) Peanut Butter Control. Pelvic injury consisted of bilateral cavernous nerve crush injury and internal pudendal bundle ligation under general anesthesia. One week following injury rats received COMP4 orally via peanut butter and/or LESWT for six weeks. MSCs, G-CSF, and/or PRP were injected intracavernosal weekly for four weeks. After one week of washout period intracavernous pressure (ICP) was recorded as EF outcome measure.

Results: There was significant (P<0.01) improvement in EF (ICP) with COMP4 (153.6±26.6) and COMP4+LESWT (174.1± 38.2) treatments compared to PNB control (109.4± 32.6). The injury control showed significant (P<0.01) reduction in ICP (113.9±21.2) compared to sham (165.4±43.8) at six weeks post-injury. PRP (161.1± 23.9) and PRP+MSC (161.9± 22.8) treatment showed significant (P<0.05) improvement in ICP but not MSC+G-CSF (132.6±6) compared to control (113.9±21.2). The ICPs recorded at 2-week post injury (117.3±6; Group 9), 6-week post-injury (113.8±21.2; Group 2) and 8-week post-injury (109.4 ± 32.6; Group 10) control groups did not vary significantly (P>0.05) confirming no spontaneous recovery.

Conclusions: COMP4, PRP, COMP4+LESWT and PRP+MSC resulted in recovery of erectile function in this animal model. These are promising candidates in treatment of ED following pelvic trauma. Further studies are needed to explore their efficacy in delayed ED treatment following injury to simulate clinical reality. 194 A Practical Model for Spermatogonial Stem Cell Transplantation for Human Fertility Restoration

Heiko H Yang MD, PhD UCSF, San Francisco, CA, USA

Abstract

A Practical Model for Spermatogonial Stem Cell Transplantation for Human Fertility Restoration

Heiko Yang, Jared E. Rosen, Puneet Kamal, Eva Gillis-Buck, Ahmed A. Hussein, Matthew Abad-Santos, Polina Lishko, James F. Smith San Francisco, CA (Presentation to be made by Dr. Yang)

Objectives: Despite improvements in childhood cancer survivorship, gonadotoxic chemotherapy in pediatric patients may result in permanent damage to spermatogonial stem cells (SSC) and result in permanent infertility. While fertility preservation via sperm cryopreservation is well established for post-pubertal boys and men, options for pre-pubertal boys remain investigational. One promising method is autologous testicular cell transplantation (TCT), a technique that has successfully restored sperm production in many animal models. In preparation for implementing the technique in humans, we sought to develop a cadaveric human model to simulate TCT injection.

Materials and methods: We utilized donated cadaveric human testes obtained from patients undergoing transgender orchiectomies to perform ultrasound guided injections. We assessed surgeon and assistant positions, needle size, injection site, and injection volume. We used sonographic contrast (Optison™), methylene blue, and GFP-labeled cells to help assess efficacy of simulated TCT injection.

Results: A 19 gauge, 2-inch long needle on a 3cc syringe enabled best flow of injection material. The characteristic streaming pattern of sonographic contrast from the rete testis toward tunica albuginea correlated with a diffuse distribution of methylene blue on gross examination. Fluorescence microscopy revealed that this resulted in the presence of GFP-labeled cells within the lumen of the seminiferous tubules.

Conclusions: We demonstrate a practical means to simulate TCT in humans. A number of significant challenges exist in learning these skills including obtaining adequate testicular tissue and tissue processing, in addition to the technical aspects of injecting cells into the Rete testis. Learning these skills and developing this infrastructure is critical prior to human implementation. 252 A Novel Approach For Management of Penile Prosthesis Infections: Staged Explantation and Delayed Salvage

Fahad M Chaus MD, MBA, Jayce Pangilinan MD, Andrew Bergersen MD, Jonathan Walker MD Department of Urology - University of Arizona, Tucson, Arizona, USA

Abstract

Objectives: Salvage procedures have been widely accepted as an effective approach to inflatable penile prosthesis infections as they avoid the fibrosis and erection shortening that result from simple explantation. More recently, salvage with malleable implants have gained popularity and have demonstrated greater infection free rates. While effective, immediate salvage procedures are underutilized, especially in emergent cases and rural hospitals. This is likely due to lack of supplies or high-volume implanters, respectively. This patient case highlights the unique management of an infected inflatable penile prosthesis (IPP) by staged explantation and delayed salvage with a malleable implant.

Methods: A patient with a history of IPP placement four years prior presented with scrotal pain and swelling. Physical exam, labs and imaging demonstrated infection, and the decision was made to replace his IPP with a malleable implant in a salvage procedure. Unfortunately, the preferred malleable device was not available at the time. As an alternate approach, the explantation was carried out in stages. In the first stage, the reservoir and pump were removed, and purulent material was evacuated from both cavities. The cavities were irrigated, while the prosthesis cylinders were left within the corporal bodies. Two days later, when the malleable implant parts were received, the patient returned to the operating room for removal of the IPP cylinders. The Mulcahy washout protocol was employed and the malleable implants were placed.

Results: The patient remained infection free and had no obvious implant issues at follow-up nine months later. This case demonstrates that an infected penile prosthesis can be successfully replaced with a malleable implant by staged explantation and delayed salvage when implant parts are not readily available. This approach may improve the low utility of infected penile prosthesis salvage.

Conclusion: Staged explantation and delayed salvage of an infected IPP with a malleable implant is an effective alternate approach to immediate salvage. 56 Outcomes of Perineal Urethrostomy for Penile Cancer: A 20-year International Multicenter Experience

Grant R Pollock MD1, Hielke-Martijn de Vries MD2, Julio Slongo MD3, Franklin Boyd MD4, Philippe E Spiess MD4, Juan Chipollini MD1 1University of Arizona, Department of Urology, Tucson, AZ, USA. 2The Netherlands Cancer Institute, Amsterdam, Netherlands, Netherlands. 3Universtiy of South Florida, Tampa, FL, USA. 4Moffitt Cancer Center, Tampa, FL, USA

Abstract

INTRODUCTION Perineal urethrostomy (PU) is often the definitive form of urinary diversion in patients with locally-advanced or anatomically, unfavorable penile cancer (PC) requiring total penectomy. Herein, we present a large, multi- institutional experience of PU-related complications and stenosis rates.

METHODS A total of 348 patients underwent PU as a means of urinary diversion for primary PC across 6 international centers from the years 2000 to 2019. Demographic and clinicopathologic characteristics were retrospectively reviewed. Stenosis-free survival was estimated using the Kaplan-Meir method. Factors associated with postoperative complications and PU stenosis were analyzed using logistic regression models.

RESULTS Median patient age was 67 years and median follow-up was 22.5 months. The median length of hospital stay was 5 days. A total of 105 patients (30.2%) developed a 30-day postoperative complication of which 75.2% were deemed minor (Clavien–Dindo Grade I and II). Wound infection (56.2%), dehiscence (15.2%), and urinary retention (11.4%) were the more common complications. The overall incidence of PU stenosis was 9.5% at a median time of 5.53 months. Twenty five patients underwent surgical revision while 8 were treated conservatively. Chemoradiation was associated with post-operative complication (OR: 2.39, p=0.029) while occurrence of complication was significantly associated with subsequent PU stenosis (OR: 4.42, p<0.001).

