An Explorative, Open, Single-arm Clinical Investigation to Collect Real-life Measurement Data in Order to Assess the Mathematical Algorithms Involved in TENA SmartCare Change Indicator.
Phase: NA
Conditions: Urinary Incontinence
Sponsor: Essity Hygiene and Health AB

Devicia AB Confidential 
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CONFIDENTIAL 
CLINICAL INVESTIGATION PLAN (CIP) 
CLINICAL INVESTIGATION TITLE: 
An explorative, open, single-arm clinical investigation to collect real-life measurement data in 
order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator. 
CLINICAL INVESTIGATION CODE: 
FUEL 
INVESTIGATIONAL DEVICE: 
TENA SmartCare Urine Sensor and Gateway 
PRINCIPAL INVESTIGATOR: 
Ulla Molander 
INVESTIGATIONAL SITE: 
Tre Stiftelser 
Vegahusen  
Vegagatan 55 
413 11 Gothenburg 
Sweden 
SPONSOR: 
Essity Hygiene and Health AB 
405 03, Gothenburg 
Sweden 
DATE: 
19-Jul-2019
This clinical investigation will be conducted in accordance with the ethical principles that have their origin 
in the Declaration of Helsinki. Furthermore, the clinical investigation will be performed in compliance with 
ISO 14155:2011, the Medical Device Directive (MDD) 93/42/EEC, Medical Device Regulation (MDR) 
2017/745, and applicable regional or national regulations. 
Version 
Revision history 
A 
First release 
B 
Minor updates and clarifications 

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CONFIDENTIAL 
This Clinical Investigation Plan contains privileged or confidential information, which is the property of the 
Sponsor. Information may not be disclosed to a third party without written authorization from the Sponsor. 
1 
SYNOPSIS 
NAME OF THE SPONSOR: 
Essity Hygiene and Health AB 
CLINICAL INVESTIGATION TITLE: 
An explorative, open, single-arm clinical investigation to collect real-life measurement data in 
order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator. 
CLINICAL INVESTIGATION CODE: 
FUEL 
INVESTIGATIONAL DEVICE: 
TENA SmartCare Urine Sensor and Gateway 
OBJECTIVES: 
Primary Objective 
The primary objective is to collect real-life measurement data using the Urine Sensor to assess 
the mathematical algorithms for wetness detection in TENA absorption products by urine 
volume quantification and .................. measurements.  
Secondary Objective 
The secondary objective is to evaluate safety through analyzing device-related adverse events 
reported during the investigation. 
OVERALL CLINICAL INVESTIGATION DESIGN: 
The purpose of this exploratory clinical investigation is to evaluate safety and to collect real-life 
measurement data using the Urine Sensor. The collected data will be used to assess the device 
related algorithms. The primary algorithms have been established and verified in a laboratory 
environment. However, several parameters differ between real-life and laboratory settings and 
can therefor be hard to predict. Consequently, real-life measurement data has been determined 
necessary to continue the product development.  
To assess the mathematical algorithms, the urine volume needs to be quantified (ml urine) and 
the .................. values from the Urine Sensor captured. Data such as; date and time of 
application, date and time of removal, Urine Sensor ID, absorbent product information (type, 
absorption level and size), leakage outside product, precence of feces, and subject’s main 
position since last absorbent product change will be recorded by the caregiver on a label located 
on a plastic bag. The absorbent product is thereafter placed in the plastic bag and provided to a 
Sponsor’ represetative. The plastic bag is weightened on a calibrated scale by the Sponsor’ 
representative and the weight documented in the electronic Case Report Form (eCRF). The 
urine spreading in the absorbent product is documented by taking a photo of the absorbent 
area of the product. The photo is uploaded in the eCRF system. All data documented by the 
caregiver on the plastic bag label are transferred to the eCRF by the Sponsor’ representative. 
The label is thereafter detached from the plastic bag and placed on a paper. The paper is 
considered source data and will be stored in a study specific binder for quality assurance and 
archiving. 
The clinical investigation will be carried out in the nursing home Tre Stiftelser in Gothenburg and 
include subjects affected with Urinary Incontinence (UI). In total 15 subjects are estimated to be 
enrolled in the exploratory clinical investigation. The clinical investigation is designed to be 
conducted in a controlled professional environment for a duration of 8 weeks. The clinical 
investigation involves two visits; one screening visit and one follow-up visit, as well as absorbent 

