Assessing the Performance, Safety and Usability of Our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Phase: NA
Conditions: Incontinence, Urge
Sponsor: Laborie Medical Technologies Inc.

 
T-DOC® NXT Clinical Study 
 
Confidential © 2018 LABORIE 
 
 
 
 
STUDY NUMBER: 
TDOC-NXT-01 
 
STUDY NAME: 
T-DOC® NXT Clinical Investigation:  
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® 
NXT Catheter for Performing Urodynamic Studies 
 
DOCUMENT: 
CLINICAL STUDY PROTOCOL 
 
NCT NUMBER: 
NCT03615001 
 
DOCUMENT VERSION & DATE: 
Version 1.0 
June 26, 2018 

 
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CLINICAL STUDY PROTOCOL 
 
DEVICE: 
T-DOC® NXT Air-Charged Urodynamic Catheters 
 
 
STUDY NUMBER: 
 TDOC-NXT-01 
 
 
STUDY NAME: 
T-DOC® NXT Clinical Investigation:  
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter 
for Performing Urodynamic Studies 
 
Version 1.0 
June 26, 2018 
 
 
 

 
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TDOC-NXT-01  
T-DOC® NXT Clinical Investigation:  
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter 
for Performing Urodynamic Studies 
 
KEY SPONSOR STUDY TEAM 
Sponsor  
Laborie Medical Technologies Canada ULC 
6415 Northwest Drive, Unit 10 
Mississauga, Ontario, Canada, L4V1X1 
+1 905 612 1170 
 
 
  
 
 
 
 
 
 
 
 
 
 
 

 
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TDOC-NXT-01  
T-DOC® NXT Clinical Investigation:  
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter 
for Performing Urodynamic Studies 
CLINICAL STUDY PROTOCOL  
PREPARED BY 
PRINT NAME: 
 
Job function: 
 
 
 
In signing the box below the approver signifies that they have reviewed the protocol and approve it on the basis that it meets the following 
requirements 
1. 
The protocol is consistent with the clinical plan 
2. 
Adequacy of sample size and appropriateness of proposed statistical analysis 
3. 
Accuracy of device description, efficacy and performance characteristics 
4. 
Biological safety of Investigational and control devices and their appropriateness for human use 
5. 
Conformance to all applicable regulations 
6. 
Adequacy in meeting business needs 
CLINICAL STUDY PROTOCOL  
 
APPROVED BY 
PRINT NAME: 
  
Job function: 
 
  
 
 
 
 
 

 
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TDOC-NXT-01  
T-DOC® NXT Clinical Investigation:  
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter 
for Performing Urodynamic Studies 
INVESTIGATOR(S)  
Principal Investigator 
  
 
 
 
 
 
 
 
 
 
PARTICIPATING SITE(S)  
 
 
 
 
 
 
 
 
INSTITUTION(S)  
 
 
 
 
 
  
 
 
 
 

 
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TDOC-NXT-01  
T-DOC® NXT Clinical Investigation:  
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter 
for Performing Urodynamic Studies 
 
"CONFIDENTIAL INFORMATION"  
Will mean all information provided by one party to the other and clearly identified as 
"CONFIDENTIAL" by the transmitting party at the time of disclosure.  If such transmittal 
occurs orally, the transmitting party will promptly reduce such transmittal in writing, mark 
and identify it as confidential, and provide such record to the other party.   
Specifically excepted from this is all information that 
1. 
was previously known by the receiving party 
2. 
is publicly disclosed except by breach of this AGREEMENT either before or subsequent to 
the receiving party's receipt of such information 
3. 
is rightfully received by the receiving party without an express obligation of confidence 
4. 
is independently developed by personnel of the receiving party without use of or reliance 
upon information from the other party 
5. 
is disclosed pursuant to any judicial or government request, requirement or order, 
provided that the disclosing party takes reasonable steps to provide the other party with 
sufficient prior notice in order to allow the other party to contest such request, 
requirement or order.  
The receiving party will not disclose CONFIDENTIAL INFORMATION without authorization 
from the disclosing party.  This provision shall remain in effect for five (5) years following 
completion of this study.  COMPANY shall be provided with patient information as allowed 
by law and will maintain the confidentiality of all such patient information, unless specifically 
required to disclose such information by law. 
INVESTIGATOR STATEMENT 
I fully understand the requirements of this study and my role as Investigator. I agree to 
participate and to comply with the requirements presented to me by Laborie.  I agree to follow 
the protocol laid out before me and to not deviate from it in any way.  I also agree to document 
all the required information as fully as I can. 
ACCEPTED BY 
PRINCIPAL INVESTIGATOR 
PRINT NAME 
TITLE  
Signature          
 

 
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TDOC-NXT-01  
T-DOC® NXT Clinical Investigation:  
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter 
for Performing Urodynamic Studies 
Document History 
 
Version 
Date Effective 
Changes 
Rationale for 
Change 
Creation 
1.0 
June 26, 2018 
- 
First Release 
Amendments 
 
 
 
 
 
This is a premarket clinical research protocol. This study is conducted in accordance with the 
clinical protocol, Good Clinical Practice, and FDA 21 CFR Parts 50, 812 – Investigational Device 
Exemptions. This study is conducted in accordance with ethical principles that have their origin 
in the Declaration of Helsinki. 
 
 

 
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Table of Contents 
 
1 
List of abbreviations ............................................................................................................ 10 
2 
INTRODUCTION ................................................................................................................... 10 
2.1 
Clinical Study Summary ............................................................................................. 10 
2.2 
Primary Hypothesis .................................................................................................... 11 
2.2.1 Primary Safety and Effectiveness Endpoints .......................................................... 12 
3 
BACKGROUND ..................................................................................................................... 13 
3.1 
Medical Device ........................................................................................................... 13 
3.2 
Prior Literature & Studies .......................................................................................... 14 
3.3 
Rationale .................................................................................................................... 15 
4 
STUDY OBJECTIVES .............................................................................................................. 15 
4.1 
Primary Objectives ..................................................................................................... 15 
4.2 
Exploratory Objectives ............................................................................................... 16 
4.3 
Claims and Intended Performance ............................................................................ 16 
4.4 
Assessment of Risks and Adverse Device Effects ...................................................... 16 
5 
MEDICAL DEVICE ................................................................................................................. 17 
5.1 
Description ................................................................................................................. 17 
5.2 
Purpose & Use ........................................................................................................... 18 
5.3 
Summary of Non-Clinical Safety & Performance Data .............................................. 18 
5.4 
Summary of Clinical Safety & Performance Data ...................................................... 18 
5.5 
Risks and Benefits ...................................................................................................... 18 
6 
STUDY DESIGN ..................................................................................................................... 19 
6.1 
Description ................................................................................................................. 19 
6.2 
Duration ..................................................................................................................... 19 
7 
PATIENT SELECTION ............................................................................................................ 19 
7.1 
Inclusion Criteria ........................................................................................................ 19 
7.2 
Exclusion Criteria ....................................................................................................... 19 
7.3 
Vulnerable Populations ............................................................................................. 20 
7.4 
Recruitment Plans ...................................................................................................... 20 
7.5 
Informed Consent ...................................................................................................... 20 
7.6 
Subject Withdrawal ................................................................................................... 20 

