A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
Phase: NA
Conditions: Incontinence, Urge
Sponsor: Laborie Medical Technologies Inc.

 
T-DOC® 5 French Clinical Study 
 
Confidential © 2017 LABORIE 
 
 
 
 
STUDY NUMBER: 
TDOC5Fr-PEDS-01 
 
STUDY NAME: 
T-DOC® 5 Fr Pediatric Clinical Investigation:  
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French 
Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects 
 
DOCUMENT: 
CLINICAL STUDY PROTOCOL 
 
NCT NUMBER: 
NCT03429270 
 
DOCUMENT VERSION & DATE: 
Version 2.02 
June 26, 2018 
 

 
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CLINICAL STUDY PROTOCOL 
 
DEVICE: 
T-DOC® 5 French Air-Charged Vesical and Abdominal Urodynamic Catheters 
 
 
 
STUDY NUMBER: 
TDOC5Fr-PEDS-01 
 
STUDY NAME: 
T-DOC® 5 Fr Pediatric Clinical Investigation:  
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged 
Catheter for Performing Urodynamic Studies on Pediatric Subjects 
 
Version 2.02 
June 26, 2018 
 
 

 
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TDOC5Fr-PEDS-01 
T-DOC® 5 Fr Pediatric Clinical Investigation: 
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged 
Catheter for Performing Urodynamic Studies on Pediatric Subjects 
KEY SPONSOR TEAM MEMBERS 
Sponsor  
Laborie Medical Technologies Canada ULC 
6415 Northwest Drive, Unit 10 
Mississauga, Ontario, Canada, L4V1X1 
905 612 1170 
Primary Monitor 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 

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TDOC5Fr-PEDS-01 
T-DOC® 5 Fr Pediatric Clinical Investigation:
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged 
Catheter for Performing Urodynamic Studies on Pediatric Subjects 
CLINICAL STUDY PROTOCOL  
PREPARED BY 
PRINT NAME: 
Job function: 
Signature : 
Date: 
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 
Signature  
Date 

 
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TDOC5Fr-PEDS-01 
T-DOC® 5 Fr Pediatric Clinical Investigation: 
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged 
Catheter for Performing Urodynamic Studies on Pediatric Subjects 
INVESTIGATOR(S) 
Principal Investigator 
 
 
 
 
  
 
 
 
Principle Investigator 
 
 
 
 
 
  
 
 
 
PARTICIPATING SITE(S) 
 
 
 
  
  
 
 
  
 
 
 
 
 
 
 
INSTITUTION(S) INVOLVED 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
  

 
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TDOC5Fr-PEDS-01 
T-DOC® 5 Fr Pediatric Clinical Investigation: 
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged 
Catheter for Performing Urodynamic Studies on Pediatric Subjects 
 
“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 subject information as allowed 

 
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by law and will maintain the confidentiality of all such subject 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, except to protect the life 
or well-being of a subject in an emergency.  I also agree to document all the required 
information as fully as I can. 
ACCEPTED BY 
PRINCIPAL INVESTIGATOR 
 
PRINT NAME 
TITLE  
Signature         
ACCEPTED BY 
PRINCIPAL INVESTIGATOR (
 
PRINT NAME 
TITLE  
Signature         
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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TDOC5Fr-PEDS-01 
T-DOC® 5 Fr Pediatric Clinical Investigation: 
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged 
Catheter for Performing Urodynamic Studies on Pediatric Subjects 
 
Document History 
 
Version 
Date Effective 
Changes 
Rationale for 
Change 
Creation 
1.0 
October 5, 
2017 
- 
First release 
Amendments 
2.0 
December 1, 
2017 
- Section 6.1 (Study 
Design) updated to 
explain investigational 
device test results will be 
given back to referring 
physician for test 
interpretation.  
- Section 3.3 (Rationale) 
removed obsolete 
sentence from previous 
study design: “As 
mentioned in Section 3.2 
above, the performance of 
ACC is often compared to 
water-perfused and this 
will be addressed under 
the secondary objective of 
this study.” 
SSRI feedback 
from 
 
IRB & document 
editing error 
 
2.01 
April 12,  
2018 
- Administrative updates: 
Removed 
 
from sponsor team. 
- Changed infusion 
transducer to optional in 
page 26. 
- Corrected “-DOC” to “T-
DOC” in page 30. 
Internal re-
structuring & 
spelling 
corrections 

 
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- Corrected page 32 
reference Section 4.5 
(does not exist) to Section 
4.4 
- Corrected spelling in 
page 42 from “soured” to 
“sourced”, page 44 from 
“stripend” to “stipend”.  
- Updated Section 20 
(Referenced Documents) 
to include 
 
forms.  
 
2.02 
June 26, 2018 
- Fixed spelling mistakes 
(“bacteruria” to 
“bacteriuria”) 
- Formatted table of 
contents to remove wrong 
headings 
- Updated Section 10.5 
(Contact Information) 
- Referred to the Statistical 
Analysis Plan in Section 
12.6 (Analysis Plan) 
Administrative 
changes 
 
This is a clinical research protocol for a pivotal human research study. 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 the ethical 
principles that have their origin in the Declaration of Helsinki. 
 
 

 
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Table of Contents 
1 
List of abbreviations ............................................................................................................ 12 
2 
INTRODUCTION ................................................................................................................... 13 
2.1 
Clinical Study Summary ............................................................................................. 13 
2.2 
Primary Hypothesis .................................................................................................... 14 
2.2.1 Primary Hypothesis Test for Safety......................................................................... 14 
2.2.2 Primary Hypothesis Test for Effectiveness ............................................................. 14 
2.3 
Secondary Hypothesis ............................................................................................... 14 
3 
BACKGROUND ..................................................................................................................... 16 
3.1 
Medical Device ........................................................................................................... 16 
3.2 
Prior Literature & Studies .......................................................................................... 18 
3.3 
Rationale .................................................................................................................... 18 
4 
STUDY OBJECTIVES .............................................................................................................. 19 
4.1 
Primary Objectives ..................................................................................................... 19 
4.2 
Secondary Objectives ................................................................................................ 19 
4.3 
Exploratory Objectives ............................................................................................... 19 
4.4 
Assessment of Risks and Adverse Device Effects ...................................................... 20 
5 
MEDICAL DEVICE ................................................................................................................. 20 
5.1 
Description ................................................................................................................. 20 
5.2 
Purpose & Use ........................................................................................................... 21 
5.3 
Summary of Non-Clinical Safety & Performance Data .............................................. 21 
5.4 
Summary of Clinical Safety and Performance Data ................................................... 22 
5.5 
Risks and Benefits ...................................................................................................... 22 
6 
STUDY DESIGN ..................................................................................................................... 22 
6.1 
Description ................................................................................................................. 22 
6.2 
Duration ..................................................................................................................... 24 
7 
SUBJECT SELECTION ............................................................................................................ 24 
7.1 
Inclusion Criteria ........................................................................................................ 24 
7.2 
Exclusion Criteria ....................................................................................................... 25 
7.3 
Vulnerable Populations ............................................................................................. 25 
7.4 
Recruitment Plans ...................................................................................................... 25 
7.5 
Informed Consent Process ......................................................................................... 25 