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product related data capturing between these visits. The follow-up visit will be scheduled in 
conjunction with the completion of data capturing.  
Visit 1: Screening visit 
•
Subject information and informed consent
•
Eligibility confirmation
•
Enrollment
•
Demographic data and baseline information; year of birth, gender, incontinence
product(s) of use the previous 6 months, bedridden/not bedridden
•
Documentation of relevant concomitant medication(s)
•
Documentation of relevant medical and surgical history
•
Evaluation of general health status
•
Urine pregnancy test in subjects with childbearing potential
•
Allocation to suitable absorbent product type(s) and size(s)
Visit 2: Follow-up visit 
•
Documentation and/or follow-up on Adverse Event (AE)/Adverse Devicie Effect
(ADE)/Serious Adverse Event (SAE)/Serious Adverse Device Effect (SADE)/Device
Deficiency (DD)
•
Concomitant medication review
•
Verification of eCRF completion
•
Study termination
INCLUSION AND EXCLUSION CRITERIA: 
Inclusion Criteria 
The subject must meet all of the following criteria to be eligible for this clinical investigation: 
1.
The subject is willing and able to provide informed consent and to participate in the
clinical investigation.
2.
The subject is  18 years of age.
3.
The subject is diagnosed with urinary incontinence.
4.
The subject is being cared for at Tre Stiftelser.
Exclusion Criteria 
Subjects meeting any of the following criteria will not be permitted to participate in the clinical 
investigation: 
1. The subject has  4 fecal ”incidences” per week.
2. The subject has severe absorbent product related skin problems, as judged by the
investigator.
3. The subject is hypersensitive related to allergic reaction to any of the included
materials, as judged by the investigator.
4. The subject has  2 intermittent urinary catheters per day.
5. The subject has a pacemaker or an implantable cardioverter-defibrillator.
6. The subject removes the incontinence product.
7. The subject demonstrates responsive behavior towards sensors.
8. The subject has any other condition that may make participation in the clinical
investigation inappropriate, as judged by investigator.
9. The subject is not cared for at Tre Stiftelser.
10. The subject is pregnant or lactating.
PERFORMANCE AND SAFETY ENDPOINTS: 

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Primary Endpoint  
Summarize the individual differences (predicted urine volume* - true urine volume**) using 
descriptive statistics. The data*** will later be used to optimize mathematical algorithms for the 
TENA SmartCare Change Indicator. 
*Prediction calculated from urine sensor values
** Urine volume determined from absorbent product weights
***Data is the combination of urine sensor values and absorbent product weights.
Secondary Endpoint:  
Incidence of adverse events and device deficiencies; AEs, ADEs, SAEs, SADEs and DDs. 
Clinical Investigation Duration: 
Point of enrolment: 
End of Aug/beginning of Sep 2019 
Total expected duration of 
the clinical investigation:  
8 weeks 
Expected duration of each 
subject’s participation:  
6 weeks 
Enrollment period: 
1 week 
STATISTICAL METHODS: 
Sample Size:  
As this is an exploratory clinical investigation, no formal sample size calculation has been 
performed. Instead, it has been assumed that ...... measurement points (absorption product 
registrations) will be required per product type. In total .. product types will be evaluated 
resulting in a need of ........ measurement points. 12 subjects are considered appropriate to 
adapt for individual spreading. Consequently, the aim is to enroll 15 subjects (20% drop-out 
rate) to capture ........measurement points during a period of 8 weeks. 
No formal analysis of data will be conducted for the FUEL clinical investigation. Primary 
endpoint data will be summarized using descriptive statistics, and incidences of adverse events 
and device deficiencies will be listed and visualized in tables.   