 
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7.7 
Suspension or Premature Termination ..................................................................... 20 
8 
MANAGEMENT OF MEDICAL DEVICE .................................................................................. 21 
8.1 
Description ................................................................................................................. 21 
8.2 
Regimen ..................................................................................................................... 22 
8.3 
Assignment to Groups ............................................................................................... 22 
8.4 
Preparation and Handling .......................................................................................... 22 
8.5 
Packaging and Labelling ............................................................................................. 22 
8.6 
Device Accountability ................................................................................................ 22 
8.6.1 Laborie to Study Site: .............................................................................................. 22 
8.6.2 Study Site Usage: .................................................................................................... 22 
8.6.3 Study Site to Laborie: .............................................................................................. 22 
8.7 
Concomitant Treatment ............................................................................................ 22 
8.8 
Subject Compliance Monitoring ................................................................................ 23 
9 
ASSESSMENT OF INVESTIGATIONAL DEVICE ....................................................................... 23 
9.1 
Endpoints ................................................................................................................... 23 
9.2 
Methods of Assessment ............................................................................................ 23 
10 
PATIENT SAFETY .................................................................................................................. 23 
10.1 Definitions .................................................................................................................. 23 
10.1.1 
Adverse Events: ............................................................................................... 24 
10.1.2 
Adverse Device Effect: ..................................................................................... 24 
10.1.3 
Device Deficiency: ............................................................................................ 24 
10.1.4 
Serious Adverse Event: .................................................................................... 24 
10.1.5 
Unanticipated Adverse Device Effect: ............................................................. 24 
10.1.6 
Unanticipated Serious Adverse Device Effect (USADE): .................................. 24 
10.2 Data Collection ........................................................................................................... 24 
10.3 Reporting ................................................................................................................... 24 
10.4 Foreseeable Events .................................................................................................... 25 
10.5 Contact Information .................................................................................................. 25 
10.6 Follow-Up ................................................................................................................... 25 
11 
STUDY PROCEDURE ............................................................................................................. 25 
11.1 Visit Schedule ............................................................................................................. 25 
11.2 Screening for Eligibility .............................................................................................. 25 

 
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11.3 Part 1 (Informed Consent) ......................................................................................... 26 
11.4 Part 2 (Urodynamic Clinic Visit) ................................................................................. 26 
11.5 End of Study (EOS) ..................................................................................................... 26 
12 
STATISTICAL CONSIDERATIONS ........................................................................................... 27 
12.1 Primary Safety and effectiveness Endpoints ............................................................. 27 
12.1.1 
Primary Effectiveness Endpoint ....................................................................... 27 
12.1.2 
Primary Safety Endpoint .................................................................................. 27 
12.2 Exploratory Analyses ................................................................................................. 27 
12.3 Sample Size Determination & Power ........................................................................ 28 
12.4 Randomization / Blinding .......................................................................................... 28 
12.5 Analysis Plan .............................................................................................................. 28 
12.6 Deviations .................................................................................................................. 28 
12.7 Early Stopping ............................................................................................................ 28 
13 
DATA HANDLING & RECORD KEEPING ................................................................................ 28 
13.1 Direct Access .............................................................................................................. 28 
13.2 Confidentiality & Security .......................................................................................... 29 
13.3 Data Handling ............................................................................................................ 29 
13.4 Case Report Form (CRF) & Source Documents .......................................................... 29 
13.5 Record Retention ....................................................................................................... 30 
13.6 Performance Monitoring ........................................................................................... 30 
14 
MONITORING, AUDITING, AND INSPECTING ...................................................................... 30 
14.1 Study Monitoring Plan ............................................................................................... 30 
14.2 Auditing and Inspecting ............................................................................................. 31 
15 
DEVIATIONS ......................................................................................................................... 31 
16 
AMENDMENTS .................................................................................................................... 31 
17 
STUDY ADMINSTRATION ..................................................................................................... 32 
17.1 Funding Source and Conflicts of Interest .................................................................. 32 
17.2 Subject Stipends or Payments ................................................................................... 32 
17.3 Committees ................................................................................................................ 32 
17.4 Study Timetable ......................................................................................................... 32 
18 
ETHICS AND REGULATORY APPROVAL ................................................................................ 32 
19 
PUBLICATION POLICY .......................................................................................................... 33 

 
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20 
ATTACHMENTS .................................................................................................................... 33 
20.1 Informed Consent Documents .................................................................................. 33 
20.2 Investigator’s Brochure.............................................................................................. 33 
20.3 Case Report Forms ..................................................................................................... 33 
21 
REFERENCES ........................................................................................................................ 33 
 
1 List of abbreviations  
ACC 
Air-Charged Catheter 
CRF 
Case Report Form 
IRB 
Institutional Review Board 
ERP 
Enterprise Resource Planning 
FDA 
Food and Drug Administration 
LUT 
Lower Urinary Tract 
LUTS 
Lower Urinary Tract Symptoms 
T-DOC® 
Commercial name for the LABORIE air-charged catheters 
T-DOC® NXT 
Next Generation T-DOC® air-charged catheter 
UDS 
Urodynamics 
NGM 
Next Generation Modular 
PIM 
Patient Interface Module  
USA 
United States of America 
WFC 
Water-Filled Catheter 
Pves 
Vesical Pressure (Single sensor bladder catheter) 
Pabd 
Abdominal Pressure (Abdominal catheter) 
Pura 
Urethral Pressure (Dual sensor bladder catheter) 
 
2 INTRODUCTION 
2.1 
Clinical Study Summary 
Number of Sites 
1 
Number of Subjects  
Minimum 20 and Maximum 40 
Objective 
The primary objective of this premarket study is to gather clinical data 
as follows: 
• 
Confirm that the T-DOC® NXT 7Fr vesical and abdominal 
catheters are safe and effective for measuring urodynamic 
pressure measurements in adults. 
The exploratory objective of this study is to gather user and patient 
impressions of device performance as follows: 

 
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• 
Assess subjective patient feedback regarding the discomfort 
and pain levels  
• 
Assess user impressions of device performances by evaluating 
the following subjective measures: ease of use, ease of 
insertion, presence of artefacts, presence of coughs/valsalva 
response, measurements and tracings of urethral pressure 
profiles, stability of the tracing, perceived time savings, ease 
of voiding around catheter, presence of use errors, and 
overall satisfaction 
Inclusion criteria 
- 
Male and Female (Adult age 21+) 
- 
Patients with clinical indication for urodynamics (UDS) testing, for 
any medically necessary reason as per the physician.     
Exclusion criteria 
- 
Patients who suffer from bladder infections (not including 
patients with asymptomatic bacteriuria) 
- 
Patients who are pregnant 
- 
Patients with recent (less than 2 weeks) pelvic floor surgery 
- 
Patients who require the use of a suprapubic catheter 
- 
Patients with significant cognitive deficiency that prevent the 
patient from giving informed consent 
Anticipated Study duration 
The proposed recruitment phase following site initiation is 8 weeks 
(first subject in to last subject out).  
 
Patients will come to the clinic for one visit, the UDS procedure, 
where data pertaining to the safety, efficacy and usability aspects of 
catheter will be collected.   
 
Test duration may be slightly longer than a standard test while 
assessment of the study materials is being made, and so discomfort 
and inconvenience associated with an extended test duration may 
occur. 
Follow-up 
No patient follow-up different than a usual UDS study will be 
required.  There is no required follow-up for the study unless there is 
an adverse event. 
Study end point 
Once the minimum subject recruitment goal is met, the sponsor will 
be informed.  The site will have an option to continue recruitment 
until the maximum is reached, or the 8 week recruitment period 
closes, whichever occurs first.   
There will be a site monitoring visit(s) as per the monitoring plan 
2.2 
Primary Hypothesis 
The primary objective of this premarket study is to gather clinical data as follows: 
• Confirm that the T-DOC® NXT vesical and abdominal catheters are safe and effective for 
measuring urodynamic(UDS) pressure measurements in adults. 