 
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7.6 
Subject Withdrawal ................................................................................................... 26 
7.7 
Suspension or premature termination ...................................................................... 26 
8 
MANAGEMENT OF MEDICAL DEVICE .................................................................................. 26 
8.1 
Description ................................................................................................................. 26 
8.2 
Regimen ..................................................................................................................... 27 
8.3 
Assignment to Groups ............................................................................................... 27 
8.4 
Preparation and Handling .......................................................................................... 27 
8.5 
Packaging and Labelling ............................................................................................. 28 
8.6 
Device Accountability ................................................................................................ 28 
8.6.1 Laborie to Study Site: .............................................................................................. 28 
8.6.2 Study Site Usage: .................................................................................................... 28 
8.7 
Concomitant Treatment ............................................................................................ 28 
8.8 
Subject Compliance Monitoring ................................................................................ 28 
9 
ASSESSMENT OF INVESTIGATIONAL DEVICE ....................................................................... 28 
9.1 
Endpoints ................................................................................................................... 29 
9.2 
Methods of Assessment ............................................................................................ 30 
10 
SUBJECT SAFETY .................................................................................................................. 31 
10.1 Definitions .................................................................................................................. 31 
10.1.1 
Adverse Events: ............................................................................................... 31 
10.1.2 
Adverse Device Effect: ..................................................................................... 31 
10.1.3 
Device Deficiency: ............................................................................................ 31 
10.1.4 
Serious Adverse Event: .................................................................................... 31 
10.1.5 
Unanticipated Adverse Device Effect: ............................................................. 31 
10.1.6 
Unanticipated Serious Adverse Device Effect (USADE): .................................. 31 
10.2 Data Collection ........................................................................................................... 31 
10.3 Reporting ................................................................................................................... 32 
10.4 Foreseeable Events .................................................................................................... 32 
10.5 Contact Information .................................................................................................. 32 
10.6 Follow-Up ................................................................................................................... 32 
11 
STUDY PROCEDURE ............................................................................................................. 32 
11.1 Visit Schedule ............................................................................................................. 32 
11.2 Screening for Eligibility .............................................................................................. 33 

 
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11.3 Day 1 (Screening & Clinic Visit) .................................................................................. 33 
11.4 Day 5-7 (Follow-Up) ................................................................................................... 33 
11.5 End of Study (EOS) ..................................................................................................... 34 
12 
STATISTICAL CONSIDERATIONS ........................................................................................... 34 
12.1 Primary Endpoint ....................................................................................................... 34 
12.1.1 
Primary Hypothesis Test for Safety ................................................................. 34 
12.1.2 
Primary Hypothesis Test for Effectiveness ...................................................... 34 
12.2 Secondary Endpoint ................................................................................................... 35 
12.3 Exploratory Endpoint ................................................................................................. 37 
12.3.1 
Exploratory Hypothesis Test for Discomfort/Pain ........................................... 37 
12.3.2 
Exploratory Data Collection regarding influencing factors on insertion depth
 
38 
12.4 Sample Size Determination & Power ........................................................................ 39 
12.5 Randomization / Blinding .......................................................................................... 39 
12.6 Analysis Plan .............................................................................................................. 40 
12.7 Deviations .................................................................................................................. 40 
12.8 Early Stopping ............................................................................................................ 40 
13 
DATA HANDLING & RECORD KEEPING ................................................................................ 40 
13.1 Direct Access .............................................................................................................. 40 
13.2 Confidentiality & Security .......................................................................................... 40 
13.3 Data Handling ............................................................................................................ 41 
13.4 Case Report Form (CRF) & Source Documents .......................................................... 41 
13.5 Record Retention ....................................................................................................... 41 
13.6 Performance Monitoring ........................................................................................... 42 
14 
MONITORING, AUDITING, AND INSPECTING ...................................................................... 42 
14.1 Study Monitoring Plan ............................................................................................... 42 
14.2 Auditing and Inspecting ............................................................................................. 43 
15 
DEVIATIONS ......................................................................................................................... 43 
16 
AMENDMENTS .................................................................................................................... 43 
17 
STUDY ADMINSTRATION ..................................................................................................... 44 
17.1 Funding Source and Conflicts of Interest .................................................................. 44 
17.2 Subject Stipends or Payments ................................................................................... 44 

 
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17.3 Committees ................................................................................................................ 44 
17.4 Study Timetable ......................................................................................................... 44 
18 
ETHICS AND REGULATORY APPROVAL ................................................................................ 44 
19 
PUBLICATION POLICY .......................................................................................................... 45 
20 
REFERENCED DOCUMENTS ................................................................................................. 45 
20.1 Informed Consent Documents .................................................................................. 45 
20.2 Investigator’s Brochure.............................................................................................. 45 
20.3 Case Report Forms: .................................................................................................... 45 
21 
BIBLIOGRAPHY ..................................................................................................................... 45 
 
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® 5 Fr  
5 French version of the T-DOC® air-charged catheter 
UDS 
Urodynamics 
USA 
United States of America 
VUDS 
Video Urodynamics  
WFC 
Water-Filled Catheter 
 
 

 
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2 INTRODUCTION 
2.1 
Clinical Study Summary 
Number of Sites 
1 – 2  
Number of Subjects  
A minimum of 10 male and 10 female subjects 12 years of age and 
younger, with an overall minimum of 28, and maximum of 33 subjects 
Objective 
The primary objective of this study is to gather clinical data as follows: 
 
• 
To confirm that the T-DOC® 5 French vesical and abdominal 
catheters are safe and effective for measuring urodynamic 
pressure in pediatric subjects 12 years of age and younger. 
 
The secondary objective of this study is to gather user feedback 
regarding device performance as follows: 
• 
To evaluate the following subjective measures using defined 
ordinal scales: ease of use, presence of artefacts, stability of 
the tracing, perceived time savings, ease of voiding around 
the catheter, presence of use errors, and overall satisfaction.  
Inclusion criteria 
• 
Male and Female (Children, 12 years of age and younger) 
• 
Subjects who are scheduled and normally indicated for 
urodynamic testing, for any medically necessary reason as per 
physician discretion.     
Exclusion criteria 
• 
Subjects who suffer from bladder infections (not including 
subjects with asymptomatic bacteriuria) 
• 
Subjects with urethral strictures 
• 
Subjects who require the use of a suprapubic catheter 
Anticipated Study duration 
The proposed recruitment phase following site initiation is 12 weeks 
(first subject in to last subject out).  
 
Subjects will come to the clinic for one visit, their urodynamic 
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 
Subject follow-up will occur 5-7 days following the test to collect 
information about any adverse events post-test.  

 
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Study end point 
Once the minimum subject recruitment goal is met, the sponsor will 
be informed.  Sites will have an option to continue recruitment until 
the maximum is reached, given recruitment does not exceed the 
allocated timeline.  There will be a site monitoring visit where the site 
will be closed out.    
2.2 
Primary Hypothesis 
Clinicians will rate the T-DOC® 5 Fr vesical and abdominal catheter as safe and effective 
for measuring urodynamic pressure in at least 95% of enrolled pediatric subjects 12 years 
of age and younger.  
For statistical purposes, this hypothesis will be examined based on the two hypothesis 
test cases found below. A questionnaire will be presented to the clinician where the 
clinicians response will be limited to two choices.  For example, for the question of safety, 
the clinician may respond with yes (the device is safe) or no (the device is not safe).  
Accordingly, a binomial distribution function will be used to evaluate the clinical study 
results related to the primary hypothesis. Because the alternative hypotheses are 
directionally based, the null hypotheses will be accepted or rejected based on one-tailed 
tests. As described in section 4.4 the sponsor team has established that subjects are 
subjected to no more than minimal risk since an IDE is not required for this study, 
therefore sample size will be determined based on a desired 95% confidence with 90% 
reliability.  
 
