Second-generation of temporary implantable nitinol device for the relief of lower urinary tract symptoms due to benign prostatic hyperplasia: results of a prospective, multicentre study at 1 year of follow-up

Abstract

Objectives: To report the clinical experience with a second‐generation of temporary implantable nitinol device (iTIND; Medi‐Tate Ltd, Or‐Akiva, Israel) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) after 1 year of follow‐up.

Patients and Methods: In all, 81 patients with LUTS, International Prostate Symptom Score (IPSS) ≥10, maximum urinary flow rate (Qmax) ≤12 mL/s, and prostate volume <75 mL, were enrolled in this prospective Research Ethics Committee‐approved multicentre study. The main exclusion criteria were: haemostatic disorders, post‐void residual urine volume (PVR) >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 5–7 days later in an outpatient setting. Demographics, perioperative results, complications (according to the Clavien–Dindo system), functional results and quality of life (QoL) were evaluated. Follow‐up assessments were conducted at 1, 3, 6 and 12 months postoperatively.

Results: The mean (sd) patient age was 65 (8.9) years, prostate volume was 40.5 (12.25) mL, Qmax was 7.3 (2.6) mL/s, IPSS was 22.5 (5.6), and the median (interquartile range) IPSS QoL score 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 at a mean (SD) of 5.9 (1.1) days after implantation, typically under topical anaesthesia. No Clavien–Dindo Grade >II complications were recorded. The mean (SD) Qmax at the 1 month follow‐up visit was 11.2 (5.7) mL/s and continued to improve thereafter, reaching 14.7 (8.1) mL/s at the 12‐month follow‐up visit (+100%). The mean (SD) IPSS urinary symptom scores were 11.7 (8.0) after 1 month and further improved to 8.8 (6.4) at the 12‐month follow‐up (−60%). In parallel, the mean (SD) IPSS QoL score drop reached 1.6 (1.3) by the end of the study. During the 12‐month period, two patients (2.4%) required medical therapy for BPH, two patients (2.4%) required transurethral resection of the prostate, whilst 10 patients were lost to follow‐up (12.3%). As compared to baseline, none of the 61 sexually active patients who completed the 12‐month follow‐up period reported sexual or ejaculatory dysfunction.

Conclusion: iTIND implantation is feasible, safe and effective in providing relief of BPH‐related symptoms, at least until 12 months postoperatively. 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 for iTIND implantation.