CONCLUSION We present the largest, reported surgical series of PU in the management of PC. Complications were not uncommon but most were managed conservatively. Development of stenosis was infrequent but linked with complications in the perioperative period. 286 Early Morbidity of Retroperitoneal Lymph Node Dissection in Testicular Cancer Patients: Analysis of the National Surgical Quality Improvement Program Database

Brent A Knight MD, Solange Bassale M.S., Yiyi Chen Ph.D., Sudhir Isharwal MD Oregon Health and Science University, Portland, OR, USA

Abstract

Objectives: Complications associated with retroperitoneal lymph node dissection (RPLND) have primarily been described from single center experiences. However, these historical studies often lack standardized reporting. We comprehensively describe the complications associated with RPLND from a prospectively- maintained and validated national database. Methods: The National Surgical Quality Improvement Program (NSQIP) database was queried for 30-day postoperative complications of RPLND (based on CPT codes) performed for testicular cancer from 2008-2018. Excision of large (>5 cm) retroperitoneal masses (CPT codes 49204-5) was used as a surrogate for post- chemotherapy (PC) RPNLD. Complications were sub-categorized by organ systems and by Clavien-Dindo grade (1-2 = low, 3-5 = high). Associations with patient and perioperative variables were analyzed with logistic regression. Results: 375 patients met inclusion criteria. Median age was 29 years (17-81 years), with 81.1% of patients being Caucasian. The median hospital length of stay was 5 days (IQR 4-7 days). 74 (19.7%) patients experienced at least one postoperative complication for a total of 125 complications. Hospital readmission occurred in 31 (8.3%) patients. 52 (13.9%) patients underwent PC RPLND, with a 34.6% complication rate. The most common organ system complications included cardiovascular (11.7%), wound dehiscence or infection (4%), and pulmonary (2.3%). The majority of complications were low Clavien-Dindo grade (12%, vs 3.5% high grade). On univariable analysis, smoking, disseminated cancer, steroid use, older age, and low albumin, hematocrit, or platelet counts were significantly associated with the occurrence of any complication, as were longer operative times and increased length of hospital stay. The Table shows multivariate analyses of factors associated with complications. Conclusions: Complication rates following RPLND in the NSQIP database are generally higher than previously published series. Increased rates were associated with smoking and unfavorable preoperative blood counts, with attendant longer operative times and hospital stays. 198 Patients Older Than 38 With Stage 3 Nonseminoma Have Decreased Survival Compared to Younger Patients

Jason K Frankel MD1, Nathan Jung MD2, Basil Ferenczi MD2, Christopher Porter MD2, John Paul Flores MD2 1Virginia Mason Medical Center, Seattle, Wa, USA. 2Virginia Mason Medical Center, Seattle, WA, USA

Abstract

Introduction:

Patients diagnosed with germ cell tumors have favorable survival thanks to effective therapy. Age has been associated with worse survival due to comorbidity. We hypothesize that even patients diagnosed slightly older than the average age of diagnosis with stage 3 disease have shorter survival. Here we aim to identify an age cut off for younger patients that may predict survival.

Methods:

The NCDB was queried for all patients diagnosed with stage 3 non-seminoma between 2004 and 2016. Patients younger than 18 and older than 65 were excluded. Kaplan Meier analysis was used to generate survival curves for age groups, attempting to identify an age cut point. Demographics and treatment information was compared between groups. For statistical significance, chi squared test was used for categorical variables while t-test was used for continuous variables.

Results:

2,526 patients with stage 3 non-seminoma were identified over the course of the study period. Analysis revealed a survival difference at age 38, showing significantly lower survival in the age 38 to 65 group (HR 2.37, CI 1.94 – 2.90). 5 and 10 year survival were 84.4% and 81.1% for the 18 - 37 group compared to 68.8% and 60.2% for the 38 – 65 group, respectively (Figure 1). Race, chemotherapy use, RPLND rate, and post- orchiectomy markers did not differ significantly between groups. The older group had more insured patients, higher income, higher Charlson Comorbodity index, and less 3b disease (Figure 2).

Conclusion:

Even patients in their late thirties and forties with Stage 3b non-seminoma have worse survival than those in their twenties and early thirties. Possible reasons for this include higher comorbidity and inability to receive optimal therapy. Further prospective study is needed to understand the true cause of this difference. 152 Adjuvant Procedures in Post-Chemotherapy Retroperitoneal Lymph Node Dissection for Testicular Cancer: A Single Tertiary Center Experience

Alireza Ghoreifi MD, Madeleine L Burg MD, Sanam Ladi Seyedian MD, Aliasger Shakir MD, Maryam Salehi MD, Sumeet Bhanvadia MD, Anne K Schuckman MD, Siamak Daneshmand MD, Hooman Djaladat MD, MS University of Southern California, Los Angeles, CA, USA

Abstract

Objectives: Oncologic outcomes of post-chemotherapy retroperitoneal lymph node dissection (PC-RPLND) for testicular tumors depend on thorough resection of the retroperitoneal template that may include adjuvant procedures, i.e. nephrectomy. The goal of this study is to evaluate the incidence, clinicopathologic characteristics, and predictive factors of these procedures during PC-RPLND.

Methods: Using our IRB-approved testis cancer database, we retrospectively reviewed the records of consented patients who underwent PC-RPLND for testicular germ cell tumors between Jan 1998 to Jan 2018. Patients’ characteristics, pathology results of the primary tumor, and surgical/pathological features of the PC- RPLND were reviewed for analysis.

Results: 173 patients included in the analysis. Baseline characteristics and perioperative outcomes of patients are presented in table 1. Out of these patients, 71 (41%) required adjuvant procedures: 43 (25%) vascular procedures, 23 (13%) nephrectomy, 11 (6.3%) gastrointestinal procedures, 6 (3.5%) adrenalectomy, and 3 (1.7%) ureteral resection/reconstruction. The details of adjuvant procedure subtypes are shown in figure 1. Fifteen (9%) had more than one procedure. In multivariable logistic regression controlling for a subset of clinically relevant variables, both pre-chemotherapy and pre-operative RP mass size (OR=1.15 and 1.17 for each cm, respectively), as well as the clinical stage at the time of orchiectomy (OR=7.1 for stage 3), were significantly associated with an increased rate of adjuvant surgery during PC-RPLND.

Conclusions: Adjuvant surgeries are common in patients undergoing PC-RPLND which significantly increases the operative time, estimated blood loss, and length of stay. Vascular procedures and nephrectomy are the most common adjuvant surgeries in these patients. Pre-chemotherapy and preoperative retroperitoneal mass size, as well as clinical stage, are associated with a significant increase in the rate of adjuvant surgery during PC-RPLND.