2.2.1 Primary Hypothesis Test for Safety 
H0: Clinicians rate T-DOC® 5 Fr vesical and abdominal catheter as safe for measuring 
urodynamic pressure in 95% of enrolled pediatric subjects  
Hα: Clinicians rate T-DOC® 5 Fr vesical and abdominal catheter as safe for measuring 
urodynamic pressure in less than 95% of enrolled pediatric subjects 
2.2.2 Primary Hypothesis Test for Effectiveness 
H0: Clinicians rate T-DOC® 5 Fr vesical and abdominal catheter as effective for 
measuring urodynamic pressure in 95% of enrolled pediatric subjects  
Hα: Clinicians rate T-DOC® 5 Fr vesical and abdominal catheter as effective for 
measuring urodynamic pressure in less than 95% of enrolled pediatric subjects 
 
2.3 
Secondary Hypothesis  
At least 80% of trained clinical users shall rate the T-DOC® 5 Fr catheter usability 
performance as 3 or better (on a scale of 1-5) for the clinical user questionnaire, 
comparing their experience with use of their currently used urodynamics catheter. The 

 
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following hypothesis test case will be used to evaluate clinical study results for the 
secondary hypothesis.  
H0: 80% of clinicians or more rate T-DOC® 5 Fr vesical and abdominal catheter 
usability performance as 3 or better comparing their experience with use of their 
currently used urodynamics catheter.   
Hα: Less than 80% of clinicians rate T-DOC® 5 Fr vesical and abdominal catheter 
usability performance as 3 or better comparing their experience with use of their 
currently used urodynamics catheter.   
A questionnaire will be presented to the clinician. For this hypothesis, clinicians will 
respond to the questions on a scale of 1 through 5.  Although there are five possible 
options, responses of 3, 4, or 5 will be tallied as a positive result while responses of 1 or 2 
will be tallied as a negative result.  Categorizing the data in this manner enables the use of 
a binomial distribution function for evaluating the clinical study results of the secondary 
hypothesis. Again, because the alternative hypothesis is directionally based, the null 
hypothesis will be accepted or rejected based on a one-tailed test. However, because the 
number of clinicians involved in the study is anticipated to be small (≤ 5), the results will 
be reported based on an 80% confidence and the calculated reliability permitted by the 
actual sample size achieved (i.e., count of clinicians).  See sections 12.3 Secondary 
Endpoint and 12.5 Sample Size Determination and Power for further details.   
 
2.4 Exploratory Hypothesis 
At least 95% of subjects capable of providing feedback on a Visual Analogue Scale, will 
grade their discomfort/pain experienced during the procedure utilizing the T-DOC® 5 Fr 
vesical and abdominal catheter at of 5 or lower, on the Wong-Baker scale from 0 (“No 
Hurt”) to 10 (“Hurts worst”).  
A Wong-Baker scale from 0 (“No Hurt”) to 10 (“Hurts worst”) will be presented to the 
subject. 
H0: 95% or more of subjects capable of providing feedback on a Visual Analogue 
Scale, will grade their discomfort/pain experienced experience during the 
procedure utilizing the T-DOC® 5 Fr vesical and abdominal catheter at 5 or lower, on 
the Wong-Baker scale from 0 (“No Hurt”) to 10 (“Hurts worst”). 
Hα: Less than 95% of subjects capable of providing feedback on a Visual Analogue 
Scale, will grade their discomfort/pain experienced experience during the 
procedure utilizing the T-DOC® 5 Fr vesical and abdominal catheter at 5 or lower, on 
the Wong-Baker scale from 0 (“No Hurt”) to 10 (“Hurts worst”). 
The subjects will be presented with copies the Wong-Baker scale from 0 (“No Hurt”) to 10 
(“Hurts worst”) and asked to respond to the questions by clinic staff who will record their 
responses on form TDOC5Fr-PEDS-01-CRF4. Subjects will respond to the question on a 
scale of 1 through 10.  To enable the use of a binomial distribution function for data 

 
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analysis of the exploratory hypothesis, responses of 1, 2, 3, 4, or 5 will be tallied as a 
positive result while responses of 6, 7, 8, 9, or 10 will be tallied as a negative result. 
Additionally, grouping the data in this manner is assumed to minimize much of the 
variation caused by the nature of subjective feedback from pediatric subjects.  Once 
more, the alternative hypothesis is directionally based, therefore, the null hypothesis will 
be accepted or rejected based on a one-tailed test. However, because the number of 
subjects capable of providing feedback on the Wong-Baker scale is anticipated to be 
limited (≤ 14), the results will be reported based on a 95% confidence and the calculated 
reliability permitted by the actual sample size achieved (i.e., count of subjects capable of 
providing feedback on the Wong-Baker scale).  See sections 12.4 Exploratory Endpoint 
and 12.5 Sample Size Determination and Power for further details.  
  
3 BACKGROUND 
3.1 
Medical Device 
Urodynamic testing makes use of both an intravesical (bladder) and abdominal (rectal) 
catheter, the aim being to make precise pressure-volume measurements in order to 
characterize LUT function, identify the causes for symptoms, and quantify related 
pathophysiological processes (Bauer et al., 2015). UDS is considered in children if the outcome 
of the test is likely to affect treatment choice, or when a treatment does not lead to an 
intended outcome.  Also, UDS testing is considered when surgical interventions are planned 
(Bauer et al., 2015).  Information is gleaned on storage function (detrusor activity, sensation, 
compliance, and capacity) and voiding function (outflow obstruction, flow pattern, detrusor 
contractility and sustainability). Abdominal pressure recordings via a small rectal balloon 
catheter are necessary to accurately assess changes in abdominal pressure as reflected in 
intravesical pressure changes (Bauer et al., 2015).  
 
Initially, WFCs were the only urodynamic 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, 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 pediatric population as movement artefact can be a common issue 
affecting interpretation of the urodynamic tracing.  There are several other advantages and 
disadvantages of the ACC method but they will not be discussed in this protocol.  
    

 
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The existing T-DOC® 7 French air-charged urodynamics catheter line was first introduced to the 
market in the early 2000s.  The design of which comprises a patent-protected catheter balloon 
charging mechanism (US6447462/EP1255485) facilitates the pressure transfer medium for 
recording urodynamic pressure and detection of urodynamic events.   The device is provided as 
a sterile, single (one-time) use catheter.  
 
 
 
 
 
  
 
 
 
 
 
The catheters under review in this clinical investigation are a smaller, 5 French version of the 
existing 7 Fr design, and are intended for use on both pediatric and adult populations for 
measuring urodynamic pressures.    
The 5 French catheter configuration under assessment will be a combination of one both a 
vesical (bladder) and rectal catheter: a single sensor vesical (bladder) urodynamics catheter, 
and an abdominal (rectal) urodynamics catheter.  
Table 1.  Dimensional changes and operational data comparison between 7 French and 5 French.  
 
Existing T-DOC® 7 French 
Proposed T-DOC® 5 French 
 
 
 
 
Pves Balloon Sensor Location 
1” from the tip 
0.78” from the tip 
Pabd Balloon Sensor Location 
1” from the tip 
0.78” from the tip 
 
 
 
Catheter Length 
23.5”  
23.5”  
Flow Rate Specification 
Maximum 70mL/min  
Maximum 50 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 

 
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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, 
Couri et al., 2007), and clinical (Gammie et al., 2016, Digesu et al., 2014) settings.  The use of 
ACCs is often compared to other methods (water-perfused or microtip catheters) like in the 
literature by Gammie et al., Digesu et al. and Cooper et al., however in this study we will not be 
collecting objective patient data comparing the performance of ACCs vs. WFCs or any other 
method.  Since this is a new investigational device, there is no prior literature examining the 
safety and effectiveness of the T-DOC® 5 Fr catheter in pediatric patients.   
 
Please refer to Section 5 of the Investigator Brochure (TDOC5Fr-PEDS-01-IB) for a more detailed 
review of the available prior clinical literature. 
 
