This study (MT02) reports >48-month (50-79 months) results of a prospective, single-arm, multicenter study (NCT02145208) of temporary implantable nitinol device (iTind®) in men with benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS).
Men with symptomatic BPH (International Prostate Symptom Score [IPSS] ≥10, Maximum flow rate [Q<inf>max</inf>] <12 mL/s, and prostate volume <75 mL) from 9 centers were enrolled from December 2014 to December 2016. Total 50/81 (62%) patients at 3/9 sites (Italy, Switzerland, and Belgium), pursued the study beyond 36 months following iTind® device, per study protocol. Due to COVID-19, follow-up was amended. Each patient was assessed once during 50-79 months postoperatively for IPSS and IPSS-quality of life (IPSS-QoL), change in medication, need for surgical re-treatment and adverse events telephonically.
Post 36 month-follow-up, 5 patients were lost to follow-up and 2 patients died unrelated to iTind® device placement. Two patients (36-48 months follow-up) required surgical re-treatments (1 transurethral resection of prostate, 1 Thulium laser enucleation of prostate). >48 months results were available for 41 patients wherein iTind® device treatment showed significant improvement in symptoms (IPSS: -45.3%, P<0.0001 and IPSS-QoL: -45.1%, P<0.0001) from baseline to 79 months post-procedure; mean±SD of 11.26±7.67 and 2.10±1.41 points, respectively. No complications were recorded between 36 up to 79 months; no patient required additional medication.
iTind® device provided significant and durable symptom reduction and improved IPSS-QoL for >48 months post treatment. No late postoperative complications were reported beyond 36 months of follow-up. Surgical re-treatment rate for >36 months was 4%.
Minerva urology and nephrology. 2023 Jun 23 [Epub ahead of print]
Daniele Amparore, Sabrina De Cillis, Claude Schulman, Gregor Kadner, Cristian Fiori, Francesco Porpiglia
Division of Urology, San Luigi Hospital, Orbassano, Turin, Italy., Division of Urology, San Luigi Hospital, Orbassano, Turin, Italy - ., Division of Urology, CHIREC Cancer Institute, University of Brussels, Brussels, Belgium., Division of Urology, Kantonsspital, Frauenfeld, Switzerland.