If funding provided, type in source company / entity name(s):

None 297 One-day hospital stay after midline extraperitoneal retroperitoneal lymph node dissection: USC experience

Hamed Ahmadi MD, Madeleine Burg MD, Sidney Roberts MD candidate, Sumeet Bhanvadia MD, Hooman Djaladat MD, Anne Schuckman MD, Siamak Daneshmand MD USC Urology, Los Angeles, California, USA

Abstract

Introduction: Median length of hospital stay (LOS) following transperitoneal retroperitoneal lymph node dissection is 3-4 days even after implementing enhanced recovery after surgery protocols in major referral centers. We have previously described the midline extraperitoneal approach for retroperitoneal lymph node dissection (EP-RPLND), which is performed through a discreet incision keeping the peritoneal envelope intact. EP-RPLND has been associated with significantly decreased morbidity including LOS compared to a transperitoneal approach. We aimed to review the feasibility and safety of an overnight hospital stay following EP-RPLND. Materials and methods: Using an IRB approved database, we reviewed all patients with GCT who underwent EP-RPLND between 2010 and 2020. Trend in size of retroperitoneal mass and LOS overtime was assessed. Perioperative and functional outcome of patients who were discharged on POD # 1 after EP-RPLND were collected. Results: Out of 151 patients who underwent EP-RPLND between January 2010 and March 2020, 131 patients were consented. Median LOS for the whole cohort was 2.5 days (IQR, 1 – 3). (Figure 1a) 32/131 (24%) patients were discharged on POD#1 including 25 patients who underwent post-chemotherapy EP-RPLND. Median size of radiologic retroperitoneal disease was 3.2 cm (IQR, 1.4 – 5.6) (Figure 1b). 31/32 (96%) patients underwent nerve sparing (NS) EP-RPLND. Median intraoperative blood loss was 400 ml (IQR, 200 – 800). Four patients underwent simultaneous adjunctive procedures including vascular repair/reconstruction in 2, right nephrectomy in 1 and concomitant neck dissection in 1. Median number of lymph nodes removed was 30 (IQR, 19 – 40). 90-day CR was 4/32 (12.5%) including 3 patients with lymphocele requiring drain placement (Clavien grade IIIa) and 1 patient with small pleural effusion, managed conservatively (Clavien grade I). There was no postoperative ileus. None of patients were readmitted following discharge. Median follow up was 341 days. Of 26/32 patients with documented ejaculation status following NS EP-RPLND, 25 (96%) reported antegrade ejaculation. Conclusions: Overnight stay following EP-RPLND is safe and is associated with desirable postoperative outcome. If funding provided, type in source company / entity name(s):

None 71 Jean Alfred Fournier- The Most Famous French Dermatovenereologist and Professor of Syphilology, Paradoxically Most Remembered for Describing Genital Gangrene

Matthew E. Karlovsky MD Arizona State Urological Institute, Phoenix, AZ, USA

Abstract

Dermatology, venerology and urology historically overlap as arts, but nowhere more dramatically evoked than with gangrene foudroyante de la verge- “fulminating” genital gangrene, first described by Paris native Jean Alfred Fournier (1832-1914), a disease for which he is most remembered, and ironically unrelated to his life’s study of syphilis in the pre-antibiotic era. First identified in 1883, fulminating gangrene of the male genitalia, he differentiated this uncommon but severe skin and fascial infection from other less aggressive types of genital infections. After seeing five cases in men, he noted diabetes, alcoholism and vascular insufficiency as important constitutional predisposing factors. Masterfully described in several lectures, he noted “a gangrenous and sudden beginning, astonishingly rapid and always considerable extension, the frequent co- existence of purple discoloration and final excessive morbidity”. Fournier meticulously documented the signs and symptoms of syphilis, a disease that became synonymous with his name. He detailed various types of syphilitic skin eruptions, precancerous nature of leukoplakia as syphilitic in origin, the cutaneous effects of mercurial and iodide treatments, and was first to famously designate tabes dorsalis and general paralysis as resulting from syphilis, terming them “parasyphilitic affections”. Fournier specialized in congenital syphilis, stating its worst affect “manifests itself by causing hecatombs of infants”, a significant cause of miscarriages and stillbirths. He founded the French Society of Dermatology and Syphilography, and the French Society for Sanitary and Moral Prophylaxis. French author Eugene Brieux dramatized Fournier’s concern of adultery in Les Avariés bringing syphilis in the home, leading to disease in women and children. Later translated into English by Upton Sinclair as “Damaged Lives”, it was made into a movie in the US in 1933. French artist, Henri de Toulouse-Laurec, Fournier’s famous patient, contracted syphilis from prostitutes whose portraits he painted, depicted Fournier in his final painting, An Examination at the Paris Faculty of Medicine, in 1901. Fournier is also eponymously famous for “Fournier’s Sign” mouth scar after healing of congenital syphilic lesions, and “Fournier’s Tibia”, thickening and bowing of the tibia also in congenital syphilis. Upon his death, Fournier was eulogized as the “benefactor of humanity”. 176 The Effect of Prior Prostate Cancer Treatment on Perioperative and Pathological Outcomes after Radical Cystectomy for Bladder cancer

Kassem S Faraj MD, Weslyn Bunn BS, Victoria Edmonds BS, David Mauler BS, Mark D Tyson MD Mayo Clinic Arizona, Phoenix, AZ, USA

Abstract

Objectives: Many men who undergo radical cystectomy (RC) for bladder cancer have previously been treated for prostate cancer. This study describes the effect of prior prostate cancer treatment on perioperative and pathological outcomes after RC for bladder cancer. Materials and methods: This was a retrospective review of all male patients who underwent RC for bladder cancer at our institution from 01/01/2007-01/01/2020. Results: In 465 male patients, 91 (19.6%) had a diagnosis of prostate cancer prior to RC. In this cohort, 42 (46.2%) patients underwent prior radical prostatectomy (RP), 29 (31.9%) previously underwent radiation therapy (RT) for prostate cancer and the remaining 20 (22%) were managed with other modalities, including 13.2% who were on active surveillance. When comparing perioperative outcomes, a rectal injury was more common in patients with prior RP (7.1%) vs RT (3.4%) and those with no prior prostate cancer diagnosis (1%) (p<0.05). Pathological outcomes revealed that pT4 disease was more common in the RT cohort (27.6% vs 2.4% in RP and 8.8% in patients with no prior prostate cancer) and pT0 was more common in patients without a prior history of prostate cancer (16.9% vs 9.5% in RP and 3.4% in RT) (p<0.05). Variant histology was more common in the RT cohort (41.4% vs 21.4% in RP and 19.0% in those without prior prostate cancer) and median lymph node count was highest in the group with no prior history of prostate cancer (15.0 vs 11.0 in RP and 12.5 in RT, p<0.05). In patients with no history of prostate cancer, 151 (40.2%) were found to have incidental prostate cancer at the time of RC. Most (67.5%) patients with incidental prostate cancer had Gleason <7 disease and only 1.3% developed metastatic prostate cancer on follow-up, compared to over 10% of the patients previously treated for prostate cancer (p<0.05). Conclusions: Patients who underwent prostate cancer treatment prior to RC may be at increased risk for worse perioperative and pathologic outcomes. As a consequence, these patients may require special perioperative considerations such as referrals to experienced cystectomy centers and medical oncology referral for assessment for appropriateness of neoadjuvant/adjuvant systemic therapies. 109 Gemcitabine for the treatment of high-risk non-muscle invasive bladder cancer: Results of safety and early efficacy from a single institution’s bladder cancer program in the BCG-shortage era.

Juan Chipollini MD The University of Arizona, Tucson, AZ, USA

Abstract

Objectives In the era of world-wide shortage of BCG, there is great need for effective therapeutic alternatives in treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). In this study, we evaluate safety and efficacy of a single-agent Gemcitabine protocol for patients with newly-diagnosed or recurrent NMBIC after BCG therapy. Materials and Methods We included 22 consecutive high‐risk NMBIC patients treated from June to December 2019. Patients were treatment-naïve or had failed at least one induction course of BCG. Patients started treatment after 4 to 6 weeks from resection. All received intravesical Gemcitabine once a week at a dose of 2000mg/50mL for 6 consecutive weeks (induction course), and then weekly for 3 consecutive weeks at 3, 6, and 12 months at physician discretion. Primary endpoint was recurrence rate. Secondary endpoints were recurrence-free survival and toxicity. For comparison, we retrospectively included 22 consecutive patients who were treated with primary BCG therapy before start of our Gemcitabine protocol implementation. Results Median follow-up was 11.5 months (range: 3.1-22.6). Approximately 77% of patients were able to complete all 6 cycles with common side-effects including dysuria (22.7%) and fatigue (22.7%). The Gemcitabine cohort consisted of 12 treatment-naïve patients (Group A) and 10 others who had failed BCG (Group B). In Group A, 8.3% of patients (1 of 12) had a recurrence at 3 months versus 40% (4 of 10) in Group B (p=0.078). Kaplan- Meier analysis for 6-month recurrence-free survival (RFS) was 88.9% for Group A versus 40% for Group B (log- rank test p=0.032). Of the 22 BCG patients, 20 were treatment-naïve. The 3-month recurrence rates were 18.2% for BCG vs 22.7% for Gemcitabine. The 6-mo RFS for Gemcitabine patients was 71.6% vs 76.2% for BCG patients (log-rank p=0.633). Subgroup analysis of treatment-naïve cases showed RFS of 88.9% vs 78.9% for Gemcitabine vs BCG, respectively (p=0.598). In non-CIS cases, RFS was 100% favoring Gemcitabine. Conclusions Implementation of Gemcitabine induction +/- maintenance for high-risk NMIBC as an alternative to BCG therapy appears safe and feasible at short-term follow-up. Our protocol offers a reasonable alternative for patients who require induction intravesical treatment or have failed previous BCG therapy. 151 A Urine-Based DNA Methylation Marker Test to Detect Upper Tract Urothelial Carcinoma: A Pilot Study

Alireza Ghoreifi MD1, Sanam Ladi Seyedian MD1, Paolo Piatti PhD2, Benjamin Jara BS2, Taikun Yamada MS2, Lucy Sanossian BS2, Wenhao Yu BS1, Andrew Hung MD1, Sumeet Bhanvadia MD1, Rene Sotelo MD1, Andre Berger MD1, Monish Aron MD1, Mihir Desai MD1, Siamak Daneshmand MD1, Gangning Liang MD, PhD1, Hooman Djaladat MD, MS1 1University of Southern California, Los Angeles, CA, USA. 2Zymo Research Corp, Orange County, CA, USA

Abstract

Objectives: Upper tract urothelial carcinoma (UTUC) is an uncommon, yet lethal tumor of the urinary tract. Diagnosis and preoperative risk stratification of these patients present distinct challenges given limitations of the current available diagnostic tools, including endoscopic biopsy and imaging. Herein, we explore the feasibility of a urine-based epigenetic assay to detect UTUC.

Materials and Methods: Under an IRB approved protocol, urine samples were collected from UTUC patients before surgery in our institution between December 2019 and May 2020. Samples were analyzed with Bladder CARE (Pangea Laboratory), a urine-based assay that measures methylation levels of 3 bladder-cancer specific biomarkers (TRNA-Cys, SIM2, and NKX1-1) and two internal control loci using methylation-sensitive restriction enzymes coupled with qPCR. Results are reported as Bladder CARE Index (BCI) score and categorized as “positive”, “high-risk”, or “negative”, which are proportional to the concentration of cancer cells in the sample.

Results: Of the 19 enrolled patients, 4 were excluded due to concurrent bladder cancer. 15 patients (16 samples) with a median age of 73 years were included in the final analysis (Table 1). Eleven patients underwent radical nephroureterectomy and 3 had ureterectomy (#9,11,13). Surgery was not performed in one patient (#8) due to regional metastasis. Among all samples, 13 (81%) showed positive/high-risk BCI results. Three samples (#5, 12, 14) did not pass the quality control due to low DNA concentration, potentially caused by diluted urine, lubricant contamination, or distal ureteral obstruction. Three patients (#4, 10, 16) had positive BCI results despite negative urine cytology. Positive predictive value and the sensitivity of this urine test to detect UTUC were 100% and 81%, respectively.

Conclusions: The proposed urine-based epigenetic assay may have utility in the diagnosis of patients with UTUC. A larger sample size study to validate the accuracy of this test is the next step.

If funding provided, type in source company / entity name(s):

Zymo Research Corp, Pangea Laboratory 153 The Impact of Bladder Cancer History on Oncological Outcomes in Patients with Upper Tract Urothelial Carcinoma

Alireza Ghoreifi MD, Ryan Atkinson BS, Willem Xu MD, Samuel Mingo BS, Wenhao Yu BS, Saum Ghodussipour MD, Gus Miranda BS, Jie Cai MS, Sumeet Bhanvadia MD, Anne Schuckman MD, Siamak Daneshmand MD, Monish Aron MD, Mihir Desai MD, Inderbir Gill MD, Hooman Djaladat MD, MS University of Southern California, Los Angeles, CA, USA

Abstract

Objectives: Approximately one-third of patients with upper tract urothelial carcinoma (UTUC) has a history of urothelial bladder cancer (UBC). The prognostic impact of UBC history in these patients has not been fully addressed. The aim of this study is to evaluate the impact of UBC history on oncological outcomes in UTUC patients.

Materials and Methods: Using our IRB approved, prospectively maintained UTUC database, we reviewed all patients undergoing radical nephroureterectomy (RNU) with intent to cure between July 2009 and December 2018. Baseline characteristics and oncologic outcomes including recurrence-free survival (RFS) and overall survival (OS) were compared between patients with and without a history of UBC.

Results: 243 patients (66% male) with a median age of 73 (48-80) years were included in the study. Out of these patients, 80 (33%) had a history of UBC (66 non-muscle invasive and 14 muscle-invasive) of which 24 (10%) were treated with radical cystectomy. The baseline characteristics of patients are shown in Table 1. In a median follow-up time of 1.4 (0.1-8.8) years, the recurrence and mortality rates after RNU were 35% and 17.3%, respectively. Multivariable cox regression model controlling for a subset of clinically relevant variables showed that history of UBC and lymphovascular invasion (LVI) were significantly associated with both decreased OS and RFS (Table 2).

