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• W4360746008 abstract "You have accessJournal of UrologyCME1 Apr 2023PD41-05 SECOND GENERATION TEMPORARY IMPLANTABLE NITINOL DEVICE (iTIND) IMPACT ON SERUM PSA LEVEL: RESULTS FROM a MULTICENTER PROSPECTIVE STUDY (MT-06-STUDY) Sabrina De Cillis, Daniele Amparore, Gabriele Volpi, Juliette Meziere, Martin Schönthaler, Grégoire Robert, Francesco Cantiello, Fernando Gómez Sancha, Andreas Becker, Carlo Terrone, Martina Beverini, Stefano Parodi, Cosimo De Nunzio, Gautier Muellhaupt, Nicolas Barry Delongchamps, Emmanuel Della Negra, Henry Who, Matteo Manfredi, Cristian Fiori, and Francesco Porpiglia Sabrina De CillisSabrina De Cillis More articles by this author , Daniele AmparoreDaniele Amparore More articles by this author , Gabriele VolpiGabriele Volpi More articles by this author , Juliette MeziereJuliette Meziere More articles by this author , Martin SchönthalerMartin Schönthaler More articles by this author , Grégoire RobertGrégoire Robert More articles by this author , Francesco CantielloFrancesco Cantiello More articles by this author , Fernando Gómez SanchaFernando Gómez Sancha More articles by this author , Andreas BeckerAndreas Becker More articles by this author , Carlo TerroneCarlo Terrone More articles by this author , Martina BeveriniMartina Beverini More articles by this author , Stefano ParodiStefano Parodi More articles by this author , Cosimo De NunzioCosimo De Nunzio More articles by this author , Gautier MuellhauptGautier Muellhaupt More articles by this author , Nicolas Barry DelongchampsNicolas Barry Delongchamps More articles by this author , Emmanuel Della NegraEmmanuel Della Negra More articles by this author , Henry WhoHenry Who More articles by this author , Matteo ManfrediMatteo Manfredi More articles by this author , Cristian FioriCristian Fiori More articles by this author , and Francesco PorpigliaFrancesco Porpiglia More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003346.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The aim of this report was to demonstrate the impact of he second-generation temporary implantable nitinol device (iTIND; Medi-Tate Ltd®, Israel) on serum PSA in the MT-06 study population. METHODS: From 06/2018 to 09/2019 patients with IPSS ≥10, Qmax <12 ml/s and prostate volume (PV) <120 ml were enrolled in this single-arm, prospective multicenter study (MT-06) and underwent iTIND implantation for the treatment of BPH-related LUTS. Patients included into the study had previously passed prostate cancer screening and none of them had a history of prostate cancer. Moreover, they were not washed out of BPH medication. PSA was assessed at baseline and at 1, 3, and 12 months postoperatively. Pearson correlation coejcient was used to examine the association between the baseline PSA and the PSA at 3 months follow-up. A p value <0.05 was considered statistical significant. RESULTS: 140 MT-06 study patients who had baseline serum PSA assessed were included in this analysis. The mean age was 61.16 years (IQR 54.33-68.89), with mean prostate volume of 37.27 ml (IQR 26.00-45.00 ml) and mean baseline serum PSA of 1.81 ng/ml (IQR 0.72-2.40 ng/ml). Post implantation PSA showed a peak at 4 weeks, reaching a mean of 3.00 ng/ml (IQR 1.03-3.46 ng/ml). This result is consistent with the iTIND mechanism of action, which by producing remodeling of the prostatic urethra, produces local inflammation from ischemic necrosis. Subsequently, the serum PSA decreased to a mean of 2.09 ng/ml (IQR 0.87-2.47 ng/ml), 1.90 ng/ml (IQR 0.64-2.81 ng/ml) at 3, and 12 months, respectively, (p values were all >0.05, respectively compared to baseline; Figure 1a). Change in PSA levels from baseline showed a linear correlation throughout the follow up, with a Pearson correlation coefficient at 3 months follow up of R=0.944 (p>0.0001) (Figure 1b). CONCLUSIONS: The implantation of iTIND for the treatment of BPH-related symptoms showed to have only a transient impact on serum PSA levels. This data suggests that the iTIND procedure is likely to not affect PSA monitoring in patients undergoing screening for prostate cancer or be on active surveillance protocols who would receive treatment for symptomatic BPH. Source of Funding: Olympus Corporation funded this study © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1060 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sabrina De Cillis More articles by this author Daniele Amparore More articles by this author Gabriele Volpi More articles by this author Juliette Meziere More articles by this author Martin Schönthaler More articles by this author Grégoire Robert More articles by this author Francesco Cantiello More articles by this author Fernando Gómez Sancha More articles by this author Andreas Becker More articles by this author Carlo Terrone More articles by this author Martina Beverini More articles by this author Stefano Parodi More articles by this author Cosimo De Nunzio More articles by this author Gautier Muellhaupt More articles by this author Nicolas Barry Delongchamps More articles by this author Emmanuel Della Negra More articles by this author Henry Who More articles by this author Matteo Manfredi More articles by this author Cristian Fiori More articles by this author Francesco Porpiglia More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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• W4360746008 title "PD41-05 SECOND GENERATION TEMPORARY IMPLANTABLE NITINOL DEVICE (iTIND) IMPACT ON SERUM PSA LEVEL: RESULTS FROM a MULTICENTER PROSPECTIVE STUDY (MT-06-STUDY)" @default.
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