A Phase 2 Trial of Intravesical Gemcitabine and Docetaxel in the Treatment of Bacillus Calmette-Guérin‒Naïve Nonmuscle-Invasive Urothelial Carcinoma of the Bladder.

PURPOSE: Combination intravesical gemcitabine and docetaxel (GemDoce) has demonstrated efficacy as second-line therapy for patients with bacillus Calmette-Guérin (BCG)‒unresponsive nonmuscle-invasive urothelial carcinoma of the bladder (NMIBC). In the context of widespread BCG shortages, we performed a phase 2 prospective trial to assess GemDoce for BCG-naïve NMIBC. MATERIALS AND METHODS: This study is a prospective, single-arm, open-label phase 2 trial for patients with BCG-naïve high-risk NMIBC. Intravesical GemDoce was given weekly for 6 weeks as induction followed by monthly maintenance therapy for 2 years among responders. The primary end point was 3-month complete response, and key secondary end points included adverse events (AEs) and 12-month recurrence-free survival. RESULTS: Twenty-five patients were enrolled between August 2020 and August 2022 with median follow-up of 19.6 months. The pretreatment pathologic stages were high-grade (HG) T1 with carcinoma in situ (CIS; n = 7), HGT1 without CIS (n = 6), HGTa (n = 9), and CIS alone (n = 3). The 3-month complete response rate was 100% and recurrence-free survival at 12 months was 92%. Two patients with pretreatment HGT1 had HGT1 recurrences at 9 and 12 months. No patients progressed to T2 disease, underwent radical cystectomy, or had any radiographic evidence of progressive disease. Grade 1 AEs were common (23/25 patients) including hematuria, urinary frequency, urgency, and fatigue. Five patients (20%) experienced a grade 3 AE including hematuria and UTI. CONCLUSIONS: In this single-arm phase 2 trial, GemDoce was well tolerated with promising efficacy for patients with BCG-naïve high-risk NMIBC.

Effectiveness of Liposomal Bupivacaine With Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Local Anesthetic for Children Undergoing Ambulatory Urologic Surgery: The Baby ORIOLES Randomized Clinical Trial.

PURPOSE: We sought to determine if the addition of liposomal bupivacaine to bupivacaine hydrochloride improves opioid-free rate and postoperative pain scores among children undergoing ambulatory urologic surgery. MATERIALS AND METHODS: A prospective, phase 3, single-blinded, single-center randomized trial with superiority design was conducted in children 6 to 18 years undergoing ambulatory urologic procedures between October 2021 and April 2023. Patients were randomized 1:1 to receive dorsal penile nerve block (penile procedures) or incisional infiltration with spermatic cord block (inguinal/scrotal procedures) with weight-based liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The primary outcome was opioid-free rate at 48 hours. Secondary outcomes included parents' postoperative pain measure scores, numerical pain scale scores, and weight-based opioid utilization at 48 hours and 10 to 14 days. RESULTS: We randomized 104 participants, with > 98% (102/104) with complete follow-up data at 48 hours and 10 to 14 days. At interim analysis, there was no significant difference in opioid-free rate at 48 hours between arms (60% in the intervention vs 62% in the control group; estimated difference in proportion -1.9% [95% CI, -20%-16%]; P = .8). We observed no increased odds of patients being opioid-free at 48 hours with the intervention compared to the control group (OR 0.96 [95% CI 0.41-2.3]; P = .9). The trial met the predetermined futility threshold for early stopping. There was no difference in parents' postoperative pain measure scores, numerical pain scale scores, or opioid utilization at 48 hours or 10 to 14 days. No difference in adverse events was observed. CONCLUSIONS: The addition of liposomal bupivacaine to bupivacaine hydrochloride did not significantly improve opioid-sparing effect or postoperative pain compared with bupivacaine hydrochloride alone among children ≥ 6 years undergoing ambulatory urologic surgery.

Does prophylactic antibiotics post pediatric pyeloplasty reduce the incidence of febrile UTIs?

PURPOSE: The use of postoperative prophylactic antibiotics in pediatric upper urinary tract reconstruction remains controversial. In this study, we examined whether low dose antibiotics administered following pediatric pyeloplasty reduce the incidence of febrile urinary tract infections at our institution. As a secondary outcome, in those patients with infection, additional analysis was performed to better quantify which patient population benefits the most from low dose prophylactic antibiotics. METHODS: Institutional review board approval (IRB) was obtained. All methods were carried out in accordance with relevant guidelines and regulations. A retrospective study was performed in patients who underwent pyeloplasty (2011-2017) at our institution. Surgical approach (laparoscopic versus robotic assisted versus open, with or without internal JJ ureteral stent) were based on surgeon preference. Patients of 8 fellowship trained pediatric urologists were included in the study period. Patients with prior history of urologic interventions or other congenital genitourinary tract abnormalities were excluded. Demographics (age, gender, ethnicity, insurance status), prior history of culture proven urinary tract infection, surgical details (administration of perioperative antibiotics), and postoperative outcomes including; 1) re-admission 30 days post-surgery, 2) any urine cultures collected due to suspected urinary tract infection. RESULTS: A total of 209 patients (149 boys, 60 girls) met our inclusion criteria with 55/209 (26%) receiving postoperative prophylactic antibiotics. The average age was 6 years (range: 2 months-18 years). Indwelling ureteral stent was used in 176 (84%) patients. Eleven patients (5%) had a culture-proven urinary tract infection within 30-days postoperatively. No significant differences were seen in postoperative complications or incidence of urinary tract infection when comparing surgical approaches, +/- ureteral stent, or the use of antibiotics. Secondary analysis noted statistically significant increase in post-operative urinary tract infection in younger children (2.8 v. 6.2 years, p = 0.02), those patients who had a positive preoperative urine culture (8/11, p = 0.01) and those with public health insurance (p = 0.038). CONCLUSION: The incidence of postoperative urinary tract infection following pyeloplasty in our cohort was relatively low. There was a higher incidence of urinary tract infection in patients less than 3 years old. The use of antibiotics in patients post pyeloplasty did not appear to affect the incidence of post-operative urinary tract infection, however, they may have a role in children who have not yet potty trained and in patients with positive preoperative urine culture.

Testicular ultrasound underestimates the size of small testicular masses: a radiologic-pathologic correlation study.

PURPOSE: Increasing use and resolution of testicular ultrasound imaging has resulted in a greater diagnosis of non-palpable small testicular masses and subsequent over-treatment with orchiectomy. Our aim was to determine the diagnostic accuracy of testicular ultrasound to accurately determine the pathologic size of small testicular masses (SMTMs) and to evaluate the association of various measurements with benign pathology. METHODS: Retrospectively, an institutional testicular cancer database was reviewed to evaluate the patients who underwent an orchiectomy for a testicular mass seen on ultrasound from 2003 to 2017. Three-dimensional measurements were compared from the ultrasound and pathology specimens, including other measures such as tumor volume and percentage of testicular volume. Finally, the predictive accuracy of maximum diameter and tumor volume to predict benign pathology was evaluated using receiver-operating curve analysis. RESULTS: We identified 208 patients and showed that ultrasound significantly underestimated sub-centimeter testicular masses (mean difference 0.56 cm, 95%CI 0.89-0.14, p = 0.004) and testicular masses between 1 and < 2 cm (mean difference 0.50 cm, 95%CI 0.97-0.15, p = 0.009). Tumor volume measured on ultrasound was consistently similar to pathologic tumor volume across all sizes and was significantly correlated (Spearman's Rho = 0.81). Mass volume had a greater predictive accuracy for benign pathology than maximum diameter using a 1 cm cut-off (AUC 0.65 vs 0.60). CONCLUSION: Using the maximal diameter, testicular ultrasound significantly miscalculated the pathologic dimensions of masses less than 2 cm compared to orchiectomy specimens. Volumetric measurements may better represent actual tumor sizes for SMTMs and may be a more useful measure for identifying those a higher risk for benign pathology, however, further studies are required.

Assessment of musculoskeletal pain and surgical ergonomic parameters among members of the American Society of Pediatric Otolaryngology.

OBJECTIVES: To assess rates of self-reported work-related pain and knowledge of ergonomic principles among fellowship trained pediatric otolaryngologists within the American Society of Pediatric Otolaryngology (ASPO). We hypothesized that pediatric otolaryngologists experience rates of musculoskeletal pain and injury similar to what has been reported among adult otolaryngologists and other surgical subspecialties. METHODS: An IRB-approved survey was distributed to members of ASPO through email listserv. Collected variables included surgeon demographic information, practice settings, surgical volume, procedure types, work-related musculoskeletal pain-related metrics, modifying factors, and knowledge/attitudes on surgical ergonomics. RESULTS: A total of 685 ASPO members were approached via email, of which 435 opened the survey email and 118 attending pediatric otolaryngologists completed the survey (response rate 27%). In all, 78% of respondents reported current or prior pain and/or injury attributed to performing surgery, 20% higher than that reported in the previous ergonomics survey of ASPO members in 2012. The most affected areas were neck/cervical spine (63%), shoulders/arms (44%), lower back/lumbar spine (36%), and hands/wrist (31%). Half of the respondents were diagnosed with musculoskeletal condition(s) attributed to performing surgery. Two-thirds required treatment (62% pharmacologic only, 9% pharmacologic and surgical intervention) for their work-related pain. Leveraging intermittent pauses during surgical procedures to adjust body position was the most reported method of addressing pain in the operating room. Only 21% report ever having received ergonomic training during their training or career. CONCLUSION: Musculoskeletal pain associated with performing pediatric otolaryngology procedures is highly prevalent and has not attenuated despite increased awareness of surgical ergonomics. Results from this study underscore the need to develop standardized surgical ergonomics curricula for pediatric otolaryngologists and trainees.

Medical School Rankings: Time to End or Time to Amend?

ABSTRACT: The recent decisions of several medical schools to no longer participate in the rankings published annually by U.S. News & World Report have added greater visibility to the issues surrounding medical school rankings than ever before. While these announcements garnered significant attention in academic medicine and from the lay public, the authors believe these events are unlikely to eliminate rankings in medical education. In this article, the authors outline the potential harms of rankings in higher education, provide a rationale for why they will likely endure despite recent scrutiny, and offer suggestions for prospective students and the academic medical community to engage with rankings in a more productive way. Criticisms of medical school rankings have been noted for decades, including their use of subjective information and data with questionable relevance to the quality of students' education or the outcomes of their educational experience, methodological concerns, and the potential harms of ranking systems (such as schools diverting their focus and resources away from initiatives that benefit students to improve their ranking). At the same time, rankings are ubiquitous in today's culture and are powerful in human decision-making, so there is reason to believe that medical school rankings may weather the current storm. Given these concerns, the authors suggest students continue to use a variety of resources to obtain information about medical schools and consider how each school fits with their own educational needs. The authors also encourage medical schools, medical education organizations, and governing medical bodies to suggest different metrics that reflect quality in medical education and that are of importance to applicants.

Critically Evaluating the Role for Postoperative Antibiotics in Patients Undergoing Urethroplasty With Buccal Mucosa Graft: A Claims Database Analysis.

OBJECTIVE: To compare outcomes among patients undergoing first-time urethroplasty with buccal mucosa graft (BMG) who receive postoperative antibiotics vs those who do not. METHODS: A retrospective cohort study was conducted using the TriNetX claims database between 2008-2022. Using CPT, ICD10, and LOINC codes, patients >18 years old undergoing primary urethroplasty with BMG who received an outpatient prescription for antibiotics between postoperative day 0-30 or did not were queried. Patients with positive preoperative urine culture or urinary tract infection (UTI) within 30days preoperatively were excluded. Surgical outcomes included 5-year revision rates and revision-free survival. Safety outcomes included new UTI within 30days, surgical site infection within 90days, or Clostridium difficile infection within 30days of urethroplasty. RESULTS: We identified 884 patients (81% antibiotic cohort, 19% nonantibiotic cohort) that met inclusion criteria. Age at time of urethroplasty, suprapubic tube presence, and pre-existing medical comorbidities were comparable between cohorts (Table 1A). There was no difference in 5-year rates and revision-free survival for endoscopic revision (11.5% vs 9.5%, relative risk (RR) 1.2, 95% CI [0.7, 2.0], recurrence-free survival (RFS) log-rank P = .6), re-do urethroplasty (12.9% vs 13.7%, RR 0.9, 95% CI [0.6, 1.5], RFS log-rank P = .7), or all-cause revision (19.8% vs 17.7%, RR 1.1, 95% CI [0.8, 1.6], P = .5) between groups. Postoperative rates of UTI, surgical site infection, and C difficile infection were similar between groups. CONCLUSION: In this large retrospective cohort study of patients undergoing urethroplasty with BMG, we observed no significant benefit from use of postoperative antibiotics on long-term revision rates or perioperative infectious complications.

