e۰Sense® Clinical Investigation: Assessing the Performance, Safety and Usability of e۰Sense® Electronic Catheters for Performing Urodynamic Studies
Phase: NA
Conditions: Urodynamics
Sponsor: Laborie Medical Technologies Inc.

DEFAULT
8/24/2021
1
Document Detail
Type:
CLN
CLN-00021[B]
Document No.:
eSense Clinical Investigation Protocol
Title:
ADELE.CAMPBELL Adele Campbell
Owner:
CURRENT
Status:
Effective Date:
Expiration Date:
24-Aug-2021
Document Build 
No.
Access Activity
Accessed By
Accessed Date
Revision Notes
 1
Check In
20-Aug-2021
ADELE.CAMPBELL
Note:
Draft was been approved by ANSM, only make changes if absolutely necessary.
 1
Check In
23-Aug-2021
ADELE.CAMPBELL
Note:

8/24/2021
2
Document Detail
Review
Document Approval
Review Purpose:
The purpose of this review is to approve the document for pre-release.
Review:
Build No.:
 1
Closed Date:
8/24/2021   7:12:32PM
Review Note:
SYSTEM AUTO CLOSE REVIEW
Sign-off By
Actor
Owner Role
Level
Sign-off Date
LAURIE.BRADBURY
LAURIE.BRADBURY Laurie 
Bradbury
CP_Approver_Quality-UNV Change 
Plan Approver Quality Universal
 1
24-Aug-2021   7:12 pm
Note To Approver: 
Note From Approver:
ADELE.CAMPBELL
ADELE.CAMPBELL Adele 
Campbell
CP_Owner Change Plan Owner
 1
23-Aug-2021   3:49 pm
Note To Approver: 
Note From Approver:Ready for release
CHRISTA.BLAISDELL
CHRISTA.BLAISDELL Christa 
Blaisdell
CP_Approver_Regulatory-UNV 
Change Plan Approver Regulatory 
Universal
 1
24-Aug-2021  12:55 pm
Note To Approver: 
Note From Approver:
NICOLE.BOSER
NICOLE.BOSER Nicole Boser
CP_Approver_Quality-Corporate 
Change Plan Approver Quality - 
Corporate
 1
23-Aug-2021   4:37 pm
Note To Approver: 
Note From Approver:
GRASSO.EBAKO
GRASSO.EBAKO Grasso Ebako
CP_Approver_Clinical-UNV Change 
Plan Approver Clinical Universal
 1
23-Aug-2021   4:00 pm
Note To Approver: 
Note From Approver:
GRASSO.EBAKO
BRUNA.COURI Bruna Couri
CP_Approver_Clinical-UNV Change 
Plan Approver Clinical Universal
 1
23-Aug-2021   4:01 pm
Note To Approver: 
Note From Approver:
ROSS.MCQUIVEY
ROSS.MCQUIVEY Ross 
McQuivey
CP_Approver_ExecutiveTeam-UNV 
Change Plan Approver Executive 
Team Universal
 1
23-Aug-2021   3:52 pm
Note To Approver: 
Note From Approver:Approved as written
DEB.KURTZ
DEB.KURTZ Deb Kurtz
CP_Approver_Marketing-UNV 
Change Plan Approver Marketing 
Universal
 1
23-Aug-2021   7:58 pm
Note To Approver: 
Note From Approver:Approve

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 1 of 41 
 
 
 
 
 
 
CLINICAL INVESTIGATION PROTOCOL 
 
DEVICE: 
e۰Sense® Electronic Vesical and Abdominal Urodynamic Catheters 
 
STUDY NUMBER: 
 ESNS-PH01 
 
STUDY NAME: 
e۰Sense® Clinical Investigation:  
Assessing the Performance, Safety and Usability of e۰Sense® Electronic Catheters for 
Performing Urodynamic Studies 
 
Laborie Document Control ID: 
CLN-00021  
 
Version B 
 
August 20, 2021 
 
 
 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 2 of 41 
 
 
ESNS-PH01 
e۰Sense® Clinical Investigation:  
Assessing the Performance, Safety and Usability of e۰Sense® Electronic Catheters for 
Performing Urodynamic Studies 
Document History 
 
Version 
Date 
Effective 
Changes 
Rationale for Change 
Creation 
1.0 
October 28, 
2019 
- 
Initial Release 
Amendment 
1.01 
December 
30, 2019 
New text under 10.1 to 
refer to CTA for country-
specific safety 
definitions. 
New sentence after 1st 
paragraph in 10.3, 
referring to CTA for 
institution-specific safety 
reporting requirements 
and details. 
Address comments 
from BfArM (German 
Regulatory Body) to 
clearly reference CTA 
for details of safety 
requirements. 
Amendment 
1.02 
January 20, 
2020 
Revised Sections 7.4 (End 
of Study) and 7.5 (Follow-
up) to clearly define end 
of the study for study 
subjects, further 
treatment and the 
follow-up plans. 
Revised text under 10.1 
to refer to safety 
reporting guidelines for 
country-specific safety 
definitions. 
Added definition and 
Section 10.1.7 - Serious 
adverse device effect 
Revised Section 10.3 with 
further information and 
Additional feedback 
received from 
competent authority 
reviewer. 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 3 of 41 
 
 
Version 
Date 
Effective 
Changes 
Rationale for Change 
reference to safety 
reporting guidelines for 
country-specific safety 
reporting requirements 
and details. 
Amendment 
V1.03 
March 10, 
2020 
Added e۰Sense® 
terminology in Section 1 
(List of Abbreviations & 
Definitions) 
Added part numbers of 
investigational devices 
under assessment in 
Section 3.3 (Medical 
Devices) 
Section 11.2.2 corrected 
Section references.  
Additional feedback 
received from 
competent authority 
reviewer. 
Amendment 
V1.04 
July 31, 2020 
(1) Amend Section 7.2 of 
protocol to expand on 
methods that can be 
used for quality checks.  
(1) Review of study 
methods against 
COVID-19 
recommendations for 
good urodynamic 
practice.  
(2) New text added to 
Section 12 regarding 
pseudonymized data 
transfer. 
(2) Clarify location of 
pseudonymized data 
transfer. Information is 
consistent with the 
patient consent and 
privacy consent.  
(3) General grammar / 
language updates (added 
EU and US abbreviations, 
corrected Section 11 tile 
to “STATISTICAL 
CONSIDERATIONS”). 
(3) Newly used 
abbreviations added 
(EU and US), Section 11 
title error required 
correction, previously 
stated “Adverse Event 
CONSIDERATIONS”. 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 4 of 41 
 
 
Version 
Date 
Effective 
Changes 
Rationale for Change 
(4) Amend the 
anticipated dates as 
listed in Table 2. 
(4) Due to delays 
experienced from the 
COVID-19 pandemic 
and project timelines, 
anticipated dates and 
durations are 
extended.  
Amendment 
B 
Refer to  
SmartSolve 
(CHANGE-
PLN-PNHL-
01150) 
(1) Additional sentence 
added on page 5 to 
clarify the applicable 
health code. 
(1) European regulation 
(EU) 2017/45 entered 
in to force on May 26, 
2021 prevails over 
public health code in 
EU Member States 
where applicable. 
(2) Amend the 
anticipated dates as 
listed in Table 2. 
(2) Due to delays 
experienced from the 
COVID-19 pandemic 
and project timelines, 
anticipated dates and 
durations are 
extended.  
(3) Update to Section 
10.1 Patient Safety 
Definitions. 
(3) Include reference to 
the definitions and 
reporting procedures 
for serious adverse 
events and device 
deficiencies in 
accordance with the 
provisions of Article 80 
of MDR (EU) 2017/745. 
(4) Update to Section 
10.5 Contact Information 
regarding adverse event 
reporting to Laborie as 
study sponsor.  
(4) IT system navigation 
made the existing 
telephone number for 
safety reporting 
telephone line 
obsolete, a new 
number is provided.  
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 5 of 41 
 
This is a premarket clinical research protocol for a pivotal human research study. This study is 
conducted in accordance with the clinical protocol, Good Clinical Practice, ISO 14155, local 
regulations, and with the ethical principles that have their origin in the Declaration of Helsinki. 
For clinical research conducted in the European Union (EU) Member States, the Medical Device 
Regulation EU 2017/745 entered in to force on May 26, 2021, which prevails over the national 
public health code in matters of conflicting information.  
 
 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 6 of 41 
 
Table of Contents 
1 
List of Abbreviations & Definitions ..................................................................................................... 9 
2 
Clinical Study Summary .................................................................................................................... 11 
3 
INTRODUCTION ................................................................................................................................ 12 
3.1 
Background ............................................................................................................................ 12 
3.2 
Rationale ................................................................................................................................ 13 
3.3 
Medical Device ....................................................................................................................... 13 
3.4 
Purpose & Use ........................................................................................................................ 14 
3.5 
Prior Literature & Studies ...................................................................................................... 14 
3.6 
Risks and Benefits .................................................................................................................. 14 
4 
STUDY OBJECTIVES ........................................................................................................................... 15 
4.1 
Primary Objectives ................................................................................................................. 15 
4.2 
Secondary Objectives ............................................................................................................. 15 
4.3 
Exploratory Objectives ........................................................................................................... 15 
5 
STUDY DESIGN .................................................................................................................................. 16 
5.1 
Description ............................................................................................................................. 16 
5.2 
Study Duration ....................................................................................................................... 17 
5.3 
Suspension or Premature Termination .................................................................................. 17 
6 
PATIENT SELECTION .......................................................................................................................... 18 
6.1 
Inclusion Criteria .................................................................................................................... 18 
6.2 
Exclusion Criteria .................................................................................................................... 18 
6.3 
Vulnerable Populations .......................................................................................................... 19 
6.4 
Recruitment Plans .................................................................................................................. 19 
6.5 
Informed Consent Process ..................................................................................................... 19 
6.6 
Subject Withdrawal ................................................................................................................ 20 
7 
STUDY PROCEDURE .......................................................................................................................... 20 
7.1 
Study & Visit Schedule ........................................................................................................... 20 
7.2 
Clinic Visit ............................................................................................................................... 21 
7.3 
Telephone Follow-Up ............................................................................................................. 22 
7.4 
End of Study (EOS) ................................................................................................................. 22 
7.5 
Follow-Up ............................................................................................................................... 22 
8 
MANAGEMENT OF MEDICAL DEVICE ............................................................................................... 23 
8.1 
Description ............................................................................................................................. 23 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 7 of 41 
 
