Post-Market Study to Assess iTind Safety in Comparison to UroLift
Trial Parameters
Brief Summary
The study objective is to evaluate the safety of the iTind device comparied to UroLift.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended 2. Willing and able to provide informed consent 3. Males ≥ 50 years of age or older 4. 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 5. Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from standard of care imaging may be accepted up to 6 months prior to Screening if the subject was not on 5-alpha reductase inhibitors (5ARIs) at that time 6. International Prostate Symptom Score (IPSS) ≥ 13 7. Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL) 8. Willing and able to complete all study visits including questionnaires at baseline and at follow-u