Urodynamic Feasibility Study Utilizing the UroLift® System

Benign Prostatic Hyperplasia Clinical Trial

— UDS  

Official title:

Urodynamic Feasibility Study (UDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271020
• Other study ID #: CP00009
• Status: Completed
• Phase: N/A
• Start date: October 25, 2018
• Est. completion date: November 27, 2019

Study information

• Verified date: May 2020
• Source: NeoTract, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 27, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
United States	Midtown Urology Associates	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NeoTract, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qmax Assessed Using Urodynamic Testing (Cystometry)	Qmax is the the maximum urinary flow rate measured in ml/s.	3 Month
Primary	Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry)	Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O.	3 Month
Primary	Pdetmax Assessed Using Urodynamic Testing (Cystometry)	Pdetmax is the maximum void pressure measured in cm H2O.	3 Month