Urodynamic Feasibility Study Utilizing the UroLift® System

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.