 
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2.2.1 Primary Safety and Effectiveness Endpoints 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint is a binary clinician response after each UDS study using the 
T-DOC® NXT Catheter to determine whether the ability to measure UDS pressure was clinically 
adequate (success) or inadequate (failure). The primary effectiveness hypothesis is a 
comparison of the lower bound for the estimate of the success rate to a minimally acceptable 
target value of 75%: 
H0: Effectiveness Success Rate is ≤ 75%  
versus  
HA: Effectiveness Success Rate is > 75%  
This hypothesis will be evaluated by comparing the lower limit of the 1-sided 95% Clopper-
Pearson confidence interval to 75%. The null hypothesis will be rejected if the lower limit of the 
1-sided 95% Clopper-Pearson confidence interval is > 75%, which indicates that a rate ≤75% 
would be inconsistent with the trial findings. 
Primary Safety Endpoint 
The primary safety endpoint is a binary clinician response after each UDS study using the T-
DOC® NXT Catheter to determine whether the safety of the device was clinically adequate 
(success) or inadequate (failure). The primary safety hypothesis is a comparison of the lower 
bound for the estimate of the success rate to a minimally acceptable target value of 75%: 
H0: Safety Success Rate is ≤ 75%  
versus  
HA: Safety Success Rate is > 75%  
This hypothesis will be evaluated by comparing the lower limit of the 1-sided 95% Clopper-
Pearson confidence interval to 75%. The null hypothesis will be rejected if the lower limit of the 
1-sided 95% Clopper-Pearson confidence interval is > 75%, which indicates that a rate ≤75% 
would be inconsistent with the trial findings.  
 
2.4  Exploratory Analyses 
The following exploratory objectives of this study are to gather data on the following:  
• Assess subjective patient feedback regarding the discomfort and pain levels  
• Assess user impressions of device performances based on their individual experience 
with existing ACC catheters by evaluating the following subjective measures: ease of 
use, ease of insertion, presence of artefacts, presence of coughs/valsalva response, 
measurements and tracings of urethral pressure profiles, stability of the tracing, 

 
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perceived time savings, ease of voiding around catheter, presence of use errors, and 
overall satisfaction  
3 BACKGROUND 
3.1 
Medical Device 
Initially, water-filled catheters (WFC) were the only UDS catheter technology available and only 
intravesical pressure was assessed (Perez & Webster, 1992). However, with the demand for 
different ways to better assess LUT dysfunction, multiple catheters types have been developed.  
Currently, there are four different UDS catheter-based technologies available: WFC, air-charged 
catheters (ACC), microtip catheters, and fiberoptic catheters. It is generally known that minimal 
tracings artefacts and non-physiological changes in pressure are desired for a reliable UDS 
tracing (Couri et al., 2017). It has been noted that ACC are less likely to be influenced by 
movement, thus decreasing the occurrence of artefacts (Cooper et al., 2011, Gammie et al., 
2014). The Sponsor views this as a great advantage in the adult population since movement 
artefact can be a common issue affecting interpretation of the UDS tracing (Cooper et al., 
2011). The study is designed to test a new generation of UDS equipment and ACC catheters. 
The existing T-DOC® 7 French UDS ACC line was first introduced to the market in the early 
2000s. The design comprises a patent-protected catheter balloon charging mechanism 
(US6447462/EP1255485) that facilitates the pressure transfer medium for recording UDS 
pressure and detection of UDS events. The device is provided as a sterile, single-use catheter.  
 
 
 
 
 
 
 
 
 
The catheters under review in this clinical investigation are the next iteration of the T-DOC® G1 
catheters called T-DOC® NXT, and are intended for use on adult populations for measuring UDS 
pressures.    
There are two T-DOC® NXT catheter configurations under assessment. The first will be a 
combination of a single sensor vesical (bladder) catheter, and an abdominal/rectal catheter.  
The second configuration will include a dual sensor bladder (urethral) catheter and an 
abdominal/rectal catheter. T-DOC® NXT catheters have gone through extensive design changes 
to provide improved performance and efficiency to our customers. Furthermore, the design has 
been improved with a new catheter-connector for easier connectivity, a modified balloon, and 
increased catheter length for better performance. Furthermore, the new design offers an easier 

 
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and effective workflow due to our new catheter-connect mechanism, which provides an 
audible and tactile feedback not present in our existing line of T-DOC® G1 catheters 
Table 1.  Dimensional changes and operational data comparison between existing T-DOC® G1 
catheters and T-DOC® NXT.  
 
Existing T-DOC® G1 
Proposed T-DOC® NXT 
 
 
 
 
 
 
 
 
 
 
 
Pves Balloon Sensor Location 
1” from the tip 
1” from the tip 
Pabd Balloon Sensor Location 
1” from the tip 
1” from the tip 
Pura Balloon Sensor Location (If 
Applicable) 
2.36” from Pves 
2.36” from Pves 
 
 
 
 
 
 
 
Catheter Length 
23.5”  
Abdominal: 31.4" 
Single/Dual sensor urethral 
catheter: 37.4" 
 
Flow Rate Specification 
Maximum 70mL/min  
70 mL / min 
Sensor Balloon Measurement 
Error 
Maximum 4.0% of applied 
pressure at 0 – 250 cmH20 
(system level) 
Maximum 4.0% of applied 
pressure at 0 –  250 cmH20 
(system level) *  
Operational Pressure Range 
0 to 250 cmH20 
0 to 250 cmH20 
*Design feasibility test results indicate <3% balloon measurement error 
3.2 
Prior Literature & Studies 
The T-DOC® ACCs have been regarded as simple to use, easy to insert, set-up, and zero to 
atmospheric pressure (Internal Doc #PD-TR-151-01).  This has been supported by clinical 
literature indicating that air-charged catheters are gaining popularity due to their simple 
handling and set-up (Chapple, MacDiarmid & Patel, 2009).  Several studies have been published 
that examine the accuracy and behaviour of ACCs, both in non-clinical (Cooper et al., 2011, 

 
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Couri et al., 2007), and clinical (T. McKinney, 2015, Gammie et al., 2016, Digesu et al., 2014) 
settings.  Since this is a new investigational device, there is no prior literature examining the 
safety and effectiveness of the T-DOC® NXT catheter in patients.   
 
Please refer to Section 5 of the Investigator Brochure (TDOC-NXT-01-IB) for a more detailed 
review of the available published literature. 
3.3 
Rationale 
The next generation T-DOC® catheter (T-DOC® NXT) is based on our previous Air-Charged 
Catheter (ACC) technology, that has undergone design changes to provide improved 
performance and efficiency to our customers. The design has been improved with a new 
catheter-connector for easier connectivity, a modified balloon and increased catheter length 
for better performance. Since T-DOC® NXT is based on an existing design, there is published 
data supporting the safety, performance and usability of the principle aspects of the design. T-
DOC® ACCs have been on the market over 10 years (>6MM sold catheters) and have collected 
significant amount of data in adults. However, due to the design changes, further evidence is 
required to confirm the safety and effectiveness of the next generation catheter prior to market 
release. The aim of this pre-market study is to collect data of the catheters’ performance and 
confirm they are safe and effective for UDS. Furthermore, the new design offers an easy and 
effective workflow due to the new catheter-connect mechanism, which provides an audible and 
tactile feedback not present in the existing line of T-DOC® catheters.  Summative usability 
testing will be conducted in a simulated environment, and will be confirmed in this pre-market 
study. A limitation to this study is that it will be conducted with the Aquarius NGM unit with a 
modified cable to allow the catheters to connect with the new catheter-connect system. This 
modification is necessary because the NXT UDS machine with new T-DOC® NXT Patient 
Interface Module (PIM) will not be available. This study will gather data to support concurrent 
design validation activities while establishing clinical safety and effectiveness of the device in 
the adult population.   
Finally, there will be no control arm, blinding, or treatment/intervention component to this 
study.  This is based on the trial design and the fact that this is a non-comparative study; 
inclusion of a sham or placebo is not feasible nor necessary, and the device under evaluation is 
not a treatment or intervention.   
For the purposes of this study, decisions regarding timing for prescribing UDS testing will be at 
the discretion of the Investigators. 
4 STUDY OBJECTIVES 
4.1 
Primary Objectives 
The primary objective of this premarket study is to gather clinical data as follows: 
• Confirm that the T-DOC® NXT 7Fr vesical and abdominal catheters are safe and effective 
for measuring UDS pressure measurements in adults. 