3.3 
Rationale 
To the study sponsors’ knowledge, previous pediatric data has not been published examining 
the safety, performance or usability of the T-DOC® air-charged UDS catheter technology in the 
pediatric population, therefore it is necessary to conduct this study in order to collect this data.  
This study will involve collection of safety and performance data, clinical user feedback, the 
recording of optimal insertion depth among other metrics, which will feed into use factors and 
product labelling. 
This is considered a pivotal study as these data will be used to comply with the essential 
requirements from a regulatory perspective.  A pilot study is not warranted based on extensive 
pre-clinical testing (see TDOC5Fr-PEDS-01-IB, Section 4) and the fact that this is not a new 
technology, nor new diagnostic technique.  UDS is a well-established technique in 
characterizing LUT function in children (Bauer et al., 2015), and the technical performance of 
ACCs has been proven to be suitable for UDS (Couri et al., 2017).  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.   
Previous literature has indicated that older children and adolescents anatomically can tolerate a 
7 French urethral catheter, from approximately the age of 10 according to one expert (Gray 
2012).  Therefore, for the purposes of our study and to be consistent with an FDA pediatric 
guidance (U.S. Department of Health and Human Services, 2014), our recruitment will focus on 
children 12 years of age and younger which will include the Pediatric Subgroups ‘Child’ (ages 2 
to 12 years of age), ‘Infant’ (>1 month to 2 years) and ‘Newborn (neonate)’ (birth to 1 month of 
age) where urodynamics is normally indicated.  It is recommended that in children born with 

 
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myelomeningocele, a tethered spinal cord, sacral angenesis, or an anorectal malformation, a 
baseline UDS should be obtained between 3 and 6 months of age and routinely yearly 
thereafter if the child is at risk for a changing neurological lesion (Drzewiecki & Bauer, 2015). 
This establishes utility of performing UDS in these very young patients.  Utility in newborns 
suffering from myelomeningocele has also been studied in order to identify those at an early 
and increased risk of rapid structural deterioration of the urinary tract (Bauer et al., 1984, Sidi, 
Dykstra & Gonzalez, 1986).  For the purposes of this study, decisions regarding timing for 
prescribing urodynamic testing will be at the discretion of the Investigators. 
 
4 STUDY OBJECTIVES 
4.1 
Primary Objectives 
The primary objective of this pivotal study is to gather clinical data as follows: 
• To confirm that the T-DOC® 5Fr vesical and abdominal catheters are safe and effective 
for measuring urodynamic pressure in pediatric subjects 12 years of age and younger. 
 
4.2 
Secondary Objectives 
The secondary objective of this pivotal study is to gather user feedback regarding device 
usability performance as follows: 
• To evaluate the following subjective measures using defined ordinal scales: ease of use, 
ease of insertion, presence of artefacts, stability of the tracing, perceived time savings, 
ease of voiding around catheter, presence of use errors and overall satisfaction. 
 
4.3 
Exploratory Objectives 
There are two exploratory objectives for this study.  The first is to gather subjective subject 
feedback from those able to communicate this feedback for exploring whether the newly 
designed, smaller sized T-DOC® 5 Fr catheters cause undue discomfort based on subjective 
subject feedback regarding the discomfort and pain level. The second exploratory objective is 
to gather initial data regarding the effect of several factors (e.g., age, gender, weight, height) on 
optimal insertion depth of the T-DOC® 5 Fr catheters. These data will be analysed to form a 
basis for suggesting further hypotheses for later research. 
  
 

 
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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.    
Urodynamic 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 occurs in 2-4% of subjects (Chapple, 
MacDiarmid & Patel, 2009).  Thus, the clinician must weigh the risks and benefits as to whether 
the urodynamic test offers additional diagnostic value beyond symptom assessment, physical 
examination and other diagnostic testing (Winters et al., 2012).   The risks of radiation exposure 
during VUDS should also be weighed against the benefits, and explained to the subject (or 
subject’s guardian), however LABORIE does not manufacture radiation-emitting devices and so 
we do not offer mitigation against these risks.    
In conclusion, the overall residual risks associated with the use of T-DOC® 5 French catheters 
within this study set-up, are acceptable when weighed against the benefits, and are no 
different than the risks when using other urodynamic catheter technologies.  The sponsor team 
has also established that subjects are subjected to no more than minimal risk since an IDE is not 
required for this study (Ref: TDOC5Fr-PEDS-01 - Risk Determination).  Lastly, UDS and VUDS are 
widely-performed procedures on pediatric subjects requiring specialized management for 
urinary incontinence/retention problems, 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 (Bauer et al., 2015). 
  
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 5 Fr vesical single sensor catheter (yellow) 
2. T-DOC 5 Fr abdominal single sensor catheters (blue) 
  

 
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Traceability of investigational study materials will be maintained via the Inventory Control Log 
(Q905-FRM-17). Traceability of non-investigational materials required for the study will be 
maintained through sales order shipment tracking using the sponsor’s ERP system.  Any 
remaining investigational material stock after study close-out will be returned to the study 
sponsor at the sponsors’ expense.    
The T-DOC® 5 French catheters are manufactured using equivalent materials to the existing T-
DOC® 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:  
 
Product Classification Rule 
In Summary: 
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 
 
5.2 
Purpose & Use 
Intended Use: The Urodynamic Catheters are intended for measuring urodynamic pressures. 
The Urodynamic Catheters are intended to be connected to Urodynamic Analyzer systems using 
a reusable electronic cable. 
Indications for Use: The Urodynamic Catheters are sterile and intended for single use on adult 
and pediatric patient population requiring urodynamic pressure monitoring through the 
measurement of bladder, vaginal, urethral and rectal pressures.   
NOTE: Recruitment of adult patients is not within the scope of this study.  Urodynamic pressure 
monitoring of vaginal and urethral pressure measurements is also not within the scope.   
 
5.3 
Summary of Non-Clinical Safety & Performance Data 
The T-DOC® 5 French family of Urodynamic catheters will be 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.  

 
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5.4 
Summary of Clinical Safety and Performance Data  
Please refer to Section 5 of the Investigator Brochure (TDOC5Fr-PEDS-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 urodynamic pressures further 
justifying the study rationale.   
 
5.5 
Risks and Benefits 
Please refer also to Section 4.4 above (Assessment of Risks and Adverse Device Effects), and 
Section 6 of the Investigator Brochure (TDOC5Fr-PEDS-01-IB). 
Risks to the subject will be no greater than those of a standard urodynamics test.  Physicians 
are responsible for determining whether subjects are normally indicated, and who would 
benefit from urodynamic testing are eligible for recruitment into this study.  There is no direct 
subject benefit for participating other than to gather objective evidence of T-DOC® 5 French air-
charged catheter clinical use.   
It is important to note the American Urological Association (AUA) has identified two clear 
categories of subjects who may benefit from urodynamic studies (Winters et al., 2012): (1) 
those in whom information beyond that obtained by a history, physical examination and basic 
tests is necessary in order to make an accurate diagnosis and direct therapeutic decisions, and 
(2) those whose LUT condition may have the potential to cause deleterious and irreversible 
effects on the upper urinary tracts. Marked functional and anatomic abnormalities can be 
present even in the absence of concomitant proportionate symptoms, particularly in subjects 
with neurologic disease.   
In conclusion, the overall residual risks associated with the use of T-DOC® 5 French catheters 
within this study set-up, are acceptable when weighed against the benefits.  The sponsor team 
has also established that subjects are subjected to no more than minimal risk since an IDE is not 
required for this study (Ref: TDOC5Fr-PEDS-01 - Risk Determination).  Lastly, Urodynamics is 
already a widely performed procedure on pediatric 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 (Bauer et al., 2015). 
 
