MP40-17 IMPACT OF REGIONAL HYPOTHERMIA ON URINARY CONTINENCE DURING RARP: RESULTS FROM A DOUBLE-BLIND RANDOMIZED CONTROL TRIAL

摘要

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy I1 Apr 2016MP40-17 IMPACT OF REGIONAL HYPOTHERMIA ON URINARY CONTINENCE DURING RARP: RESULTS FROM A DOUBLE-BLIND RANDOMIZED CONTROL TRIAL Kamaljot Kaler and Thomas Ahlering Kamaljot KalerKamaljot Kaler More articles by this author and Thomas AhleringThomas Ahlering More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.163AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We performed a multi-institutional double-blind randomized control trial to assess if regional hypothermia via reduce inflammation could improve urinary continence using an endorectal cooling balloon (ECB) during robotic-assisted radical prostatectomy (RARP). METHODS 200 patients undergoing RARP were randomized at 3 institutions. Five high volume surgeons were selected in order to reduce surgeon related confounders: 2 with >500, 3 with >2500-3500 cases. Patients were blinded to the use of ECB and data was acquisitioned by a blinded independent contractor. Primary and secondary outcomes were time to and overall pad-free continence (assessed at 30, 60, 90, 180 and 365 days). All patients had follow up at all time points. RESULTS Baseline demographics are evenly distributed in Table 1. Figure 1 and Table 2 shows no difference in continence between groups. Figure 2 shows surgeon outcome variability was a problematic confounder. 30-day % pad-free continence varied significantly (3, 20, 31, 50, 36%). The surgeon confounder resulted in under powering. CONCLUSIONS The RCT was confounded due to variable surgeon outcomes. As such there was no demonstrated benefit with the ECB. Subgroup analysis needs to be performed to further delineate potential benefit. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e557-e558 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Kamaljot Kaler More articles by this author Thomas Ahlering More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...