8.2 
Regimen ................................................................................................................................. 24 
8.3 
Assignment to Groups ............................................................................................................ 24 
8.4 
Preparation and Handling ...................................................................................................... 24 
8.5 
Packaging and Labelling ......................................................................................................... 24 
8.6 
Device Accountability ............................................................................................................. 24 
8.6.1 Laborie to Study Site: .......................................................................................................... 24 
8.6.2 Study Site Usage: ................................................................................................................. 24 
8.6.3 Study Site to Laborie: .......................................................................................................... 24 
8.7 
Concomitant Treatment ......................................................................................................... 25 
8.8 
Subject Compliance Monitoring............................................................................................. 25 
9 
ASSESSMENT OF INVESTIGATIONAL DEVICE .................................................................................... 25 
9.1 
Endpoints ............................................................................................................................... 25 
9.2 
Methods of Assessment ......................................................................................................... 27 
10 
PATIENT SAFETY................................................................................................................................ 27 
10.1 Definitions .............................................................................................................................. 27 
10.1.1 Adverse Events: ................................................................................................................... 27 
10.1.2 Adverse Device Effect: ........................................................................................................ 28 
10.1.3 Device Deficiency: ............................................................................................................... 28 
10.1.4 Serious Adverse Event:........................................................................................................ 28 
10.1.5 Unanticipated Serious Adverse Device Effect: .................................................................... 28 
10.1.6 Severe Complications: ......................................................................................................... 28 
10.2 Data Collection ....................................................................................................................... 29 
10.3 Reporting ................................................................................................................................ 29 
10.4 Foreseeable Events ................................................................................................................ 30 
10.5 Contact Information ............................................................................................................... 30 
10.6 Follow-Up ............................................................................................................................... 30 
11 
STATISTICAL CONSIDERATIONS ........................................................................................................ 30 
11.1 Primary Analyses .................................................................................................................... 30 
11.1.1 Primary Endpoint ................................................................................................................ 30 
11.1.2 Sample Size Determination & Power: ................................................................................. 31 
11.2 Secondary Analyses ................................................................................................................ 31 
11.2.1 Secondary Endpoint: ........................................................................................................... 31 
11.2.2 Sample Size Determination & Power: ................................................................................. 32 
11.3 Exploratory Analyses .............................................................................................................. 32 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 8 of 41 
 
11.3.1 First Exploratory Endpoint: ................................................................................................. 32 
11.3.2 Second Exploratory Endpoint.............................................................................................. 33 
11.3.3 Third Exploratory Endpoint ................................................................................................. 33 
11.3.4 Fourth Exploratory Endpoint .............................................................................................. 33 
11.4 Randomization / Blinding ....................................................................................................... 33 
11.5 Analysis Population ................................................................................................................ 33 
11.6 Deviations............................................................................................................................... 34 
11.7 Interim Analysis ...................................................................................................................... 34 
12 
DATA HANDLING & RECORD KEEPING ............................................................................................. 34 
12.1 Direct Access .......................................................................................................................... 34 
12.2 Confidentiality & Security ...................................................................................................... 34 
12.3 Data Handling ......................................................................................................................... 35 
12.4 Case Report Form (CRF) & Source Documents ...................................................................... 35 
12.5 Record Retention ................................................................................................................... 36 
12.6 Performance Monitoring ....................................................................................................... 36 
13 
MONITORING, AUDITING, AND INSPECTING .................................................................................... 36 
13.1 Study Monitoring Plan ........................................................................................................... 36 
13.2 Auditing and Inspecting ......................................................................................................... 37 
14 
DEVIATIONS ...................................................................................................................................... 38 
15 
AMENDMENTS .................................................................................................................................. 38 
16 
STUDY ADMINSTRATION .................................................................................................................. 38 
16.1 Funding Source and Conflicts of Interest ............................................................................... 38 
16.2 Subject Stipends or Payments ................................................................................................ 39 
16.3 Committees ............................................................................................................................ 39 
17 
ETHICS AND REGULATORY APPROVAL ............................................................................................. 39 
18 
PUBLICATION POLICY ........................................................................................................................ 39 
19 
RELATED STUDY DOCUMENTS .......................................................................................................... 39 
19.1 Informed Consent Documents ............................................................................................... 39 
19.2 Case Report Forms ................................................................................................................. 39 
19.3 Investigator Brochure ............................................................................................................ 40 
20 
REFERENCES...................................................................................................................................... 40 
 
 
 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 9 of 41 
 
1 List of Abbreviations & Definitions 
ACC 
Air-Charged Catheters 
COGS 
Cost of Goods Sold 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
EC 
Ethics Committee 
EMA 
European Medicines Agency 
EN 
European Standards 
EOS 
End of Study 
e۰Sense® 
Tradename used to describe the urodynamics catheter technology being 
tested in this clinical investigation.  
 
The terminology used throughout this document refers to the previous 
version of the device as the “existing” or “currently marketed” e۰Sense® 
catheter bearing CE-mark with part numbers as follows:   
 37041005 – 7 FR Bladder (Single Sensor) Urodynamic Catheter 
 37041105 – 7 FR Bladder (Single Sensor Coudé) Urodynamic 
Catheter  
 37042005 – 7 FR Bladder & Urethral (Dual Sensor) Urodynamic 
Catheter 
 37042105 – 7 FR Bladder & Urethral (Dual Sensor Coudé) 
Urodynamic Catheter 
 37040005 – 7 FR Abdominal Urodynamic Catheter  
 
The new version (test product) is referred to as the “updated” e۰Sense® 
catheter, and is the investigational device being evaluated as part of this 
study with part numbers as follows: 
 CATEB27 – e۰Sense® 7 FR Single Sensor Bladder Catheter 
 CATEB37 – e۰Sense® 7 FR Dual Sensor Urethral Catheter  
 CATEA17 – e۰Sense® 7 FR Abdominal Catheter  
 CATEB27C – e۰Sense® 7 FR Single Sensor Coudé Bladder Catheter 
(NOT WITHIN SCOPE OF THIS STUDY) 
 
CATEB37C – e۰Sense® 7FR Dual Sensor Coudé Urethral Catheter 
(NOT WITHIN SCOPE OF THIS STUDY) 
EU 
European Union 
Exploratory 
Synonymous with the term observational  
FPFV 
First Patient First Visit 
GDPR 
European General Data Protection Regulation (EU) 2016/679 
Fr 
French 
ICF 
Informed Consent Form 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 10 of 41 
 
ICS 
International Continence Society 
IP 
Investigational Product 
ISO 
International Organization for Standardization  
LPLV 
Last Patient Last Visit 
LUT 
Lower Urinary Tract  
MCC 
Maximum Cystometric Capacity 
MMS 
Medical Measurement Systems 
NPRS 
Numerical Pain Rating Scale 
Pabd 
Abdominal Pressure 
Pdet 
Detrusor Pressure 
PI 
Principal Investigator 
Pura 
Urethral Pressure 
Pves 
Intravesical Pressure 
SCI 
Spinal Cord Injury 
Subject 
Individual who participates in the clinical investigation.  Synonymous with 
the term patient.  
UDS 
Urodynamics 
UPP 
Urethral Pressure Profile 
US 
United States 
VUDS 
Video Urodynamics 
WFC 
Water-Filled Catheters 
WPU 
Wireless Patient Unit 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 11 of 41 
 
2 Clinical Study Summary 
Number of Sites 
Two to Four 
Number of Subjects  
Minimum 60 and Maximum 65 (minimum 15 recruited at each site) 
Objective 
The primary objective of this pivotal study is to gather clinical data as follows: 
 
Confirm that the updated e۰Sense® catheters are safe and effective for 
urodynamic use in subjects medically indicated for urodynamics (UDS) 
testing.  
The secondary objectives of this study are to gather clinical data as follows: 
 
To report the severe complication-free rate for the updated e۰Sense® 
catheters.  
The following exploratory objectives of this study are to gather data on the 
following:  
 
Assess subjective subject feedback regarding the discomfort and pain 
levels.  
 
Assess user impressions of the updated e۰Sense® catheters compared 
with their experience using the existing catheters at their site, by 
evaluating the following subjective measures: ease of use, ease of 
insertion and removal, ease of securing the catheter, tracing stability 
(overall, during filling, voiding and UPP where applicable), tracing 
quality (overall, Pves, Pabd, Pura where applicable), channel 
subtraction quality, visibility on Video Urodynamics (VUDS, where 
applicable), catheter stiffness, sensor location, patient tolerance, and 
overall usability performance.  
 
Assess pre-test resting pressures while sitting, standing and supine, 
where patient is able. 
 
Assess resting pressures at the recorded patient position during various 
points of the UDS test (every 100mL of filling, at maximum cystometric 
capacity (MCC) and post-void).  
Inclusion criteria 
Male and Female subjects (Age: 21 years and over) who are medically indicated 
for UDS testing. 
Exclusion criteria 
 
Subjects with significant cognitive deficiency that prevent the patient from 
giving informed consent 
 
Subjects suffering from an active bladder infection (not including subjects 
with asymptomatic bacteriuria) 
 
Pregnant women 
 
Subjects with recent (less than 2 weeks) pelvic floor surgery 
 
Subjects who require the use of a suprapubic catheter 
Anticipated Study 
duration 
The proposed recruitment phase following site initiation from First Patient First 
Visit (FPFV) to Last Patient Last Visit (LPLV) is approximately 18 weeks per site.  
 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 12 of 41 
 
Subjects will come to the clinic for one visit, the UDS procedure, where data 
pertaining to the safety, effectiveness, and usability aspects of the e۰Sense® 
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 
Each subject will be contacted three to five days post-test in order to record the 
occurrence of any adverse events.  Any subject with persistent symptoms shall 
be followed until it is resolved, and the site must notify Laborie of the outcome 
of the follow-up. Any follow-up medical intervention prescribed is at the 
discretion of the Investigator.   
Study end point 
Once each site has met the minimum recruitment goal of 15 subjects, the 
sponsor will be informed. Following this, the site may have the option to 
continue recruitment until the study-wide maximum is reached, based on the 
discretion of the sponsor. Additional enrolment following the minimum 
recruitment goal will be dictated by the final number of sites initiated.  
3 INTRODUCTION 
3.1 
Background 
UDS catheters are a urological device that are intended for transient (<60 min) and short-term 
use (>60 but <120 min) during conventional invasive UDS examinations. Ambulatory UDS 
monitoring (>120 minutes) conducted outside of a lab setting can also be prescribed when 
medically indicated, however ambulatory cases will not be performed as part of this study.  
Initially, water-filled catheters (WFC) were the only UDS catheter technology available and only 
intravesical (Pves) pressure was assessed1. However, with the demand for different and better 
ways to assess lower urinary tract (LUT) dysfunction, multiple catheter technologies have been 
developed. Currently, there are several different UDS catheter-based technologies available: 
WFC, Air-Charged Catheters (ACC), and electronic catheters such as the e۰Sense® solid-state 
catheters. The legal manufacturer for the 1st generation e۰Sense® UDS catheters is PendraCare 
International B.V., however this technology is now owned by Laborie Medical Technologies.  
The e۰Sense® urodynamic catheters consist of three configurations, which were released on 
the market in February 2014:  
1) 7Fr bladder and urethral (dual sensor) catheter  
2) 7Fr bladder (single sensor) catheter  
3) 7Fr abdominal (single sensor) catheter 
The e۰Sense® UDS catheters are intended to perform pressure measurement in the bladder, 
urethra, and rectum or vagina. The e۰Sense® coudé tip catheters (part numbers CATEB27C, 
CATEB37C) are not within the scope of this study and will not be available for this clinical 
investigation. 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 13 of 41 
 
