Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH

Eligibility Criteria

• 1. Male 45 years of age or older
• 2. Diagnosis of BPH
• 3. Experiencing symptoms of BPH as indicated by an IPSS ≥8 and ≤30
• 4. Willing to wash out of current BPH medication(s), as applicable
• 5. An appropriate candidate for both BPH therapies evaluated in this study.
• 6. Ability to understand and consent to participate in this study
• 7. Willing and able to participate in follow-up evaluations
• 1. Use of alpha blocker for BPH unless washed-out for 30 days
• 2. Use of daily phosphodiesterase type 5 inhibitor (PDE5i) for BPH unless washed-out for 30 days
• 3. 5-alpha-reductase inhibitors for BPH used within 6 months of therapy initiation
• 4. Current urinary tract infection or prostatitis
• 5. Current gross hematuria
• 6. Urinary incontinence presumed due to incompetent sphincter
• 7. Catheter-dependent urinary retention within 1 month prior to enrollment
• 8. Prostate volume greater than 100 cc as measured by TRUS
• 9. Prostate specific antigen level of greater than 10 ng/ml within one year of enrollment unless prostate cancer has been ruled out
• 10. History of neurogenic or atonic bladder
• 11. History prostate cancer treatment
• 12. Known to be hypersensitive to tamsulosin HCl or any component of tamsulosin HCl capsules
• 13. Known allergy to nickel, titanium, or stainless steel
• 14. Prior minimally invasive or surgical intervention for BPH
• 15. Urethral conditions that may prevent insertion of delivery system into bladder.
• 16. Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
• 17. History of medical, surgical or other conditions that, in the opinion of the investigator, would interfere with the treatment or evaluation of the subject