Olympus Corporation of the Americas
The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.
Both iTind and UroLift are minimally invasive treatment options for relieving lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The iTind device is a temporary, self-expanding nitinol implant that remains in place for 5 to 7 days to reshape the prostatic urethra through localized ischemic pressure and tissue remodeling. In contrast, the UroLift system involves the permanent placement of transprostatic implants that retract the enlarged lateral lobes of the prostate to widen the urethral lumen. This study is designed to directly compare the safety and effecti…
Inclusion Criteria: 1. Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended 2. Willing and able to provide informed consent 3. Males ≥ 50 years of age or older 4. PSA \< 4 ng/ml or if the PSA is 4 - 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the Principal Investigator (PI) by local standard of care methods within prior 6 months 5. Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from standard of care…
The iTind is implemented for 5-7 days
UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.