Status:
COMPLETED
Urodynamic Feasibility Study Utilizing the UroLift® System
Lead Sponsor:
NeoTract, Inc.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04271020
Start Date
October 25 2018
End Date
November 27 2019
Last Update
June 11 2020
Active Locations (1)
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1
Midtown Urology Associates
Austin, Texas, United States, 78705