Urodynamic Feasibility Study Utilizing the UroLift® System

Study Overview
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Brief Summary
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UDS evaluates the impact of Prostatic Urethral Lift (PUL) as measured by pressure flow, urodynamic testing (UDS) and an optional UroCuff Testing, an alternative urodynamic test. In addition, standard BPH measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and at the follow-up visits.

Official Title
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Urodynamic Feasibility Study (UDS)

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: UroLift


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UroLift<br> | Device: UroLift<br>* The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qmax Assessed Using Urodynamic Testing (Cystometry) | Qmax is the the maximum urinary flow rate measured in ml/s. | 3 Month | 
| Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry) | Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O. | 3 Month | 
| Pdetmax Assessed Using Urodynamic Testing (Cystometry) | Pdetmax is the maximum void pressure measured in cm H2O. | 3 Month |