Conclusions: In patients with upper tract urothelial carcinoma, history of bladder cancer, as well as LVI at nephroureterectomy, are associated with decreased OS and RFS. If funding provided, type in source company / entity name(s):

None 283 Contemporary Outcomes of Primary Urethral Cancer at a Tertiary Care Center

Robert Fisch BA, Saum B Ghodoussipour MD, Daniel Jiang MD, Anirban P Mitra MD, PhD, Sanam Ladi-Seyedian MD, Gus Miranda BS, Anne K Schuckman MD, Hooman Djaladat MD, Sumeet K Bhanvadia MD, Siamak Daneshmand MD Keck Medicine of USC, Los Angeles, CA, USA

Abstract

Introduction and Objectives: Primary urethral cancer (PUC) is a rare and aggressive malignancy with a paucity of evidence regarding prognostic factors and treatment options. This study seeks to report our 25-year experience treating PUC at a high-volume tertiary care center. Methods: Using an IRB approved database, we collected clinical and pathologic data on all patients who were treated for PUC at our institution between 1994 and 2019. Clinical outcomes included recurrence-free (RFS) and overall survival (OS). Log rank statistics were used to assess associations between clinical variables and outcomes. Results: We identified 55 patients (26 male, 29 female) who were treated for PUC. The median age at diagnosis was 61 years and the median age at definitive therapy was 63 years. Clinical stage ranged from localized disease (cT1/T2) in 36.4% to non-localized (cT3+) in 30.9%. Of patients with non-localized disease, 6.7% received neoadjuvant radiotherapy, 20% received neoadjuvant chemotherapy and 26.7% had surgery followed by adjuvant chemotherapy. Recurrence rates in patients with clinically non-localized disease was 45.6%. Clinical nodal involvement (cTanyN+) was noted in 21.8% of all patients and 53.3% of patients with cT3+ disease. Surgical therapies included transurethral resection (5.5%), open resection (3.6%), partial or total urethrectomy (36.4%), urethrectomy combined with cystectomy (41.8%), and total penectomy (3.6%). Lymph node dissection was performed in 54.5% of all patients with a mean 35.1 nodes removed. Pathologically confirmed nodal metastases were found in 33.3% of patients with a mean of 8.5 positive nodes found at lymphadenectomy. Histological subtypes included urothelial carcinoma (30.9%), squamous cell carcinoma (29.1%), adenocarcinoma (34.5%) including clear cell adenocarcinoma (9.1%), melanoma (1.8%), and leiomyosarcoma (1.8%). At a median follow up 18.5 months, 47.3% of patients recurred and 21.8% of patients died. Male gender (p=0.004) and type of definitive therapy (p<0.001) were associated with recurrence, with combined cystectomy and urethrectomy producing the longest RFS. Administration of adjuvant chemotherapy (p=0.044) was associated with increased OS. In our cohort, we did not note a statistically significant association of pathologic stage with recurrence (p=0.88) or survival (p=0.55). Conclusions: Primary urethral carcinoma is associated with poor RFS and OS. More aggressive definitive therapies may prolong RFS. 200 Reviewing the Impact of Neuraxial Anesthesia on ERAS after Radical Cystectomy: A Systematic Review and Meta-Analysis

Syed N Rahman BS, Daniel J Cao BS, Viktor X Flores MD, Thomas F Monaghan BS, Jeffrey P Weiss MD, Andrew G Winer MD SUNY Downstate Health Sciences University, Brooklyn, NY, USA

Abstract

REVIEWING THE IMPACT OF NEURAXIAL ANESTHESIA ON ERAS IN RADICAL CYSTECTOMY: A SYSTEMATIC REVIEW AND META-ANALYSIS

Syed N. Rahman, BS, *Daniel J. Cao, BS, Viktor X. Flores, MD, Thomas F. Monaghan, BS, Jeffrey P. Weiss, MD, Andrew G. Winer, MD Brooklyn, New York. Presentation to be made by Mr. Syed N. Rahman.

Introduction/Objectives: Patients undergoing radical cystectomy (RC) for muscle-invasive bladder cancer have marked rates of complications and mortality. The Enhanced Recovery After Surgery (ERAS) protocol incorporates neuraxial anesthesia across institutions, but supporting evidence is lacking. This study aims to synthesize current evidence regarding neuraxial anesthesia during RC across long and short-term outcomes.

Methods: We searched PubMed, EMBASE, and Cochrane databases for studies published up to May 2020. Random effects meta-analyses were performed to identify pooled hazard ratios (HR) and effect sizes (Cohen’s d) for multiple outcomes. Demographic differences were analyzed. We applied the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies to evaluate the quality of evidence.

Results: Of 550 identified studies, 9 met criteria for inclusion. Neuraxial anesthesia did not affect overall and cancer-specific survival but was associated with earlier time to recurrence with a pooled HR of 1.50 (95% CI 1.13 -2.00, p<0.001). An association with increased overall complications, surgical site infections, and postoperative myocardial infarctions was observed (pooled OR 1.25 [1.13, 1.37], 1.21 [1.05, 1.40], 1.44 [1.08, 1.92] respectively, p<0.001). Significant reductions in opioid consumption and pain reduction up to 1 day post- RC were noted (Cohen’s d: -0.34 [-0.56, -0.13] and -0.30[-0.50, -0.10] respectively, p<0.001). No effect was seen on length of stay (LOS) and further pain reduction.

Conclusions: Neuraxial anesthesia may be associated with increased complications after RC and no change in LOS. This may be partially due to inadequate pain control late during the post-operative course. Further evidence regarding recurrence is required.

Source of Funding: None

Table 1. Odds Ratios for Complications Stratified by Complication Type

175 The use of perioperative transversus abdominis plane block in patients undergoing radical cystectomy: does timing of the block matter?

Kassem S Faraj MD, Victoria S Edmonds BS, Sam Snider BS, Kathleen Olson MD, Weslyn Bunn BS, Mark D Tyson MD Mayo Clinic Arizona, Phoenix, AZ, USA

Abstract

Objectives: The transversus abdominis plane (TAP) block has been effective in providing adequate pain control and limiting opioid use in patients undergoing major abdominal surgeries. Little is known regarding the efficacy of pre-incisional versus postoperative TAP block. This study investigates this comparison in the context of radical cystectomy (RC). Materials and Methods: This is a retrospective study that reviewed all patients who underwent RC between January 2011 and January 2020. Patients with chronic opioid use and who underwent other major surgery at the time of RC were excluded. Patients were stratified into three cohorts: preoperative TAP block, postoperative TAP block, no TAP block. A sensitivity analysis was done that included only patients since 2015, when TAP blocks were introduced into our practice. Results: In 463 patients, the median (IQR) age was 72.0 (65.0-77.0) years. There were 66 (14.3%) patients who received a TAP block, 16 (24.2%) of whom received a preoperative TAP block. Patients who received a preoperative TAP block had the shortest median hospital LOS (5.5 days vs 6 days in both the postoperative and no TAP block cohorts, respectively, p=0.039). The return of bowel function was slowest in those who did not receive a TAP block (3.0 days vs 2.5 days in TAP cohort, p=0.003). Patients who had a preoperative TAP block received the lowest median OME per hospital stay (208 mg vs 235 mg for postoperative TAP block and 320.5.0 mg in patients who did not receive a TAP block, p=0.005). The use of PCA was lowest in the preoperative TAP block cohort (31.3% vs 40.0% in the postoperative TAP block cohort and 73.6% in the patients who did not receive a TAP block (p<0.001). The sensitivity analysis confirmed that the median OME consumed per hospital stay was lowest in the preoperative TAP block cohort. Conclusion: Preoperative TAP blocks appeared to be associated with lower OME use in the postoperative setting compared to postoperative TAP blocks and no TAP blocks. This study is limited by its retrospective nature, small sample size and the presence of confounders that may affect desired outcomes. 177 The Relationship Between Operative Duration and Perioperative Outcomes After Radical Cystectomy