3.2 
Rationale  
This study involves testing an updated e۰Sense® catheter design, which is based on the 
currently CE marked e۰Sense® catheter technology, on human subjects. The design has been 
changed to remove copper wires in the lumen and add the original flex print with the intent of 
making the product manufacturable in higher quantities. Since the updated e۰Sense® catheter 
is based on an existing design, there are clinical and non-clinical data showing the safety, 
performance and usability of the existing catheter. However, due to the design changes, further 
clinical evidence is required to confirm the updated e۰Sense® catheters are safe and effective 
prior to market release. The aim of this pre-market study is to collect clinical data on the 
updated e۰Sense® catheters’ usability, confirm they are safe and effective for UDS studies, and 
to assess subjective user impressions of the updated e۰Sense® catheters compared with their 
experience using the existing catheters at each site. 
3.3 
Medical Device 
The catheters used in the 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. 
e۰Sense® 7Fr Single Sensor Bladder Catheters (blue connector) 
 
Part number: CATEB27 
2. 
e۰Sense® 7Fr Abdominal Catheters (red connector) 
 
Part number: CATEA17 
3. 
e۰Sense® 7 Fr Dual Sensor Urethral Catheters, available for optional urethral 
pressure measurement studies (blue connector) 
 
Part number: CATEB37 
Traceability of investigational study materials will be captured and maintained via an Inventory 
Control Log. Any remaining investigational material stock after study close out, will be returned 
to the study sponsor at the sponsors’ expense. 
The e۰Sense® urodynamic catheters are manufactured using a Technical Polyurethane (TPU) 55 
Durameter, a silicone adhesive, a UV curing adhesive, and an epoxy adhesive.  These materials 
are all verified as biocompatible in accordance with the standards EN ISO 10993-5 and -10 and -
18 – Biological evaluation of medical devices. 
None of the materials 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 (US) and Canada, respectively: 
- 
For the European Union (EU), Class IIa, Rule 5 per Annex IX of the Medical Device 
Directive and Annex VIII of the Medical Device Regulation (EU MDR 2017/745) 
entering in to force on May 26, 2021 in EU Member States. 
- 
For the US, Class II per 21 CFR 876.1620 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 14 of 41 
 
- 
For Canada, Class II, Rule 2 per Health Canada Medical Device Regulations 
(SOR/98-282) 
3.4 
Purpose & Use 
Intended Use: The e۰Sense® catheters are intended to be used to fill the bladder and/or 
measure pressure within bladder, urethra, and rectum or vagina during UDS study on a patient. 
Indications for Use: The e۰Sense® catheters are provided sterile and intended for single use on 
patients requiring UDS pressure monitoring through the measurement of bladder, urethral, and 
rectal (or vaginal) pressures. 
Target Users: Use of product is restricted to health professionals with relevant and adequate 
training (e.g. urologist, gynaecologists, physician assistant urology/gynaecology, specialist 
urology/gynaecology nurses, urodynamicists), and who are familiar with the 
possible/conceivable complications in a urology examination room (e.g. hospital or medical 
clinic with appropriate facilities). 
Medical Indications: Use of the product is limited to diagnostic examinations during UDS study 
of patients presenting with LUT symptoms suggestive of a medical disorder/dysfunction related 
to the urinary tract. 
3.5 
Prior Literature & Studies 
Since the e۰Sense® catheter is one of the newest urodynamics catheter technologies available 
on the market, there are limited published literature available making use of the technology.   
Please refer to the Investigator’s Brochure (ESNS-PH01-IB) for a detailed review of the literature 
and study data (clinical and non-clinical) available to date.  
3.6 
Risks and Benefits 
Risks to the subject will be no greater than those of a conventional UDS test. Physicians are 
responsible for determining whether subjects are medically indicated and would benefit from 
UDS testing. There is no direct subject benefit for participating other than to gather evidence of 
e۰Sense® urodynamic catheters’ clinical use.  
There is also no need for any repeat catheterization or UDS testing using an approved (non-
investigational) UDS catheter.  UDS test results using the investigational device will be provided 
back to the referring physician for test interpretation. The investigational device must first pass 
design verification and manufacturing process validation in accordance with ISO 13485 before it 
can be used in this clinical investigation. Given this, the sponsor has no reason to suspect device 
safety and performance will be any different as compared to the currently marketed e۰Sense® 
UDS catheter. Therefore, the data collected using the investigational device will be used in the 
test interpretation for each subject enrolled, unless there is reason to believe the test should be 
repeated. This can happen under normal (non-investigational) circumstances if the test was 
inconclusive2.  
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 15 of 41 
 
Subjects may experience temporary discomfort upon insertion of the catheters. Test duration 
may be slightly longer than a standard test while assessment of the study materials is being 
made, and so discomfort and inconvenience associated with an extended test duration may 
occur. 
UDS testing exposes subjects to risks of urethral instrumentation which can result in infection, 
urethral trauma and pain3. Other risks can include transient discomfort during or following the 
procedure, transient dysuria or bleeding (haematuria) following the procedure, or urinary tract 
infection, which occurs in approximately 2-4% of subjects4. Autonomic dysreflexia can also 
occur in those patients with spinal cord injury (SCI), and those at the level of T6 or higher are 
particularly prone5,6.  As well, accidental ureter catheterization, where the ureter orifice is 
accidentally catheterized, can occur.  A summary of the available safety data concerning these 
risks is presented in the Investigator’s Brochure.   
The overall risks associated with the use of e۰Sense® catheters within this study set-up are 
acceptable when weighed against the benefits and are no different than the risks encountered 
when using other UDS catheter technologies. Lastly, UDS is a widely performed test on subjects 
requiring specialized management for urinary incontinence/retention problems, as 
recommended by the International Continence Society (ICS)7, and is useful in characterizing LUT 
function, identifying causes of symptoms and quantifying related pathophysiological 
processes8. Thus, the clinician must weigh the risks and benefits as to whether the UDS test 
offers additional diagnostic value beyond symptom assessment, physical examination and other 
diagnostic testing3. 
Refer to: ESNS-PH01-IB-01-VXX - eSense Investigator’s Brochure (PRC-026597) 
4 STUDY OBJECTIVES 
4.1 
Primary Objectives 
The primary objective of this pivotal study is to gather clinical data as follows: 
 Confirm that the updated e۰Sense® catheters are safe and effective for urodynamic use 
in subjects medically indicated for urodynamics testing.  
4.2 
Secondary Objectives 
The secondary objective of this pivotal study is to gather clinical data as follows: 
 To report the severe complication-free rate for the updated e۰Sense® catheters.  
4.3 
Exploratory Objectives 
The following exploratory objectives of this study are to gather data on the following:  
 Assess user impressions of the updated e۰Sense® catheters compared with their 
experience using the existing catheters at each site, by evaluating the following 
subjective measures: ease of use, ease of insertion and removal, ease of securing the 
catheter, tracing stability (overall, during filling, voiding and UPP where applicable),  
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 16 of 41 
 
tracing quality (overall, Pves, Pabd and Pura where applicable), channel subtraction 
quality, visibility on VUDS (where applicable), catheter stiffness, sensor location, patient 
tolerance, and overall usability performance. 
 Assess subjective subject feedback regarding their discomfort and pain levels.  
 Assess pre-test resting pressures while sitting, standing and supine, where patient is able.  
 Assess resting pressures at the recorded patient position during various points of the 
UDS test (every 100mL of filling, at MCC, and post-void).  
5 STUDY DESIGN 
5.1 
Description 
This premarket, single-arm, open-label study will be conducted where subjects will undergo a 
conventional UDS study that will be conducted according to Good Urodynamic Practices9 using 
the investigational device. As explained in Section 3.6, there is no need for any repeat 
catheterization or repeat UDS test using an approved (non-investigational) UDS catheter.  
Urodynamic test results using the investigational device will be provided back to the referring 
physician for test interpretation. The urodynamic information collected using the 
investigational device will be used in the UDS test interpretation for each subject enrolled, 
unless there is reason to believe the test should be repeated (i.e. inconclusive results).   
Subject data including age, relevant medical history, height, weight, adverse events during or 
after the test, etc., will be collected on each subject’s Case Report Form (CRF). 
The following table gives a high-level overview of the study design and subject flow-through, as 
well as identifying which items are considered standard of care vs. non-standard clinic/hospital 
procedures.  
Table 1. High-level overview of subject flow-through within this study, indicating whether item is 
considered standard of care or non-standard clinic/hospital procedure. 
Item # 
Subject Study Flow-Through 
Standard vs.  
Non-standard Procedures & 
Data Collection Points 
1 
Adult subjects are referred for UDS testing 
Standard  
2 
Subjects are approached to enrol in the study during their 
UDS visit and provide voluntary informed consent 
Non-standard  
3 
UDS testing is conducted according to Good Urodynamic 
Practices9 and standard clinic/hospital procedures, as per 
the needs of the patient. 
Standard  
3a 
Pre-test resting pressures are recorded while sitting, 
standing and supine, where patient is able.  
Non-standard 
4 
CRFs are completed (UDS Visit, Relevant Medical History, 
Clinical User and Subject Questionnaires, Adverse Event, 
Device Deficiency and Follow-up)  
Non-standard 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 17 of 41 
 
Item # 
Subject Study Flow-Through 
Standard vs.  
Non-standard Procedures & 
Data Collection Points 
4a 
Adverse events are documented and followed until 
resolution. Telephone call 3-5 days to record any adverse 
events experienced post-test.  
Standard/Non-standard* 
*Depending on clinic/hospital policies, this item may be considered standard or non-standard.  
5.2 
Study Duration 
The expected duration of each subject’s participation is one clinic visit to receive their already 
requested UDS test. A follow-up call will be conducted three to five days later to collect adverse 
event information post-test.   
Once ethics board approval is received, site training and initiation is expected to take 1-2 
weeks. The duration of active recruitment for this study is estimated at 37 weeks. Database 
lockout and study report completion is estimated at approximately 7 weeks after the last 
subject is recruited.  The entire study is anticipated to take a total of 43 weeks, refer to Table 2 
for details. 
Table 2. Proposed Study Timeline 
PROPOSED STUDY TIMELINE 
TOTAL DURATION 
(WEEKS) 
ANTICIPATED DATES 
PROPOSED SITE TRAINING & INITIATION PHASE 
2  
June 2020 
PROPOSED RECRUITMENT:1st subject in to 30 
(Primary Objective) 
20 
June 2020 – 
December 2020 
PROPOSED RECRUITMENT: Thirty to last subject 
out (Secondary Objective) 
17 
September 2021 – 
December 2021 
PROPOSED DATABASE LOCKOUT 
1 
January 2022 
PROPOSED STUDY REPORT COMPLETION 
6 
Q1 2022 
TOTAL (WEEKS) 
43 
 
ESTIMATED COMPLETION (QUARTER) 
Q1 2022 
March 2022 
NOTE: Anticipated dates and timeline may be updated based upon COVID-19 pandemic 
situation and recruitment rates.  
 