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2 
SPONSOR CIP APPROVAL PAGE 
The undersigned hereby confirms that they have read and understood the content of this 
Clinical Investigation Plan (CIP) and further approves its content. 
______________________________ 
______________________ 
Arne Böhling  
Date (dd-Mmm-yyyy) 
Clinical Affairs Director, Essity 
______________________________ 
______________________ 
Sofia Hagman 
Date (dd-Mmm-yyyy) 
Global Product Owner, Essity

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3 
TABLE OF CONTENTS 
1 
SYNOPSIS .................................................................................................................................................... 2 
2 
SPONSOR CIP APPROVAL PAGE .......................................................................................................... 5 
3 
TABLE OF CONTENTS ............................................................................................................................. 6 
4 
DEFINITIONS AND ACRONYMS ........................................................................................................... 9 
5 
INTRODUCTION ..................................................................................................................................... 10 
5.1 
Background .......................................................................................................................... 10 
6 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE ...................... 12 
6.1 
Manufacturer ....................................................................................................................... 12 
6.2 
Identification of Clinical Investigational Medical Device ..................................................... 13 
6.2.1 
Classification According to MDR ...................................................................................... 13 
6.2.2 
Urine Sensor .................................................................................................................... 13 
6.2.3 
Gateway ........................................................................................................................... 14 
6.2.4 
TENA SmartCare Backend Services .................................................................................. 14 
6.2.5 
TENA SmartCare Change Indicator Application ............................................................... 15 
6.2.6 
Device Labeling ................................................................................................................ 15 
6.3 
Device Traceability ............................................................................................................... 15 
6.4 
Intended Use ........................................................................................................................ 15 
6.5 
Indication and Population .................................................................................................... 16 
6.6 
Manufacturing and Materials .............................................................................................. 16 
6.7 
Training and Experience ....................................................................................................... 16 
6.8 
Installation and Use ............................................................................................................. 17 
6.8.1 
Normal Use ...................................................................................................................... 17 
6.8.2 
Installation and Use ......................................................................................................... 17 
6.9 
Cleaning ................................................................................................................................ 18 
6.10 
Gateway Installation ............................................................................................................ 19 
6.11 
Contraindications for Use .................................................................................................... 20 
7 
JUSTIFICATION OF CLINICAL INVESTIGATION DESIGN ........................................................... 21 
8 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL 
INVESTIGATION ............................................................................................................................................. 22 
8.1 
Anticipated Clinical Benefits ................................................................................................ 22 
8.2 
Anticipated Adverse Device Effects ..................................................................................... 22 
8.3 
Residual Risks ....................................................................................................................... 22 
8.4 
Risks Associated with Participating in the Clinical Investigation ......................................... 22 
8.5 
Possible Interactions with Concomitant Medical Treatments ............................................. 23 
8.6 
Risk Control .......................................................................................................................... 23 
8.7 
Risk-to-Benefit Rationale ..................................................................................................... 23 
9 
OBJECTIVES AND HYPOTHESES OF THE CLINICAL INVESTIGATION .................................. 25 

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9.1 
Primary Objective................................................................................................................. 25 
9.2 
Secondary Objectives ........................................................................................................... 25 
9.3 
Hypothesis............................................................................................................................ 25 
9.4 
Claims and Intended Performance of the Investigational Device ....................................... 25 
9.5 
Risks and Anticipated Device Effects ................................................................................... 25 
10 
DESIGN OF THE CLINICAL INVESTIGATION ........................................................................... 26 
10.1 
General ................................................................................................................................. 26 
10.1.1 
Primary Endpoint ......................................................................................................... 26 
10.1.2 
Secondary Endpoints ................................................................................................... 27 
10.2 
Investigational Device(s) and Comparator(s) ....................................................................... 27 
10.3 
Subjects ................................................................................................................................ 27 
10.3.1 
Inclusion Criteria ......................................................................................................... 27 
10.3.2 
Exclusion Criteria ......................................................................................................... 27 
10.3.3 
Number of Subjects ..................................................................................................... 27 
10.3.4 
Methods of Assigning Subjects to the Different Treatment Arms .............................. 28 
10.3.5 
Subject Withdrawal or Discontinuation ...................................................................... 28 
10.4 
Clinical Investigation Duration ............................................................................................. 28 
10.5 
Clinical Investigation Procedures ......................................................................................... 28 
10.5.1 
Schedule of Clinical Investigation Procedures/Assessments ...................................... 28 
10.5.2 
Demographic Data and Baseline Measurements ........................................................ 30 
10.5.3 
Performance Variables and Measurements ................................................................ 31 
10.5.4 
Safety Variables and Measurements .......................................................................... 31 
10.5.5 
Activities Performed by Sponsor ................................................................................. 31 
10.5.6 
Potential Confounding Factors .................................................................................... 31 
11 
MONITORING PLAN ........................................................................................................................ 33 
11.1 
Subject Records and Source Data ........................................................................................ 33 
11.2 
Access to Source Data and Documentation ......................................................................... 33 
12 
STATISTICAL CONSIDERATIONS ............................................................................................... 34 
12.1 
Statistical Design, Method and Analytical Procedures ........................................................ 34 
12.2 
Sample Size .......................................................................................................................... 34 
12.3 
Level of Significance and Power ........................................................................................... 34 
12.4 
Drop-out Rates ..................................................................................................................... 34 
12.5 
Pass/fail Criteria ................................................................................................................... 34 
12.6 
Interim Analysis .................................................................................................................... 34 
12.7 
Criteria for Termination on Statistical Grounds ................................................................... 34 
12.8 
Reporting of Deviations from the Original Statistical Analysis Plan (SAP) ........................... 34 
12.9 
Subgroups for Analysis ......................................................................................................... 34 
12.10 
Procedures that Take into Account All the Data .................................................................. 34 

