LBA01-06 LONG TERM FOLLOW-UP OF AN INTERNATIONAL MULTICENTER PROSPECTIVE STUDY IN APPLICATION OF TEMPORARY IMPLANTABLE NITINOL DEVICE (iTind) IN MEN WITH LOWER URINARY TRACT SYMPTOMS FOR BPH

You have accessJournal of UrologyCME1 May 2022LBA01-06 LONG TERM FOLLOW-UP OF AN INTERNATIONAL MULTICENTER PROSPECTIVE STUDY IN APPLICATION OF TEMPORARY IMPLANTABLE NITINOL DEVICE (iTind) IN MEN WITH LOWER URINARY TRACT SYMPTOMS FOR BPH Daniele Amparore, Sabrina De Cillis, Cristian Fiori, Gregor Kadner, Claude Schulman, and Francesco Porpiglia Daniele AmparoreDaniele Amparore More articles by this author , Sabrina De CillisSabrina De Cillis More articles by this author , Cristian FioriCristian Fiori More articles by this author , Gregor KadnerGregor Kadner More articles by this author , Claude SchulmanClaude Schulman More articles by this author , and Francesco PorpigliaFrancesco Porpiglia More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002669.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To report IPSS, QoL and treatment failure rate up to 79-months for the MT02 study with implantation of the temporary implantable nitinol device (iTind; Medi-Tate Ltd®, Israel) in men with lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). METHODS: Three out of nine international centers consented to continue the international prospective multicenter study on patients with LUTS due to BPO (IPSS ≥10, Qmax <12ml/sec, and prostate volume <75ml) beyond 36 months following implantation of iTind. Out of the originally enrolled 81 patients, 50 were followed-up at sites in Italy, Switzerland, and Belgium. Due to Covid-19 the originally planned follow-up scheme was amended: Each patient was assessed once during a timeframe of 50-79 months post-operatively by IPSS and IPSS-QoL, change in medication and adverse events via a telephone call. Patients were analyzed in three groups according to their follow-up time point (clustered into groups from 48-59 months, 60-71 months, and 72-83 months). RESULTS: Fifty to 79 months results were available for 42 patients. Four patients were lost to follow-up and two patients deceased from reasons unrelated to the iTind device. Only two patients had treatment failures (one patient underwent TURP, the other ThuLEP), while no patient required any additional medication. IPSS average results were 12.63±8.84 (50-59m, N=24), 8.85±5.54 (60-71m, N=13) and 9.20 ±5.85 (72-79m, N=5). QoL average results were 2.21±1.69 (50-59m, N=24), 1.85±0.99 (60-71m, N=13) and 1.80±1.10 (72-79m, N=5). IPSS (-8.88, -10.31, and -9.60) and IPSS-QoL (-2.04, -1.85 and -1.80) improved significantly for all groups vs. baseline, respectively (p <0.0001). Functional data is shown in Figure 1. No late post-operative complications were observed between 50 and 79 months. CONCLUSIONS: iTind for treatment of LUTS secondary to BPO is an effective and safe procedure providing significant and effective reduction in symptoms and quality of life durable up to 79 months (6.6 years) with only 4% of treatment failures after 3-year follow-up. Source of Funding: Olympus Corporation of the Americas (former Medi-Tate) funded this study © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e1037 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniele Amparore More articles by this author Sabrina De Cillis More articles by this author Cristian Fiori More articles by this author Gregor Kadner More articles by this author Claude Schulman More articles by this author Francesco Porpiglia More articles by this author Expand All Advertisement PDF downloadLoading ...