 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 18 of 41 
 
5.3 
Suspension or Premature Termination 
The investigation may be suspended or prematurely terminated by the Investigator, Sponsor, 
EC or Regulatory Authority for significant and documented reasons. The terminating party shall 
justify its decision and promptly inform the other parties with whom they are in direct 
communication.   
Should a new risk or serious health threat arise during the course of the investigation, a risk 
assessment may determine the risk to subjects is unacceptable when weighed against the 
benefits. The investigation may then be prematurely terminated by either the Sponsor, 
Principle Investigator, EC or Regulatory Authority.   
All investigation subjects will be informed with appropriate follow-up should the study be 
suspended or prematurely terminated due to a safety concern or serious health threat.   
Other reasons for suspension or premature termination include:  
- 
Serious or repeated protocol deviations  
- 
Slow recruitment exceeding project timelines 
- 
Investigational device is not producing expected results  
Following a suspension, the risk assessment may determine appropriate corrective actions 
necessary to allow the study to resume. The rationale and relevant data supporting this 
decision will be provided to the Investigator, EC and where appropriate, the regulatory 
authority. The Investigator or authorized designee shall inform enrolled subjects that the study 
has resumed, reasons for resumption, and reminded that they may withdraw from the study at 
any time, without penalty. The ICF shall be updated to include any new information pertaining 
to risks and potential adverse events.   
Early stopping or continuation of recruitment will be at Laborie’s discretion depending on 
project timelines and whether the minimums sample size has been recruited.  Early stopping 
will not depend on interim results. 
6 PATIENT SELECTION 
6.1 
Inclusion Criteria 
 Male and Female subjects (Age: 21 years and over) who are medically indicated for UDS 
testing.     
6.2 
Exclusion Criteria 
 Subjects with significant cognitive deficiency that prevent the subject from giving 
informed consent 
 Subjects suffering from an active bladder infection (not including subjects with 
asymptomatic bacteriuria) 
 Pregnant women 
 Subjects with recent (less than 2 weeks) pelvic floor surgery  
 Subjects who require the use of a suprapubic catheter 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 19 of 41 
 
6.3 
Vulnerable Populations 
The targeted subject group is not considered a vulnerable population. 
6.4 
Recruitment Plans 
To satisfy the primary objective, the target enrolment is a minimum of 30 subjects with an 
attempted UDS study (e۰Sense® catheter has made contact with the patient’s body). To satisfy 
the secondary objective, the target enrolment is a minimum 60 subjects with an attempted UDS 
study (e۰Sense® catheter has made contact with the patient’s body). In addition, the study 
sponsor will allow up to 65 subjects (5 additional) during the allowable recruitment and project 
time given the minimum recruitment goals are met. Please refer to Section 11 for details on 
sample size determination. 
Subjects who are visiting the UDS clinic for their medically indicated UDS test will be 
approached regarding participation in this study. It is estimated that study-wide recruitment of 
60 subjects should take approximately 18 weeks of active recruitment at each site. Recruitment 
will be monitored by Laborie through scheduled meetings with the site co-ordinator. If the 
subject signs the informed consent, this will be treated as the point of enrolment.   
The minimum number of clinical sites shall be two. The maximum number of sites allowed for 
this study shall be four. A minimum of 15 subjects per site is required to ensure proper 
distribution across sites. Once each site has met the minimum recruitment of 15 subjects, the 
sponsor will be informed. Following this, the site may have the option to continue recruitment 
until the study-wide maximum is reached, based on the discretion of the sponsor.  Additional 
enrolment following the minimum recruitment goal will be dictated by the final number of sites 
initiated.  
6.5 
Informed Consent Process 
The ICF used by the Investigator for obtaining the subject's informed consent must be reviewed 
and approved by the Sponsor, if any changes pertaining to site are changed/modified prior to 
submission to the appropriate EC for approval/favourable opinion. Once the approval letter is 
received from EC, the letter must be submitted to the sponsor prior to recruitment of subjects. 
The Investigator (according to applicable regulatory requirements), or a person designated by 
the Investigator and under the Investigator's responsibility, should fully inform the subject of all 
pertinent aspects of the clinical investigation, including the written information given approval 
by the Ethics Committee (EC). Any new information in regard to the study or investigational 
device will be provided to the subject by the site. All documentation given to subjects, including 
written consent, will be translated into the country’s official language for each investigational 
site. As part of the written Informed Consent Form (ICF), the subject will be informed on the 
processing of his/her personal data in accordance with Art. 13, 14 GDPR including a relevant 
declaration of consent to be signed separately. 
Prior to a subject’s participation in the clinical investigation, the ICF should be signed, full name 
printed and personally dated by the subject or by the subject’s legally acceptable 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 20 of 41 
 
representative, and by the person who conducted the informed consent discussion. A copy of 
the signed and dated ICF will be provided to the subject. 
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 
subjects being recruited are attending their UDS appointment as a pre-scheduled visit. 
6.6 
Subject Withdrawal 
Subjects may withdraw voluntarily from the study at any time, without penalty, or the 
Investigator may terminate a subject’s participation (see Section 5.3). The Investigator will 
notify the Sponsor when a subject has withdrawn from the study (and if possible, the reason for 
the withdrawal), and this will be recorded on the subject’s CRF. Subjects who withdraw, or 
those not considered to be part of the primary analysis population, will be allowed to be 
replaced by another subject should project timelines allow. Subjects will not be replaced due to 
poor results. This also applies in cases in which the subject withdraws his or her consent under 
data protection law according to Art. 7 GDPR. Please refer to Section 11 Statistical 
Considerations for further details.   
7 STUDY PROCEDURE 
7.1 
Study & Visit Schedule 
The study consists of two parts (Clinic Visit & Follow-up).  The subject consent and UDS Visit 
may or may not be condensed to one visit. Refer to Table 3 for details. 
Table 3. Visit Schedule. 
Evaluation 
Clinic Visit 
Post-Test 
UDS Visit 
Follow-up 
Informed Consent  
X 
 
Inclusion Criteria 
X 
 
Exclusion Criteria 
X 
 
Relevant Medical History 
X 
 
UDS Study 
X 
 
Record any Adverse Events 
X 
 
Complete CRFs 1, 2, 4, 5 for each subject 
and CRF 3 at the end of each clinic day. 
Complete CRF 6 (Device Deficiency Form) 
where applicable. 
X 
 
Complete CRF 7, three to five days post-test.   
 
X 
 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 21 of 41 
 
7.2 
Clinic Visit 
 Determine if the subject is eligible for the study. 
 Conduct informed consent discussion with the subject and complete signature section. 
 Conduct urine sediment or dipstick test. 
 Collect relevant medical history and record on the subject’s CRF (ESNS-PH01-CRF-02*).  
 Collect and record other subject details as required on ESNS-PH01-CRF-01* (weight, 
height, age, sex, subject condition (neurogenic or non-neurogenic), subject symptoms 
(storage or voiding), etc.). 
 Study personnel will explain what will happen during the UDS test to the subject or 
subjects’ representative. 
 Study personnel will prepare UDS equipment, study materials, other sterile disposables 
and supplies as required for the UDS study and record catheter LOT number information 
on ESNS-PH01-CRF-01*. 
 Follow the investigational device instructions for use to zero, place the catheters and 
record all necessary pre-test data on ESNS-PH01-CRF-01* (ie. insertion depth in cm, any 
problems during insertion). 
 Record pre-test Pves and Pabd resting pressures in each position: sitting, supine and 
standing on ESNS-PH01-CRF-01, where patient is able. 
 Conduct UDS study including quality checks according to ICS Good Urodynamic Practice9 
recommendations, ensuring good pressure transmission and catheter positioning 
wherever possible. A minimum of three quality checks (e.g. beginning, middle and end) 
must be performed during the study.  
 NOTE: As per ICS Good Urodynamic Practice, cough method is considered the 
gold standard as the primary quality check method9.  However, in light of the 
COVID-19 pandemic valsalva manoeuvre or gentle external pressure on the 
abdomen can be also considered an acceptable quality check method17.  The 
cough method still should be prioritized as the accepted gold standard, however 
should a situation arise where asking the patient to cough may not be 
appropriate (e.g. high-risk area, hospital policy) then valsalva or external 
pressure quality check methods can be performed.    
 At the conclusion of the UDS test, study personnel will ask subjects to answer questions 
on urodynamic discomfort/pain experience and record all data on ESNS-PH01-CRF-04*.  
 If the subject experiences any adverse events during their UDS test, the details are to be 
recorded on ESNS-PH01-CRF-05*.   
 Review urodynamic tracings post-test, and record the observed Pves and Pabd resting 
pressures every 100 mL of filling or where pressures are first stable (+/- 50mL) on ESNS-
PH01-CRF-01*. Add event markers at each point resting measurements are recorded 
and complete all other ESNS-PH01-CRF-01 sections*.  
 Investigator to complete Investigator Assessment and signature page on ESNS-PH01-
CRF-01*.  
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 22 of 41 
 
