MP01-05 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®
F. PorpigliaCristian FioriDaniele AmparoreG. VolpiGregor KadnerManit AryaMassimo ValérioNicolaas LumenBrian Sh HoSergio AlonsoClaude SchulmanNeil Barber
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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 ...Cite
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The treatment of male lower urinary tract symptoms (LUTS) due to benign prostatic obstruction represents one of the major interesting aspects in urological clinical practice. Although transurethral resection of the prostate is still considered the surgical gold standard for treatment of benign prostatic hyperplasia with prostate volume <80 mL, various minimally invasive surgical treatments (MITs) have been developed to overcome the limitations of the "conventional" surgery. To date, there are no validated tools to evaluate the surgical outcomes of MITs; however, in the past, BPH-6 has been used for this purpose. In this systematic review, we evaluated the efficacy and safety of MITs according to BPH-6 score system. We focused our attention on MITs based on mechanical devices (prostatic urethral lift and the temporary implantable nitinol device) and techniques for prostate ablation (image guided robotic waterjet ablation and convective water vapor energy ablation). Evidence shows that MITs are capable of leading to an improvement in LUTS without having an overwhelming impact on complications and are a valid alternative to other treatments in patients who wish to preserve their sexual function or in case of inapplicability of conventional surgery. However, comparative studies between these techniques are still missing.
Ablative case
Gold standard (test)
Minimally invasive procedures
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Urinary retention
Refractory (planetary science)
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iTIND is the second-generation version of the temporary nitinol implantable device (TIND), which has emerged over the past decade as one of the latest additions to the library of minimally invasive surgeries now available to treat bothersome lower urinary tract symptoms (LUTS) caused by benign prostate enlargement. While the key procedural steps remain the same, it now carries specific modifications designed to improve its efficacy and safety profile further. With the option to perform implantation under local anaesthesia, it can be delivered on an ambulatory basis and in the office setting. While the formal position of iTIND in current guidelines is yet to be determined, 12-month data demonstrates that it can improve both objective and subjective outcome measures, which are sustained at short-term follow up.
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Lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia (BPH) obviously impair the quality of life of middle-aged and elderly men. Current management of BPH includes wait-and-watch, medical therapy, and conventional surgery. As a new approach, minimally invasive surgery has been playing an increasingly important role in the management of BPH, with potential advantages of less operative trauma, quicker recovery, lower risk of postoperative complications and higher quality of life. This review mainly discusses prostatic urethral lift (Urolift® System), transurethral water vapor therapy (Rezūm® System) and robot-guided high-energy water ablation (PROCEPT Aquablation™ System).
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Transurethral resection of the prostate (TURP) is considered the 'gold standard' for the surgical management of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). However, during recent years TURP has been challenged by several minimally invasive therapies (MITs). The reasons for the development of these MITs are the need for anesthesia and the rather unchanged morbidity of TURP, including ejaculation disorders. Mechanical MITs may represent an attractive option for treating LUTS/BPO by using mechanical forces to maintain urethral patency without cutting, ablating, heating or removing prostatic tissue. The present paper provides an update on currently available mechanical devices for the treatment of LUTS/BPO including the prostatic urethral lift (PUL), the temporary implantable nitinol device, and new intraprostatic implants. It analyzes the evidence for their safety, tolerability, and efficacy in clinical practice and aims to define those subpopulations of patients who will benefit from these MITs. It is obvious that there is a wide variation in the degree of mature of the available mechanical MITs. Time and high-quality long-term studies will decide which of these therapies will be accepted by patients and urologists. At the moment, PUL is claiming its position in the armamentarium of BPO treatment.
Tolerability
Retrograde ejaculation
Gold standard (test)
Minimally invasive procedures
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