The study objective is to evaluate the safety of the iTind device comparied to UroLift.
Both iTind and UroLift are minimally invasive treatment options for relieving lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The iTind device is a temporary, self-expanding nitinol implant that remains in place for 5 to 7 days to reshape the prostatic urethra through localized ischemic pressure and tissue remodeling. In contrast, the UroLift system involves the permanent placement of transprostatic implants that retract the enlarged lateral lobes of the prostate to widen the urethral lumen. This study is designed to directly compare the safety and effectiveness of the iTind device versus the UroLift system in treating LUTS due to BPH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
206
Mayo Clinic Arizona
Phoenix, Arizona, United States
RECRUITINGIncidence 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
Time frame: 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
Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months
Difference in change of QoL scores from baseline between iTind and UroLift
Difference in change of QoL scores from baseline between iTind and UroLift
Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months
Difference in rate of re-intervention
Difference in rate of re-intervention between iTind and UroLift groups
Time frame: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
Difference in reporting between iTind and UroLift groups
Difference in reporting between iTind and UroLift groups in overall incidence of adverse events.
Time frame: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
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