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12.11 
Missing, Unused or Spurious Data ....................................................................................... 35 
12.12 
Exclusion of Particular Information from the Testing of the Hypothesis ............................ 35 
13 
DATA MANAGEMENT ..................................................................................................................... 36 
13.1 
Electronic Data Capture (EDC) ............................................................................................. 36 
13.2 
Data Retention ..................................................................................................................... 37 
13.3 
Monitoring, Audits and Inspections ..................................................................................... 37 
14 
AMENDMENTS TO THE CIP .......................................................................................................... 38 
15 
DEVIATIONS FROM THE CIP ........................................................................................................ 39 
16 
DEVICE ACCOUNTABILITY ........................................................................................................... 40 
17 
STATEMENTS OF COMPLIANCE .................................................................................................. 41 
17.1 
Institutional Ethics Review ................................................................................................... 41 
17.1.1 
IEC Submission ............................................................................................................ 41 
17.1.2 
CA Submission ............................................................................................................. 41 
17.2 
Insurance .............................................................................................................................. 41 
18 
INFORMED CONSENT PROCESS .................................................................................................. 42 
19 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES .............. 43 
19.1 
Definitions ............................................................................................................................ 43 
19.2 
Methods for Discovering and Documenting AE/ADE .......................................................... 44 
19.2.1 
Severity ........................................................................................................................ 44 
19.2.2 
Causality ...................................................................................................................... 44 
19.3 
Methods for Discovering and Documenting Device Deficiencies ........................................ 46 
19.4 
Reporting of SAE/SADE and Device Deficiencies with SADE Potential ................................ 46 
19.5 
Data Monitoring Committee ................................................................................................ 47 
20 
VULNERABLE POPULATION ........................................................................................................ 48 
21 
SUSPENSION OR EARLY TERMINATION OF THE CLINICAL INVESTIGATION ............. 49 
21.1 
Criteria for Breaking the Blinding Code ............................................................................... 49 
21.2 
Subject Follow-up ................................................................................................................ 49 
22 
PUBLICATION POLICY ................................................................................................................... 50 
23 
REFERENCES ..................................................................................................................................... 51 
24 
APPENDICES ...................................................................................................................................... 52 
24.1 
Appendix A – Clinical Investigation Plan Agreement Form .................................................. 52 
24.2 
Appendix B – Clinical Investigation Contact List .................................................................. 53 
24.3 
Appendix C – Declaration of Helsinki ................................................................................... 55 

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4 
DEFINITIONS AND ACRONYMS 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
App 
Application  
ASADE 
Anticipated Serious Adverse Device Effect 
BMI 
Body Mass Index 
CA 
Competent Authority 
CIP 
Clinical Investigation Plan 
CIR 
Clinical Investigation Report 
eCRF 
Electronic Case Report Form 
CRO 
Contract Research Organization 
DD 
Device Deficiency 
DEU 
Dependent End User, synonymous with “subject” 
DMC 
Data Monitoring Committee 
DMP 
Data Management Plan 
DMR 
Data Management Report 
DVP 
Data Validation Plan 
EDC 
Electronic Data Capture 
EEA 
European Economic Area 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation (EU) 2016/679 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICS 
International Continence Society 
IEC 
Independent Ethics Committee 
IFU 
Instructions for Use 
ISF 
Investigation Site File 
ISO 
International Organization for Standardization 
MDD 
Medical Device Directive 93/42/EEC 
MDR 
Medical Device Regulation (EU) 2017/745 
PCB 
Printed circuit board 
PI 
Principal Investigator 
QoL 
Quality of Life 
Residual Risk 
Risk remaining after risk control measures has been taken 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SDV 
Source Data Verification 
SOP 
Standard Operating Procedure 
UI 
Urinary Incontinence 
USADE 
Unanticipated Serious Adverse Device Effect 
WHO 
World Health Organization 