 After completing a day of Urodynamic procedures using the investigational device, the 
user will fill out the clinical user questionnaire and record all necessary data on ESNS-
PH01-CRF-03*. 
7.3 
Telephone Follow-Up 
 Three to five days post-test, site personnel will contact subjects by telephone to check 
whether any adverse events were experienced post-test. Call details to be documented 
on ESNS-PH01-CFR-07* and any adverse event information recorded on ESNS-PH01-CFR-
05*.  
Note: If an adverse event occurs during the study, any follow-up medical intervention 
prescribed is at the discretion of the Investigator. This information should also be recorded on 
the subject’s CRF (ESNS-PH01-CRF-01*) and adverse event form (ESNS-PH01-CRF-05*). 
Note: If a device deficiency occurs during the study, this information shall be recorded on the 
device deficiency case report form (ESNS-PH01-CRF-06)*. 
*All CRF’s, with de-identified subject tracings and video images (where applicable) must be sent 
to the sponsor (Laborie) for data collection/analysis. 
7.4 
End of Study (EOS) 
At the conclusion of their UDS test and clinic visit, the subject is no longer required to undergo 
any further study-related procedures.  Subject follow-up will be performed as described in 
Section 7.5 below. 
Once a site has completed its target recruitment, the sponsor (Laborie) will schedule a time to 
close-out the site, either in person or by telephone as per the monitoring plan. All study related 
files will be collected and reviewed for completeness. The EOS is considered the point when all 
subjects have been followed up and data collection is completed. 
7.5 
Follow-Up 
Study staff will telephone each subject three to five days post-test to inquire about possible 
adverse events that may have occurred after their UDS test.   All follow-up call details will be 
recorded on the follow-up CRF (ESNS-PH01-CFR-07) and update the subjects’ adverse event 
form (ESNS-PH01-CRF-05), where applicable.   
The focus of the follow-up call is to gather information about study-related adverse events, 
which are adverse events that are possibly, probably or definitely related to the study 
procedure.   
For subjects who did not experience any adverse events or were not experiencing symptoms at 
the time of their follow-up call, their direct involvement in the study ends at the time of the 
telephone follow-up call.  All subjects who did experience adverse events will be followed until 
resolution, and this information shall be recorded on the subject’s CRF (ESNS-PH01-CRF-01) and 
adverse event form (ESNS-PH01-CRF-05).  
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 23 of 41 
 
In the case of persistent adverse events, regular follow-up will be performed by study staff until 
resolution, at which point the subject’s direct involvement in the study will end.  Any follow-up 
medical intervention prescribed and frequency of future follow-ups to treat an adverse event, 
will be at the discretion of the Investigator.   
Since subjects who experience adverse events are being followed until resolution, the length of 
time a subject is participating in the study can vary.  A subjects participation will end if they 
report no adverse events at the three to five day follow-up call, or when the reported adverse 
event has resolved.  
Follow-up on any treatment decisions made by the Investigator are not the focus of the present 
study and will not be followed up.  Only adverse events related to the urodynamics procedure 
or use of the investigational device are the focus of the present study. 
8 MANAGEMENT OF MEDICAL DEVICE 
8.1 
Description 
The following devices and equipment will be required for each subject. Those indicated by 
asterisk (*) are to be sourced and provided by the sponsor and those indicated by “IP” are 
defined as investigational products: 
 Medical Measurement Systems (MMS) Nexam Urodynamic System already in use by the 
site, or on loan from the Sponsor 
 Uroflowmetry device configured with the UDS equipment and computer pressure-flow 
studies, already in use by site (optional) 
 One e۰Sense® 7Fr Abdominal Catheter per subject (*) (IP) 
 One e۰Sense® 7Fr Single Sensor Bladder Catheter or one e۰Sense® 7Fr Dual Sensor 
Urethral Catheter per subject (*) (IP) 
 EMG cable (optional component at the discretion of the site) 
 EMG patches (optional component at the discretion of the site) 
 Nexam wireless remote (optional component at the discretion of the site) 
 Wireless Patient Unit (WPU)  
 Pump tubing (*) 
 1000 mL beaker (optional) 
 One saline bag per subject  
 Tape  
 Lubricant  
 Gloves  
 Any other supplies deemed necessary for conducting a UDS study 
The clinical trial agreement (CTA) will further specify the equipment and disposables that will be 
provided to the site.  
Note: The CTA will supersede materials provided by Laborie listed above.  
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 24 of 41 
 
Note: Monitoring of electromyography (EMG) activity is considered optional at the discretion of 
the site and is not included in analysis of study endpoints.  The measurement of UDS pressures 
is not influenced by EMG activity also being measured simultaneously.   
8.2 
Regimen 
N/A – there is no treatment regimen required as part of this study. 
8.3 
Assignment to Groups 
No stratification of subjects will be utilized based on study design. 
8.4 
Preparation and Handling 
The UDS system and e۰Sense® catheters will be prepared and maintained by the physician or 
delegated site personnel. 
8.5 
Packaging and Labelling 
Investigational device labelling will appear on all investigational materials under Laborie’s and 
national regulations. A copy of the investigational label is shown in the Investigator’s Brochure. 
8.6 
Device Accountability 
All e۰Sense® devices used directly for UDS procedures on enrolled subjects must be recorded 
using the device LOT number on the subjects CRF form and inventory control log. Any unused 
investigational devices shall be returned to the sponsor. The sponsor will provide the 
appropriate instructions for their safe return.  
8.6.1 Laborie to Study Site: 
All investigational devices or equipment transferred between Laborie and the study site must 
be recorded through the Inventory Control Log. This includes postal deliveries and any 
deliveries made in person by Laborie. Any equipment or devices that are not used and are not 
returned to Laborie must also be recorded on the Inventory Control Log. It is Laborie’s 
responsibility to ensure that all inventory both at Laborie and the study site correlate. All 
investigational device accountability will be recorded through the Inventory Control Form. 
8.6.2 Study Site Usage: 
All investigational devices used directly for testing subject samples must be recorded on the 
Inventory Control Form. All investigational devices used by the study site that are not directly 
used for the testing of subject samples must also 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. All non-investigational devices or material usage will not be 
recorded or traced. 
8.6.3 Study Site to Laborie: 
Any equipment or devices that are not used and are returned to Laborie must be recorded on 
the Inventory Control Form.  
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 25 of 41 
 
When the devices have been received by Laborie, it is Laborie’s responsibility to ensure that all 
inventory control forms, both at Laborie and at the study site, correlate. 
Note: All investigational devices must be returned to Laborie, however, non-investigational 
materials/accessories can be left at the site for continued use or returned as agreed upon with 
the sponsor. Please reference the CTA for further details.  
8.7 
Concomitant Treatment 
Not applicable for this study. 
8.8 
Subject Compliance Monitoring 
Not applicable for this study. 
9 ASSESSMENT OF INVESTIGATIONAL DEVICE 
9.1 
Endpoints  
The ESNS-PH01 study consists of one primary objective, one secondary objective and four 
exploratory objectives.   
Primary Objective: 
The primary endpoint will be measured by recording the clinician safety and effectiveness 
rating for each subject on their CRF. The clinicians will indicate whether each of the e۰Sense® 
bladder and abdominal catheters are safe & effective for urodynamic use in at least 30 enrolled 
subjects. Given the intended use of the device, and the fact that there is no single or combined 
objective measures generated from the UDS test that can establish the safety and 
effectiveness, it is justified to obtain clinicians’ feedback via a binary response whether the 
device is safe and effective for urodynamic use.   
Secondary Objective: 
The secondary endpoint will be measured by recording the number of severe complications and 
serious adverse events for each subject on their CRF. Due to the low risk profile of UDS, the 
sponsor would like to report the severe complication-free rate for any severe complications 
associated with UDS, and therefore this secondary safety endpoint was planned. Additionally, 
the sponsor would like to collect and assess this information due to a lack of available published 
data using the e۰Sense® catheter technology. 
First Exploratory Objective: 
The first exploratory endpoint will be measured by collecting usability data in a questionnaire 
format. At the end of each clinic day a trained clinical user shall complete the questionnaire on 
CRF 3. When evaluating the usability of a device, the sponsor feels it’s appropriate to use a 
subjective ordinal scale response while assessing human and device usability factors. 
 
 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 26 of 41 
 
Second Exploratory Objective: 
The second exploratory endpoint will be measured by collecting subject feedback regarding the 
level of discomfort and pain experienced during their Urodynamic test using the Numerical Pain 
Rating Scale (NPRS) on CRF 4. Subjects will grade their discomfort/pain on the NPRS from 0 (“No 
Pain”) to 10 (“Worst Pain”). Given the subject population, use of the NPRS is a validated tool in 
evaluating pain ratings in adults10-12.      
Third Exploratory Objective:  
The third exploratory endpoint will be measured by recording initial resting pressures using the 
updated e۰Sense® catheters while each subject is positioned in a sitting, standing and supine 
position, if patient mobility allows. Resting pressures will be recorded on each subjects’ CRF 1 
during their UDS visit. Resting pressure is considered an important quality control parameter in 
urodynamics9,13,14,16. As described in the Good Urodynamic Practices9 (albeit in the context of 
WFC), the initial intravesical and abdominal resting pressures are real, are different between 
patients, and depend significantly on patient’s position. The sponsor would like to collect and 
assess initial resting pressures for the e۰Sense® catheters, due to a lack of available published 
data using the e۰Sense® catheter technology. 
Fourth Exploratory Objective:  
The fourth exploratory endpoint will be measured by recording resting pressures using the 
updated e۰Sense® catheters during various points of the UDS test as applicable (every 100 mL 
of filling, MCC, and post-void) at the recorded patient position (sitting, standing, or supine).  
Patients are to remain in the same position throughout, however supplemental positions can 
be used (e.g. performing provocative manoeuvres). Resting pressures and patient position will 
be recorded on each subjects’ CRF 1 during their urodynamics visit. Again, resting pressure is 
considered an important quality control parameters in urodynamics9,13,14,16. The sponsor would 
like to collect and assess resting pressures during the UDS test for the e۰Sense® catheters, due 
to a lack of available published data using the e۰Sense® catheter technology. 
Table 4 shows the relationship between all study endpoints and case report forms. 
Table 4. CRF data and relationship to study objectives 
Case Report Form 
 
Relationship of data recorded to study objectives  
CRF 1 (UDS Visit)  
Primary endpoint for safety and effectiveness 
Third and fourth exploratory endpoints for UDS 
CRF 2 (Relevant Medical History)  
N/A – Collected for patient demographic and eligibility 
reasons 
CRF 3 (Clinical User Questionnaire)  First exploratory endpoint for usability evaluation 
CRF 4 (Subject Questionnaire)  
Second exploratory endpoint for discomfort/pain levels  
CRF 5 (Adverse Events) 
Secondary safety endpoint for adverse events and 
severe complications. 
Supports primary endpoint and collected for safety data 
collection purposes 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 27 of 41 
 
Case Report Form 
 
Relationship of data recorded to study objectives  
CRF 6 (Device Deficiency) 
Supports primary endpoint and collected for safety data 
collection purposes 
CRF 7 (Follow-Up) 
Supports secondary safety endpoint for adverse events 
and severe complications. 
Supports primary endpoint and collected for safety data 
collection purposes. 
 
