Urodynamic Feasibility Study (UDS)
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Sponsor: NeoTract, Inc.

 
NeoTract, Inc. PROPRIETARY & CONFIDENTIAL 
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NeoTract, Inc. UroLift® System 
Executive Protocol Summary 
 
Urodynamic Feasibility Study (UDS) 
Clinical Protocol Number: CP00009, Rev B 
08 October 2018 
NCT Number: NCT04271020 
 
 
Sponsored by: 
NeoTract, Inc., a wholly owned subsidiary of  
Teleflex®, Inc. 
Interventional Urology 
 
 
 
This document is a confidential communication of NeoTract, Inc., a wholly owned 
subsidiary of Teleflex, Inc. Acceptance of this document constitutes the agreement 
by the recipient that no unpublished information contained herein will be published 
or disclosed without prior written approval from NeoTract, Inc. 
 
 

 
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PROTOCOL SUMMARY 
Study Title 
Urodynamic Feasibility Study (UDS) 
Device Name and 
Indications for Use 
NeoTract® UroLift® System UL400. This device was cleared for 
marketing in the USA on September 13, 2013. 
The UroLift System is indicated for the treatment of symptoms due to 
urinary outflow obstruction secondary to benign prostatic hyperplasia 
(BPH), including lateral and median lobe hyperplasia in men 45 years of 
age or older.   
Study Goals 
 
To prospectively collect urodynamic data prior to, and 3 
months after PUL, with the UroLift System, and to assess the 
impact of the PUL procedure on prostatic obstruction, bladder 
health and other urodynamic parameters.  
 
To obtain evidence which may support the design of an 
expanded study. 
Subject Population 
10 to 20 males over the age of 45, diagnosed with symptomatic benign 
prostatic hyperplasia (BPH) and intended for PUL procedure with the 
UroLift System will be enrolled at a single center. 
Since this is the first study to assess the impact of PUL procedure using 
pressure flow studies, the population is planned to be similar to the 
population studied in the LIFT Study.  
Study Design 
This is a prospective, non-randomized, single-arm, single-center study. 
This is the first exploratory study of the impact of PUL as measured by 
pressure flow urodynamic testing (UDS). UDS will be performed at 
screening and at the 3-month follow-up visits. UDS will include an 
assessment of obstruction and bladder health as measured by Qmax 
(maximum urinary flow rate) and Pdet (detrusor pressure) at Qmax, 
and Pdetmax (maximum voiding pressure), as well as capturing all 
other standard urodynamic parameters. UroCuff as an alternative form 
of urodynamics testing will be an optional test performance at baseline 
and at 3M follow-up.  
In addition, standard BPH measures such as symptoms, qualify of life, 
uroflowmetry and post void residual will be evaluated at the follow-up 
visits. The analysis of the 3-month data is intended to evaluate the 
possibility of expanding the scope of the study. There will be no formal 
hypothesis testing.   
 
 

 
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CM00110 Rev A 
Study Title 
Urodynamic Feasibility Study (UDS) 
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  
Key Exclusion Criteria  
Key exclusion criteria are listed below.  
See Section 6.3 for the full, detailed list of selection criteria. 
Subjects will be excluded for any of the following: 
 
In current urinary retention  
 
Post void residual (PVR) urine > 250 ml  
 
Have 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  
 
History of prostate or bladder cancer  
 
Elevated 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 medications known to affect urological function unless 
washed-out (see protocol list) 
 
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 
 
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. 
 
 
 
 

 
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Anticipated Study Duration 
Protocol Completion 
August 2018 
IRB Submission  
August 2018 
IRB Approval 
September 2018 
First Patient In (FPI) 
September 2018 
Last Patient In (LPI) 
February 2019 (20 subjects) 
3-month Analysis 
May 2019 
Study Close 
June 2019 
1 STUDY DESIGN 
1.1 Study Objectives 
The aim of this feasibility study is to determine the impact of PUL using the UroLift System 
on standard pressure flow measures for men with BPH. Feasibility and safety objectives 
include:  
 
Feasibility – Assess changes in obstruction and bladder health after PUL with the UroLift 
System.  
 
Safety- Determined by the absence of any investigator-reported serious adverse events (SAEs) 
associated with the device or procedure 
1.2 Study Design 
This is a prospective, non-randomized, single- arm, study. This is the first exploratory study of 
the impact of PUL as measured by pressure flow, urodynamic testing (UDS). UDS will be 
performed at screening and the 3-month follow-up visits and will include an assessment of 
obstruction and bladder health as measured by Qmax and Pdet@Qmax, and by Pdetmax, and 
other standard urodynamic parameters. Investigators have the option to use UroCuff, 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. The analysis of the 3-
month data is intended to evaluate the possibility of expanding the scope of the study.  
2    ENROLLMENT CRITERIA 
    2.1   Inclusion Criteria 
Subjects enrolled in this clinical study must meet all the following criteria: 
1. Male gender  
2. Diagnosis of symptomatic BPH  