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5 
INTRODUCTION 
5.1 Background 
The definition of Urinary Incontinence (UI) is “the complaint of any involuntary leakage of urine”, 
according to the International Continence Society (ICS). UI is a common complaint throughout the 
world known to carry a profound effect on social and physiological well-being. However, 
estimates of prevalence depend on the definition of incontinence and the population studied. 
Consequently, the estimates varies in the literature (1) (2). Among adults older than 65 years and 
living at home while receiving home care services a prevalence rate of 46% has been identified. 
Factors associated with higher incidence of UI are e.g. high age, high Body Mass Index (BMI), a 
large number of reasons for admission to homecare, impaired mobility, diabetes mellitus and 
fecal incontinence (3). Even if not proven to have negative impact on interactions with family and 
friends in all populations UI has been reported to impact on self-rated health and other measures 
of quality of life (QoL). Positive associations between UI and depression have been identified (4), 
as well as to isolation, skin ulceration/ moisture-associated skin damage, urinary tract infection, 
sleep disturbances, fatigue, falls and fractures (5).  
Among a plethora of treatment options, conservative management is the first-in-line option for 
most patients with UI. Conservative management comprises lifestyle interventions (weight loss, 
smoking cessation, fluid reduction, constipation management), physical therapies (pelvic floor 
muscle training/exercises (PFMT/PFME) and vaginal cones), behavioral therapies (bladder 
training, prompted or scheduled/timed voiding) and mechanical devices (continence pessaries, 
urethral plugs). Little evidence is available to support use of drug therapy over conservative 
treatment options. In addition, patient satisfaction is generally lower (1). As such, 
pharmacological treatments are generally indicated if conservative management options have 
failed. Pharmaceutical options include antimuscarinic drugs, 3-antagonists, duloxetine, 
estrogen, desmopressin, and botulinum toxin type A injections. Surgical management (e.g. open 
abdominal retropubic suspension, laparoscopic retropubic suspension, midurethral sling 
procedures, traditional suburethral sling procedures, anterior vaginal repair, bladder neck needle 
suspensions, peri-urethral injections and artiﬁcial sphincters) is the highest risk option available 
for treatment of UI and mainly aim to lift and support the urethrovesical junction (1) (6) (7) (8) (9)
(10) (11) (12). As described, a wide range of active treatments are available for UI. For use in
addition, or as separate measures, conservative and passive containment strategies such as
toileting programs, pads etc. may be used for management of UI. Containment is important for
UI patients when active treatment does not cure the problem, or is not available/possible and in
patients who prefer containment over active treatment with its associated risks. This includes the
use of absorbent pads, urinary catheters, external collection devices, penile clamps for men and
intravaginal devices for women (1).
During the ongoing marketing of the TENA product line of incontinence products the need for 
easy-to-use products and solutions to support caregivers have been identified. Typically, an 
absorbing incontinence product is changed three to four times per day. Changing too early leads 
to unutilized products being discarded and changing too late implies a risk of leakages onto 
garments and furniture as well as risk of moisture-associated skin damage. To provide quality care 
and reassure that the incontinent individual is comfortable, a caregiver checks the saturation 
status of each pad on average 2-3 times between changes. These checks involve components such 
as touch-feel, looking, and/or asking that not only implies worry for the caregiver but also is an 
invasion of the privacy of the incontinent individual being cared for. 
The TENA SmartCare Change Indicator is an accessory to TENA incontinence products. The 
accessory is designed to facilitate the caregiver’s decision to change the TENA incontinence 

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product by informing the caregiver about increasing saturation of the absorbent core. Market 
introduction of the TENA SmartCare Change Indicator aims to reduce the number of manual 
checks resulting in a simplified and more comfortable life of caregivers as well as the subjects 
suffering from UI However, before market introduction of the TENA SmartCare Change Indicator 
can commence the involved mathematical algorithms needs to be evaluated and assessed. 
The purpose of this exploratory clinical investigation is to collect real-life measurement data using 
the TENA SmartCare Urine Sensor and Gateway. The collected data will be used to evaluate and 
assess the involved device related algorithms.  

