Urodynamic Feasibility Study Utilizing the UroLift® System (UDS)

Urodynamic Feasibility Study (UDS)

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 Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: UroLift

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Midtown Urology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: UroLift

Device: UroLift; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NeoTract, Inc.
• Investigators: Principal Investigator: Brian Mazzarella, MD, Midtown Urology Associates

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Actual): April 22, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CP00009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes