Urodynamic Feasibility Study Utilizing the UroLift® System

NCT ID: NCT04271020

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-25
• Study Completion Date: 2019-11-27

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UroLift

Group Type: EXPERIMENTAL

UroLift

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

NeoTract, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Mazzarella, MD

Role: PRINCIPAL_INVESTIGATOR

Midtown Urology Associates

Locations

Midtown Urology Associates

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP00009

Identifier Type: -

Identifier Source: org_study_id