Treatment Outcomes of High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) in Real-World Evidence (RWE) Studies: Systematic Literature Review (SLR).

BACKGROUND: To date, there has been limited synthesis of RWE studies in high-risk non-muscle invasive bladder cancer (HR-NMIBC). The objective of this research was to conduct a systematic review of published real-world evidence to better understand the real-world burden and treatment patterns in HR-NMIBC. METHODS: An SLR was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines with the scope defined by the Population, Intervention Comparators, Outcomes, and Study design (PICOS) criteria. EMBASE, MEDLINE, and Cochrane databases (Jan 2015-Jul 2020) were searched, and relevant congress abstracts (Jan 2018-Jul 2020) identified. The final analysis only included studies that enrolled ≥100 patients with HR-NMIBC from the US, Europe, Canada, and Australia. RESULTS: The SLR identified 634 RWE publications in NMIBC, of which 160 studies reported data in HR-NMIBC. The average age of patients in the studies was 71 years, and 79% were males. The rates of BCG intravesical instillations ranged from 3% to 86% (29-95% for induction and 8-83% for maintenance treatment). Five-year outcomes were 17-89% recurrence-free survival (longest survival in patients completing BCG maintenance), 58-89% progression-free survival, 71-96% cancer-specific survival (lowest survival in BCG-unresponsive patients), and 28-90% overall survival (lowest survival in patients who did not receive BCG or instillation therapy). CONCLUSION: BCG treatment rates and survival outcomes in patients with HR-NMIBC vary in the real world, with better survival seen in patients completing maintenance BCG, responding to treatment, and not progressing to muscle-invasive disease. There is a need to better understand the factors associated with BCG use and discontinuation and for an effective treatment that improves outcomes in HR-NMIBC. Generalization of these results is limited by variations in data collection, reporting, and methodologies used across RWE studies.

Short communication: Ex-vivo effects of fluoxetine on production of biomarkers for inflammation and neurodevelopment by the placenta.

Fluoxetine is commonly prescribed during pregnancy but developmental exposure to the drug, like infection, is associated with sex-specific behavioral changes in the offspring. We evaluated the effects of Fluoxetine on production of biomarkers for inflammation (pro/anti-inflammatory cytokines) and neurodevelopment (Brain-Derived Neurotrophic Factor, BDNF) in the presence and absence of infection in female and male placenta explant cultures. In addition to minor anti-inflammatory effects of the drug, Fluoxetine had significant sex- and infection-dependent effects on BDNF production. Further studies are needed to determine the extent to which these observed changes occur in vivo and their impact on pregnancy and neurodevelopmental outcomes.

The Rising Incidence of Penile Prosthesis Surgery as the First Line Surgical Treatment for Peyronie's Disease.

INTRODUCTION: Peyronie's disease is a potentially debilitating connective tissue disorder of the penis that at times requires surgical intervention. There is a dearth of multi-center or community-level data regarding management trends. The aim of this study was to perform the first population-based assessment of surgical practice patterns in the treatment of Peyronie's disease among New York State urologists. METHODS: We used the New York Statewide Planning and Research Cooperative System (SPARCS) database to identify all patients who underwent surgical treatment for Peyronie's disease between 2003 and 2016. We used descriptive statistics and multinomial regression modeling to assess predictors of treatment choice. RESULTS: Among 1,733 patients who underwent surgical treatment for Peyronie's disease, 30% underwent insertion of a penile prosthesis alone and 40% underwent insertion of a penile prosthesis with concurrent auxiliary procedures. Penile prosthesis (alone or in combination) was the first line surgical treatment in 21% of patients without documented erectile dysfunction. Relative rates of performing tunical plication and penile grafting decreased over time (both p <0.05), while insertion of a penile prosthesis/insertion of penile prosthesis with concurrent auxiliary procedures rates correspondingly increased (p=0.012). CONCLUSIONS: Insertion of penile prosthesis is by far the most commonly performed primary procedure for Peyronie's disease in New York State, with 1 in 5 patients without erectile dysfunction receiving an implant. While this trend cannot be explained by an administrative data set alone, it does warrant further exploration, as the declining utilization of alternate surgical treatments could compromise surgeon comfort in performing penile grafting and/or tunical plication in the future and may exacerbate disparities in treatment over time.

Gender Affirming Surgery Experience and Exposure among Reconstructive Urologists.

INTRODUCTION: There is a paucity of data on contemporary practice patterns regarding gender affirming surgery among reconstructive urologists. METHODS: We surveyed members of GURS (Society of Genitourinary Reconstructive Surgeons), an international association of mostly academic urologists specializing in urological reconstruction. An 18-question leadership approved survey was emailed to every member of the society globally. Multivariable logistic regression models assessed factors influencing attitudes toward gender affirming surgery. RESULTS: Of 304 members surveyed 80 (26%) completed the questionnaire. Of the respondents 89% had seen a transgender patient in their practice in the preceding year, with most (76%) seeing 10 or fewer transgender patients yearly. Of the respondents 50% stated that their organization wanted to develop a multidisciplinary gender affirming surgery program. Only 5% performed primary gender affirming surgery, and the most common procedures (43%) involved correction of complications of primary surgeries performed elsewhere. Of the respondents 66% were interested in pursuing additional gender affirming surgery training, and 75% thought that gender affirming surgery should be a discipline within GURS. Being in an organization that wanted to develop a multidisciplinary program predicted for desire to pursue additional gender affirming surgery training (OR 6.46, p=0.006) and the belief that gender affirming surgery should be a GURS subdiscipline (OR 4.42, p=0.032). Age 40 years or older predicted for belief that gender affirming surgery should not be covered by public insurance programs (OR 0.12, p=0.012). CONCLUSIONS: Most reconstructive urologists see a low volume of transgender patients and repair complications of primary gender affirming surgery performed elsewhere. Most respondents think that gender affirming surgery should be a discipline within GURS. Younger age and working for an organization interested in developing a multidisciplinary gender affirming surgery program influence positive attitudes toward gender affirming surgery.