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Urodynamic Feasibility Study Utilizing the UroLift® System (UDS)

Primary Purpose

Benign Prostatic Hyperplasia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

UroLift

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Midtown Urology Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UroLift

Arm Description

Outcomes

Primary Outcome Measures

Qmax Assessed Using Urodynamic Testing (Cystometry)

Qmax is the the maximum urinary flow rate measured in ml/s.

Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry)

Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O.

Pdetmax Assessed Using Urodynamic Testing (Cystometry)

Pdetmax is the maximum void pressure measured in cm H2O.

Secondary Outcome Measures

Full Information

NCT ID

NCT04271020

First Posted

February 4, 2020

Last Updated

May 26, 2020

Sponsor

NeoTract, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04271020

Brief Title

Urodynamic Feasibility Study Utilizing the UroLift® System

Acronym

UDS

Official Title

Urodynamic Feasibility Study (UDS)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

October 25, 2018 (Actual)

Primary Completion Date

April 22, 2019 (Actual)

Study Completion Date

November 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeoTract, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UroLift

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

UroLift

Intervention Description

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.

Primary Outcome Measure Information:

Title

Qmax Assessed Using Urodynamic Testing (Cystometry)

Description

Qmax is the the maximum urinary flow rate measured in ml/s.

Time Frame

3 Month

Title

Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry)

Description

Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O.

Time Frame

3 Month

Title

Pdetmax Assessed Using Urodynamic Testing (Cystometry)

Description

Pdetmax is the maximum void pressure measured in cm H2O.

Time Frame

3 Month

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Patients must be male. The study is evaluation the population of men diagnosed with benign prostatic hyperplasia.

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Mazzarella, MD

Organizational Affiliation

Midtown Urology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Midtown Urology Associates

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

12. IPD Sharing Statement

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Urodynamic Feasibility Study Utilizing the UroLift® System

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