iTind is a temporary nitinol implant (iTind; Medi-Tate Ltd, Hadera, Israel) that is left in for 5–7 days and reshapes the prostatic urethra. The device uses nitinol struts located at the 12, 5 and 7 o'clock positions which create ischemic pressure to incise the bladder neck and resolve the BPO.
The device is implanted under direct vision using a standard rigid or flexible 19F–22F cystoscope, as an outpatient procedure, under IV sedation or local anesthesia. The total average procedure time is 3–5 min. Catherization is not required after the procedure.
The implant is removed with an open-ended 22F Foley standard catheter under local anesthesia.
Amparore et al. reported in a 3-year prospective, single arm, multicenter clinical study of 81 patients with average prostate volume of 40.5 ml, considerable functional improvements in IPSS, QoL, Qmax and PVR of 8.55 + 6.38, 1.76 + 1.32, 15.2 + 6.59 ml/s and 9.38 + 17.4 ml, improved from baseline by −58.2, −55.6 + 114.7, and −85.4% (all with P < 0.0001).
No intraoperative complications were reported. Postoperative complications were Clavien–Dindo I or II and resolved in a month. No sexual or ejaculatory dysfunction was observed.
The 3-year surgical retreatment rate was 8.7% (8 patients) and 6.2% (5 patients) required drug therapy.
Chughtai et al. reported a prospective, randomized, controlled, single-blinded study compared to sham arm (insertion and removal of an 18F silicon Foley catheter). 175 patients (118 iTind vs 57 sham), prostate volume 25–75cc. An IPSS of −9.0 ± 8.5 points (40.1%) and −9.25 in IPSS (P < 0.0001) were noted in the iTind arm at 3 and 12 months, respectively.
Complications were mostly Clavien-Dindo grade I or II in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred. The surgical retreatment rate a 12 months was 4.7%.
Curr Opin Urol. 2021;31(5):461-467. © 2021 Wolters Kluwer Health, Inc.