9.2 
Methods of Assessment 
The e۰Sense® catheters will be used to assess and record bladder pressure (vesical and/or 
urethral - for applicable subjects) and abdominal pressure, which are in turn interpreted by the 
clinician to identify UDS events. These measurements will be recorded using an MMS Nexam 
UDS system. The resulting interpretations and conclusions regarding safety, effectiveness, and 
usability of the investigational device, will be made by the Investigator overseeing the subject’s 
case on the relevant case report form. 
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 rejected. 
10 PATIENT SAFETY 
10.1 Definitions 
Investigators shall refer to the Safety Reporting Guidelines (ESNS-PH01-SRG-01) for country-
specific safety definitions and requirements, which includes the provisions of Article 80 of 
MDR (EU) 2017/45 prevailing over the public health code in EU Member States, where 
applicable.   
10.1.1 Adverse Events (MDR EU 2017/45):  
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs, 
including abnormal laboratory finding, in subjects, users or other persons, in the context of a 
clinical investigation, whether or not related to the investigational medical device 
NOTE 1 This definition includes events related to the investigational medical device or the 
comparator. 
NOTE 2 This definition includes events related to the procedures involved. 
NOTE 3 For users or other persons, this definition is restricted to events related to investigational 
medical devices. 
 
 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 28 of 41 
 
10.1.2 Adverse Device Effect (ISO14155:2020):  
Any adverse event related to the use of an investigational medical device. 
NOTE 1 This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of 
the investigational medical device. 
NOTE 2 This definition includes any event resulting from use error or from intentional misuse of 
the investigational medical device. 
NOTE 3 This includes ‘comparator’ if the comparator is a medical device.  
10.1.3 Device Deficiency (MDR EU 2017/45):  
Any inadequacy in the identity, quality, durability, reliability, safety or performance of an 
investigational device, including malfunction, use errors or inadequacy in information supplied 
by the manufacturer. 
10.1.4 Serious Adverse Event (MDR EU 2017/45):  
Any adverse event that led to any of the following: 
a) death; 
b) serious deterioration in health of the subject, that resulted in any of the following: 
i. 
life-threatening illness or injury,  
ii. 
permanent impairment of a body structure or a body function,  
iii. 
hospitalisation or prolonged hospitalization,  
iv. 
medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to body structure or a body function, 
v. 
chronic disease, 
c) foetal distress, foetal death or a congenital physical or mental impairment or birth 
defect.  
 
NOTE per ISO 14155: Planned hospitalization for a pre-existing condition, or a procedure required by 
this protocol, without serious deterioration in health, is not considered a serious adverse event. 
10.1.5 Unanticipated Serious Adverse Device Effect (ISO14155:2020): 
Serious adverse device effect which by nature, incidence, severity or outcome has not been 
identified in the current risk assessment. 
NOTE:  Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, 
severity or outcome has been identified in the risk assessment. 
10.1.6 Severe Complications (sponsor definition): 
A severe complication is defined an adverse event (whether expected or non-expected) that 
has been evaluated on CRF 5 as: 
- 
Severity graded as either Severe (3) or Life-Threatening (4) and;  
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 29 of 41 
 
- 
Study Procedure Relationship graded as Probably Related (3) or Definitely Related (4) 
and;  
- 
Action taken with respect to study device required Invasive Medical Intervention (4) 
and/or resulted in Hospitalization (5) and; 
- 
The outcome for the subject resulted in recovered with Major Sequelae (3), 
Ongoing/Continuing Treatment (4), Condition Worsened (5) or Death (6).    
Or otherwise any adverse event categorized as a Serious Adverse Event (See Section 10.1.4 for 
definition).  
NOTE: An invasive medical intervention refers to any medical intervention or oral medication 
treatment lasting one week (seven days) or longer. Conversely, a non-invasive treatment refers to 
any medical intervention or oral medication lasting less than one week (seven days).  
10.1.7 Serious adverse device effect (ISO14155:2020) 
An adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event.    
10.2 Data Collection 
All adverse events, device deficiencies or any other event or information for potential 
unanticipated safety concerns shall be recorded and reported to the sponsor on the 
appropriate CRF: 
 ESNS-PH01-CRF-01: For initial of recording of any adverse event, device deficiency or 
other event/information regarding a potential unanticipated safety concern.   
 ESNS-PH01-CRF-05: For reporting adverse event full details 
 ESNS-PH01-CRF-06: For reporting device deficiencies full details 
 ESNS-PH01-CRF-07: For recording patient follow-up details  
These data shall be recorded and reported for both the primary and secondary analysis 
populations (see Section 11.5). Where required, EC and/or regulatory authorities shall be 
notified within a specified time period.  
10.3 Reporting 
All adverse events, device deficiencies and other events or information for potential 
unanticipated safety concerns will be reported as soon as possible to the sponsor for 
evaluation. The Sponsor is responsible for the classification of adverse events and will review 
the Investigator’s assessment to determine seriousness and relationship to the investigational 
device.  Laborie will carefully evaluate all serious adverse events, regardless of whether or not 
they are related to the investigational medical device or anticipated. Likewise, not only safety 
endpoint events but all serious adverse events have to be assessed with regard to patient 
safety and are to be compared to acceptable occurrence rates. 
In the case of disagreement between the Sponsor and Investigator, the Sponsor shall 
communicate both opinions to the concerned parties (EC/regulatory authority, where 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 30 of 41 
 
required). Reports to EC and regulatory authorities will be made within the required time 
period.  All Investigators shall be informed, in writing, of all the serious adverse events at all 
investigation sites that have been reported to the sponsor, and ensure that they are reported 
to their EC.   
Investigators shall make reference to the Safety Reporting Guidelines (ESNS-PH01-SRG-01) for 
details on country-specific safety reporting requirements and other pertinent details.  
Should a suspension or premature termination occur due to a serious health threat, the EC and 
regulatory authority shall be notified as well (see Section 5.3). Deviations from this protocol 
under emergency circumstances where the rights, safety or well-being of the subject were of 
concern, must be reported as soon as possible to the sponsor, EC and/or regulatory authority 
where required (see Section 14).    
The number and type of adverse events will be summarized in the clinical study report. 
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 3.6 above and the Investigator’s Brochure for a detailed analysis of expected risks. 
10.5 Contact Information 
In the event of a serious adverse event or serious adverse device effect, please inform Laborie 
personnel within 24 hours. A safety reporting telephone line is available at the number below: 
Telephone: +1 (603) 766-3308 (North American, Eastern Time) 
10.6 Follow-Up 
Site personnel will telephone the subject three to five days post-test and inquire as to whether 
any adverse events have occurred after their UDS test.   
If an adverse event occurred, any follow-up medical intervention prescribed is at the discretion 
of the Investigator and shall be recorded on the subjects’ Adverse Event Case Report Form 
(ESNS-PH01-CRF-05).  Please refer to Section 7.5 above for further detail.  
11 STATISTICAL CONSIDERATIONS 
11.1 Primary Analyses 
11.1.1 Primary Endpoint 
The primary safety and effectiveness endpoint is a composite endpoint based on clinician 
response after each UDS study using the investigational device (e۰Sense® catheter) to 
determine whether the urodynamic use of the catheter was clinically adequate (success) or 
inadequate (failure). A procedure is considered a success when the clinician determines the 
investigational device to be both safe and effective as per the Investigator Assessment on CRF 
1. If these criteria are not met, the procedure is classified as a failure. The primary effectiveness 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 31 of 41 
 
hypothesis is a comparison of the lower bound for the estimate of the success rate to a 
minimally acceptable target value of 75%: 
H0: Composite Safety and Effectiveness Success Rate is ≤ 75%  
versus  
HA: Composite Safety and Effectiveness Success Rate is > 75%  
This 1-sided hypothesis will be evaluated by comparing the lower limit of the 97.5% 1-sided 
Clopper-Pearson confidence interval to the target value. If the lower limit of the 97.5% 1-sided 
Clopper-Pearson confidence interval is greater than the target value, the null hypothesis will be 
rejected, and it will be concluded that an effectiveness rate ≤ 75% is inconsistent with the 
investigation findings. The lower limit of the 97.5% 1-sided Clopper-Pearson confidence interval 
is identical to the lower limit of a 2-sided 95% Clopper-Pearson confidence interval, so the 2-
sided Clopper-Pearson 95% confidence interval may be calculated for computational ease. In 
addition, a 1-sided, 1-sample binomial test will be performed to calculate a p-value. P < 0.025 
will be considered statistically significant. 
11.1.2 Sample Size Determination & Power: 
The null hypotheses for the primary composite effectiveness endpoint is designed to rule out 
success rates ≤ 75%. Based on clinical judgement and previous testing, the true success rate for 
both safety and effectiveness are assumed to exceed 95%. Thus, the power calculation assumes 
a true success rate of 96% for the composite safety and effectiveness endpoint. 
Power was determined by 10,000 binomial simulations (assuming success rate 96%) for each 
sample size, and power was calculated as the proportion of simulations for which the null 
hypothesis would be rejected based on the lower limit of the 2-sided 95% Clopper-Pearson 
confidence interval.  Analysis of 30 subjects would provide 88% power to rule out a success rate 
≤ 75% when the true success rate is assumed to be 96%, based on a 1-sided test with type I 
error rate of 2.5%.  This primary analysis and endpoint requires a minimum of 30 subjects to 
ensure adequate power15.  
11.2 Secondary Analyses 
11.2.1 Secondary Endpoint: 
The secondary safety endpoint is to report the severe complication-free rate for the updated 
e۰Sense® catheters.  The secondary safety hypothesis is a comparison of the lower bound for 
the estimate of the success rate to a minimally acceptable target value of 95%: 
H0: Severe complication-free rate of ≤ 95%  
versus  
HA: Severe complication-free rate of > 95%  
This 1-sided hypothesis will be evaluated by comparing the lower limit of the 95% 1-sided 
Clopper-Pearson confidence interval to the target value. If the lower limit of the 95% 1-sided 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 32 of 41 
 
