The study objective is to evaluate the safety of the iTind device comparied to UroLift.
Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended
Willing and able to provide informed consent
Males ≥ 50 years of age or older
PSA < 4 ng/dl, ng/ml or if the PSA is 4 - 10 ng/dl, 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
History of prostate cancer or suspected, should be ruled out to the satisfaction of the PI by local standard of care methods within prior 6 months
Confirmed or suspected bladder cancer within the last 2 years
History of acute bacterial prostatitis within the last 2 years
Median lobe obstruction of the prostate as confirmed by cross-sectional imaging
Olympus Corporation of the Americas
Lead sponsor
Olympus Europe SE & Co. KG
Collaborator