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

Exclusion Criteria18

• 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
• PSA value \> 10 ng/dl, ng/ml
• Contraindicated for iTind or UroLift as determined by the PI
• Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes or other neurological disorders that affect bladder function
• Clinically significant bladder diverticulum
• Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter
• Prior rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites or previous rectal surgery (e.g., if a transrectal probe is used), pelvic radiotherapy or radical pelvic surgery, urinary diversion surgery, prostate surgery, balloon dilation, urethral stent implantation, laser prostatectomy, or any other invasive treatment to the prostate, or penile prosthesis that may prevent insertion of the iTind or UroLift device
• An active urinary tract infection
• Hematuria or cystolithiasis within the last 3 months
• Prostate volume \> 75 cc
• Post-void residual volume (PVR) \> 250 mL
• Actively using catheterization or unable to void naturally
• Unable to complete the required washout period for alpha blockers
• Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to randomization
• Known or suspected allergy to nickel, titanium or polyester/polypropylene