Functional, urinary and sexual oucomes after treatment with temporary implantable nitinol device (ITIND) in men with luts. 6 months interim results of the MT-06 study

INTRODUCTION AND OBJECTIVE: To evaluate the functional and sexual outcomes after treatment with temporary implantable nitinol device (iTind; Medi-Tate Ltd, Israel); a novel minimally-invasive treatment for Lower Urinary Tract Symptoms (LUTS)due to Benign Prostatic Hyperplasia (BPH) METHODS: Following EC approval, 70 men with symptomatic BPH (IPSS≥10, Qmax < 12ml/sec, and prostate volume (PV) <120ml) were enrolled in a single arm, prospective multicenter study (MT06). Patients with a large median lobe (>12 mm), previous prostatic surgery, neurological dysfunction and urinary tract infections were excluded. Patients were not washed out of drug therapy before the procedure. I-TIND was implanted through a cystoscopy under sedation and it was removed 5-7 days later under local anesthesia. Post-operative VAS, QoR VAS, complications (Clavien Dindo-Grading System) were recorded. Preservation of urinary continence and sexual and ejaculatory function were assessed according to ISI, MSHQ-EjD and SHIM. Post-operative IPSS, QL, Qmax were also assessed at 1, 3, and 6 months post-operatively RESULTS: Overall 70 patients were enrolled, median age was 62.31yrs, mean PV 37.68ml (15-80ml). Baseline and follow-up data are reported in table 1. No intraoperative complications were observed and the average post-operative VAS score was3.24 ±2.56. On average patients returned to daily life after 4.3 days following the retrieval procedure, and mean QoR VAS was 0.77. Significant improvements (p<0.0001) from baseline levels were recorded in IPSS, QoL and peak flow in response to iTind treatment at 6 months, and sexual and urinary continence were preserved (Table 1) CONCLUSIONS: iTind is a well-tolerated, minimally-invasive treatment for BPH-related LUTS offering a rapid recovery and return to daily life, preservation of sexual function and urinary continence as well as a significant improvement of symptoms and urinary flow at 6 months follow up