Clopper-Pearson confidence interval is greater than the target value, the null hypothesis will be 
rejected, and it will be concluded that a severe complication-free rate ≤ 95% is inconsistent 
with the investigation findings. The lower limit of the 95% 1-sided Clopper-Pearson confidence 
interval is identical to the lower limit of a 2-sided 90% Clopper-Pearson confidence interval, so 
the 2-sided Clopper-Pearson 90% confidence interval may be calculated for computational 
ease. In addition, a 1-sided, 1-sample binomial test will be performed to calculate a p-value. P < 
0.05 will be considered statistically significant.  
11.2.2 Sample Size Determination & Power: 
The null hypothesis for the secondary safety endpoint is designed to rule out success rates ≤ 
95%. Based on clinical judgement and previous testing, a true success rate of 100% is assumed.   
Power was determined by 10,000 binomial simulations (assuming success rate 100%) for each 
sample size, and calculation of the proportion of simulations or which the null hypothesis would 
be rejected based on the lower limit of the 2-sided 90% Clopper-Pearson confidence interval.  
Analysis of 60 subjects would provide 99% power to rule out a success rate ≤ 95% when the 
true success rate is assumed to be 100%, based on a 1-sided test with type I error rate of 5%.  
This study requires a minimum of 60 subjects for adequate power to reject the null hypothesis 
when the true assumed rate is 100%, however the final sample size will be based on site 
enrolment capabilities within the project timeline. In addition, the study sponsor will allow up 
to 65 subjects (5 additional) during the allowable recruitment and project time given the 
minimum recruitment goals are met. The additional subjects will ensure the desired confidence 
and reliability levels are met should any data or subjects be excluded from the primary analysis 
population (See Section 11.5) or if the subject withdraws (See Section 6.6). If the enrolment 
target is not reached, the exact confidence interval will be calculated for the data available, but 
no hypothesis test will be conducted.   
11.3 Exploratory Analyses 
Descriptive statistics will be used to summarize and analyse the results of each of the 
exploratory endpoints at the completion of the study. 
11.3.1 First Exploratory Endpoint:  
The first exploratory endpoint is to assess user impressions of the updated e۰Sense® catheters  
compared with their experience using the existing catheters at their site, by evaluating the 
following subjective measures: ease of use, ease of insertion and removal, ease of securing the 
catheter, tracing stability (during filling, voiding and UPP where applicable), tracing quality 
(overall, Pves, Pabd and Pura where applicable), channel subtraction quality, visibility on VUDS 
(where applicable), instruction for use evaluation, catheter stiffness, sensor location, patient 
tolerance, and overall usability performance.  
The reported value in the usability performance survey will be analysed using proportions of 
levels and combined proportions of groupings. This includes levels (1 to 5), “Yes and No”, 
“Better, Same or worse” and any other questions related to usability. The results will also be 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 33 of 41 
 
analysed grouped by the site’s existing catheter technology (e.g. grouping by water, air, or 
electronic technology results). Additionally, the results will be plotted over time to observe the 
trend as the study continues (preferably a line plot with daily responses over time). 
11.3.2 Second Exploratory Endpoint 
The second exploratory endpoint is to assess subjective subject feedback regarding their 
discomfort and pain levels.  
The reported value in the patient survey will be analysed using proportions of levels and 
combined proportions of groupings. This includes levels (0 to 10) and “Yes and No”. 
11.3.3 Third Exploratory Endpoint 
The third exploratory endpoint is to assess pre-test resting pressure of the e۰Sense® catheters 
at sitting, standing, and supine patient positions.  
11.3.4 Fourth Exploratory Endpoint 
The fourth exploratory endpoint is to assess resting pressure of the e۰Sense® catheters at the 
recorded patient position during various points of the UDS test (every 100mL of filling, MCC, 
and post-void). 
11.4 Randomization / Blinding 
Randomization and/or blinding is not utilized in this study based on the study design. 
11.5 Analysis Population 
The primary analysis population to be considered in this study will include enrolled subjects 
who have been successfully catheterized using the investigational device. Should 
catheterization fail due to a device deficiency, and/or adverse event, these subjects will still be 
included in the primary analysis and this information shall be recorded on the subjects’ CRF#1 
(ESNS-PH01-CRF-01), as well as on the adverse event form (ESNS-PH01-CRF-05), or device 
deficiency form (ESNS-PH01-CRF-06) as applicable. However, should catheterization fail due to 
patient factors (i.e. the characteristics of the catheter didn’t meet patient anatomical needs, 
coudé tip required, inappropriate French size), these subjects will be considered as part of the 
sensitivity analysis population.   
All subjects in the primary analysis population will be included in the primary analysis of the 
hypotheses tests. The sensitivity analysis population will also be analysed as the “intent to 
treat” population, however results of this population will not dictate success or failure of the 
study and are meant for comparison purposes only.  Data will be analysed as outlined in Section 
12.1. 
Any subjects who are enrolled but for any reason subsequently withdraw from the study prior 
to being catheterized with the investigational device, will be excluded from analysis.  The 
justification being they were never touched, and no measurements were made with the 
investigational device.   
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 34 of 41 
 
If any CRFs are found to be incomplete, the study monitor will follow-up as to the reasoning. If 
for some reason a clinical user is unable to fully complete their questionnaire, the questions 
they have completed will be included in the analysis. Data will be monitored as the study 
progresses, refer to Section 6.7 for details pertaining to suspension or premature termination. 
11.6 Deviations 
In any event there are deviations from the original statistical plan, they will be described and 
justified in the final report. 
11.7 Interim Analysis  
Once 30 primary analysis population subjects complete the study the primary composite safety 
and effectiveness analysis will be conducted for regulatory purposes. Once all (60-65) subjects 
are complete, the secondary endpoint analysis will be performed. In addition, the exploratory 
endpoints will be assessed and an exploratory analysis of the composite (primary) safety and 
effectiveness endpoint including all subjects will be performed.   
There are currently no criteria for stopping the study early on statistical grounds. Refer to 
Section 5.3 for details about suspension or premature termination. 
12 DATA HANDLING & RECORD KEEPING 
12.1 Direct Access 
The investigator/institution will permit investigation-related monitoring, audits, EC review, and 
regulatory inspections by providing direct access to the source data/documents as needed.  
Regarding the subjects’ personal data including health data, such data is provided in a de-
identified (pseudonymized) form wherever possible and not otherwise necessary. 
12.2 Confidentiality & Security  
All information disclosed or provided by the Sponsor (or any company/institution acting on 
their behalf), or produced during the Clinical Investigation, including, but not limited to, the 
Clinical Investigation Protocol, the CRFs, the Investigator's Brochure and the results obtained 
during the course of the Clinical Investigation, is confidential. The Investigator or any person 
under his/her authority agrees to undertake to keep the information confidential.  In particular, 
the Investigator undertakes (1) not to make the information accessible to third parties - directly 
or indirectly, in writing, orally or in any other way - without the prior written approval of the 
Sponsor, (2) to use it exclusively within the scope defined by this Clinical Investigation Protocol 
and (3) to take all necessary measures to prevent third parties from becoming aware of and 
exploiting the information (obligation to secrecy, non-use and security). This does not apply in 
cases where the Investigator is obliged by law or other relevant regulations (e.g. ISO 14155) to 
grant third parties (e.g. such as regulatory authorities, ECs) access to the data. The Investigator 
will inform the sponsor immediately if a third-party requests access to the data. 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 35 of 41 
 
However, the submission of this Clinical Investigation Protocol and other necessary 
documentation to the EC is expressly permitted, the EC members having the same obligation of 
confidentiality. 
If Sub-Investigators are utilized, the Sub-Investigators shall be bound by the same obligation as 
the Investigator. The Investigator shall inform the Sub-Investigators of the confidential nature 
of the Clinical Investigation. 
The Investigator and the Sub-Investigators shall use the information solely for the purposes of 
the Clinical Investigation, to the exclusion of any use for their own or for a third party's account. 
All data sent to Laborie will be confidential and all subject identifiers will be blacked 
out/redacted before being sent to Laborie. Documents will be kept in a secure location and all 
digital information will be kept following General Data Protection Regulation (GDPR) and local 
government regulations. 
If the Investigator and/or Sub-Investigators transmit personal data to Laborie, or Laborie itself 
collects personal data within the European Union, the personal data will also be transmitted to 
Canada and to the United States, where members of Laborie’s team involved in the study are 
situated. With regards to the transmission of data to Canada, there is a European Commission 
Adequacy Decision (Commission Decision of 20.12.2001 - 2002/2/EC). With regards to the 
transmission of data to Laborie in the United States, the relevant Laborie entities have entered 
into standard contractual clauses according to Art. 46 para. 2 (c) GDPR, regarding appropriate 
safeguards for the protection of personal data.  
Regarding the transmission of personal data, including health data, to supervisory authorities 
and/or government regulators in the United States insofar as mandatory for Laborie in order to 
comply with the relevant US legal obligations to which they may be subject, this may only take 
place on the condition of consent, per Art. 49 para. 1 (a) GDPR, together with the information 
that there is no equivalent level of data protection in the United States to that of the European 
Union, and that personal data may be further processed and transmitted by the receiving 
supervisory authorities and government regulators in a way which would not be possible under 
European data protection regulations.    
12.3 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 analysis and presentations. The data management plan will further describe 
data handling.  
12.4 Case Report Form (CRF) & Source Documents 
All study staff will be trained on the protocol requirements, CRF and questionnaire completion, 
and their training documented. It is the responsibility of the Investigator to maintain adequate 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 36 of 41 
 
and accurate CRFs designed by Laborie to record all observations and other data pertinent to 
the clinical investigation. All CRFs and questionnaires should be completed in their entirety in a 
neat, legible manner to ensure accurate interpretation of data. Should a correction be made, 
the information to be modified must not be overwritten, but rather crossed out, corrected and 
initialled by the study staff member authorized to make entries and/or corrections to the CRFs. 
Source documents 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. 
To confirm the quality of the study, pseudonymized UDS data files will be requested by the 
sponsor for each subject. A unique subject code will be assigned to each subject based on the 
site number and sequential subject number (e.g. 101-001). The Investigator is responsible for 
maintaining subject identifying information strictly confidential, secure and inaccessible to 
unauthorized persons. CRFs will be treated as source data in the event that the original 
information is entered on the CRFs first (and no source document worksheet is utilized for that 
data point). 
12.5 Record Retention 
An Investigator or Sponsor shall maintain the records required by European Medicines Agency 
(EMA) during the investigation and for a period of 25 years after the latter of the following two 
dates: the date on which the investigation is terminated or completed, or the date that the 
records are no longer required for purposes 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. 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. 
12.6 Performance Monitoring 
Study Monitors will periodically check questionnaire data to ensure all fields are entered as 
complete as possible and inquire as to whether any usability issues are being encountered as 
the study progresses. 
13 MONITORING, AUDITING, AND INSPECTING 
13.1 Study Monitoring Plan 
Laborie is responsible for developing a monitoring plan prior to study initiation, the monitoring 
plan will consist of a risk-based approach depending on monitoring needs for the clinical 
investigation.  
The Investigator agrees to provide reliable data and all information requested by the Clinical 
Investigation Protocol (with the help of the CRFs, questionnaires or other appropriate 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 37 of 41 
 
