About this trial
The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.
Eligibility criteria
Qualifiers
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/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
Disqualifiers
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 bladder cancer within the last 2 years or currently suspected bladder cancer
History of acute bacterial prostatitis within the last 2 years
Median lobe obstruction of the prostate as confirmed by cross-sectional imaging
Trial design
Treatments tested in this trial
- iTind
- UroLift
Treatment groups
Sponsors and collaborators
Olympus Corporation of the Americas
Lead sponsor
Olympus Europe SE & Co. KG
Collaborator