 
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4.2 
Exploratory Objectives 
The exploratory objective of this study is to gather user impressions of device performance as 
follows: 
• Assess subjective patient feedback regarding the discomfort and pain levels  
• Assess user impressions of device performances based on their individual experience 
with existing ACC catheters evaluating the following subjective measures: ease of use, 
ease of insertion, presence of artefacts, presence of coughs/Valsalva response, 
measurements and tracings of urethral pressure profiles, stability of the tracing, 
perceived time savings, ease of voiding around catheter, presence of use errors and 
overall satisfaction 
4.3 
Claims and Intended Performance  
• The T-DOC® NXT catheter causes minimal discomfort during insertion, during the test, 
and removal 
• Adverse Event Claims as per results 
• Subjective claims: 
o The T-DOC® NXT catheters are safe and effective for use on adult patients 
o The T-DOC® NXT catheters are easy to use 
o The T-DOC® NXT catheters are easy to set-up / zero 
o The T-DOC® NXT catheters are easy to insert 
o The T-DOC® NXT catheters have consistent/stable tracings  
o The T-DOC® NXT catheter has adequate subtracted pressures 
 
4.4 
Assessment of Risks and Adverse Device Effects 
Risks to the subject will be no greater than those of a standard UDS test.  Subjects may 
experience temporary discomfort upon insertion of the catheters.  Test duration may be slightly 
longer than a standard test while assessment of the study materials is being made, and so 
discomfort and inconvenience associated with an extended test duration may occur.    
UDS testing exposes subjects to risks of urethral instrumentation which can result in infection, 
urethral trauma and pain (Winters et al. 2012).  Other risks can include transient discomfort 
during or following the procedure, transient dysuria or bleeding (hematuria) following the 
procedure, or urinary tract infection, which occurs in 2-4% of subjects (Chapple, MacDiarmid & 
Patel, 2009).   
In conclusion, the overall residual risks associated with the use of T-DOC® NXT catheters within 
this study set-up, are acceptable when weighed against the benefits, and are no different than 
the risks when using other UDS catheter technologies.  The sponsor team has also established 
that patients are subjected to no more than minimal risk since an IDE is not required for this 
study (Ref: TDOC-NXT-01 - Risk Determination).  Lastly, UDS is a widely-performed procedure 
on subjects requiring specialized management for urinary incontinence/retention problems, as 

 
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recommended by the ICS (Abrams et al., 2013), and is useful in characterizing LUT function, 
identifying causes of symptoms and quantifying related pathophysiological processes (Rosier 
PF., 2013). Thus, the clinician must weigh the risks and benefits as to whether the UDS test 
offers additional diagnostic value beyond symptom assessment, physical examination and other 
diagnostic testing (Winters et al., 2012).    
5 MEDICAL DEVICE 
5.1 
Description 
The catheters used in this study will be design verified, sterilized and appropriately labelled 
before the clinical investigation can begin.    
The catheter device models to be evaluated as part of this study include:  
1. T-DOC® NXT vesical single sensor catheter (blue) 
2. T-DOC® NXT abdominal single sensor catheters (red) 
3. T-DOC® NXT Vesicle, dual sensor catheter available for optional urethral 
measurement studies (blue and yellow) 
  
Traceability of investigational study materials will be maintained via the Inventory Control Log 
(Q905-FRM-17). Any remaining investigational material stock after study close-out will be 
returned to the study sponsor at the sponsors’ expense.    
The T-DOC® NXT catheters are manufactured using equivalent materials to the existing T-DOC® 
G1 catheters 
, and are verified biocompatible in 
accordance with the standards EN ISO 10993-5 and -10 and -18 – Biological evaluation of 
medical devices.   
None of the materials being used in this study contain biologically active substances or 
pharmacological agents.  
From a Regulatory standpoint, the following medical device classification rules apply in Europe, 
the United States and Canada, respectively:  
 
For the European Union, Class IIa 
For the United States, Class II as per FDA 
For Canada, Class II as per Health Canada Medical Device Regulations 
 

 
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5.2 
Purpose & Use 
Intended Use: The Air-charged Urodynamic Catheters are intended for measuring Urodynamic 
pressures. The Air-charged Urodynamic Catheters are intended to be connected to 
Urodynamics Analyzer systems using a reusable electronic component. 
Indications for Use: The UDS Catheters are sterile and intended for single use on adult patient 
population requiring UDS pressure monitoring through the measurement of bladder, urethral, 
and rectal (or vaginal) pressures.   
5.3 
Summary of Non-Clinical Safety & Performance Data 
The T-DOC® NXT family of UDS catheters has been tested per ISO 10993 and must meet all 
biocompatibility requirements for acute tissue contacting devices which includes Cytotoxicity, 
Sensitization, and Irritation.  Furthermore, design verification studies will be undertaken to 
verify that Level 2 design requirements are met.  Please refer to the Investigator Brochure for 
further details.  
5.4 
Summary of Clinical Safety & Performance Data 
Please refer to Section 5 of the Investigator Brochure (TDOC-NXT-01-IB) for detailed review of 
relevant previous clinical safety and performance data.  In all literature presented, the T-DOC® 
air-charged catheters are safe and effective for measuring UDS pressures further justifying the 
study rationale.   
 
5.5 
Risks and Benefits 
Risks to the subject will be no greater than those of a standard UDS test.  Physicians are 
responsible for determining whether subjects are normally indicated, and who would benefit 
from UDS testing. Subjects must meet all inclusion criteria to be eligible for recruitment into 
this study.  There is no direct subject benefit for participating other than to gather objective 
evidence of T-DOC® NXT 7 Fr ACC clinical use.  Please refer also to Section 4.5 above 
(Assessment of Risks and Adverse Device Effects), and Section 6 of the Investigator Brochure 
(TDOC-NXT-01-IB). 
 
The sponsor has also established that patients are subjected to no more than minimal risk since 
an IDE is not required for this study (Ref: TDOC-NXT-01 - Risk Determination).  Lastly, UDS is 
already a widely performed procedure on subjects requiring specialized management for 
urinary incontinence issues, as recommended by the ICS (Abrams et al., 2013), and is useful in 
characterizing LUT function, identifying causes of symptoms and quantifying related 
pathophysiological processes (Rosier P.F., 2013).  In conclusion, the overall residual risks 
associated with the use of T-DOC® NXT catheters within this study set-up, are acceptable when 
weighed against the benefits.   

 
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6 STUDY DESIGN 
6.1 
Description 
This premarket study will be conducted where a minimum number of subjects will undergo a 
conventional UDS study that will be conducted according to Good UDS Practices (Rosier et al., 
2016).  Subject data including age, medical history, height, weight, adverse events during or 
immediately following the test, catheter insertion depth etc., will be collected on each patient’s 
CRF.  There will be no control arm, blinding, or treatment/intervention component to this 
study.   
 
