Presentation Authors: Francesco Porpiglia*, Cristian Fiori, Daniele Amparore, Gabriele Volpi, Orbassano, Italy, Gregor Kadner, Frauenfeld, Switzerland, Arya Manit, London, United Kingdom, Massimo Valerio, Lausanne, Switzerland, Lumen Nicolaas, Gent, Belgium, Brian SH Ho, Hong Kong, Hong Kong, Sergio Alonso, Madrid, Spain, Claude Schulman, Brussels, Belgium, Neil Barber, London, United Kingdom
Introduction: A new, minimally invasive, surgical technique to treat benign prostatic hyperplasia (BPH) symptoms is represented by the Temporary Implantable Nitinol Device (TIND â€“ 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 (Â±2.6 ml/sec), mean (SD) IPSS score was 22.5 (Â±5.6) and median (SD) IPSS QoL was 4 (2:5). No intraoperative complications were recorded. The devices were retrieved 5.9Â±1.1 days following implantation. No >grade 2 complications were recorded. Mean Qmax at 1 month follow-up stood at 11.2Â±5.7 mL/sec and continued to improve thereafter, reaching 14.9Â±8.1 mL/sec at the 12 month follow-up visit (+ 100%). IPSS urinary symptom scores was 11.7Â± 8.0 after 1 month and further improved to 8.8Â±6.4 at the 12 month follow-up (-60%). Mean QoL IPSS score drop reached 1.6Â±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.