6 STUDY DESIGN 
6.1 
Description 
This pivotal study will be conducted where a minimum number of subjects will undergo a 
conventional urodynamic study (VUDS or non-VUDS) using the investigational device that will 
be conducted according to Good Urodynamic Practices (Rosier et al., 2016).  There is no need 

 
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for any repeat catheterization or urodynamics testing using an approved (non-investigational) 
urodynamics catheter.  Urodynamic test results using the investigational device will be provided 
back to the referring physician for test interpretation.  Given positive test results for the 
investigational device design verification and manufacturing process validation in accordance 
with ISO 13485, the sponsor has no reason to suspect device safety and performance will be 
any different as compared to the currently marketed T-DOC® 7 French catheter.   Therefore, to 
reiterate, the urodynamics pressure data collected using the investigational device will be used 
in the referring physician’s test interpretation for each participant enrolled, unless there is 
reason to believe the test should be repeated.  This can happen under normal (non-
investigational) circumstances if the test was inconclusive (Abrams, 2006).  
Further subject data collected will include age, medical history, height, weight, adverse events 
during or immediately following the test and 5-7 days follow-up, catheter insertion depth etc., 
as objective evidence on each patients CRF.  There will be no control arm, blinding, or 
treatment/intervention component to this study.   
In order to evaluate prospective product claims, a usability questionnaire will also be 
completed (one per clinical user, defined as an individual trained and certified to perform UDS).   
The study aim is to enlist 5 clinical users across 1-2 sites.  Five users will allow for 85% of use 
errors to be detected (U.S. Department of Health and Human Services, 2016).  A minimum of 1 
physician should be utilized.  
The following schematic diagram gives a high-level overview of the study design and subject 
flow-through: 

 
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6.2 
Duration 
The expected duration of each subject’s participation is one clinic visit to receive their already 
prescribed urodynamics 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 3-4 months.  Database lockout and study report completion is 
estimated at 2 months after the last subject is recruited.  
7 SUBJECT SELECTION 
7.1 
Inclusion Criteria 
• Male and Female (Children and infants, 12 years of age and younger) 
 
• Subjects who are scheduled and normally indicated for urodynamics testing, for any 
medically necessary reason as per the physician.     
 

 
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7.2 
Exclusion Criteria 
• 
Subjects who suffer from bladder infections (not including subjects with asymptomatic 
bacteriuria) 
• 
Subjects with urethral strictures 
• 
Subjects who require the use of a suprapubic catheter 
 
7.3 
Vulnerable Populations 
Subjects inherently represent a vulnerable population group, and so consideration for 
anatomical and physiological differences from adult subjects will be taken into consideration.  
The major premise of this study is that the T-DOC® 5 French catheter is smaller in size, and is 
therefore better suited for subjects with a smaller anatomy.   
 
7.4 
Recruitment Plans 
The target enrolment is a minimum of 28 subjects up to a maximum enrolment of 33 subjects.  
A minimum of 10 male patients and 10 female patients shall be recruited so that insertion 
depths and any usability issues identified with one or both genders can be reliably identified.   
Subjects who are visiting the urodynamics clinic for their medically-indicated urodynamics test 
will be approached regarding participation in this study.   It is estimated that recruitment will be 
3 subjects per week, therefore it should take approximately 9-12 weeks to recruit 28-33 
subjects.  Recruitment will be monitored through scheduled meetings with the site co-
ordinator.  If the subject and legal guardian sign the informed consent, this will be treated as 
the point of enrolment.   
7.5 
Informed Consent Process 
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 and 
parents/guardians of all pertinent aspects of this clinical trial, including the written information 
giving a favourable opinion by the IRB.  New information in regard to 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’s parent/guardian, and by the 
person who conducted the informed consent discussion.  Additionally, the subject’s assent 
should be collected.  A copy of the signed and dated written Informed Consent Form & Assent 
will be provided to the subject/guardian.  The date of informed consent and assent should be 
recorded on the subject’s CRF.   
The Informed Consent Form & Assent 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. 

 
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The Informed Consent process will follow the ethical procedures as outlined in 21 CFR Part 50 – 
Subpart D – Additional Safeguards for Children in Clinical Investigations.  The IRB will determine 
whether there is no more than minimal risk to the child in determining whether one or both 
parents must provide their consent.  Provisions will be made for soliciting assent of the child 
wherever possible.       
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 urodynamics 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.  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 or evidence of noncompliance, or serious 
and/or continuing noncompliance which could affect any of subject safety, device performance 
or integrity of study data.  
This study does not include blinding and so a process for accessing and unblinding subjects and 
Investigators is not required.  
 
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 Urodynamics processor already in use  
• Computer/laptop with Laborie UDS-120 urodynamics software already loaded and in 
use by each site 
• Infusion transducer (optional) 
• Uroflowmetry/Urocap device configured with the Urodynamics processor and computer 
for pressure-flow studies, already in use by each site (optional) 

 
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• T-DOC® transducer cables: 
o Pabd (blue) – Abdominal channel reusable cable  
o Pves (yellow) – Bladder channel reusable cable  
• One (1) air-charged T-DOC® 5 Fr abdominal single sensor catheter per subject  
• One (1) air-charged T-DOC® 5 Fr radiopaque or non-radiopaque single 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 Urodynamics pump tubing infusion line per subject (must be Laborie part 
number: TUB500) 
• 1000 mL beaker* (whatever is currently in use at the site)  
• One (1) sterile saline bag per subject* 
• One (1) bottle omniopaque / contrast fluid per subject (VUDS only)* 
• Tape*  
• Lubricant* 
• Gloves* 
• Any other supplies deemed necessary for conducting a Urodynamic study* 
 
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 
Once enrolled, subjects will be stratified to male and female subjects (defined as gender at 
birth), and to ensure minimum enrolment targets are met.  This includes:  
• A minimum of 10 male subjects 
• A minimum of 10 female subjects 
 
8.4 
Preparation and Handling 
The Urodynamics system and air-charged catheters will be prepared, and maintained by the 
physician.  Catheters should be stored between -25°C to +50°C. 

 
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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 Form.  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 Template as well.  When 
the devices have been received by Laborie, it is their 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. 
 
8.7 
Concomitant Treatment 
This study will not make use of any concomitant treatments nor will the subject samples 
interact with any medical treatment or medications.  
 
8.8 
Subject Compliance Monitoring 
Not applicable in this study. 
 
9 ASSESSMENT OF INVESTIGATIONAL DEVICE 
 

 
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9.1 
Endpoints 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
To confirm the T-DOC® 5Fr 
vesical and abdominal catheters 
as a safe and effective means of 
measuring urodynamic pressure 
in pediatric subjects 12 years of 
age and younger. 
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® 5 Fr vesical 
and abdominal catheters are safe 
and effective for measuring 
urodynamics pressure in at least 
95% 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 
urodynamics test 
that can establish the 
safety and 
effectiveness, it is 
justified to obtain 
clinician feedback via 
a binomial response 
whether the device 
was safe and/or 
effective for 
measuring 
urodynamic 
pressure.   
Secondary 
 
 
To evaluate the usability of the 
device by collecting subjective 
feedback using defined ordinal 
scales: ease of use, ease of 
insertion, presence of artefacts, 
stability of the tracing, 
perceived time savings, ease of 
voiding around catheter, 
presence of use errors and 
overall satisfaction. 
The usability performance 
endpoint will be captured in a 
questionnaire format.   At least 
80% of trained clinical users shall 
rate the T-DOC® 5 Fr performance 
as 3.0 or better (on a scale of 1-5) 
on the study outcome 
questionnaire. 
 
When evaluating the 
usability of a device, 
the Sponsor feels its 
appropriate to use a 
subjective ordinal 
scale response while 
evaluating human 
and device usability 
factors.    
Tertiary/Exploratory  
 
 
To explore whether the newly 
designed, smaller sized T-DOC® 
5 Fr catheters causes undue 
This exploratory endpoint will be 
measured by collecting patient 
feedback (within the abilities of 
Given the patient 
population, use of 
the Wong-Baker face 

 
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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
discomfort based on subjective 
subject feedback regarding the 
discomfort and pain level, for 
those able to communicate such 
feedback  
the child) regarding the level of 
discomfort and pain experienced 
during their Urodynamic test 
using the Wong-Baker visual 
analogue scale.   
95% of patients capable of 
providing feedback on a Visual 
Analogue Scale, will grade their 
discomfort/pain at 5 or lower, on 
the Wong-Baker scale from 0 (“No 
Hurt”) to 10 (“Hurts worst”). 
pain scale is a proven 
tool in evaluating 
pain ratings in 
children and can be 
used for children as 
young as 3 years old 
(Hockenberry, Wilson 
& Rodgers, 2016).   
To explore the effect of several 
factors (e.g., age, gender, 
weight, height) on optimal 
insertion depth of the T-DOC® 5 
Fr catheters.  
Subjects’ age, gender, weight, and 
height will be recorded on 
TDOC5Fr-PEDS-01-CRF1. These 
data will be analysed to determine 
a subject stratification approach 
to be used in examining further 
hypotheses for later research 
regarding optimal insertion depth. 
The sponsor would 
like to collect this 
information, due to a 
lack of available 
published data.  
 