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6 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
The TENA SmartCare Change Indicator consists of a reusable Urine Sensor, attached to the 
outside of a TENA absorbent incontinence product and an app installed on one or more 
smartphones. 
The TENA SmartCare Change Indicator provides decision support for caregivers to know when it 
is time to change their Dependent End User’s (DEU) absorbent incontinence product, replacing 
the traditional checking procedure. The system shows the urine saturation level of the absorbing 
incontinence product making manual checking superfluous.  
The TENA SmartCare Change Indicator continuously monitors the saturation level of the TENA 
absorbent incontinence product by using a sensor placed on the outside of the absorbent 
incontinence product.  
The status is shown in a User Interface (app). The saturation level may be shown/shared with 
one or more caregivers smartphones using a cloud-based solution. 
 
 
Figure 1. Visualization of the TENA SmartCare Change Indicator system. The modules involved in this 
investigation is within the blue box. 
 
In the FUEL clinical investigation only the subparts Urine Sensor (with sensor strip and transmitter) 
and Gateway will be involved. For visualization of TENA SmartCare Change Indicator system, see 
figure 1 above. For more information on the device see the Investigator’s Brochure (IB) (13). 
6.1 Manufacturer 
Essity Hygiene and Health AB 

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405 03 Gothenburg 
Sweden 
Essity Hygiene and Health AB (Essity) is the manufacturer of the TENA SmartCare Change Indicator 
(including the Urine Sensor and Gateway). Manufacturing and packaging of the TENA SmartCare 
Change Indicator are all conducted by or on behalf of Essity.  
6.2 Identification of Clinical Investigational Medical Device 
6.2.1 Classification According to MDR 
Incontinence is classified as a disease by ICS in cooperation with World Health Organization 
(WHO), and together with the intended use being to give alleviation of a disease, the incontinence 
products are thus classified as Medical Devices per the definition in Article 2(1), of Regulation (EU) 
2017/745 (MDR).  
According to MDR Annex VIII, TENA SmartCare Change Indicator, being a non-invasive accessory 
to the medical device, TENA absorbent incontinence product, complies to Rule 1 and is thereby 
classified as a Class I medical device. However, as the TENA SmartCare Change Indicator also have 
embedded software, which do not pose any risk to the user if failure occurs, Rule 11 is also 
applicable. 
In conclusion, TENA SmartCare Change Indicator has been classified according to Annex VIII of 
MDR as a non-invasive accessory to the medical device TENA absorbing incontinence product 
according to Rule 1 and Rule 11 and consequently classified as a Class I medical device. The TENA 
SmartCare Change Indicator is currently not CE marked. 
6.2.2 Urine Sensor 
The Urine Sensor, see figure 2, is the combination of the Transmitter and the Sensor Strip when 
combined and attached to each other. For this clinical investigation, the Urine Sensor hardware 
version no. 5 will be used. . 
Figure 1. The Urine Sensor is placed on the outside of an absorbing incontinence product. 
6.2.2.1 
Transmitter 
The Urine Sensor is attached to the outside of a TENA absorbent incontinence product. 
Periodically, the sensor estimates                                 the absorbent incontinence product, 