instrument) in an attributable, legible, complete, original, and accurate 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 Clinical Investigation is responsible to Health Authorities for taking all 
reasonable steps to ensure the proper conduct of the Clinical Investigation Protocol as regards 
ethics, Clinical Investigation Protocol compliance, integrity and validity of the data recorded on 
the CRFs 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 Clinical Investigation.  
At regular intervals during the Clinical Investigation, 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 Clinical Investigation Protocol 
requirements, and any emergent problems. The monitoring plan will describe the frequency, 
extent, and nature of monitoring.  
During these monitoring visits, the following but not exhaustive list of points will be inspected 
with the Investigator: subject informed consent, subject recruitment and follow-up, Serious 
Adverse Event documentation and reporting, outcome events documentation and reporting, 
Investigational Product allocation, Investigational Product accountability, use and quality of 
data. 
13.2 Auditing and Inspecting 
For the purpose of ensuring compliance with the Clinical Investigation Protocol, Good Clinical 
Practice and applicable regulatory requirements, the Investigator should permit inspection by 
applicable regulatory authorities.  
The Investigator agrees to allow the official inspectors to have direct access to his/her study 
records for review, being understood that these personnel are bound by professional secrecy 
and as such, will not disclose any personal identity or personal medical information. 
The Investigator will make every effort to help with the performance of the inspections, 
granting access to all necessary facilities, data, and documents to the designated inspectors. 
As soon as the Investigator is notified of a future inspection by the authorities, the Investigator 
will inform 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 audit or inspections. 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 38 of 41 
 
14 DEVIATIONS 
All departures from the approval 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 operation procedures. Deviation 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 investigation results, then Laborie will 
conduct a root cause analysis and implement appropriate corrective and preventative actions.  
Serious deviations from the approved protocol are considered to be those which impact subject 
rights and safety, or data integrity and security.  Serious or repeated protocol deviations on the 
part of the Investigator may be grounds for termination of the clinical investigation (see Section 
6.7 above). The sponsor may also consider other corrective actions including protocol re-
training, site visit, conference call or a formal warning letter.   
Investigators may request prior written approval for a study deviation or change in study 
protocol. A protocol amendment may be required, and EC/regulatory authorities notified 
where applicable.   
Deviations from the protocol to protect the rights, safety and well-being of subjects under 
emergency circumstances may proceed without prior approval from the sponsor, EC or 
regulatory authority. Such deviations shall be documented and reported to the sponsor and EC 
as soon as possible.   
15 AMENDMENTS 
If there are any changes to the protocol during the clinical study application process or during 
the length of the clinical study in progress, the protocol with amendments will be sent to the 
applicable EC and regulatory authorities for notification and review. If an amendment is made 
to the protocol during an ongoing study, 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 prior written agreement by the Sponsor, and 
prior review and documented approval/favourable opinion from the EC and regulatory 
authorities (as applicable) 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 ICF. The Investigator must receive an EC approval/favourable opinion concerning the 
revised ICF prior to implementation of the change. 
16 STUDY ADMINSTRATION 
16.1 Funding Source and Conflicts of Interest 
Laborie will be the sponsor and the financial details are covered in the CTA. 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 39 of 41 
 
16.2 Subject Stipends or Payments 
If allowable under national and institutional policies, subjects can be offered a 40€ stipend for 
their participation in the study to offset the cost of parking and/or meals required during their 
clinic visit. This amount is subject to change pending ethics review, and if allowable, the final 
stipend amount will be indicated in the subject ICF.   
The sponsor has covered this study by means of an insurance covering bodily injury or property 
damage arising out of the clinical investigation. The certificate of insurance evidencing the 
coverage, insurance company, policy number, and the sum insured are provided in the study 
file. 
16.3 Committees 
A Data Monitor Committee will not be utilized in this study based on the evaluation of the level 
of potential risks. 
17 ETHICS AND REGULATORY APPROVAL 
The clinical study will not begin until the appropriate approvals from the EC and regulatory 
authority have been obtained. Any additional requirements imposed by the EC and regulatory 
authority will be followed. This clinical study will be conducted in compliance with all 
international laws and regulations, and national laws and regulations of the countries in which 
the clinical investigation is performed, as well as any applicable guidelines. The investigation 
will be registered on eudract.ema.europa.eu and on www.clinicaltrials.gov publicly accessible 
databases. 
18 PUBLICATION POLICY 
The results of this clinical investigation may be submitted for peer-reviewed publication, 
regardless of positive or negative results. Publication rights and details are covered in the CTA. 
19 RELATED STUDY DOCUMENTS 
19.1 Informed Consent Documents 
- 
ESNS-PH01-ICF-01 eSense Informed Consent Form 
19.2 Case Report Forms 
- 
ESNS-PH01-CRF-01 eSense UDS Visit Case Report Form 
- 
ESNS-PH01-CRF-02 eSense Medical History Case Report Form 
- 
ESNS-PH01-CRF-03 eSense Clinical User Questionnaire Case Report Form 
- 
ESNS-PH01-CRF-04 eSense Subject Questionnaire Case Report Form 
- 
ESNS-PH01-CRF-05 eSense Adverse Event Case Report Form 
- 
ESNS-PH01-CRF-06 eSense Device Deficiency Case Report Form 
- 
ESNS-PH01-CRF-07 eSense Follow-Up Case Report Form 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 40 of 41 
 
19.3 Investigator Brochure 
- 
ESNS-PH01-IB-01 eSense Investigator’s Brochure 
20 REFERENCES 
1. Perez, L. M., & Webster, G. D. (1992). The history of urodynamics. Neurourology and 
Urodynamics, 11(1), 1–21. https://doi.org/10.1002/nau.1930110102 
 
2. Abrams P. Urodynamics. Springer Science & Business Media; 2006. p.287 
 
3. Winters, J. C., Dmochowski, R. R., Goldman, H. B., Herndon, C. D. A., Kobashi, K. C., Kraus, S. 
R., …Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. (2012). 
Urodynamic studies in adults: AUA/SUFU guideline. The Journal of Urology, 188(6 Suppl), 
2464–2472. https://doi.org/10.1016/j.juro.2012.09.081 
 
4. Chapple, C. R., MacDiarmid, S. A., & Patel, A. (2009). Urodynamics Made Easy. Elsevier 
Health Sciences 
 
5. Curt A, Nitsche B, Rodic B, Schurch B & Dietz V. Assessment of autonomic dysreflexia in 
patients with spinal cord injury. Journal of Neurology, Neurosurgery, & Psychiatry 1997, 
62:473-77. 
 
6. Giannantoni A, Di Stasi SM, Scivoletto G, Mollo A, Silecchia A, Fuoco U & Vespasiani G. 
Autonomic dysreflexia during Urodynamics. Spinal Cord 1998; 36:756-60. 
 
7. Abrams, P., Andersson K.E., Artibani W., Birder L., Bliss D., Brubaker L., Cardozo, L., Chapple, 
C., Cottenden, A., de Ridder D., Dmochowski R., Dumoulin C., Drake M., Fry C., Hanno P., 
Herschorn S., Kelleher C., Koelbl H., Khoury S., Madoff R., Maher C., Milsom I., Moore K.H., 
Moore K.N., Newman D., Nijman R., Rosier P., Staskin D., Thuroff J., Tubaro A., Vodusek D., 
Wein A. (2013) Recommendations of the International Scientific Committee: Evaluation and 
treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence Abrams P., 
Cardozo L., Khoury S., Wein A. (Eds.) Incontinence: 5th International Consultation on 
Incontinence, Paris, February 2012. (pp. 1904-1907). ICUD-EAU 
 
8. Rosier P.F. The evidence for urodynamic investigation of patients with symptoms of urinary 
incontinence. F1000prime Rep. 2013;5:8. https://doi.org/10.12703/P5-8 
 
9. Rosier PFWM, Schaefer W, Lose G, Goldman HB, Guralnick M, Eustice S, et al. International 
Continence Society Good Urodynamic Practices and Terms 2016: Urodynamics, 
uroflowmetry, cystometry, and pressure-flow study. Neurourology and Urodynamics. 2017 
Jun;36(5):1243-1260.  
 
Status CURRENT Effective 8/24/2021

 
e۰Sense® Clinical 
Investigation Protocol 
CLN-00021-ESNS-
PH01-PR-01 
Version B 
 
Confidential © 2021 LABORIE   
 
Page 41 of 41 
 
10. Childs, John D., Sara R. Piva, and Julie M. Fritz. “Responsiveness of the Numeric Pain Rating 
Scale in Patients with Low Back Pain.” Spine 30, no. 11 (June 1, 2005): 1331–34. 
https://doi.org/10.1097/01.brs.0000164099.92112.29. 
 
11. Jensen, M. P., and C. A. McFarland. “Increasing the Reliability and Validity of Pain Intensity 
Measurement in Chronic Pain Patients.” Pain 55, no. 2 (November 1993): 195–203. 
 
12. Rodriguez, C. S. “Pain Measurement in the Elderly: A Review.” Pain Management Nursing: 
Official Journal of the American Society of Pain Management Nurses 2, no. 2 (June 2001): 
38–46. https://doi.org/10.1053/jpmn.2001.23746.  
 
13. Sullivan JG, Swithinbank L, Abrams P. Defining achievable standards in urodynamics—a 
prospective study of initial resting pressures. Neurourol Urodyn. 2012 Apr 1;31(4):535–40. 
 
14. Gammie, A., Abrams, P., Bevan, W., Ellis-Jones, J., Gray, J., Hassine, A., … Hashim, H. (2015). 
Simultaneous in vivo comparison of water-filled and air-filled pressure measurement 
catheters: Implications for good urodynamic practice. Neurourology and Urodynamics, n/a-
n/a. https://doi.org/10.1002/nau.22827  
 
15. Fleiss, J.L., Levin, B., & Cho Paik, M. (2003). Statistical Methods for Rates and Proportions 
(3rd ed.). New York, NY: Wiley 
 
16. Liao L., Kirschner-Hermanns R., and Schaefer W. (1999) Urodynamic quality control: 
quantitative plausibility control with typical value ranges. Neurourology and Urodynamics 
18(abstract 99a):365-366. 
   
17. Hashim H, Thomas L, Gammie A, Farullo G, Finazzi-Agrò E. Good urodynamic practice 
adaptations during the COVID-19 pandemic. Neurourology and Urodynamics. 2020;39:1897–
1901.https://doi.org/10.1002/nau.24441 
Status CURRENT Effective 8/24/2021