9.2 
Methods of Assessment 
A T-DOC® 5 French air-charged catheter will be used to assess and record bladder and 
abdominal pressures which are in turn used by the clinician to identify urodynamic events.   
These measurements will be recorded using a LABORIE urodynamics system.   The resulting 
interpretations regarding safety, effectiveness, and usability will be made by the physician 
overseeing the subject’s case.  Patients capable of providing feedback regarding their level of 
discomfort experienced during the procedure with the T-DOC® 5Fr vesical and abdominal 
catheters will be presented with copies of the Wong-Baker scale from 0 (“No Hurt”) to 10 
(“Hurts worst”) and asked questions by clinic staff who will record their responses on form 
TDOC5Fr-PEDS-01-CRF4. Subjects will respond to the questions on a scale of 1 through 10.   
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.   

 
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10 SUBJECT SAFETY 
10.1 Definitions 
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 subject, 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 subject 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. 

 
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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 
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 4.4 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, 
and at 5-7 days post-test follow-up.   
 
11 STUDY PROCEDURE 
11.1 Visit Schedule 
Evaluation 
Screening & Clinic Visit 
Follow-up  
Day 1 
Day 5-7 
Informed Consent & Assent 
X 
  
Inclusion Criteria 
X 
  
Exclusion Criteria 
X 
  
Record any Adverse Events 
X 
X 

 
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Questionnaire for Operator 
(once minimum 3 subjects 
completed) 
 
X 
 
11.2 Screening for Eligibility 
Subject’s may be screened for eligibility for this study by referencing the inclusion criteria.  No 
special testing is required in order to determine eligibility.   
 
11.3 Day 1 (Screening & Clinic Visit) 
1. 
Determine if the subject is eligible for this study. 
2. 
Conduct Informed Consent and Assent discussion with the subject and guardian 
and sign where required. 
3. 
Collect medical history and record in case report form (TDOC5Fr-PEDS-01-CRF2).  
4. 
Collect and record other patient details as required on TDOC5Fr-PEDS-01-CRF1 
[weight (lbs), height (‘,”), date of birth, sex, etc]. 
5. 
Site personnel will explain what will happen during the urodynamics test to the 
subject/parent or caregiver.   
6. 
Site personnel will prepare urodynamics equipment, study materials, other 
sterile disposables and supplies as required for the urodynamic study and record 
catheter lot number information on TDOC5Fr-PEDS-01-CRF1. 
7. 
Follow the investigational device instructions for use for placing the catheters.    
Record insertion depth once catheter is in place on TDOC5Fr-PEDS-01-CRF1.   
8. 
Conduct urodynamic study according to Good Urodynamic Practice 
recommendations, including regular cough checking to ensure good pressure 
transmission and catheter positioning wherever possible (Rosier et al., 2016).  
9. 
If within capabilities of the child, and if their condition allows, complete 
TDOC5Fr-PEDS-01-CRF4 – Subject Questionnaire.  
 
11.4 Day 5-7 (Follow-Up) 
1. 
Site personnel will telephone the subject’s guardian/caregiver and inquire about 
any adverse events that occurred after Visit 1 that may or may not be persistent. 
Record the call details on the subjects’ CRF (TDOC5Fr-PEDS-01-CRF1).  
 
NOTE: If an adverse event occurs during this study, any follow-up intervention prescribed is at 
the discretion of the Investigator.  Each subject will be contacted 5-7 days post-test in order to 
record the occurrence of any adverse events.  Any subject with persistent symptoms post-test 
shall be followed until such a time it is resolved, and the site must notify Laborie of the 

 
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outcome of the follow-up. This information should also be recorded on the subjet’s CRF 
(TDOC5Fr-PEDS-01-CRF1). 
 
11.5 End of Study (EOS) 
At the conclusion of the urodynamics test, the subject is no longer required to undergo any 
further study-related procedures, with the exception of a 5-7 day telephone follow-up. 
Once a clinical user has performed a minimum of 3 urodynamic studies and the related tasks 
under this protocol, they are then eligible to complete the Usability Questionnaire (TDOC5Fr-
PEDS-01-CRF3).      
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 Section 14.1.  All study related files 
will be collected and reviewed for completeness.  Final arrangements will be discussed 
regarding payment at this point in time.  The EOS is considered the point when all subjects have 
been followed-up and data collection completed.   
 
12 STATISTICAL CONSIDERATIONS 
12.1 Primary Endpoint 
In order to satisfy the primary endpoint, each subject CRF will include a binomial question 
regarding clinician acceptance of the device as being both safe and effective.  According to the 
risk determination outlined in section 4.4 Assessment of Risks and Adverse Device Effects, no 
more than minimal risk is foreseen for the subject by participating in this study.  Given this, the 
allowable Type I error (α) will be 5% (1-confidence), such that the clinician will grade the device 
as being safe and effective for 95% of subjects enrolled in this study.   Whereas the 
corresponding Type II error is estimated at 10% (reliability). As stated earlier, safety and 
effectiveness will be evaluated separately via the following sets of hypotheses:  
 
12.1.1 Primary Hypothesis Test for Safety 
H0: Clinicians rate T-DOC® 5 Fr vesical and abdominal catheter as safe for measuring 
urodynamic pressure in 95% of enrolled pediatric subjects  
Hα: Clinicians rate T-DOC® 5 Fr vesical and abdominal catheter as safe for measuring 
urodynamic pressure in less than 95% of enrolled pediatric subjects 
12.1.2 Primary Hypothesis Test for Effectiveness 
H0: Clinicians rate T-DOC® 5 Fr vesical and abdominal catheter as effective for 
measuring urodynamic pressure in 95% of enrolled pediatric subjects  

 
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Hα: Clinicians rate T-DOC® 5 Fr vesical and abdominal catheter as effective for 
measuring urodynamic pressure in less than 95% of enrolled pediatric subjects 
In both cases, analysis of the clinical results will be performed as outlined below based on a 
binomial distribution.  In general, the probability mass function of a binomial random 
variable X is: 
f(x)= ((𝑛
𝑥) 𝑝𝑥(1 −𝑝)𝑛−𝑥) 
 
In this study, n represents the number of patients accepted into the trial; x represents the 
number of procedures for which clinicians rate the device as safe or effective (as the case may 
be); and p = 0.95 (as stated in the null hypothesis that 95% of the time clinicians rate the device 
as safe or effective as the case may be).  
Because the alternative hypotheses are directionally based, the null hypotheses will be 
accepted or rejected based on one-tailed tests.  If the numbers of patients accepted into the 
trial is 28 as expected (see section 12.2 Sample Size Determination & Power), the test statistic, 
for both one-tailed tests with an α =.05, will be:  
 
𝑃(𝑡𝑟𝑢𝑒 𝑋≤ 𝑥) = (28
𝑥) 0.95𝑥(1 −0.95)28−𝑥 ≤ 0.05 
 
Solving for 𝑥 in the case of 28 patients results in the null hypothesis being rejected when 24 
procedures or fewer are rated as safe and accepted when 25 or more procedures have been rated 
safe.  The actual results will be tabulated based on the actual number of patients excepted into the 
study. 
 
