You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I (MP01)1 Apr 2019MP01-05 THE RESULTS OF ONE ARM MULTICENTER PROSPECTIVE STUDY ON AN INNOVATIVE MINIMALLY INVASIVE SURGICAL TECHNIQUE FOR LUTS MANAGEMENT: THE SECOND GENERATION TEMPORARY IMPLANTABLE NITINOL DEVICE (I-TIND) MEDITATE® Francesco Porpiglia*, Cristian Fiori, Daniele Amparore, Gabriele Volpi, Gregor Kadner, Arya Manit, Massimo Valerio, Lumen Nicolaas, Brian SH Ho, Sergio Alonso, Claude Schulman, and Neil Barber Francesco Porpiglia*Francesco Porpiglia* More articles by this author , Cristian FioriCristian Fiori More articles by this author , Daniele AmparoreDaniele Amparore More articles by this author , Gabriele VolpiGabriele Volpi More articles by this author , Gregor KadnerGregor Kadner More articles by this author , Arya ManitArya Manit More articles by this author , Massimo ValerioMassimo Valerio More articles by this author , Lumen NicolaasLumen Nicolaas More articles by this author , Brian SH HoBrian SH Ho More articles by this author , Sergio AlonsoSergio Alonso More articles by this author , Claude SchulmanClaude Schulman More articles by this author , and Neil BarberNeil Barber More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000554869.68263.6dAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: A new, minimally invasive, surgical technique to treat benign prostatic hyperplasia (BPH) symptoms is represented by the Temporary Implantable Nitinol Device (TIND-Meditate). We present the results of a one-arm, multi-center, international prospective study to define the efficacy of second generation of MediTate i-TIND in subjects with BPH. METHODS: The i-TIND is composed of three nitinol elongated struts and an anchoring leaflet. It is preloaded by crimping it into the delivery system. When positioned, the struts of expand and determine a radial force with ischemic necrosis and incision of bladder neck and prostatic urethra. The inclusion criteria were: IPSS > 10; peak urinary flow (Qmax) < 12 mL/sec and prostate volume < 75 cc. All patients stopped alpha-blockers and 5alpha-reductase inhibitors before the implantation. The procedure was performed using a rigid 17F cystoscope, under light sedation. 5 days after the implantation the device was removed, without anesthesia. We evaluated demographic, perioperative, functional results and quality of life (QoL) questionnaire. We reported the results at 3, 6 and 12 months. RESULTS: The mean (SD) patient age was 65 (8.9) years, the mean (SD) prostate volume was 40.5 (12.25) mL, mean (SD) Qmax was 7.3 (±2.6 ml/sec), mean (SD) IPSS score was 22.5 (±5.6) and median (SD) IPSS QoL was 4 (2:5). No intraoperative complications were recorded. The devices were retrieved 5.9±1.1 days following implantation. No >grade 2 complications were recorded. Mean Qmax at 1 month follow-up stood at 11.2±5.7 mL/sec and continued to improve thereafter, reaching 14.9±8.1 mL/sec at the 12 month follow-up visit (+ 100%). IPSS urinary symptom scores was 11.7± 8.0 after 1 month and further improved to 8.8±6.4 at the 12 month follow-up (-60%). Mean QoL IPSS score drop reached 1.6±1.3 by the end of the study. During the 12 month period, 2 patients (2.4%) required medications for BPH, 2 patients (2.4%) required TURP. As compared to baseline, none of the 61 sexually active patients who completed the 1 year follow up period reported sexual or ejaculatory dysfunction. CONCLUSIONS: More studies are necessary to define the durability of the results but second generation i-TIND implantation is a safe and effective minimally-invasive technique for the treatment of BPH related symptoms until one year follow up. Source of Funding: none Orbassano, Italy; Frauenfeld, Switzerland; London, United Kingdom; Lausanne, Switzerland; Gent, Belgium; Hong Kong, Hong Kong; Madrid, Spain; Brussels, Belgium; London, United Kingdom© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e2-e2 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Francesco Porpiglia* More articles by this author Cristian Fiori More articles by this author Daniele Amparore More articles by this author Gabriele Volpi More articles by this author Gregor Kadner More articles by this author Arya Manit More articles by this author Massimo Valerio More articles by this author Lumen Nicolaas More articles by this author Brian SH Ho More articles by this author Sergio Alonso More articles by this author Claude Schulman More articles by this author Neil Barber More articles by this author Expand All Advertisement PDF downloadLoading ...