You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology III (PD18)1 Sep 2021PD18-04 UROLIFT AND REZUM: A COMPARISON OF DEVICE RELATED ADVERSE EVENTS IN A NATIONAL REGISTRY Elie Kaplan-Marans, James Cochran, Andrew Wood, Elliot Dubowitch, Michael Lee, and Ariel Schulman Elie Kaplan-MaransElie Kaplan-Marans More articles by this author , James CochranJames Cochran More articles by this author , Andrew WoodAndrew Wood More articles by this author , Elliot DubowitchElliot Dubowitch More articles by this author , Michael LeeMichael Lee More articles by this author , and Ariel SchulmanAriel Schulman More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002007.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Urolift and Rezum have demonstrated efficacy as minimally invasive surgical therapies (MIST) for the treatment of benign prostatic hyperplasia (BPH). Both modalities can be safely performed in the ambulatory setting and offer superior preservation of sexual function than alternative treatments. Our objective was to describe device malfunctions and complications to help guide procedural selection and performance. METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was examined for reports related to the use of Urolift and Rezum for the treatment of BPH between January 1, 2015 and July 1, 2020. Reports were evaluated for device malfunctions and surgical complications using a previously described externally validated classification system developed for the MAUDE database. Chi square analysis was used for statistical comparison between groups. RESULTS: A total of 289 adverse events were reported: UroLift (n=132) and Rezum (n=157). The most common UroLift device malfunctions were device misfire (n=27), needle fragmentation (n=21), failed needle retraction (n=6), and misplaced implant (n=5). The most common Rezum device malfunctions were unresolvable error message (n=19), generator failure (n=10), packaging dysfunction (n=8), and failed needle retraction (n=6). As seen in table 1, there were 69 (52%) severe or life threatening adverse events for UroLift vs. 24 (15%) for Rezum (p<0.001). Notable complications included: UroLift (3 laparotomies, 1 arterial embolization, 21 blood transfusions, 13 pelvic or retroperitoneal hematomas, 1 bladder perforation, 1 percutaneous nephrostomy, 1 orchiectomy, 16 implants needing to be removed, 9 implants causing a problem with a later procedure); Rezum (1 blood transfusion, 1 bladder perforation, 3 epididymites, 2 hydrocele infections). CONCLUSIONS: Urolift had more severe adverse event reports in a national registry than Rezum. Many of these events were related to bleeding or to the improper placement or failed deployment of the UroLift implants. Both patients and providers should be aware of potential risks when selecting these novel BPH treatments. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e356-e356 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Elie Kaplan-Marans More articles by this author James Cochran More articles by this author Andrew Wood More articles by this author Elliot Dubowitch More articles by this author Michael Lee More articles by this author Ariel Schulman More articles by this author Expand All Advertisement Loading ...