Kassem S Faraj MD, Nathanael Judge BS, Mark D Tyson MD Mayo Clinic Arizona, Phoenix, AZ, USA

Abstract

Objectives: Prolonged operative times are associated with increased risk of complications in major abdominal operations. The present study tested the hypothesis that longer operative times are associated with increased risk of perioperative complications after radical cystectomy (RC). Materials and Methods: Adult patients who underwent RC from January 1, 2012, through December 31, 2016, were identified from the National Surgical Quality Improvement Program database. A natural log transformation was used to determine cutoff points for operative times at 33rd, 67th, and 90th percentiles: 272, 371, and 479 minutes, respectively. Cohorts were A (£272 min), B (273-371 min), C (372-479 min), and D (>479 min). Multivariable logistic regression analysis was performed to identify associations between operative time and perioperative complications. Operative time was treated as a continuous variable and unit of time was per 60 minutes. Results: Among 5,610 patients, the distribution across cohorts was A, 1,993 patients; B, 1,818; C, 1,171; and D, 628. Cohort D had a higher incidence of pulmonary embolism (PE), deep vein thrombosis (DVT), urinary tract infection (UTI), sepsis, 30-day readmission, and blood transfusion rate and had a longer median hospital length of stay. Multivariable analysis showed that operative time (per 60 min) was associated with increased risk of DVT (OR 1.10, P=.04), PE (OR 1.15, P=.01), UTI (OR 1.08, P=.004), readmission (OR 1.04, P=.03), and blood transfusion (OR 1.23, P<.001). Conclusions: Longer operative times during RC are associated with a higher rate of perioperative complications, likely due to common causes that both increase OR times due to case difficulty as well as increase the risk of complications. These findings may be confounded by disease stage, surgeon experience, or variations in perioperative management protocols, or a combination. As a consequence, modifications in surgical/treatment approach may be considered to reduce operative times in patients who are at risk for increased complications. 178 Extended duration venous thromboembolism chemoprophylaxis after Radical Cystectomy: A Single-Institutional Experience

Kassem S Faraj MD, Derek W Scott BS, Rohan Singh BS, Mark D Tyson MD Mayo Clinic Arizona, Phoenix, AZ, USA

Abstract

Objectives: Venous thromboembolism (VTE) is a complication seen after major abdominal surgeries, including radical cystectomy (RC). Extended duration anticoagulation therapy has been found to be effective in reducing the risk of developing VTE in trials evaluating major oncological surgeries. This practice has not been universally adopted in the care of patients undergoing RC. This study evaluates the efficacy of extended DVT prophylaxis in patients undergoing RC. Materials and Methods: This is a retrospective review that included all patients who underwent RC at our institution between 01/2007-01/2020. Exclusion criteria included the following: patients with a prior history of VTE, those on anticoagulation prior to surgery, thrombosis events after 90 days, RC for benign indication, and RC for non-bladder indication. A VTE included any symptomatic deep vein thrombosis or pulmonary embolism that occurred within 90-days after surgery. A multivariable regression analysis was done to identify factors associated with the development of a VTE.

Results: In 524 patients, the median age was 72 years and medium BMI 28 kg/m2. Sixty-four percent of patients had clinical T2 or greater disease. Neoadjuvant chemotherapy was used in 50.3% of cT2+ patients. The median operative time was 339 minutes. Thirty eight (7.3%) patients received extended DVT prophylaxis. In the entire cohort, eight-percent of patients developed a symptomatic VTE event. A VTE was more common in patients who did not receive extended DVT prophylaxis vs those who did (2.6% vs 8.4%), but this was not statistically significant (p=0.121). Patients who developed a VTE were more likely to have developed a postoperative lymphocele (OR 3.277, p=0.043) and have experienced a longer operative time (OR 1.420, p=0.001). A multivariable regression model was done that included confounders related to VTE, as well as extended DVT prophylaxis. This model revealed that extended DVT prophylaxis (OR 0.122, p=0.048) and operative time (OR 1.517, p=0.001) were significantly associated with development of a symptomatic VTE. Conclusions: Extended duration DVT prophylaxis is associated with a reduced risk of developing a symptomatic VTE after RC. In patients undergoing RC who are candidates, extended DVT prophylaxis should be offered to reduce the risk of VTE. 182 Variation in lymph node yield after radical cystectomy: the role of the pathology assistant

Kassem S Faraj MD, Nathanael Judge BS, Yu-Hui Chang PhD, Melissa Stanton MD, Mark D Tyson MD Mayo Clinic Arizona, Phoenix, AZ, USA

Abstract

Objectives: Lymph node yield during radical cystectomy (RC) may have long-term survival implications. Variability in lymph node count may be due to individual processing technique. This study tests the hypothesis that lymph node yield will vary by pathology assistant (PA). Methods and Materials: This is a single-institution retrospective review that included all patients who underwent a radical cystectomy with pelvic lymph node dissection for bladder cancer from 01/01/2007- 01/01/2018. Data were collected on preoperative clinical factors, operative, and post-operative details, including the pathologists’ assistant (PA) involved in gross processing of the specimens and the pathologist assigned to the case. Predicted mean lymph node counts were generated using multivariable linear regression analysis. Results: In a total of 430 patients who underwent cystectomy with a lymph node dissection, the median lymph node count (IQR) was 15.0 (11.0-21.0). The frequency of the limits of lymphadenectomy was as follows: external iliac, internal iliac and obturator (true pelvis) (34.2%), true pelvis plus common iliac to the level of the aortic bifurcation (49.3%) and inferior mesenteric artery (IMA) (16.5%). There were 6 PAs and 6 surgeons in the analysis. On descriptive analysis, there were differences in lymph node yield when looking at the following variables: level of lymph node dissection, clinical stage, neoadjuvant chemotherapy, surgical approach, surgeon, pathologist, and pathology assistant (p<0.05). On multivariable linear regression analysis, adjusted lymph node counts varied between surgeons, pathologists, clinical stage, and level of lymph node dissection, but not by PA (p=0.18). Conclusions: Lymph node yield after radical cystectomy varies on several known levels including surgeon, extent of lymphadenectomy, and pathologist. This study found no significant variation in lymph node yield according to pathology assistant. 247 Small bowel obstruction after cystectomy: Does diversion type make a difference?

