Urodynamic Feasibility Study Utilizing the UroLift® System

Completed · Not applicable

Conditions studied: Benign Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT04271020

Run by

NeoTract, Inc.

People needed

12

Starts

2018-10-25

Expected to finish

2019-11-27

Last updated by the study team

2020-06-11

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Midtown Urology Associates — Austin, Texas, United States

Full record on ClinicalTrials.gov

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