The study objective is to evaluate the efficacy and safety of the iTind device compared 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/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
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
Parallel
iTind
DeviceThe iTind is implemented for 5-7 days
UroLift
Procedure/SurgeryUroLift is a minimally invasive procedure where permanent implants are placed in the prostate.
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 12 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 12 months
Incidence of all intraoperative and post-operative adverse events (AEs) (i.e., related to procedure and/or device) through 3 months post-procedure.
Incidence of all intraoperative and post-operative adverse events (AEs) (i.e., related to procedure and/or device) through 3 months post-procedure.
Difference in change of IPSS from baseline between iTind and UroLift groups at 1, 6, 24, and 36 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 1, 6, 24, and 36 months
Difference in change of QoL scores (SHIM, MSHQ-EjD, SF-6D) from baseline between iTind and UroLift at 1, 3, 6, 12, 24, and 36 months
Difference in change of QoL scores (SHIM, MSHQ-EjD, SF-6D) from baseline between iTind and UroLift at 1, 3, 6, 12, 24, and 36 months
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Olympus Corporation of the Americas
Lead sponsor
Olympus Europe SE & Co. KG
Collaborator