Kathleen M Olson MD, Kassem S Faraj MD, Lanyu Mi MS, Mark D Tyson MD, Robert Ferrigni MD Mayo Clinic, Phoenix, AZ, USA

Abstract

Objectives: Cystectomy has the highest morbidity and mortality of any urologic surgery. Bowel complications are common, including small bowel obstruction (SBO) which is estimated to occur in 2.6-7.4% of patients and may vary based on urinary diversion type. The goal of this study is to further evaluate if SBO incidence varies based on urinary diversion and determine if there are factors that increase risk of post-operative SBO. Materials and Methods: After IRB approved protocol, a retrospective review was performed on all patients who underwent cystectomy at Mayo Clinic Arizona from 1/2007 through 3/2020. Patients without urinary diversion were excluded. Post-operative SBO was defined as CT findings of transition point in combination with symptoms of SBO requiring hospital admission. Descriptive statistics were used to compare groups.

Results: In a total of 662 patients who underwent cystectomy with urinary diversion, 13.4% of patients developed SBO post-operatively. The most common cause of SBO was intestinal adhesions, accounting for 49.3% of cases, and median time to SBO was 126 days. The incidence of SBO was significantly greater in patients who underwent ileal conduit vs neobladder diversion (14.6% vs 5.7%, respectively, p=0.02). There was no difference between location, cause, management, or time to presentation based on diversion type. When looking at SBO incidence overall, there was no significant difference based on age, sex, BMI, smoking history, neo-adjuvant chemotherapy, prior radiation, prior SBO, prior abdominal surgery, operative approach, and duration of surgery when comparing those who developed SBO post-operatively to those who did not. Conclusions: The results of this study confirm that post-operative SBO in patients undergoing cystectomy is common, affecting 13.4% of patients. The majority present after 30 days, are localized to the abdomen, and are due to adhesions. Patients undergoing ileal conduit are significantly more likely to develop SBO compared to neobladder. This study helps to better counsel patients when making their decision on diversion type. While this study identifies a significant difference in SBO incidence based on diversion type, it does not answer why there is a difference. Further research should aim to identify the cause and develop prevention techniques. Funding: None 260 The Effect of Chronic Kidney Disease on Outcomes After Radical Cystectomy

Charles Nguyen BS1, Saum Ghodoussipour MD2, Matthew Winter MD2, Sumeet Bhanvadia MD2, Hooman Djaladat MD2, Anne Schuckman MD2, Siamak Daneshmand MD2, Monish Aron MD2, Inderbir Gill MD2, Mihir Desai MD2 1Keck School of Medicine of USC, Los Angeles, California, USA. 2USC Institute of Urology, Los Angeles, California, USA

Abstract

Objectives: To assess the impact of chronic kidney disease (CKD) on outcomes after radical cystectomy (RC) and pelvic lymph node dissection in patients with bladder cancer treated within a high-volume tertiary referral center. Methods: A total of 1,214 patients underwent RC with intent to cure from 2009 to 2019 as identified from our prospectively collated institutional database. The Modification of Diet in Renal Disease (MDRD) GFR (mL/min/1.73 m²) was calculated and the entire cohort was categorized based on baseline GFR: Group A = GFR>60 (Normal), Group B = GFR>30-59 (Stage 3 CKD) and Group C = GFR <30 (Stage 4 CKD). Pre-, intra- and postoperative characteristics, oncological outcomes, 90-day perioperative outcomes and survival outcomes were compared. Multivariable logistic regression was used to control for confounding variables. Results: We identified 722 (59.5%) patients in Group A, 448 (36.9%) in Group B and 44 (3.6%) in Group C. Patients with worse CKD were older and had significantly worse overall comorbidity (ASA and CCMI) (all p<0.001). On univariate analysis, worse CKD status was associated with higher pathologic stage, lymph node metastases and positive soft tissue margins (all p<0.0001). The rate of perioperative blood transfusion was higher in patients with worse CKD (31.2% vs 43.1% vs 63.6% for Group A, B and C, respectively, p<0.0001) as were 90-day complications (70.1% vs 75.2% vs 86.4%, p=0.02) and readmissions (28% vs 32.6% vs 43.2%, p=0.04). Patients with worse CKD had worse overall survival (77% vs 73% vs 55% p<0.0001). On multivariable analysis, worse CKD was independently associated with adverse pathology including extravesical and nodal positive disease (OR=6.6, 95% CI 3.1-14.0) 90-day readmissions (OR 2.09, 95%CI 1.11-3.94) and perioperative transfusion (OR 2.08, 95%CI 1.05-4.11) Conclusions: CKD is prevalent in patients undergoing radical cystectomy. We found CKD to be independently associated with a higher likelihood of non-organ confined disease and lymph node metastases as well as 90- day readmissions and transfusion. 309 Long Term Renal Function in Patients with CKD following Radical Cystectomy and Orthotopic Neobladder: Matched Case-Control Study

Hamed Ahmadi MD, Sharath S Reddy BA, Charles Nguyen BS, Sanam Ladi-Seyedian MD, Sidney Roberts BA, Alireza Ghoreifi MD, Sumeet Bhanvadia MD, Hooman Djaladat MD, Anne Schuckman MD, Siamak Daneshmand MD Keck School of Medicine (USC), Los Angeles, CA, USA

Abstract

Objectives: Orthotopic neobladder (ONB) following radical cystectomy (RC) has been traditionally discouraged in patients with chronic kidney disease (CKD) due to concerns regarding diminishing renal function over time and associated metabolic derangements. This study evaluates long-term renal function in patients with CKD IIIa who underwent RC and ONB compared to matched controls. Methods: Using our institutional database, patients with glomerular filtration rate (GFR) between 45 and 60 ml/min who underwent RC and ONB were selected as cases. A control group of patients with GFR ≥60 ml/min was selected. Groups were matched based on age, baseline hypertension/diabetes mellitus, perioperative chemotherapy, and preoperative hydronephrosis. A decrease in GFR >10 ml/min during the follow up was considered significant. A multivariate Cox regression analysis was performed to identify predictors of GFR decline below baseline (45 ml/min in case and 60 ml/min in control group) and significant GFR decline in each group. Results: Of 1237 patients in the database who underwent intent-to-cure RC and ONB, 508 patients were enrolled (254 in each group). Mean preoperative GFR was 53.3 ml/min in cases and 78.8 ml/min in controls. Median follow up was 3.7 years. During follow-up, GFR stayed above baseline in 51% of cases compared to 46% of controls (P=0.5). However, mean time to significant GFR drop was significantly longer in cases compared to controls (5.6 years vs 2 years, respectively; P<0.001) (Figure 1). In multivariate analysis, neoadjuvant chemotherapy was found to be the strongest predictor of GFR decline below baseline as well as significant GFR decline in cases (Table 1). Conclusions: Patients with CKD IIIa who undergo ONB seem to have comparable long-term renal function to those with GFR ≥60 ml/min. ONB reconstruction is a safe option for patients with CKD IIIa patients desiring continent diversion.

278 TIMING AND LOCATION OF RECURRENCES FOLLOWING OPEN AND ROBOT- ASSISTED RADICAL CYSTECTOMY FOR UROTHELIAL CARCINOMA OF THE BLADDER

Jim K Shen MD1, Hamed Ahmadi MD2, Saum Ghodoussipour MD2, Bertram E Yuh MD1, Nora H Ruel MA1, Pooya Banapour MD1, Frank A Myers MD1, Clayton S Lau MD1, Sia Daneshmand MD2, Kevin G Chan MD1 1City of Hope National Medical Center, Duarte, CA, USA. 2University of Southern California Institute of Urology, Los Angeles, CA, USA

Abstract

Objectives: Data has emerged regarding possible differences in location and timing of recurrences after robot-assisted radical cystectomy (RARC) compared to the gold standard of open radical cystectomy (ORC). This study compares large cohorts from two referral centers specializing in RARC and ORC to investigate this question.