The following steps gives a high-level overview of the study design and subject flow-through 
based on number of patients enrolled: 
• Adult patients are referred for UDS testing 
• Patient are approached to enrol in the study during their UDS visit and give informed 
consent  
• Urodynamic testing is conducted, and case report forms are completed 
• Adverse events are followed for closure 
6.2 
Duration 
The expected duration of each subject’s participation is one clinic visit to receive their already 
prescribed UDS test.   Once ethics board approval is received, site training and initiation is 
expected to take 1-2 weeks, whereas the estimated duration of active recruitment for this 
study is estimated at 2 months.  Database lockout and study report completion is estimated at 
less than 1 month after the last subject is recruited.  
7 PATIENT SELECTION 
7.1 
Inclusion Criteria 
• Male and Female (Adult age 21+) 
• Patients who are scheduled and indicated for UDS testing, for any medically necessary 
reason as per the physician.     
7.2 
Exclusion Criteria 
• Patients who suffer from bladder infections (not including patients with asymptomatic 
bacteriuria) 
• Patients who are pregnant 
• Patients with recent (less than 2 weeks) pelvic floor surgery  
• Patients who require the use of a suprapubic catheter 
• Patients with significant cognitive deficiency that prevent the patient from giving informed 
consent 

 
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7.3 
Vulnerable Populations 
The targeted subject group is not a vulnerable population 
7.4 
Recruitment Plans 
The target enrolment is a minimum of 20 patients (maximum 40). 
Subjects who are visiting the UDS clinic for their medically-indicated UDS test will be 
approached regarding participation in this study.   It is estimated that recruitment should take 
approximately 2 months.  Recruitment will be monitored through scheduled meetings with the 
site co-ordinator.  If the subject signs the informed consent, this will be treated as the point of 
enrolment.   
7.5 
Informed Consent  
The Investigator (according to applicable regulatory requirements), or a person designated by 
the Investigator, and under the Investigator's responsibility, should fully inform the subject of 
all pertinent aspects of this clinical trial, including the written information giving a favourable 
opinion by the IRB.  New information regarding the study will be provided to the subject by the 
Site. 
Prior to a subject’s participation in the clinical trial, the written Informed Consent Form should 
be signed, name filled in and personally dated by the subject and by the person who conducted 
the informed consent discussion.  A copy of the signed and dated written Informed Consent will 
be provided to the subject.  The date of the informed consent should be recorded on the 
subject’s CRF.   
The Informed Consent Form used by the Investigator for obtaining the subject's informed 
consent must be reviewed and approved by the Sponsor prior to submission to the appropriate 
IRB for approval/favourable opinion. 
The study sponsor does not foresee any circumstances where emergency enrolment would 
occur due to the device indication (it is not used in emergency situations), and the fact that 
patients being recruited are attending their UDS appointment as a pre-scheduled visit.  
7.6 
Subject Withdrawal 
Subjects may withdraw voluntarily from the study or the investigator may terminate a subject’s 
participation (see below). The Investigator will notify the sponsor when a subject is withdrawn 
from the study (and if possible why), and this will be recorded on the subject’s CRF and 
withdrawal form.  Subjects who withdraw from the trial will be allowed to be replaced by 
another subject.  
7.7 
Suspension or Premature Termination 
The study may be terminated prematurely if the Sponsor or the Investigator feel that the 
equipment is not producing results as expected which could be due to inappropriate operator 
handling or faulty equipment.  The Investigator and/or sponsor would determine termination 
by observing unanticipated problems, design defects, evidence of noncompliance, or serious 

 
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and/or continuing noncompliance which could affect any of subject safety, device performance 
or integrity of study data.  
8 MANAGEMENT OF MEDICAL DEVICE 
8.1 
Description 
The following devices and equipment will be required for each patient.  Those indicated by 
asterisk (*) are to be sourced and provided by the site:  
• Laborie UDS equipment already in use  
• Computer/laptop with Laborie UDS-120 UDS software already loaded and in use by each 
site 
• Infusion transducer (optional) 
• Uroflowmetry/Urocap device configured with the UDS equipment and computer for 
pressure-flow studies, already in use by each site (optional) 
• T-DOC® transducer backwards compatibility cables: 
o Pabd (red) – Abdominal channel reusable cable  
o Pves (blue) – Bladder channel reusable cable   
o Pura (yellow)- Urethral channel reusable cable (optional) 
• One (1) air-charged T-DOC® NXT abdominal single sensor catheter per subject  
• One (1) air-charged T-DOC® NXT single sensor catheter or one (1) air-charged T-DOC® 
NXT dual sensor catheter per subject 
• EMG cable (optional component at the discretion of the site)  
• EMG patches (optional component at the discretion of the site) 
• Laborie UDS pump tubing infusion line per subject (must be Laborie part number: 
TUB500) 
• 1000 mL beaker* (whatever is currently in use at the site) (optional) 
• Weight of 500g provided by Laborie (optional?) 
• One (1) sterile saline bag per subject* 
• Tape*  
• Lubricant* 
• Gloves* 
• Any other supplies deemed necessary for conducting a UDS study* 
 

 
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The study agreement will further specify the equipment and disposables that will be required 
and provided by Laborie. 
8.2 
Regimen 
N/A – there is no treatment regimen required as part of this study. 
8.3 
Assignment to Groups 
No stratification of subjects will be utilized based on study design. 
8.4 
Preparation and Handling 
The Urodynamic system and air-charged catheters will be prepared, and maintained by the 
physician.   
8.5 
Packaging and Labelling 
Investigational device labelling will appear on all investigational materials under FDA 21 CRF 
Subpart 812.5.  A copy of the investigational label is shown the Investigator’s Brochure.  
8.6 
Device Accountability 
All devices used directly for testing subjects must be recorded using the device LOT number on 
the subjects CRF form.   
8.6.1 Laborie to Study Site: 
All investigational devices or equipment transferred between Laborie and the study site must 
be recorded through the Inventory Control Log.  This includes postal deliveries and any 
deliveries made in person by Laborie.  Any equipment or devices that are not used and are 
returned to Laborie must be recorded on the Inventory Control Log as well.  It is Laborie’s 
responsibility to ensure that all inventory both at Laborie and the study site correlate.  All 
investigational device accountability will be recorded through the Inventory Control Form.  
8.6.2 Study Site Usage: 
All devices used directly for testing subject samples must be recorded on the Inventory Control 
Form.  All devices used by the study site that are not directly used for the testing of subject 
samples must be recorded on the Inventory Control Form.  This includes any devices used for 
training or demonstration or any devices which are noted to be defective when opened. 
8.6.3 Study Site to Laborie: 
Any equipment or devices that are not used and are returned to Laborie must be recorded on 
the Inventory Control Form.  
When the devices have been received by Laborie, it is Laborie’s responsibility to ensure that all 
inventory control forms both at Laborie and the study site correlate. 
8.7 
Concomitant Treatment 
Not applicable in this study  

 
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8.8 
Subject Compliance Monitoring 
Not applicable in this study. 
9 ASSESSMENT OF INVESTIGATIONAL DEVICE 
9.1 
Endpoints 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
To confirm the T-DOC® NXT vesical 
and abdominal catheters are a safe 
and effective means of measuring 
UDS pressure in adults. 
The primary endpoint will be 
measured by recording the clinician 
safety and effectiveness rating for 
each patient on their CRF.  The 
clinician will indicate whether the T-
DOC® NXT vesical and abdominal 
catheters are safe and effective for 
measuring UDS pressure in at least 20 
of patients enrolled.    
Given the intended use 
of the device, and the 
fact that there is no 
single or combination 
of objective measures 
generated from the 
UDS test that can 
establish the safety and 
effectiveness, it is 
justified to obtain 
clinician feedback via a 
binary response 
whether the device 
was safe and/or 
effective for measuring 
UDS pressure.   
 
