To report 3-year follow-up results of the first implantations with the Temporary Implantable Nitinol Device (TIND - Meditate® ) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
Thirty-two patients with LUTS were enrolled in this prospective study. The study was approved by the local Ethics Committee. Inclusion criteria were: age > 50 years, IPSS scores ≥ 10, peak urinary flow (Qmax) ≤ 12 ml/sec, prostate volume < 60 cc. TIND was implanted within the bladder neck and the prostatic urethra under light sedation, and removed 5 days later, in an outpatient setting. Demographics, perioperative results, complications (according to Clavien Dindo classification), functional results and quality of life (QoL) were evaluated. Follow-up assessment was made at 3 and 6 weeks, and 3, 6, 12, 24 and 36 months after the implantation. Student t, ANOVA and Kruskall Wallis tests were used for the statistical analysis.
At baseline, mean (standard deviation, SD) patient age was 69.4 (8.2), the mean prostate volume was 29.5 (7.4) mL and the Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14-23) and QoL score was 3 (3-4). All the implantations were successful, with a mean total operative time of 5.8 minutes. No intraoperative complications recorded. Change from baseline in IPSS, QoL score and Qmax was significant at every follow-up time point. After 36 months of follow-up, a 41% rise in Qmax was achieved (mean: 10.1 ml/sec), median IPSS was 12 (6-24) and median IPSS QoL was 2 (1-4). Four early complications (12.5%) were recorded, including 1 case of urinary retention (3.1%), 1 case of transient incontinence due to device displacement (3.1%), and 2 cases of infections (6,2%). No further complications were recoded during the 36 months follow up.
The extended follow-up period corroborated our previous findings and suggested that the TIND implantation is safe, effective and well tolerated, for at least 36 months following treatment. This article is protected by copyright. All rights reserved.
BJU international. 2018 Jan 23 [Epub ahead of print]
Francesco Porpiglia, Cristian Fiori, Riccardo Bertolo, Andrea Giordano, Enrico Checcucci, Diletta Garrou, Giovanni Cattaneo, Stefano De Luca, Daniele Amparore
Division of Urology, Dept. Of Oncology- School of Medicine, University of Turin, San Luigi Hospital, Orbassano Turin.