Pd57-05 Review of Spaceoar Complications in the Maude Database With Focus on Rectal Wall Infiltration

You have accessJournal of UrologyProstate Cancer: Localized: Radiation Therapy (PD57)1 May 2024PD57-05 REVIEW OF SPACEOAR COMPLICATIONS IN THE MAUDE DATABASE WITH FOCUS ON RECTAL WALL INFILTRATION Benjamin H. Shpeen, David Musheyev, Michael West, Netanel Yom Tov, Matthew Antonellis, Sally Zhou, Benjamin Ilyayev, and Ariel Schulman Benjamin H. ShpeenBenjamin H. Shpeen , David MusheyevDavid Musheyev , Michael WestMichael West , Netanel Yom TovNetanel Yom Tov , Matthew AntonellisMatthew Antonellis , Sally ZhouSally Zhou , Benjamin IlyayevBenjamin Ilyayev , and Ariel SchulmanAriel Schulman View All Author Informationhttps://doi.org/10.1097/01.JU.0001008808.16085.aa.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In 2015, SpaceOAR, a polyethylene glycol-based gel, was granted FDA approval to be used to help reduce toxicity from radiation therapy (RT) in the treatment of prostate cancer. It works by creating a buffer between the target prostate tissue and the adjacent rectal wall. Since its development, reporting of adverse events has been limited. Here, we seek to characterize how often rectal wall infiltration (RWI) occurs and what the subsequent management was after injection. METHODS: The MAUDE Database was queried from 2015 to 2021 looking for adverse events, specifically RWI, associated with SpaceOAR and SpaceOAR Vue. Clavien-Dindo complication grade was assigned to each adverse event. Additional data was collected regarding a patient's ability to continue RT despite RWI. Fisher's exact test was used to compare Clavien-Dindo classification and whether the patient had any change or delay in their treatment. RESULTS: Overall, there were 193 unique adverse events related to RWI that were recorded from 2019 to 2021. Prior to 2019, reporting of adverse events was negligible. Of the 193 reported events, 170 (88%) were classified as Clavien-Dindo grade I complications. There were 11 (5.6%) grade 2, 11 (5.6%) grade 3, and 1 (0.5%) grade 4 complication. Of the grade 3 complications, 9 of 11 were classified as grade 3b as they required flexible sigmoidoscopy and/or colonoscopy under general anesthesia. 3 patients went on to require diverting colostomy or ileostomy. When comparing complication grade and whether patients had their treatment course altered or delayed, there was no statistically significant difference (p=0.43) as most patients continued their treatment as originally planned. CONCLUSIONS: SpaceOAR has been previously shown to significantly reduce GI and GU toxicity related to RT. However, side effects related to its placement, including RWI, have likely been underreported. RWI can pose a significant risk to the patient and may lead to significant morbidity. While many patients can be treated conservatively with stool softeners and pain medication, there are reports of patients requiring more invasive surgeries. Fortunately, it does not appear that the Clavien-Dindo classification delayed treatment in our cohort of patients although a greater sample size is needed in the future to further substantiate our findings. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1210 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Benjamin H. Shpeen More articles by this author David Musheyev More articles by this author Michael West More articles by this author Netanel Yom Tov More articles by this author Matthew Antonellis More articles by this author Sally Zhou More articles by this author Benjamin Ilyayev More articles by this author Ariel Schulman More articles by this author Expand All Advertisement PDF downloadLoading ...