Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH

Stage 1

Inclusion criteria

• Male ≥50 years of age and ≤ 80 years old.
• Will undergo planned prostatectomy.
• Participant understands and is willing to the informed consent form.
• Prostate Volume between 30cc and 80cc.
• Prostate length ≥ 3cm

Exclusion criteria

• Unable to comply with the clinical protocol.
• Vulnerable population such as inmates or developmentally delayed individuals.
• Any medical condition or treatment, which in the opinion of the investigator may interfere with the procedure, such as:

• 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 is not prohibited).
• Use of alpha-blockers within 2 weeks of pre-treatment (baseline) evaluation.
• Use of 5-α-reductase inhibitors within 6 months of pre-treatment (baseline) evaluation.
• American Society of Anesthesiologists score (ASA) > 3.
• Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
• Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
• Other urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
• Previous rectal surgery, other than hemorrhoidectomy
• Current gross hematuria.
• Known allergy to nickel or titanium or stainless steel.

Stage 2

Inclusion criteria

• Male ≥50 years old.
• Suspected symptomatic benign prostatic hyperplasia (BPH).
• International Prostate Symptom Score (IPSS) >13.
• Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml).
• Participant understands and is willing to the informed consent form.
• Prostate Volume between 30cc and 80cc.
• Prostate length ≥ 3cm and ≤ 5cm

Exclusion criteria

• Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
• Concomitant participation in another interventional study.
• Unable to comply with the clinical protocol including all the follow-up requirements.
• Vulnerable population such as inmates or developmentally delayed individuals.
• Significant comorbidities which would affect study participation.
• 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.]
• Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
• Compromised renal function due to obstructive uropathy.
• Active Urinary Tract Infection (UTI).
• Obstructive or protruding median lobe.
• American Society of Anesthesiologists score (ASA) > 3.
• Known neurogenic bladder or neurological disorders that might affect bladder or function.
• Recent myocardial infarction (less than three months).
• Concomitant bladder stones.
• Current gross hematuria.
• Active or history of epididymitis within the past 3 months.
• Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
• Confirmed or suspected malignancy of bladder.
• History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms.
• Other urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
• Bacterial prostatitis within the last 12 months.
• Previous rectal surgery, other than hemorrhoidectomy.
• Current uncontrolled diabetes (i.e., hemoglobin A1c ≥ 9%).
• Known allergy to nickel or titanium or stainless steel.