3-Year follow-up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction

Abstract

Objectives: To report 3-year follow-up results of the first implantations with a temporary implantable nitinol device (TIND^® ; Medi-Tate Ltd., Or Akiva, Israel) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Patients and methods: In all, 32 patients with LUTS were enrolled in this prospective study. The study was approved by the local Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) ≥10, peak urinary flow (Q_max ) <12 mL/s, and prostate volume <60 mL. The 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 assessments were made at 3 and 6 weeks, and 3, 6, 12, 24 and 36 months after the implantation. The Student's t-test, one-way analysis of variance and Kruskal-Wallis tests were used for statistical analyses.

Results: At baseline, the mean (standard deviation, sd) patient age was 69.4 (8.2) years, prostate volume was 29.5 (7.4) mL, and Q_max was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14-23) and the QoL score was 3 (3-4). All the implantations were successful, with a mean total operative time of 5.8 min. No intraoperative complications were recorded. The change from baseline in IPSS, QoL score and Q_max was significant at every follow-up time point. After 36 months of follow-up, a 41% rise in Q_max was achieved (mean 10.1 mL/s), the median (IQR) IPSS was 12 (6-24) and the IPSS QoL was 2 (1-4). Four early complications (12.5%) were recorded, including one case of urinary retention (3.1%), one case of transient incontinence due to device displacement (3.1%), and two cases of infection (6.2%). No further complications were recorded during the 36-month follow-up.

Conclusions: The extended follow-up period corroborated our previous findings and suggests that TIND implantation is safe, effective and well-tolerated, for at least 36 months after treatment.

Keywords: BPH; LUTS; TIND; #UroBPH; minimally invasive techniques; nitinol; urethral implantable device.