To report the clinical experience with a second generation of temporary implantable nitinol device (iTind; Medi-Tate ltd, Israel) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) after 1 year of follow up.
81 patients with LUTS, IPSS ≥10, Qmax < 12 ml/sec, prostate volume <75 ml were enrolled in this prospective REC-approved multi-center study. Main exclusion criteria were haemostatic disorders, post-void residual (PVR) volume >250 mL, obstructive median lobe and previous prostate surgery. The iTind was implanted within the bladder neck and the prostatic urethra under light sedation, using a rigid cystoscope. The device was removed 5 to 7 days later in an outpatient setting. Demographics, perioperative results, complications (according to the Clavien system), functional results and quality of life (QoL) were evaluated. Follow-up assessments were made at 4 weeks, 3, 6 and 12 months postoperatively.
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). All the implantations were successful, with no intraoperative complications recorded; all patients were discharged on the same day of surgery. The devices were retrieved 5.9±1.1 days following implantation, typically under topical anesthesia. No >grade 2 complications were recorded. Mean Qmax at the 1 month follow-up visit stood at 11.2±5.7 mL/sec and continued to improve thereafter, reaching 14.7±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%). In parallel, 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 medical therapy for BPH, 2 patients (2.4%) required TURP whilst 10 patients were lost of follow up (12.3%). As compared to baseline, none of the 61 sexually active patients who completed the 1 year follow up period reported sexual or ejaculatory dysfunction.
iTind implantation is feasible, safe and effective in providing relief of BPH related symptoms, at least until one year post operatively. Sexual and ejaculatory functions are fully preserved. Further studies with a longer follow up period are needed to assess the durability of these results and to clearly define the indications of the iTind implantation. This article is protected by copyright. All rights reserved.
BJU international. 2018 Nov 01 [Epub ahead of print]
Francesco Porpiglia, Cristian Fiori, Daniele Amparore, Gregor Kadner, Arya Manit, Massimo Valerio, Nicolaas Lumen, Brian Sh Ho, Sergio Alonso, Claude Schulman, Neil Barber
Division of Urology, Dept. Of Oncology- School of Medicine, University of Turin, San Luigi Hospital, Orbassano (Turin), Italy., Division of Urology, Spital Thurgau Frauenfeld, Switzerland., Division of Urology, UCLH, London, United Kingdom., Division of Urology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland., Division of Urology, Gent University Hospital, Belgium., Division of Urology, Queen Mary Hospital, Hong Kong., Division of Urology, La Paz University Hospital, Madrid, Spain., Division of Urology, CHIREC Cancer Institute (CCI), Urology Brussels, Belgium., Division of Urology, Frimley Health, London, UK.