Urodynamic Feasibility Study Utilizing the UroLift® System

Inclusion criteria

• Male gender
• Diagnosis of symptomatic BPH
• Age ≥ 45 years
• International Prostate Symptom Score (IPSS) ≥ 13
• Peak urine flow rate ≤ 12 ml/sec, voided volume ≥ 125 ml
• Prostate volume ≤ 80 cc per ultrasound

Exclusion criteria

• Current urinary retention
• Post void residual (PVR) urine > 250 ml
• Have an obstructive or protruding median lobe of the prostate
• Active urinary tract infection at time of treatment
• Current gross hematuria
• Previous BPH surgical procedure
• Previous pelvic surgery or irradiation
• History of neurogenic or atonic bladder
• Stress urinary incontinence
• Biopsy of the prostate within the past 6 weeks
• Life expectancy estimated to be less than 1 year
• History of prostate or bladder cancer
• Elevated Prostate-Specific Antigen (PSA) without ruling out prostate cancer
• History of compromised renal function or upper tract disease
• Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
• Use of the following medications pre-screening (uroflow, questionnaires):

• Within 4 months of baseline assessment: estrogen, any drug producing androgen suppression, or anabolic steroids
• Within 3 months of baseline assessment: 5-alpha-reductase inhibitors
• Within 2 weeks of baseline assessment: alpha-blockers, gonadotropin-releasing hormonal analogs, anticholinergics or cholinergic medication or phenylephrine, pseudoephedrine, or imipramine medications
• Within 1 week of baseline assessment, unless documented on stable dose for ≥ 6 months: beta blockers, antidepressants, anticonvulsants, and antispasmodics
• Cystolithiasis within the prior 3 months
• History of co-morbidities that would affect having an elective urological procedure including: prostatitis, conditions that preclude the insertion of the UroLift System.
• Other co-morbidities that could impact the study results such as:
• Severe cardiac arrhythmias uncontrolled by medications or pacemaker
• Congestive heart failure New York Heart Assocation (NYHA) III or IV
• History of uncontrolled diabetes mellitus
• Significant respiratory disease in which hospitalization may be required
• Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
• A known allergy to nickel, titanium, or stainless steel
• Unable or unwilling to complete all required questionnaires and follow up assessments
• Unable or unwilling to sign informed consent form
• Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.