The Impact of Hypogonadism on Surgical Outcomes Following Primary Urethroplasty: Analysis of a Large Multi-institutional Database.

OBJECTIVE: To compare surgical outcomes among a cohort of eugonadal and hypogonadal patients undergoing primary urethroplasty (UP). METHODS: A retrospective cohort study was conducted using TriNetX between 2008-2023. Patients who were eugonadal and hypogonadal (symptoms plus testosterone <300 ng/dL) prior to UP were compared. A subgroup analysis of hypogonadal patients was performed to compare those with testosterone replacement therapy (TRT) vs TRT-naïve prior to UP. Propensity-score matching was used to adjust for differences in comorbidities. Outcomes were 5-year revision rates and revision-free survival for endoscopic revision and redo UP following primary UP. RESULTS: We identified 12,556 eugonadal and 488 hypogonadal patients (153 TRT+, 335 TRT-) undergoing UP. Median age at UP and follow-up was 55years and 5years, respectively. After propensity-score matching, we compared 477 eugonadal and 477 hypogonadal patients. Hypogonadal patients had a statistically significantly higher 5-year redo UP rate (11% vs 6%, relative risk [RR] 1.5 [95%CI, 1.2-2.2]; P = .01) when compared to eugonadal patients however there was no difference in 5-year rates of endoscopic revision (11% vs 11%, RR 1.0 [95%CI, 0.7-1.5]; P = 1.0). We observed no difference in 5-year revision-free survival time for endoscopic revision or redo UP between groups. Hypogonadal patients treated with TRT had a significantly higher 5-year redo UP rate (15% vs 7%, RR 1.8 [95%CI, 1.1-3.3]; P = .02) compared to hypogonadal patients that were TRT-naïve prior to UP. There was no difference in rates of endoscopic revision (14% vs 10%, RR 1.3 [95%CI, 0.7-2.4]; P = .2) between subgroups. CONCLUSION: Pre-existing hypogonadism may modestly adversely affect surgical outcomes following primary UP based on data from a large, retrospective cohort study.

Long-Term Management of Problems in Cloacal Exstrophy: A Single-Institution Review.

INTRODUCTION: Cloacal exstrophy (CE) is the most severe malformation of the exstrophy-epispadias complex. This study aims to discuss long-term sequela in a single major institution with a high volume of CE patients. MATERIALS AND METHODS: A prospectively maintained database of 1490 patients on the exstrophy epispadias spectrum (145 cloacal exstrophy) from 1974 to 2023. The patient database was reviewed for CE patients >10 years of age for genitourinary, gastrointestinal, orthopedic, and psychosocial outcomes. RESULTS: A total of 63 patients (43.4%) with ≥10 years of follow up were included for analysis. Thirty-nine (61.9%) patients were 18 years or older. Twenty-two (34.9%) patients were female and 39 (61.9%) male, 14 of whom were gender converted at birth. Two female patients conceived naturally and delivered via cesarean section. No male born CE patients had biological children. Catheterizable channels were common (45/63, 71.4%) and most (88.9%) were continent. Gastrointestinal diversion was managed mostly by colostomy (37/63, 58.7%). Three out of five (60.0%) patients who underwent PSARP were continent of stool. Twenty-two (34.9%) patients were wheelchair-bound. Psychosocial diagnoses included 52.4% (33/63) patients with anxiety/depression and 27.0% with chronic pain. Out of 56 patients evaluated by physical therapy, 75% were independent in ADL performance. Of patients older than 18, 79.5% (31/39) had attended college and 82.1% (32/39) were gainfully employed. CONCLUSION: Advances in critical care, nutrition, gastrointestinal, orthopedic, and urologic management have resulted in survival rates approaching 100% among patients with CE. While these children face long-term sequela spanning various organ systems, many lead independent and fully-functional lives. TYPE OF STUDY: Prognosis Study. LEVEL OF EVIDENCE: Level IV.

