Post-Market Study to Assess iTind Safety in Comparison to UroLift

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorOlympus Corporation of the Americas

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

256 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Olympus Corporation of the Americas

Lead sponsor

Olympus Europe SE & Co. KG

Collaborator