 
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3. Age ≥ 45 years  
4. International Prostate Symptom Score (IPSS) ≥ 13  
5. Peak urine flow rate ≤ 12 ml/sec on a voided volume ≥ 125 ml  
6. Prostate volume to ≤ 80 cc per ultrasound  
    2.2   Inclusion Criteria 
Subjects will be excluded from the study if any of the following conditions apply: 
1. Current urinary retention  
2. Post void residual (PVR) urine > 250 ml  
3. Have an obstructive or protruding median lobe of the prostate  
4. Active urinary tract infection at time of treatment  
5. Current gross hematuria  
6. Previous BPH surgical procedure  
7. Previous pelvic surgery or irradiation  
8. History of neurogenic or atonic bladder  
9. Stress urinary incontinence  
10. Biopsy of the prostate within the past 6 weeks  
11. Life expectancy estimated to be less than 1 year  
12. History of prostate or bladder cancer  
13. Elevated PSA without ruling out prostate cancer 
14. History of compromised renal function or upper tract disease 
15. Known coagulopathies or subject on anticoagulants or antiplatelets other than 
aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to 
procedure)  
16. Use of the following medications pre-screening (uroflow, questionnaires): 
o Within 4 months of baseline assessment: estrogen, any drug producing 
androgen suppression, or anabolic steroids  
o Within 3 months of baseline assessment: 5-alpha-reductase inhibitors  
o Within 2 weeks of baseline assessment: alpha-blockers, gonadotropin-
releasing hormonal analogs, anticholinergics or cholinergic medication or 
phenylephrine, pseudoephedrine, or imipramine medications  
o Within 1 week of baseline assessment, unless documented on stable dose 
for ≥ 6 months: beta blockers, antidepressants, anticonvulsants, and 
antispasmodics  
17. Cystolithiasis within the prior 3 months  
18. History of co-morbidities that would affect having an elective urological 
procedure including: prostatitis, conditions that preclude the insertion of the 
UroLift System. 
19. Other co-morbidities that could impact the study results such as:  
o Severe cardiac arrhythmias uncontrolled by medications or pacemaker 
o Congestive heart failure NYHA III or IV  
o History of uncontrolled diabetes mellitus  

 
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o Significant respiratory disease in which hospitalization may be required  
o Known immunosuppression (i.e. AIDS, post-transplant, undergoing 
chemotherapy)  
20. A known allergy to nickel, titanium, or stainless steel 
21. Unable or unwilling to complete all required questionnaires and follow up 
assessments  
22. Unable or unwilling to sign informed consent form  
23. Currently enrolled in any other investigational clinical research trial that has not 
completed the primary endpoint. 
 

 
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Table 1 : Schedule of Procedures 
 
Summary of Procedures
Tests & Assessments
Screening
Procedure through 
Release 
1-3 Day
Visit 
3 Month
Visit 
(+ 7 days) 
Informed Consent 
X 
 
 
 
Medical History, including Sexual 
Function and Catheter Use 
X 
 
 
 
Questionnaires 
 
Urinary Symptoms 
X 
 
 
X 
Patient Satisfaction 
 
 
 
X 
ICIQ-UI Short Form 
X 
 
 
If indicated 
Testing Procedures 
 
UroLift Procedure 
 
X 
 
 
Pressure Flow Studies  
X 
 
 
X 
UroCuff Test (optional) 
X 
 
 
X 
Flexible Cystoscopy with Video 
X 
 
 
 
Uroflowmetry 
X 
 
X 
X 
PVR 
X 
 
X 
X 
PSA 
X 
 
 
 
UA 
X 
X 
X 
X 
Urine Culture & Sensitivity 
X 
 
If indicated 
If indicated 
TRUS or Pelvic Ultrasound 
X 
X 
 
 
Review any changes or updates to concomitant medications, adverse events or interventions 
Concomitant Medications 
X 
 
 
X 
Adverse Events 
 
 
X 
X 
Intervention 
 
 
 
X 
3 STATISTICAL METHODS 
Descriptive reports will be provided for this preliminary evaluation. Data will be expressed 
as the mean ± SD for continuous variables and as frequencies for categorical variables. 
3.1 Sample Size Justification 
As this is a feasibility study, a formal sample size calculation is not required. However, we 
estimate that the number of participants required to get an initial assessment of 
urodynamic parameters pre and post PUL with UroLift will be between 10 and 20.  

 
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3.2 Study Objectives 
The aim of this feasibility study is to determine the impact of PUL using the UroLift System on 
standard pressure flow measures for men with BPH. Feasibility and safety objectives include: 
 
Feasibility – Assess changes in obstruction and bladder health after PUL with the 
UroLift System. 
 
Safety – Determined by the absence of any investigator-reported serious adverse 
events (SAEs) associated with the device or procedure.  
3.3 Statistical Methods 
No statistical hypothesis will be tested. Descriptive reports will be provided for this 
preliminary evaluation. Data will be expressed as the mean ± SD for continuous variables and 
as frequencies for categorical variables.  
4    ANALYSES 
This is the first exploratory study of the impact of PUL as measured by pressure flow, 
urodynamic testing (UDS). UDS will be performed at screening and the 3-month follow-up 
visits and will include an assessment of obstruction and bladder health as measured by Qmax 
and Pdet@Qmax, and by Pdetmax, and other standard urodynamic parameters. Investigators 
have the option to use UroCuff, 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. The analysis of 
the 3-month data is intended to evaluate the possibility of expanding the scope of the study.  
4.1 Adverse Events 
Adverse events will be summarized by overall adverse events (AEs), severe AEs (grade 3 or 
higher on CTCAE scale), AEs related to device and/or procedure, serious adverse events 
(SAEs), and SAEs related to device and/or procedure separately, and UADEs. 
4.2 Interim Analysis 
 
The Urodynamics Feasibility Study will enroll at least 10 patients and then an interim 
analysis of the urodynamic parameters may be conducted.