12.2 Secondary Endpoint 
To satisfy the secondary (usability) endpoint, a categorical response variable using a defined 
ordinal data scale will be used.  At least 80% of clinical users, who have performed three or 
more procedures with subject device, shall rate the T-DOC® 5 Fr catheter usability performance 
as 3.0 or better (on a scale of 1-5) for the clinical user questionnaire, comparing their 
experience with use of their currently used urodynamics catheter. For this endpoint, eligible 
clinicians will respond to the questions on a scale of 1 through 5.  To enable analysis based on a 
Binomial Distributions, responses of 3, 4, or 5 will be tallied as a positive result while responses 
of 1 or 2 will be tallied as a negative result.  However, because the number of clinicians who 
perform three procedures or more with the T-DOC® 5 Fr vesical and abdominal catheter during 
this study is anticipated to be small (≤ 5), the results will be reported based on the confidence 
of 95% (based on the assumed minimal risk level described in section 4.4) and the calculated 
reliability permitted by the actual sample size achieved (i.e., count of eligible clinicians). The 
following hypothesis test case will be used to evaluate clinical study results. 
 

 
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H0: 80% of clinicians rate T-DOC® 5 Fr vesical and abdominal catheter usability 
performance as 3 or better compared to their experience with their currently used 
urodynamics catheter.   
Hα: Less than 80% of clinicians rate T-DOC® 5 Fr vesical and abdominal catheter 
usability performance as 3 or better compared to their experience with their 
currently used urodynamics catheter.   
The probability mass function of a binomial random variable X stated above will again be used 
to analyse the questionnaire data. For the secondary endpoint, n represents the number of 
clinicians who performed three or more procedures with the T-DOC® 5 Fr vesical and abdominal 
catheter; x represents the number of procedures for which the eligible clinicians rate the device 
usability performance as 3 or better compared to their experience with their currently used 
urodynamics catheter; and p = 0.8 (as stated in the null hypothesis that 80% of the time 
clinicians rate the device usability performance as 3 or better compared to their experience 
with their currently used urodynamics catheter).  
Again, because the alternative hypothesis is directionally based, the null hypotheses will be 
accepted or rejected based on a one-tailed test.  For example, if the numbers of clinicians 
eligible to complete a questionnaire is 5, the test statistic, for the one-tailed tests, with an α 
=.05 will be:  
P(true X≤ 𝑥)= (5
𝑥) 0.8𝑥(1 −0.8)5−𝑥 ≤ . 05 
 
Again, if it is assumed that 5 clinicians respond to the questionnaire, the reliability level would 
be 55% (see Section 12.5 Sample Size Determination and Power). Solving for 𝑥 based on this 
assumption would then result in the null hypothesis being rejected when 1 or fewer clinicians 
rate the T-DOC® 5 Fr vesical and abdominal catheter usability performance as 3 or better 
compared to their experience with their currently used urodynamics catheter and accepted 
when 2 or more clinicians rate the T-DOC® 5 Fr vesical and abdominal catheter usability 
performance as 3 or better compared to their experience with their currently used urodynamics 
catheter.  
 
Alternatively, a second calculated confidence and reliability level combination could be 80% 
and 70%, respectively, based on 5 clinicians responding to the questionnaire.  In this case, if the 
numbers of clinicians eligible to complete a questionnaire is 5, the test statistic, for the one-
tailed tests, with an α =0.2 (i.e., 1-confidence level) will be:  
P(true X≤ 𝑥)= (5
𝑥) 0.8𝑥(1 −0.8)5−𝑥 ≤ . 2 
 
Solving for 𝑥 would result in the null hypothesis being rejected when 2 or fewer clinicians rate 
the T-DOC® 5 Fr vesical and abdominal catheter usability performance as 3 or better compared 
to their experience with their currently used urodynamics catheter and accepted when 3 or 
more clinicians rate the T-DOC® 5 Fr vesical and abdominal catheter usability performance as 3 
or better compared to their experience with their currently used urodynamics catheter. 

 
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Due to the minimal risk of the device as stated in section 4.4, the study team has opted to use a 
combination of levels where the confidence level is stated as 95% (i.e., α = 0.05), and the 
reliability (power) of the test will be calculated, though it will likely be significantly reduced.   
 
The actual results will be tabulated based on the actual number of clinicians who respond to 
the questionnaire.  
 
12.3 Exploratory Endpoint 
12.3.1 Exploratory Hypothesis Test for Discomfort/Pain 
To satisfy the first exploratory endpoint (subject experience), a categorical response variable 
using the Wong-Baker scale from 0 (“No Hurt”) to 10 (“Hurts worst”) will be used.  The stated 
exploratory endpoint is that 95% of patients capable of providing feedback on a Visual 
Analogue Scale, will grade their discomfort/pain of 5 or lower, on the Wong-Baker scale from 0 
(“No Hurt”) to 10 (“Hurts worst”).  To enable analysis based on a Binomial Distributions, 
responses of 1, 2, 3, 4, or 5 will be tallied as a positive result while responses of 6, 7, 8, 9, or 10 
will be tallied as a negative result. Additionally, grouping the data in this manner is assumed to 
minimize much of the variation caused by the nature of subjective feedback from pediatric 
subjects.  A confidence level of stated as 95 % (i.e., α = 0.05) has been selected based on the 
risk determination that no more than minimal risk is foreseen for the subject by participating in 
this study (4.4 Assessment of Risks and Adverse Device Effects).  As stated earlier, the following 
hypothesis test case will be used to evaluate the exploratory clinical study results. 
 
H0: 95% or more of subjects capable of providing feedback on a Visual Analogue 
Scale, will grade their discomfort/pain experienced experience during the 
procedure utilizing the T-DOC® 5 Fr vesical and abdominal catheter at 5 or lower, on 
the Wong-Baker scale from 0 (“No Hurt”) to 10 (“Hurts worst”). 
Hα: Less than 95% of subjects capable of providing feedback on a Visual Analogue 
Scale, will grade their discomfort/pain experienced experience during the 
procedure utilizing the T-DOC® 5 Fr vesical and abdominal catheter at 5 or lower, on 
the Wong-Baker scale from 0 (“No Hurt”) to 10 (“Hurts worst”). 
The subjects will be presented with copies the Wong-Baker scale from 0 (“No Hurt”) to 10 
(“Hurts worst”) and asked to respond to the questions by clinic staff who will record their 
responses on TDOC5Fr-PEDS-01-CRF4. As with the previous endpoints, the alternative 
hypothesis is directionally based, therefore, the null hypothesis will be accepted or rejected 
based on a one-tailed test. Because the subjects range in age from 2-12 years, the number of 
subjects capable of providing feedback on the Wong-Baker scale is anticipated to be limited (≤ 
14). Similar to the secondary hypothesis, the study team has opted to use a combination of 
levels where the confidence level is stated as 95% (i.e., α = 0.05), and the reliability (power) of 
the test will be calculated, based on the sample size achieved (i.e., count of subjects capable of 

 
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providing feedback on the Wong-Baker scale). See section 12.5 Sample Size Determination and 
Power for further details.   
The probability mass function of a binomial random variable X as stated for the primary and 
secondary endpoints will again be used to analyse the subjects’ questionnaire data. For the 
exploratory endpoint, n represents the number of subjects capable of providing feedback on 
the Wong-Baker scale; x represents the number of subjects who rate their discomfort/pain 
experienced during the procedure utilizing the T-DOC® 5 Fr vesical and abdominal catheter at 5 
or lower on the Wong-Baker scale from 0 (“No Hurt”) to 10 (“Hurts worst”); and p = 0.95 (as 
stated in the null hypothesis that 95% of subjects capable of providing feedback on a Visual 
Analogue Scale, will grade their discomfort/pain experienced experience during the procedure 
utilizing the T-DOC® 5 Fr vesical and abdominal catheter at 5 or lower).  
Again, because the alternative hypothesis is directionally based, the null hypotheses will be 
accepted or rejected based on a one-tailed test.  For example, if the numbers of subjects 
capable of responding to the questionnaire is 10, the test statistic, for the one-tailed tests, will 
be:  
P(true X≤ 𝑥)= (14
𝑥) 0.95𝑥(1 −0.95)14−𝑥 ≤ 0.05 
 
Again, if it is assumed that 14 subjects respond to the questionnaire, the reliability level would 
be approximately 80% (see Section 12.5 Sample Size Determination and Power). Solving for 𝑥, 
with the assumed count of subjects would result in the null hypothesis being rejected when 12 
or fewer subjects capable of providing feedback on a Visual Analogue Scale, grade their 
discomfort/pain experienced experience during the procedure utilizing the T-DOC® 5 Fr vesical 
and abdominal catheter at 5 or lower, on the Wong-Baker scale from 0 (“No Hurt”) to 10 
(“Hurts worst”).   
The actual results will be tabulated based on the actual number of subjects who respond to the 
questionnaire.  
 