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processes the estimates and transmits the data wirelessly, using Bluetooth, to the Gateway. 
Data is collected from the outside of the absorbing incontinence product. 
The Transmitter consists of the following components: 
•
A plastic housing provides necessary protection a................................... 
chemical ..........sub
•
An electronic circuit board is internally connected to electrodes that measure             
                       and stores the data. All data is transferred wireless to the caregivers User 
Interface/App for presentation.
•
A coin cell battery provides energy to the sensor. .
•
A Bluetooth radio modem allows the sensor to wirelessly transmit the collected 
data .......
•
..s.
6.2.2.2 
Sensor Strip 
The Sensor Strip extend the Transmitter to collect i     ............ signals from the TENA absorbent 
incontinence product. 
i 
The Sensor Strip consists of the following components: 
•
A flexible,               circuit board            provides the extension of signals from the 
Transmitter 
•
A          material provides attachment of the Sensor Strip to the outside of the 
absorbent incontinence product.
•
A cover material provides necessary protection ................................................... 
chemical .
•
A                     contact establishes the contact between the Strip and the Transmitter.
•
.
6.2.3 Gateway 
The Gateway is a unit communicating in two directions. Its sole purpose is to receive the 
collected data from the Transmitter and forward the data to the Cloud solution via a cellular 
network. 
communicate with the cellular network. 
The Gateway consists of the following components: 
•
A plastic housing provides necessary protection against ingress.
•
An electronic circuit board .                                    antennas and passive components.
•
A                   radio modem allows the gateway to wireless receive the collected data 
from the Transmitter using standardized protocols.
•
A .                      modem allows the Gateway to wireless transmit the collected data to 
the Cloud solution.
•
A power supply supports the gateway with power to operate.
6.2.4 TENA SmartCare Backend Services 
The Backend Services consists of two different parts, the Device Backend Service and the 
Application Backend Service. The TENA SmartCare Backend Services are not part of this clinical 
investigation. 

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6.2.4.1 
Device Backend Service 
The Cloud Solution provides the communication path between the Gateway and the TENA 
SmartCare Applications using public cellular networks and internet infrastructure.  
6.2.4.2 
Application Backend Service 
The Backend services in the cloud are used to handle application specific services                                      
used by th                                                                         used to ensure secure data handling and 
privacy.  
6.2.5 TENA SmartCare Change Indicator Application 
The application software can be installed on one or more smartphones. It receives data from the 
cloud solution and presents status information to the caregivers. 
For professional caregivers managing several resident in one home, additional management tools 
and consoles to overview and manage the residents are needed, in combination with handhelds 
smartphones. The application is not part this clinical investigation.   
6.2.6 Device Labeling 
Urine Sensors used in the investigation will be labeled with “For use in clinical study only”, date 
and ID No, see figure 3. 
Figure 3. Labeling of the Urine Sensor (not to scale). The labeling will be present as stickers put clearly visible on the 
Urine Sensor and Gateway. 
6.3 Device Traceability 
The Sponsor and site personnel will keep records documenting the location of all investigational 
devices from shipment from Sponsor, usage by study participants, and return to Sponsor (if 
applicable). This will be documented by a shipment log at the Sponsor and in device accountability 
log(s) stored at the site. The device accountability log at site will include the following information: 
•
Date and ID Number for each delivered device.
•
Date and subject Number for each used device.
•
Date for each device returned to Sponsor from site (if applicable).
The investigational devices will be handled and stored safely, properly and in agreement with the 
provided storage conditions. Returned and unused investigational devices are accounted for at 
the return to the Sponsor.  
The monitor will verify the accountability process at the site during the site monitoring visits. 
6.4 Intended Use 
The TENA SmartCare Change Indicator is an accessory to absorbent incontinence products, 
intended for use on individual(s) suffering from urinary incontinence in a home or professional 
Urine Sensor. 
Device for use in 
clinical 
investigation only 
ID No: 0000 
Date: yyyy-mm-dd 
Gateway. 
Device for use in 
clinical 
investigation only
ID No: 0000 
Date: yyyy-mm-dd 

