First multi-center, real-world study on the Temporary Implantable Nitinol Device (iTIND) for the management of lower urinary tract symptoms related to benign prostatic obstruction

Background/Objectives: Lower urinary tract symptoms (LUTSs) due to benign prostatic obstruction (BPO) represent a common condition affecting aging men. Transurethral resection of the prostate represents the gold standard surgical treatment but is not without complications such as retrograde ejaculation, bleeding and urinary retention. The temporary implantable nitinol device (iTIND) is considered a minimally invasive surgical technique, designed to treat LUTS while preserving erectile and ejaculatory function. Herein we report the results of a multi-center, real-world assessment of the iTIND procedure. Methods: Data from five international centers treating LUTS with the iTIND device were collected. We recorded changes through an International Prostatic Symptom Score (IPSS) questionnaire with Quality of Life (QoL), International Index of Erectile Function (IIEF5) questionnaire, antegrade ejaculatory function, maximum flow (QMax), post voiding residual volume (PVR) and freedom from repeat intervention. Results: A total of 74 subjects were enrolled; median follow-up was 12 months. IPSS and QoL changed from a median of 23 and 4 points at baseline to 11 and 2 points, respectively, at the last follow-up. A mean improvement in Qmax and PVR from 9 mL/s and 56 mL at baseline to 13 mL/s and 40 mL was noticed at the last follow-up. Total median operative time was 10 min, and the median time of iTIND indwell time was 7 days. The median device removal time was 5 min. There were no changes in IIEF5 scores and antegrade ejaculation rate. No intraoperative complications were reported, and non-serious postoperative complications occurred in six patients (two urinary retention, two mild haematuria, two urinary tract infection). Finally, four patients underwent reoperation during the follow-up period. All procedures were performed as outpatient day cases. Conclusions: Our results confirms that treatment with the iTIND is effective and safe in terms of improving urinary symptoms and quality of life without impacting sexual function. Longer follow-up is required to better define the durability of this minimally invasive procedure.