12.3.2 Exploratory Data Collection regarding influencing factors on insertion depth 
To satisfy the second exploratory endpoint, subject data including gender, age, height, weight, 
adverse events during or immediately following the test and 5-7 days follow-up, catheter 
insertion depth will be collected as objective evidence on each patient’s CRF, where insertion 
depth is considered the response variable and assumed to be influenced by gender, age, height, 
weight and/or BMI.  Adverse event data will be factored into the assessment of the adequacy of 
the individual insertion depth used during the subject’s procedure. 
The collected data will be reported using graphical tools for central tendency and dispersion of 
insertion depths based on gender, age, height, weight, and BMI.  The goal of reporting data in 
this manner is to facilitate the identification of a natural subject stratification approach for use 
in later research regarding optimal insertion depth.   

 
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Based on the stated data collection and analysis approach, the anticipated outcome of this 
endpoint, and the fact that the subject population is not being controlled for age, height, or 
weight, this study exploratory objective is being evaluated as a case-series observational study. 
Accordingly, sample size will not be pre-determined based on pre-ordained confidence and 
reliability statements. 
 
12.4 Sample Size Determination & Power 
Sample size calculations were and will be performed in accordance with Binomial Distribution 
theory (except for the second exploratory objective), utilizing the following formula:   
𝑛= 𝑙𝑛(1 −𝑐𝑜𝑛𝑓𝑖𝑑𝑒𝑛𝑐𝑒 𝑙𝑒𝑣𝑒𝑙)
𝑙𝑛(𝑟𝑒𝑙𝑖𝑎𝑏𝑖𝑙𝑖𝑡𝑦)
 
Where n is the number of samples (e.g., patients, clinicians), and ln is natural log.  In the case of 
the primary endpoint, the desired confidence level and reliability have been stated as 95% and 
90% respectively. Hence the minimum required number of samples for the primary endpoint is 
28 as shown below. 
𝑛=
𝑙𝑛(1−0.95)
𝑙𝑛(0.90)  = 28 
In addition, the study sponsor will allow up to 33 subjects (20% additional) during the allowable 
recruitment time period given the minimum recruitment goals are met (see Section 6.1 for and 
Section 7.1 for stratification and recruitment requirements).  The additional subjects will ensure 
that the desired confidence and reliability levels are met should any data or subjects be 
disqualified due to technical errors or if any subject requests to exit the study.   
In the case of the secondary endpoint, the confidence level has been stated to be 80% and the 
reliability statement will be calculated based on the actual number of clinicians who respond to 
the questionnaire. For instance, if 5 clinicians respond to the questionnaire, and an α = 0.20 
(i.e., (1- confidence level)) is maintained, the reliability of this test will drop to approximately 
73%.  
In the case of the first exploratory endpoint, the confidence level has been stated to be 95% 
and the reliability statement will be calculated based on the actual number of subjects who 
respond to the questionnaire. For instance, if 14 subjects respond to the questionnaire, and an 
α = 0.05 (i.e., (1- confidence level)) is maintained, the reliability of this test would be 
approximately 80%.  
In all cases, test statistics will be calculated based on the actual number of samples achieved. 
 
12.5 Randomization / Blinding 
Randomization and/or blinding is not utilized in this study based on study design. 
 

 
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12.6 Analysis Plan 
All subjects enrolled will be considered in the final analysis.  Data will be analysed as discussed 
in Section 12.1 above.  A Statistical Analysis Plan containing the details of the analyses and 
hypothesis testing will be finalized prior to database lock. 
If any CRFs are found to be incomplete, the study monitor will follow-up as to the reasoning 
why.  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. 
 
12.7 Deviations 
In any event there are deviations from the original statistical plan they will be described and 
justified in the final report. 
 
12.8 Early Stopping 
An interim data analysis will be conducted once 30 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. 
 
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. 

 
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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 urodynamic data files (DTA files) are requested by the sponsor for each patient, to 
confirm the quality of the tracing.  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 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 

 
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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 sourced 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. During these monitoring visits, the following, but not exhaustive list of points will be 
scrutinized with the Investigator: subject informed consent, subject recruitment and follow-up, 
Adverse Event documentation and reporting, outcome events documentation and reporting, 
Investigational Product allocation, Investigational Product accountability, and quality of data. 
 

 
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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 this personnel is 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 START DATE (Planning) 
8 
JULY 10, 2017 
PROPOSED SITE TRAINING & INITIATION 
PHASE 
1 
NOVEMBER 20, 2017 
PROPOSED RECRUITMENT (1st subject in 
to last subject out) 
12 - 14 
NOVEMBER 27, 2017 
PROPOSED DATABASE LOCKOUT 
4 
MARCH 16, 2018 
PROPOSED STUDY REPORT 
COMPLETION 
4 
MARCH 30, 2018 
TOTAL (WEEKS / MONTHS) 
34 / 81/2 
 
ESTIMATED COMPLETION (QUARTER) 
Q2 FY2018 
APRIL 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 

 
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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.   
 
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 REFERENCED DOCUMENTS 
20.1 Informed Consent Documents 
- 
TDOC5Fr-PEDS-01-AF1 – Pediatric Assent Form 
 
- 
TDOC5Fr-PEDS-01-ICF1 – Informed Consent Form 
 
- 
TDOC5Fr-PEDS-01-AF3 - Pediatric Assent Form 
 
- 
TDOC5Fr-PEDS-01-ICF3 - Informed Consent Form 
 
- 
TDOC5Fr-PEDS-01-AF2 - Pediatric Assent Form 
  
- 
TDOC5Fr-PEDS-01-ICF2 - Informed Consent Form 
 
- 
TDOC5Fr-PEDS-01-HA - HIPAA Authorization 
  
- 
TDOC5Fr-PEDS-01-HA - HIPAA Authorization 
 
20.2 Investigator’s Brochure  
- 
TDOC5Fr-PEDS-01-IB T-DOC 5 French Investigator’s Brochure 
 
20.3 Case Report Forms:  
- 
TDOC5Fr-PEDS-01-CRF1 - Case Report Form 1 
- 
TDOC5Fr-PEDS-01-CRF2 - Case Report Form 2 
- 
TDOC5Fr-PEDS-01-CRF3 - Case Report Form 3 
- 
TDOC5Fr-PEDS-01-CRF4 - Case Report Form 4 
 
21 BIBLIOGRAPHY  
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Wein A. (2013) Recommendations of the International Scientific Committee: Evaluation 
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(1984). Predictive Value of Urodynamic Evaluation in Newborns With Myelodysplasia. 
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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 
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Digesu, G. A., Derpapas, A., Robshaw, P., Vijaya, G., Hendricken, C., & Khullar, V. (2014). Are the 
measurements of water-filled and air-charged catheters the same in urodynamics? 
International Urogynecology Journal, 25(1), 123–130. https://doi.org/10.1007/s00192-
013-2182-z 
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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Gammie, A., Clarkson, B., Constantinou, C., Damaser, M., Drinnan, M., Geleijnse, G., … (The 
International Continence Society Urodynamic Equipment Working Group). (2014). 
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… Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. (2012). 
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. Urodynamic Clinical Testing. Reference Doc#PD-TR-151-01