9.2 
Methods of Assessment 
A T-DOC® NXT air-charged catheter will be used to assess and record bladder and abdominal 
pressures which are in turn used by the clinician to identify UDS events.   These measurements 
will be recorded using a LABORIE UDS system.   The resulting interpretations regarding safety, 
effectiveness, and usability will be made by the physician overseeing the subject’s case.   
All study outcome data captured will be compiled and analysed by the LABORIE study team to 
determine if the endpoints were successfully achieved based on whether the null hypotheses 
were accepted or rejected.   
10 PATIENT SAFETY 
10.1 Definitions 
 

 
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10.1.1 Adverse Events:  
Any untoward medical occurrence in a subject, whether or not related to the investigational 
medical device. 
10.1.2 Adverse Device Effect:  
Any adverse event related to the use of an investigation medical device. 
10.1.3 Device Deficiency:  
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety 
or performance 
10.1.4 Serious Adverse Event:  
An adverse event that: 
1. Led to a death; 
2. Led to a serious deterioration in health of a patient, user, or others that: 
a. Results in a life-threatening illness or injury; 
b. Results in a permanent impairment of a body structure or body function; 
c. Requires in patient hospitalization or prolongation of existing hospitalization; 
d. Results in medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to body structure or a body function; 
3. Led to foetal distress, foetal death or a congenital abnormality/birth defect.  
10.1.5 Unanticipated Adverse Device Effect: 
Any serious adverse effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigation protocol or application, or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects. 
10.1.6 Unanticipated Serious Adverse Device Effect (USADE): 
Serious adverse device effect which by nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report. 
10.2 Data Collection 
Adverse events, device deficiencies, serious adverse events, and unanticipated adverse device 
effect shall be recorded on the CRF. 
10.3 Reporting 
All serious adverse events and unanticipated adverse device effects occurring during the 
investigation will be reported as soon as possible, but no later than 10 working days after the 

 
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Investigator/Laborie first learns of the effect. This information will be submitted to 
Laborie/investigator and the IRB.  
10.4 Foreseeable Events 
For a complete Risk Management Report please refer to the Risk Management File.  The 
residual risks have been deemed acceptable and the benefits overweighs the risks.  Please also 
refer to Section 4.5 above Assessment of Risks and Adverse Device Effects 
10.5 Contact Information 
In the event of a serious adverse event and serious adverse device event please contact: 
 
 
 
 
10.6 Follow-Up 
If an adverse event occurs, any follow-up intervention prescribed is at the discretion of the 
Investigator,  and the site must notify Laborie of the outcome of the follow-up.  The study 
safety endpoint will be measured by capturing adverse event data both during the study visit.   
11 STUDY PROCEDURE 
11.1 Visit Schedule 
 
Evaluation 
Screening & Clinic Visit 
Part 1* 
Part 2 
Informed Consent  
X 
 
Inclusion Criteria 
X 
Exclusion Criteria 
X 
UDS Study 
 
X 
Record any Adverse Events 
X 
Complete CRF 
 
X 
*Part 1 and Part 2 may be combined into 1 visit 
11.2 Screening for Eligibility 
Subjects may be screened for eligibility for this study by referencing the inclusion criteria.  No 
special testing is required in order to determine eligibility.   

 
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11.3 Part 1 (Informed Consent)  
1. 
Conduct Informed Consent discussion with the subject and sign 
 
11.4 Part 2 (Urodynamic Clinic Visit) 
1. 
Determine if the subject is eligible for this study. 
2. 
Conduct Informed Consent discussion with the subject and sign. 
3. 
Collect medical history and record in case report form (TDOC-NXT-01- CRF2). 
4. 
Collect and record other patient details as required on TDOC-NXT-01- CRF1 
[weight (lbs), height (‘,”), date of birth, sex, etc]. 
5. 
Site personnel will explain what will happen during the UDS test to the 
subject/parent or caregiver.   
6. 
Site personnel will prepare UDS equipment, study materials, other sterile 
disposables and supplies as required for the UDS study and record catheter lot 
number information on TDOC-NXT-01- CRF1. 
7. 
Follow the investigational device instructions for use for placing the catheters.    
Record all the necessary data on TDOC-NXT-01- CRF1.   
8. 
Conduct UDS study according to ICS Good UDS Practice recommendations, 
including regular cough checking to ensure good pressure transmission and 
catheter positioning wherever possible (Rosier et al., 2016). Record all the 
necessary data on TDOC-NXT-01- CRF1. 
9. 
Site personnel to ask patients to answer questions on urodynamic experience 
and record all data on TDOC-NXT-01- CRF4. 
10. 
After completing a day of urodynamics, the user is to fill out a questionnaire and 
record all necessary data on TDOC-NXT-01- CRF3. 
 
 
NOTE: If an adverse event occurs during this study, any follow-up intervention prescribed is at 
the discretion of the Investigator.  This information should also be recorded on the subject’s 
CRF (TDOC-NXT-01- CRF1-) and the AE form (TDOC-NXT-01- CRF5).  
11.5 End of Study (EOS) 
At the conclusion of the UDS test, the subject is no longer required to undergo any further 
study-related procedures. 
Once a site has completed its target recruitment, the sponsor (Laborie) will schedule a time to 
close-out the site, either in person or by telephone as per the monitoring plan.  All study related 
files will be collected and reviewed for completeness.  The EOS is considered the point when all 
subjects have been followed-up and data collection completed.   

 
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12 STATISTICAL CONSIDERATIONS 
12.1 Primary Safety and effectiveness Endpoints 
12.1.1 Primary Effectiveness Endpoint 
The primary effectiveness endpoint is a binary clinician response after each UDS study using the 
T-DOC® NXT Catheter to determine whether the ability to measure UDS pressure was clinically 
adequate (success) or inadequate (failure). The primary effectiveness hypothesis is a 
comparison of the lower bound for the estimate of the success rate to a minimally acceptable 
target value of 75%: 
H0: Effectiveness Success Rate is ≤ 75%  
versus  
HA: Effectiveness Success Rate is > 75%  
This hypothesis will be evaluated by comparing the lower limit of the 1-sided 95% Clopper-
Pearson confidence interval to 75%. The null hypothesis will be rejected if the lower limit of the 
1-sided 95% Clopper-Pearson confidence interval is > 75%, which indicates that a rate ≤75% 
would be inconsistent with the trial findings. 
12.1.2  Primary Safety Endpoint 
The primary safety endpoint is a binary clinician response after each UDS study using the T-
DOC® NXT Catheter to determine whether the safety of the device was clinically adequate 
(success) or inadequate (failure). The primary safety hypothesis is a comparison of the lower 
bound for the estimate of the success rate to a minimally acceptable target value of 75%: 
H0: Safety Success Rate is ≤ 75%  
versus  
HA: Safety Success Rate is > 75%  
This hypothesis will be evaluated by comparing the lower limit of the 1-sided 97.5% Clopper-
Pearson confidence interval to 75%. The null hypothesis will be rejected if the lower limit of the 
1-sided 97.5% Clopper-Pearson confidence interval is > 75%, which indicates that a rate ≤75% 
would be inconsistent with the trial findings. 
12.2 Exploratory Analyses 
• Assess subjective patient feedback regarding the discomfort and pain levels  
• Assess user impressions of device performances based on their individual experience 
with existing ACC catheters by evaluating the following subjective measures: ease of 
use, ease of insertion, presence of artefacts, presence of cough/valsalva response, 
measurements and tracings of urethral pressure profiles, stability of the tracing, 
perceived time savings, ease of voiding around catheter, presence of use errors and 
overall satisfaction 

