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
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.
Incidence of all intraoperative and post-operative complications
Incidence of all intraoperative and post-operative complications (i.e., related to procedure and/or device) at 3 months
Difference in change from baseline between iTind and UroLift groups in International Prostate Symptom Score (IPSS)
Difference in change of International Prostate Symptom Score (IPSS) from baseline between iTind and UroLift groups
Difference in change of QoL scores from baseline between iTind and UroLift
Difference in change of QoL scores from baseline between iTind and UroLift
Difference in rate of re-intervention
Difference in rate of re-intervention between iTind and UroLift groups
Difference in reporting between iTind and UroLift groups
Difference in reporting between iTind and UroLift groups in overall incidence of adverse events.
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Olympus Corporation of the Americas
Lead sponsor
Olympus Europe SE & Co. KG
Collaborator