Materials and Methods: Patients undergoing RARC at City of Hope and ORC at University of Southern California from 2004-2016 for nonmetastatic urothelial carcinoma of the bladder were included. The site(s) of first recurrence after surgery were categorized as local, distant, or urothelial. Recurrence-free (RFS) and overall survival (OS) was calculated using the Kaplan Meier method and compared using log rank tests. Chi square tests were used to compare distribution of recurrence locations between ORC and RARC. Multivariable Cox proportional hazards regression modeling was used to determine independent predictors of RFS and OS. p<0.05 was considered statistically significant.

Results: 321 RARC and 1218 ORC patients were included in the study. RARC patients were more likely to be male, have ASA score ≥3, and receive neoadjuvant chemotherapy. RARC patients were less likely to have a positive urethral margin, undergo super-extended lymph node dissection, and receive adjuvant chemotherapy. They also had lower lymph node yield. Proportions of local-only, urothelial-only, or distant recurrences did not differ significantly between RARC and ORC patients. The RARC and ORC cohorts did not significantly differ in OS, overall RFS, distant RFS, or local RFS. The ORC cohort had superior urothelial RFS (p=0.04). RARC was not an independent predictor of OS (HR 0.81, 95% CI 0.62-1.04), overall RFS (HR 0.83, 95% CI 0.65-1.07), distant RFS (HR 0.78, 95% CI 0.58-1.04), local RFS (HR 0.62, 95% CI 0.30-1.27), or urothelial RFS (HR 1.61, 95% CI 0.80-3.25).

Conclusions: In a large retrospective comparison of RARC and ORC cohorts, timing and location of recurrences were comparable after intermediate-term follow-up.

Source of Funding: None

318 Induction Chemotherapy in Clinically Node Positive Bladder Cancer: Pre- Operative Radiologic Variables Can Predict Response

Ryan Atkinson, BS BS, Saum Ghodoussipour, MD MD, Willem Xu, MD MD, Khoa Tran, MD MD, Gus Miranda, BS BS, Jie Cai, MS MS, Sumeet Bhanvadia, MD MD, Anne Schuckman, MD MD, Siamak Daneshmand, MD MD, Hooman Djaladat, MD, MS MD, MS Department of Urology, USC/Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, Ca, USA

Abstract

Purpose: To evaluate outcomes after radical cystectomy (RC) and pelvic lymph node dissection (PLND) for patients with clinically node positive (cN+) urothelial bladder cancer and to determine preoperative imaging variables that may predict pathologic nodal status. Methods: We identified all patients with cTanyN+M0/M1a bladder cancer who underwent RC and PLND with intent to cure at our institution. Clinical characteristics and oncologic outcomes were analyzed. Pre and post- chemotherapy CT scans were reviewed to characterize lymph node size and morphology. We also sought to determine associations between post-chemotherapy radiology variables and pathologic response. Results: We identified 130 patients with clinically node positive bladder cancer. Final pathology confirmed nodal metastases (pN+) in 93 (71.5%) patients. Patients with pN+ disease had a higher clinical stage including cT4 in 24.7% compared to 10.8% in those with complete nodal response (pN0) (p=0.044). Induction chemotherapy was administered to 76 (58.5%) patients prior to RC, including 31 (83.7%) with pN0 disease and 45 (48.4%) with pN+ disease (p<0.001). Downstaging of disease in the bladder and complete nodal response rates were greater in patients who received chemotherapy compared to those who had surgery alone (43.4% vs. 12.9%, respectively and 46.1% vs 11.1%, respectively, p<0.0001 for both). pN+ status was associated with higher overall morality (HR 2.03, 95%CI 1.13 -3.66) and recurrence (HR 2.09, 95% CI 1.16 – 3.77) when compared to patients who were pN0. Review of 29 post chemotherapy CT scans showed that patients with pN+ disease had a greater median number of enlarged nodes (3.5 vs. 1, p=0.03) and median size of largest node (8.5mm vs. 6.0mm, p=0.02) on imaging compared to those with pN0 disease. An 8.0mm cut-off diameter for a positive node provided a sensitivity and specificity of 72% and 80% respectively (c-index=0.761, p=0.014). The positive predictive value was 87% (95% CI 58%-98%), and negative predictive value was 62% (95% CI 32%-85%). Conclusions: Patients with clinically node positive bladder cancer may have significant nodal response after induction chemotherapy. Our data suggest a post-chemotherapy CT scan with an 8mm nodal size cut-off may be a better predictor of pathologic nodal status than more traditional measures. 321 Effect of Time Between Neoadjuvant Chemotherapy to Radical Cystectomy on Pathological Downstaging for Bladder Cancer

Andrew Duchesne BS, Solange Bassale MS, Jasper Bash MD, Sudhir Isharwal MD, Christopher Amling MD, Jen- Jane Liu MD Oregon Health & Science University, Portland, Oregon, USA

Abstract

Objective: Neoadjuvant chemotherapy (NAC) prior to radical cystectomy (RC) is the standard of care for the treatment of muscle invasive bladder cancer; however, the optimal timing between NAC and RC is controversial. Our objective was to determine the effect of time between NAC initiation and RC on pathological downstaging, and the effect on postoperative complications.

Methods: We identified patients who underwent NAC followed by RC between 2009 and 2019. Data was extracted from the National Surgery Quality Improvement Program (NSQIP) and OHSU Cancer Registry (CR), in addition to manual chart review. Time from NAC initiation to RC, NAC regimen and number of cycles, type of surgery and urinary diversion, and clinical T stage were evaluated as potential predictors. Patients were stratified into four date ranges based on quartiles (<100, 100-120, 120-140, and >140 days from NAC initiation to RC). Univariate logistic regression analysis was used to test the association between potential predictors and downstaging. Complications were defined as 30-day readmission or post-operative death.

Results: We identified 123 patients who underwent NAC and RC with available data. The median (range) number of NAC cycles completed was 4 (1-9). 41% of patients with any clinical T stage were downstaged to pT0, pTa, or pTis, and 25% were downstaged to pT0. There was no difference in downstaging based on time from NAC initiation to RC among the four date ranges. Number of NAC cycles was marginally significant for downstaging to either pT0, pTa or pTis OR 1.5 (0.99 – 2.26); p=0.057. Clinical T stage and NAC regimen were independently associated with postoperative complications; OR = 2.6 (1.01 – 6.6) for clinical T3/T4 vs others, p=0.047; OR = 4.14 (1.29 – 13.37) for gemcitabine or etoposide and cisplatin vs MVAC, p=0.017.

Conclusions: We found no difference in downstaging based on time between NAC initiation to RC; however, patients who received more NAC cycles were more likely to be downstaged, although this finding was only marginally significant. Complications were higher in patients with clinical T3 and T4 disease and those who received gemcitabine or etoposide and cisplatin vs MVAC.

If funding provided, type in source company / entity name(s):

None