 
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12.3 Sample Size Determination & Power 
The null hypotheses for the primary safety and the primary effectiveness endpoints are 
designed to rule out success rates ≤ 75%. There will be no type I error adjustment for 
simultaneous testing of these endpoints within the same trial. Based on clinical judgement and 
previous testing, the true success rate for both safety and efficacy is assumed to exceed 95%. 
Thus, the power calculation is identical for the safety and effectiveness endpoints, and a true 
success rate of 96% is assumed for each endpoint. 
Analysis of 20 subjects would provide 81% power to rule out a success rate ≤ 75% when the 
true success rate is assumed to be 96%, based on a 1-sided test with type I error rate of 5%.  
This study requires a minimum of 20 subjects to ensure adequate power, but the final sample 
size will be based on site enrolment capabilities. If 30 subjects or 40 subjects are enrolled, the 
power to rule out a success rate ≤ 75% will be 96% and 99%, respectively (Fleiss, J.L. et al., 
2003). 
12.4 Randomization / Blinding 
Randomization and/or blinding is not utilized in this study based on study design. 
12.5 Analysis Plan 
A Statistical Analysis Plan containing the details of the analyses and hypothesis testing will be 
finalized prior to database lock. All subjects who complete the UDS study will be considered in 
the final analysis.  Data will be analysed as discussed in Section 12.1 above.   
If any CRFs are found to be incomplete, the study monitor will follow-up as to the reasoning.  If 
for some reason a clinical user is unable to complete their questionnaire, the questions they 
have completed will be included in the analysis.  Data will be monitored as the study 
progresses, please refer to Section 7.7 for details about suspension or premature termination. 
12.6 Deviations 
In any event there are deviations from the original statistical plan, they will be described and 
justified in the final report. 
12.7 Early Stopping 
An informal interim data analysis will be conducted once 20 subjects have been recruited in 
order validate the product design meets the user requirements.   
There are currently no criteria for stopping the study early on statistical grounds, however 
please refer to Section 7.7 for details about suspension or premature termination.   
13 DATA HANDLING & RECORD KEEPING 
13.1 Direct Access 
The Investigator/Institution will permit trial-related monitoring, audits, IRB review, and 
regulatory inspections by providing direct access to the source data/documents as needed. 

 
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13.2 Confidentiality & Security  
All information disclosed or provided by the Sponsor (or any company/institution acting on 
their behalf), or produced during the study, including, but not limited to, the Study Protocol, 
the CRFs, the Instructions for Use and the results obtained during the course of the study, is 
confidential.  The Investigator or any person under his/her authority agrees to undertake to 
keep confidential and not to disclose the information to any third party without the prior 
written approval of the Sponsor. 
However, the submission of this Study Protocol and other necessary documentation to the 
Ethics Committee (IRB) is expressly permitted, the IRB members having the same obligation of 
confidentiality. 
The Sub-Investigators, if employed, shall be bound by the same obligation as the Investigator. 
The Investigator shall inform the Sub-Investigators of the confidential nature of the Usability 
Study. 
The Investigator and the Sub-Investigators shall use the information solely for the purposes of 
the Study, to the exclusion of any use for their own or for a third party's account. 
All data to Laborie will be confidential and all subject identifiers will be blacked out before 
being sent to Laborie. Documents will be kept in a secure location and all digital information 
will be kept following HIPAA and local government regulations. 
13.3 Data Handling 
A list of individuals will be maintained who are authorized to make any changes to the data. 
Data will be reviewed by the Sponsor (outside of monitoring personnel), and requests for 
clarification and/or corrections will be made through the monitor. Once the review is 
conducted, the database will be considered clean and ready for analysis. Missing values will 
remain missing, i.e. no attempt will be made to input missing values and only observed values 
will be used in data analyses and presentations. 
13.4 Case Report Form (CRF) & Source Documents 
All study staff will be trained on the protocol requirements and questionnaire completion. It is 
the responsibility of the Investigator to maintain adequate and accurate questionnaires and 
CRFs designed by Laborie to record all observations and other data pertinent to the clinical 
investigation.  All questionnaires and CRFs should be completed in their entirety in a neat, 
legible manner to ensure accurate integration of data. Should a correction be made, the 
information to be modified must not be overwritten.  The corrected information will be 
transcribed by the authorized person on the questionnaire.  Source document worksheets for 
recording data will be created as agreed upon by the sponsor or the site as required.  Data from 
the source documents should be entered into the CRF after each subject’s visit.  The 
anonymized UDS data files (DTA files) requested by the sponsor for each patient, to confirm the 
quality of the study.  A unique subject code will be assigned to each subject based on the site 
number (100) and sequential subject number (i.e. 100-001). The investigator is responsible for 
maintaining subject identifying information.  CRF’s will be treated as source data in the event 

 
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that the original information is entered in the CRF first (and no source document worksheet is 
utilized for that data point).   
13.5 Record Retention 
An investigator or sponsor shall maintain the records required by 21 CFR Part 812.140 during 
the investigation and for a period of 2 years after the latter of the following two dates: The date 
on which the investigation is terminated or completed, or the date that the records are no 
longer required for purposes of supporting a premarket approval application or a notice of 
completion of a product development protocol. The Investigator must maintain confidential all 
study documentation, and take measures to prevent accidental or premature destruction of 
these documents. All essential documents from the Investigator will be kept in the Investigator 
binder.  All sponsor essential documents will be kept in the study master file. The investigator 
and sponsor shall also maintain a record of their location of the respective essential documents. 
If the Investigator's personal situation is such that archiving can no longer be ensured by 
him/her, the Investigator shall inform the Sponsor and the relevant records shall be transferred 
to a mutually agreed upon designee. 
13.6 Performance Monitoring 
Monitors will periodically check questionnaire data to ensure all fields are entered as far as 
possible and inquire as to whether any usability issues are being encountered as the study 
progresses.  
14 MONITORING, AUDITING, AND INSPECTING 
14.1 Study Monitoring Plan 
The Investigator agrees to provide reliable and accurate data, and all information requested by 
the study protocol (with the help of any questionnaire, other appropriate instruments) in an 
attributable, legible, contemptuous, original, accurate, and complete form according to the 
instructions provided and to ensure direct access to source documents to Sponsor 
representatives. Any changes to the soured data shall be traceable and not obscure the original 
entry. 
The Sponsor of this Study is responsible to Health Authorities for taking all reasonable steps to 
ensure the proper conduct of this study protocol with regards to ethics, protocol compliance, 
integrity and validity of the data recorded on the CRF and questionnaires. Thus, the main duty 
of the Monitoring Team is to help the Investigator and the Sponsor maintain a high level of 
ethical, scientific, technical and regulatory quality in all aspects of the study.  
At regular intervals during the study, the site will be contacted, through monitoring visits, 
letters or telephone calls, by a representative of the Monitoring Team to review study progress, 
Investigator and subject compliance with study protocol requirements, and any emergent 
problems. The monitoring plan will describe the frequency, extent, and nature of monitoring. 
 

 
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14.2 Auditing and Inspecting 
For the purpose of ensuring compliance with the study protocol, Good Clinical Practice and 
regulatory requirements, the Investigator should permit inspection by applicable regulatory 
body authorities. This investigation will not include audits conducted by the Sponsor. 
 
The Investigator agrees to allow the inspectors to have direct access to his/her study records 
for review, being understood that these personnel are bound by professional secrecy, and as 
such will not disclose any personal identity or personal medical information. 
 
