Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

Exclusion Criteria

• •1. Concomitant participation in another interventional study.
• •2. Unable to comply with the clinical protocol including all the follow-up requirements.
• •3. Vulnerable population such as inmates or developmentally delayed individuals.
• •4. Significant comorbidities which would affect study participation.
• •5. Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
• •6. Any medical condition or treatment, which in the opinion of the investigator may interfere with the procedure, such as:
• •* Use of concomitant medications (e.g., anticholinergics, antispasmodics, or antidepressants) affecting bladder function.
• •* Patient with coagulopathy due to medications or congenital condition - inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure; low dose aspirin therapy not prohibited.
• •* Alpha-blockers within 2 weeks of pre-treatment (baseline) evaluation.
• •* Taking 5-alpha reductase inhibitors (5-ARI) within 6 months (3 months for type II 5-ARI) of pre-treatment (baseline) evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued throughout the study).
• •* Patient is taking steroids. \[Note: Patients approved for the trial who are using the above medications will continue using them after the trial, except for Alpha blockers\]
• •7. Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
• •8. Compromised renal function due to obstructive uropathy.
• •9. Active Urinary Tract Infection (UTI).
• •10. Obstructive or protruding median lobe
• •11. American Society of Anaesthesiologists score (ASA) \> 3.
• •12. Known neurogenic bladder or neurological disorders that might affect bladder or function.
• •13. Recent myocardial infarction (less than three months).
• •14. Concomitant bladder stones.
• •15. Current gross hematuria.
• •16. Active or history of epididymitis within the past 3 months.
• •17. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
• •18. Confirmed or suspected malignancy of bladder.
• •19. History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms.
• •20. Other Urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
• •21. Bacterial prostatitis within the last 12 months.
• •22. Previous rectal surgery, other than hemorrhoidectomy.
• •23. Current uncontrolled diabetes (i.e., hemoglobin A1c ≥ 9%).
• •24. Known allergy to nickel or titanium or stainless steel.