PD18-10 THE ITIND TEMPORARILY IMPLANTED NITINOL DEVICE FOR THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC HYPERPLASIA: A MULTICENTER, RANDOMIZED, CONTROLLED TRIAL (2021)

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology III (PD18)1 Sep 2021PD18-10 THE ITIND TEMPORARILY IMPLANTED NITINOL DEVICE FOR THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC HYPERPLASIA: A MULTICENTER, RANDOMIZED, CONTROLLED TRIAL Bilal Chughtai, Dean Elterman, Neal Shore, Marc Gittleman, Jay Motola, Sheldon Pike, Craig Herman, William Terens, Alfred Kohan, Ricardo Gonzalez, Aaron Katz, Jeffrey Schiff, Evan Goldfischer, Ivan Grunberger, Le Mai Tu, Mark Alshak, and Jed Kaminetsky Bilal ChughtaiBilal Chughtai More articles by this author , Dean EltermanDean Elterman More articles by this author , Neal ShoreNeal Shore More articles by this author , Marc GittlemanMarc Gittleman More articles by this author , Jay MotolaJay Motola More articles by this author , Sheldon PikeSheldon Pike More articles by this author , Craig HermanCraig Herman More articles by this author , William TerensWilliam Terens More articles by this author , Alfred KohanAlfred Kohan More articles by this author , Ricardo GonzalezRicardo Gonzalez More articles by this author , Aaron KatzAaron Katz More articles by this author , Jeffrey SchiffJeffrey Schiff More articles by this author , Evan GoldfischerEvan Goldfischer More articles by this author , Ivan GrunbergerIvan Grunberger More articles by this author , Le Mai TuLe Mai Tu More articles by this author , Mark AlshakMark Alshak More articles by this author , and Jed KaminetskyJed Kaminetsky More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002007.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. METHODS: Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5 to 7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months post-operatively using the IPSS, peak urinary flow rate (PFR), residual urine, quality of life (QoL), and the International Index of Erectile Function (IIEF). Unblinding occurred at 3 months. RESULTS: A total of 175 men (mean age 61.1±6.5) participated (118 iTind vs 57 sham). 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, versus 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (p<0.0001), a 3.52ml/s increase in PFR (p<0.0001) and a 1.9-point reduction in QoL (p<0.0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred. CONCLUSIONS: Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function. Source of Funding: Medi-Tate Ltd. sponsored this study © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e359-e359 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Bilal Chughtai More articles by this author Dean Elterman More articles by this author Neal Shore More articles by this author Marc Gittleman More articles by this author Jay Motola More articles by this author Sheldon Pike More articles by this author Craig Herman More articles by this author William Terens More articles by this author Alfred Kohan More articles by this author Ricardo Gonzalez More articles by this author Aaron Katz More articles by this author Jeffrey Schiff More articles by this author Evan Goldfischer More articles by this author Ivan Grunberger More articles by this author Le Mai Tu More articles by this author Mark Alshak More articles by this author Jed Kaminetsky More articles by this author Expand All Advertisement Loading ...