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Importance: Female external urinary collection devices were designed with the goal of decreasing the risk of catheter-associated urinary tract infections, which can have significant clinical complications. The BD PureWick urinary collection system, C. R. Bard, Inc., a wholly owned subsidiary of BD, Franklin Lakes, NJ, was the first device to enter the market and has had a widespread distribution. There is a lack of clinical data evaluating the safety of the PureWick device., Objectives: This study aimed to evaluate adverse events associated with the PureWick device using reports from the U.S. Food and Drug Administration Manufacturer and User Device Experience database., Study Design: A retrospective case series was conducted of adverse events from the database, which includes the adverse events and patient demographics from mandatory and voluntary reporters. Grounded theory was applied, utilizing inductive reasoning to identify salient keywords in the analysis of adverse events., Results: A total of 1,406 reports were submitted to the database from January 2016 to October 2023, with each report having at least 1 adverse event complaint. Report complaints were classified by patient injury (n = 1412, 67.6%), device malfunction (n = 459, 22.1%), user error (n = 125, 6.0%), device instructions (n = 83, 4.0%) and death (n = 6, 0.29%). Salient keywords include urinary tract infection, skin irritation, and device leakage., Conclusions: There are adverse events associated with the PureWick external urinary collection device in reports from the U.S. Food and Drug Administration database. These findings warrant additional studies to assess the safety of the PureWick for patients using the device in the hospital and at home., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2025 American Urogynecologic Society. All rights reserved.)

Bladder cancer (BCa) remains a significant source of morbidity and mortality. BCa is one of the most expensive tumors to treat, in part because of a lack of nonsurgical options. The recent advent of immunotherapy, alone or in combination with other compounds, has improved therapeutic options. Resistance to immunotherapy remains common, and many patients do not have durable response. Recent advances indicate immunotherapy efficacy may be tied in part to the endogenous bacteria present in our body, more commonly referred to as the microbiome. Laboratory and clinical data now support the idea that a healthy microbiome is critical to effective response to immunotherapy. At the same time, pathogenic interactions between the microbiome and immune cells can also serve to drive formation of tumors, increasing the complexity of these interactions. Given the rising importance of immunotherapy in BCa, understanding how we might be able to alter the microbiome to improve therapeutic efficacy offers a novel route to improved patient care. The goal of this review is to examine our current understanding of microbial interactions with the immune system and cancer with an emphasis on BCa. We will further attempt to define both current gaps in knowledge and future directions that may yield beneficial results to the field., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)