National Postoperative Opioid Prescribing Rates Following Pediatric Urology Procedures Before and After the 2018 American Academy of Pediatrics Challenge to Reduce Opioid Prescribing: A Claims Database Analysis.

OBJECTIVE: To evaluate trends in opioid prescribing rates following pediatric urologic surgery. METHODS: We queried the TriNetX Research database for patients under age 18 who underwent one of seven common pediatric urology procedures. We identified the proportion of patients that received an oral opioid prescription within 5days of surgery. The primary analysis evaluated the trend in postoperative opioid prescriptions using 3-month intervals from January 2010 to December 2022. We performed an interrupted time series analysis assessing trends in opioid prescribing patterns both before and after the American Academy of Pediatrics challenge. RESULTS: Of the 81,644 pediatric urology procedures, 29,595 (36.2%) received a postoperative opioid prescription, including 29.8% of circumcisions, 25.8% of hydrocelectomies, 39.6% of hypospadias repairs, 42.7% of pyeloplasties, 42.8% of ureteral reimplants. For all procedures we observed rising rates of opioid prescribing, increasing by 0.9% per 3-month interval prior to the challenge statement release from 2010 to 2018. We observed an overall significant decrease in opioid prescribing by 2.2% per 3-month interval following the challenge statement release. Additionally, since 2018, there was a significant decrease in opioid prescribing in all of the race, ethnicity, and age cohorts. CONCLUSION: Opioid prescribing following pediatric urology procedures has sharply decreased following the 2018 American Academy of Pediatrics challenge statement which underscores the value of cross-specialty quality improvement initiatives. Nonetheless, opioid prescribing remains high with potential racial or age disparities that warrant further investigation.

A Double-Blinded Randomized Controlled Trial Assessing the Efficacy of Opioid Disposal Instructions with Parental Education on Proper Opioid Disposal Rates Following Ambulatory Pediatric Urologic Surgery.

OBJECTIVES: To determine if the administration of standardized opioid disposal instructions with focused parental education improves proper disposal of leftover opioid medication among families of children undergoing ambulatory urologic surgery compared to routine postoperative instructions. METHODS: A prospective, double-blinded, single-center randomized controlled trial was conducted in children 6-18 years undergoing ambulatory urology procedures between October 2021 and April 2023. Patients were randomized (1:1) to receive either the Food and Drug Administration (FDA) opioid disposal best practices worksheet plus nursing parental education or routine postoperative instructions alone. All patients were prescribed acetaminophen and ibuprofen and a per-protocol rescue opioid prescription. The primary outcome was rate of proper opioid disposal at 10-14 days post-procedure. Secondary outcomes included parents' postoperative pain measure (PPPM) scores, numerical pain scale (NPS) scores, and weight-based opioid utilization at 48 hours and 10-14 days. RESULTS: We randomized 104 participants (53 intervention, 51 control) with 97% (101/104) complete follow-up data at 10-14 days. Patient demographics, procedural characteristics, and analgesia use were similar between groups. We observed no significant difference in proper opioid disposal rates between arms (31% intervention vs 18% control; estimated difference in proportion 13% [95% CI, -4%-29%]; P = .1). There were no increased odds of proper disposal of leftover opioid medication at 10-14 days with the intervention compared to the control (OR 2.0 [95% CI 0.8-5.1]; P = .1). We observed no differences in PPPM scores, NPS scores, or opioid utilization at 48 hours or 10-14 days. CONCLUSION: Providing formal opioid disposal instructions with parental education did not improve proper disposal of leftover opioid medication nor did it alter post-discharge opioid utilization after pediatric urologic surgery.

Infantile versus childhood posterior urethral valve diagnosis: management patterns and clinical outcomes at opposite ends of the spectrum.

