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

Inclusion Criteria:

1. Diagnosis of lower urinary tract symptoms presumed to be secondary to benignprostatic enlargement causing bladder outlet obstruction for which treatment isrecommended

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 beruled out to the satisfaction of the Principal Investigator (PI) by local standardof 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 monthsprior to Screening if the subject was not on 5-alpha reductase inhibitors (5ARIs) atthat time

6. International Prostate Symptom Score (IPSS) ≥ 13

7. Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume mustbe ≥ 125 mL)

8. Willing and able to complete all study visits including questionnaires at baselineand at follow-up visits

Exclusion Criteria:

1. History of prostate cancer or suspected, should be ruled out to the satisfaction ofthe PI by local standard of care methods within prior 6 months

2. Confirmed or suspected bladder cancer within the last 2 years

3. History of acute bacterial prostatitis within the last 2 years

4. Median lobe obstruction of the prostate as confirmed by cross-sectional imaging

5. PSA value > 10 ng/dl, ng/ml

6. Contraindicated for iTind or UroLift as determined by the PI

7. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease,multiple sclerosis, cerebral vascular accident, diabetes or other neurologicaldisorders that affect bladder function

8. Clinically significant bladder diverticulum

9. Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectaldisease, artificial urinary sphincter, incompetent sphincter, urinary incontinencedue to incompetent sphincter

10. Prior rectal surgery (other than hemorrhoidectomy) or history of rectal disease ifthe 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 stentimplantation, laser prostatectomy, or any other invasive treatment to the prostate,or penile prosthesis that may prevent insertion of the iTind or UroLift device

11. An active urinary tract infection

12. Hematuria or cystolithiasis within the last 3 months

13. Prostate volume > 75 cc

14. Post-void residual volume (PVR) > 250 mL

15. Actively using catheterization or unable to void naturally

16. Unable to complete the required washout period for alpha blockers

17. Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg)within the last 7 days prior to randomization

18. Known or suspected allergy to nickel, titanium or polyester/polypropylene