MP25-09 SECOND GENERATION OF TEMPORARY IMPLANTABLE NITINOL DEVICE (ITIND) IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS): WHO PROFIT MOST FROM TREATMENT? 2YEAR RESULTS OF THE MT-02-STUDY

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You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I (MP25)1 Apr 2020MP25-09 SECOND GENERATION OF TEMPORARY IMPLANTABLE NITINOL DEVICE (ITIND) IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS): WHO PROFIT MOST FROM TREATMENT? 2YEAR RESULTS OF THE MT-02-STUDY Gregor Kadner*, Valerio Massimo, Manit Arya, Nicolaas Lumen, Brian SH Ho, Sergio Alonso, Claude Schulman, Neil Barber, Daniele Amparore, and Francesco Porpiglia Gregor Kadner*Gregor Kadner* More articles by this author , Valerio MassimoValerio Massimo More articles by this author , Manit AryaManit Arya More articles by this author , Nicolaas LumenNicolaas Lumen 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 , Neil BarberNeil Barber More articles by this author , Daniele AmparoreDaniele Amparore More articles by this author , and Francesco PorpigliaFrancesco Porpiglia More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000864.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Assessing medium-term functional results of a novel minimally-invasive treatment for LUTS due to benign prostatic hyperplasia (BPH) with 2nd generation temporary implantable nitinol device (iTind; Medi-Tate Ltd, Israel): 2yr FU of a single-arm, prospective, international multicenter study, and identify preoperative baseline parameters predicting success or failure of iTind treatment. METHODS: 81 men with symptomatic BPH (IPSS≥10, Qmax < 12ml/sec, and PV <75ml) were enrolled. Patients with PVR>250ml, previous prostatic surgery, confounding bladder or sphincter dysfunction, active UTI and haemostatic disorders were excluded. Patients were washed out 1 month for alpha-blockers and 6mos for 5-ARIs. A subgroup of patients with median lobe were assessed separately. The implantation procedure was performed under light sedation and removal was 5-7 days later. OR-time, VAS, complications (CD-Grading System); and functional results (PVR, Qmax, IPSS), QoL and sexual and ejaculatory function were assessed. Follow-up (FU) was done at 1, 3, and 6mos, and 1 and 2yrs. RESULTS: Of the 81 patients initially enrolled, FU included 67 men at 1yr and 51 men at 2yrs. For the 51 men included in the present analysis, median age was 65yrs, median PV 37ml (16-65ml). Qmax 7.6±2.2ml/sec and PVR 65.9±38.5ml. IPSS and QoL scores were 20.51±4.58 and 4.0±0.9, respectively. No intraoperative complications were observed and the average VAS score was 3.2 ±1.6. All objective and subjective measures showed a response to iTind treatment with significant improvements (p<0.0001) from baseline levels at all assessment points: PVR dropped to 14.26±24.0ml, Qmax increased to 16.00±7.43ml/sec. IPSS-score and QoL improved to 8.51±5.51 and 1.76±1.32. Sexual and ejaculatory function was preserved in all patients. Excluding the patients lost at FU, 4 patients required additional medical therapy and 5 patients underwent TURP (6.5%). In conclusion, for the patients followed to 2yrs, the success rate is 82.4%. None of the preoperative parameters recorded predict response to iTind treatment. Patients with median lobe (n=10) did not respond to iTind treatment. CONCLUSIONS: iTind is a safe, minimally-invasive treatment for BPH-related LUTS showing marked and durable improvement of functional parameters, symptoms, QoL, and preservation of sexual function at 2yr FU. Preoperative baseline parameters do not seem to predict success of iTind treatment, except for median lobe which makes the treatment non effective in our study. Source of Funding: NONE. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e394-e394 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Gregor Kadner* More articles by this author Valerio Massimo More articles by this author Manit Arya More articles by this author Nicolaas Lumen 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 Daniele Amparore More articles by this author Francesco Porpiglia More articles by this author Expand All Advertisement PDF downloadLoading ...