The Investigator will make every effort to help with the performance of the inspections, giving 
access to all necessary facilities, data, and documents.  
 
As soon as the Investigator is notified of a future inspection by the authorities, he will inform 
the Sponsor and authorize the Sponsor to participate in this inspection. 
 
The confidentiality of the data verified and the protection of the subjects should be respected 
during these inspections.  
  
Any result and information arising from the inspections by the regulatory authorities will be 
immediately communicated by the Investigator to the Sponsor. The Investigator shall take 
appropriate measures required by the Sponsor to take corrective actions for all problems found 
during the inspections. 
15 DEVIATIONS 
All departures from the approved protocol shall be documented by the Investigator. All 
deviations will be recorded on the subject CRF, and a deviation report will be sent to Laborie 
and the ethics board, as required.  Timelines for notification will be subject to ethics board 
standard operating procedures.  Deviations will be reviewed and signed off by the sponsor. If 
deviations are observed/reported that significantly affect or have the potential to significantly 
affect human subject protection or reliability of the trial results, then LABORIE will conduct a 
root cause analysis and implement appropriate corrective and preventative actions. 
16 AMENDMENTS 
If there are any changes to the protocol during the application of the study or during the length 
of the clinical study in progress, the IRB will be notified for review.  During an ongoing study if 
an amendment is made to the protocol the amended protocol will be sent to the applicable 
institution within the timelines required.  The Investigator should not implement any deviation 
from, or changes to the clinical protocol without agreement by the sponsor and prior review 
and documented approval/favourable opinion from the IRB of an amendment, except when 
necessary to eliminate an immediate hazard(s) to a clinical study subject. In some instances, an 
amendment may require a change to the Informed Consent Form. The investigator must 

 
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receive an IRB approval/favourable opinion concerning the revised Informed Consent Form 
prior to implementation of the change. 
17 STUDY ADMINSTRATION 
17.1 Funding Source and Conflicts of Interest 
Laborie will be the sponsor and the financial details are covered in the Investigator Agreement. 
17.2 Subject Stipends or Payments 
Subjects will be offered a $40 USD stipend for their participation in the study to offset the cost 
of parking and/or meals required during their clinic visit.   
The Sponsor has covered this study by means of an insurance covering bodily injury or property 
damage arising out of the clinical trial. The certificate of insurance evidencing the coverage, 
insurance company, policy number and the sum insured are provided in the Study’s File. 
17.3 Committees 
A Data Monitor Committee will not be utilized in this study based on the evaluation of the level 
of potential risks. 
17.4 Study Timetable 
PROPOSED STUDY TIMELINE 
TOTAL DURATION (WEEKS) 
ACTUAL DATES 
PROPOSED SITE TRAINING & INITIATION 
PHASE 
1  
July 2018 
PROPOSED RECRUITMENT (1st subject in 
to last subject out) 
8 
July- September 2018 
PROPOSED DATABASE LOCKOUT 
1 
October 2018 
PROPOSED STUDY REPORT 
COMPLETION 
3 
October 2018 
TOTAL (WEEKS / MONTHS) 
- 
 
ESTIMATED COMPLETION (QUARTER) 
Start Q4 FY2018 
End of October 2018 
18 ETHICS AND REGULATORY APPROVAL 
This study will not begin until the appropriate approvals from the IRB have been obtained.  Any 
additional requirements imposed by the IRB will be followed.  This study will be conducted in 
compliance with all international laws and regulations, and national laws and regulations of the 
countries in which the usability study is performed, as well as any applicable guidelines.   

 
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19 PUBLICATION POLICY 
The results of the study may be submitted for publication, whether peer-reviewed or marketing 
materials. Publication rights and details are covered in the Investigator Agreement, there may 
be other authors involved in the creation of the publication. 
20 ATTACHMENTS 
20.1 Informed Consent Documents 
- 
TDOC-NXT-01-ICF - Informed Consent Form 
 
20.2 Investigator’s Brochure 
- 
TDOC-NXT-01-IB T-DOC NXT Investigator’s Brochure 
 
20.3 Case Report Forms 
- 
TDOC-NXT-01- CRF1Case Report Form 1 
- 
TDOC-NXT-01- CRF2Case Report Form 2 
- 
TDOC-NXT-01- CRF3Case Report Form 3 
- 
TDOC-NXT-01- CRF4Case Report Form 4 
- 
TDOC-NXT-01- CRF5Case Report Form 5 
21 REFERENCES 
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Moore K.N., Newman D., Nijman R., Rosier P., Staskin D., Thuroff J., Tubaro A., Vodusek D., 
Wein A. (2013) Recommendations of the International Scientific Committee: Evaluation 
and treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence 
Abrams P., Cardozo L., Khoury S., Wein A. (Eds.) Incontinence: 5th International 
Consultation on Incontinence, Paris, February 2012. (pp. 1904-1907). ICUD-EAU. 
Chapple, C. R., MacDiarmid, S. A., & Patel, A. (2009). Urodynamics Made Easy. Elsevier Health 
Sciences. 
Cooper, M. A., Fletter, P. C., Zaszczurynski, P. J., & Damaser, M. S. (2011). Comparison of air-
charged and water-filled urodynamic pressure measurement catheters. Neurourology and 
Urodynamics, 30(3), 329–334. https://doi.org/10.1002/nau.20991 
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analysis of the T-DOC® air-charged catheters: An alternate technology for urodynamics. 
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measurements of water-filled and air-charged catheters the same in urodynamics? 

 
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Drzewiecki B.A., Bauer S.B. (2015) Urodynamics in the pediatric patient in I. Franco, P. Austin, 
S.B. Bauer (Eds.) Pediatric Incontinence: Evaluation and Clinical Management (pp 91-98). 
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Fleiss, J.L., Levin, B., & Cho Paik, M. (2003). Statistical Methods for Rates and Proportions (3rd 
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International Continence Society Urodynamic Equipment Working Group). (2014). 
International continence society guidelines on urodynamic equipment performance. 
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Gammie, A., Abrams, P., Bevan, W., Ellis-Jones, J., Gray, J., Hassine, A., … Hashim, H. (2016). 
Simultaneous in vivo comparison of water-filled and air-filled pressure measurement 
catheters: Implications for good urodynamic practice. Neurourology and Urodynamics, 
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McKinney, T. B., Babin, E. A., Ciolfi, V., McKinney, C. R., & Shah, N. (2018). Comparison of water   
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Perez, L. M., & Webster, G. D. (1992). The history of urodynamics. Neurourology and  
        Urodynamics, 11(1), 1–21. https://doi.org/10.1002/nau.1930110102 
Rosier P.F.W.M., Schaefer W., Lose G., Goldman H.B., Guralnick M., Eustice S., et al. 
International Continence Society Good Urodynamic Practices and Terms 2016: 
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2016 Dec 1;n/a-n/a. 
Rosier P.F. The evidence for urodynamic investigation of patients with symptoms of urinary  
incontinence. F1000prime Rep. 2013;5:8. https://doi.org/10.12703/ P5-8 
U.S. Department of Health and Human Services Food and Drug Administration Center for 
Devices and Radiological Health, Office of Device Evaluation Center for Biologics Evaluation 
Research (2014) Premarket Assessment of Pediatric Medical Devices – Guidance for 
Industry and Food and Drug Administration Staff.  Retrieved July 21, 2017 from: 
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U.S. Department of Health and Human Services Food and Drug Administration Center for 
Devices and Radiological Health, Office of Device Evaluation Center for Biologics Evaluation 
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. Urodynamic Clinical Testing. Reference Doc#PD-TR-151-01