Hypothesis / aims of study
The iTind (Medi-Tate Ltd.) device, comprised of 3 nitinol struts & an anchoring leaflet, is deployed in the prostatic urethra where it expands, resulting in ischemic incisions & a re-shaping of the bladder neck & prostate. The device is implanted in 5 minutes using a rigid cystoscope. After 5 days it is removed through a 22F catheter. The device is Health Canada approved. Three-year clinical outcomes & economic comparisons are made to the prostatic urethral lift (PUL) system (UroLift - NeoTract Inc.).
Study design, materials and methods
A one-arm single-centre, prospective study of the iTind in 32 men was conducted. Similarly, the L.I.F.T. study, a multi-centre, sham-controlled prospective study with similar inclusion criteria & outcomes examining the PUL has published its 3yr results.
Results
At baseline patient's mean (SD) total prostate volume (TPV), IPSS score, QoL & Qmax were 29.5 (+7.4), 19 (14-23), 3 (3-4), & 7.6 (2.2) ml/sec. After 36 months IPSS score, QoL & Qmax were 12 (6-24), 2 (1-4) & 10.4 ml/sec. Only 1 patient (3.1%) required TURP. By comparison, the PUL study baseline patient's mean (SD) TPV, IPSS score, QoL, & Qmax were 44.5 (+12.47), 22.3 (13-35), 4.6 (4.4-4.8), 7.9 (3-13) ml/sec. After 36 months IPSS score, QoL, & Qmax were 12.7 (11-14), 2.2 (1.9-2.6), & 11.8 (10.6-13) ml/sec. The iTind resulted in superior Qmax (p=0.033) & similar IPSS (p=0.098) & QoL (p=0.192) improvements compared to PUL implant at 3 years. In Canada the iTind device cost is approx. $2500 CAD & 1 device is used per case. The approx. cost of a PUL implant is $800 CAD/implant & the mean number of PUL implants used in the L.I.F.T. study was 5.2. Thus, in Canada the approx. cost per PUL procedure will be $4160 CAD.
Interpretation of results
Small sample size in the may limit the interpretations of outcomes in this study. However, the iTIND sample population represents the largest reported cohort in the literature to date. Clinical data were based off multiple sources.