NCT04271020CompletedNot Applicable
Urodynamic Feasibility Study (UDS)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NeoTract, Inc.
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Qmax Assessed Using Urodynamic Testing (Cystometry)
Study Overview
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 BPH measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and at the follow-up visits.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Qmax Assessed Using Urodynamic Testing (Cystometry)
Time Frame: 3 Month
Qmax is the the maximum urinary flow rate measured in ml/s.
Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry)
Time Frame: 3 Month
Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O.
Pdetmax Assessed Using Urodynamic Testing (Cystometry)
Time Frame: 3 Month
Pdetmax is the maximum void pressure measured in cm H2O.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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