BACKGROUND: Management patterns and outcomes are poorly defined in cases of late PUV diagnosis. OBJECTIVE: To compare post-ablation management and clinical outcomes of patients with infantile (<1 year) versus childhood (>5 year) PUV diagnosis to gain insight into the pathologies at opposite ends of the PUV spectrum. STUDY DESIGN: A multicenter retrospective cohort study was conducted using the TriNetX research network between 2006 and 2022. TriNetX synthesizes insurance claims and electronic medical record data for over 110 million patients from 92 healthcare organizations. We defined two cohorts: 1) The <1 year arm had an index diagnosis of PUV and cystoscopy with valve ablation within 1 year of life, 2) the >5 year arm had an index diagnosis of PUV and valve ablation after age 5. We report rates and time-to-first use of antispasmodics, alpha-blockers, CIC, bladder botox, enterocystoplasty or Mitrofanoff or secondary cutaneous vesicostomy, and CKD. RESULTS: We identified 569 patients (323 <1 year; 246 >5 year). Median age at diagnosis was 1 month (median follow-up 8 years) and 9 years (median follow-up 10 years) for the <1 year and >5 year cohorts, respectively. Following ablation, both arms were primarily managed with antispasmodics, with no difference between groups. The >5 year arm was significantly more likely to receive alpha-blockers or bladder botox. The <1 year arm was significantly more likely to be started on CIC, undergo enterocystoplasty, Mitrofanoff or secondary cutaneous vesicostomy, or renal transplantation. The <1 year arm had significantly higher rates and shorter time-to-progression to all stages of CKD. DISCUSSION: Despite higher utilization of conservative strategies among patients with a late PUV diagnosis, these patients had superior renal outcomes and low rates of progression to invasive treatments. Limitations include potential inaccuracies in medical coding as well as variations in thresholds to initiate CIC, perform surgical reconstruction, or proceed with renal transplantation at participating centers. CONCLUSIONS: These findings provide evidence that a late PUV diagnosis reflects an overall milder disease process.

Perioperative opioid prescribing after male fertility procedures is associated with new persistent opioid use: retrospective analysis of a large claims database.

OBJECTIVE: To assess the risk of new persistent opioid use in opioid-naïve men who underwent male fertility procedures. DESIGN: Retrospective cohort study using a claims database. SETTING: A database linking electronic medical record data and claims-assessing men who underwent fertility procedures between 2010 and 2021. PATIENT(S): Opioid-naïve men who underwent fertility procedures (open or laparoscopic varicocelectomy, spermatocele excision, and testicular excisional or incisional biopsy) without further surgical intervention requiring anesthesia in the 2 years after the index procedure. Those with and without perioperative opioid prescriptions were propensity score matched on age, race/ethnicity, smoking status, mental health diagnoses, and preoperative pain diagnoses. INTERVENTION(S): Perioperative opioid prescription. MAIN OUTCOME MEASURE(S): The primary outcome was the incidence of new persistent opioid use (opioid prescription 3-9 months after the index fertility procedure). The secondary outcome was prolonged opioid use (opioid prescription 9-24 months after the index fertility procedure). RESULT(S): A total of 387,565 men who underwent fertility procedures were identified, of whom 25.1% received an opioid prescription. After propensity score matching, 97,215 men were included; 4.7% of men who received a perioperative opioid prescription developed new persistent opioid use compared with 2.2% of those without a perioperative opioid prescription (risk ratio, 2.16; 95% confidence interval, 2.05-2.27; number needed to harm, 39). When assessing each unique fertility procedure independently, men who received perioperative opioids had statistically higher odds of developing new persistent opioid use for all procedure types. Men with new persistent opioid use were much more likely to go on and develop prolonged opioid use than men without new persistent opioid use. CONCLUSION(S): Opioid prescription after male fertility procedures is associated with a significant risk of new persistent opioid use, emphasizing the importance of judicious opioid prescribing for male fertility procedures.

Abdominal Mass in a Phenotypic Female with 46,XY Differences in Sex Development.

We present a case of a large intra-abdominal mass found to be localized pure seminoma within a retained gonad of a 53-year-old phenotypic female with 46,XY differences in sex development (DSD) and androgen insensitivity syndrome (AIS). Our management included extirpation of the mass with contralateral gonadectomy. Historically, patients with AIS would undergo gonadectomy to mitigate the lifetime risk of testicular germ cell tumor development; however, growing evidence suggests safety in retention and surveillance of these gonads into adulthood. This case highlights the importance of lifetime surveillance of patients with 46,XY DSD who elect to retain their gonads.