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environment who are dependent on one or more caregivers to change the absorbent 
incontinence products. The TENA SmartCare Change Indicator estimates the degree of urine 
saturation in the absorbent incontinence product and notifies the caregiver(s). This facilitates 
the caregiver’s decision regarding when to change the absorbent incontinence product (14). 
Note, based on the objective for the FUEL exploratory clinical investigation only TENA SmartCare 
Urine Sensor and Gateway will be used. 
6.5 Indication and Population 
The target population in the FUEL exploratory clinical investigation is adult subjects diagnosed 
with UI and cared for at Tre Stiftelser. Tre Stiftelser is a professional nursing home located in 
Gothenburg. The intended user are professional and qualified nursing staff at Tre Stiftelser.  
6.6 Manufacturing and Materials 
Manufacturing and packaging of the TENA SmartCare Change Indicator are all conducted by or for 
Essity. Details regarding manufacturing of study devices are given in the IB (13).  
No parts of the TENA SmartCare Change Indicator are in direct contact with the subject’ tissues 
or body fluids. In addition, TENA SmartCare Change Indicator does not contain any medicinal 
products, human or animal tissues or their derivates or other biological active substances. 
The only products in direct contact with the subject’ tissues and body fluids are the TENA 
absorbent products used during the clinical investigation. These products are CE-marked Class I 
medical devices and will be used according to their approved intended use. As for TENA SmartCare 
Change Indicator, the TENA absorbent products do not contain any medicinal products, human or 
animal tissues or their derivates or other biological active substances.  
6.7 Training and Experience 
The Principal Investigator (PI) and designated nurses/coordinators/assistant nurses will receive 
device related training prior to clinical investigation initiation to ensure that the Urine Sensor, 
Gateway and TENA incontinence products are used according to Sponsor’s instructions. It is the 
responsibility of the Sponsor to ensure that involved staff is appropriately trained on the 
investigational devices. 
Prior to involvement in the clinical investigation the PI and nurses/coordinators involved in any 
investigational visit will receive relevant investigational training(s), e.g. CIP content, safety 
reporting procedures and timelines, informed consent process and forms, regulatory 
requirements including Good Clinical Practice (GCP), electronic Case Report Form (eCRF) content, 
use and registration, and content/logs etc. of the Investigator’s Site File (ISF) etc. The training is 
conducted to ensure subject safety, compliance to approved CIP and applicable 
regulations/guidelines, and accuracy of obtained clinical data.  
Assistant nurses only involved in the absorbent product change procedure will receive training 
relevant for their delegated task(s), e.g. how and when to complete the absorption product 
documentation, information of AE occurrence to be forwarded to the PI, nurse and relevant 
coordinator(s) etc. 
The PI will ensure that appropriate training relevant to the clinical investigation is given to any 
other site personnel involved in the investigation and that new information of relevance to the 
performance of the investigation is forwarded to staff involved.  

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6.8 Installation and Use 
6.8.1 Normal Use 
•
The Urine Sensor is intended to be single patient use.
•
The incontinence product is single use.
•
If the Urine Sensor or Gateway is broken, it will be replaced 
•
The Urine Sensor will not be used attached to the patient’s skin during normal use. It is 
attached to the outside of the incontinence product which is in contact with the 
patient’s skin.
•
The operator of the Urine Sensor is the caregiver of the patient in a home or healthcare 
environment. When used in professional healthcare environment, a professional 
caregiver will perform the same operations.
•
Attachment of the Urine Sensor on the incontinence product is considered primary 
operating function.
•
The Urine Sensor should only interact with the caregiver, not the patient. T(15).
6.8.2 Installation and Use 
The Sensor Strip assembling will be performed by a Sponsor’ representative at the start of the 
clinical investigation. This installation will not be handled by involved site personnel. For details 
on the sensor strip assembling and change, see figure 3. 
Figure 3. Assemble Sensor strip/Change sensor strip 

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After assembling of the Sensor Strip to the Transmitter, the Urine Sensor can be used for 
registration of urine on the allocated absorption product(s). For details on how to place and 
remove the Urine Sensor from the TENA absorbent products, see figure 4 and 5. Note, to initiate 
registration,                                                                                                                                                                             
In .............................................................this study, the device will not be turned off by 
 
o 
 
Figure 4. Place transmitter on absorbent area of the incontinence product 
Figure 5. Change absorbent product 
After changing of absorbent product, place the used product in the prepared plastic bag. Fill in 
the remaining sections of the label and hand over the plastic bag to the Sponsor’s 
representative. Prepare a new plastic bag and document applicable information linked to the 
new absorbent product on the label, e.g. date and time of application, absorbent product type 
etc.  
6.9 Cleaning 
See figure 6 for cleaning instructions of the Urine Sensor and Gateway. 

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Figure 6. Cleaning instruction for Urine Sensor and Gateway. 
6.10 Gateway Installation 
Gateways will be installed                                                                                                                   The 
installation will be performed by a Sponsor’ representative well in time of the clinical 
investigation initiation. For details on the Gateway installation, see figure 7. 

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Figure 7. Gateway installation 
6.11 Contraindications for Use 
There are no contra indications for use as long as the absorbent product is suitable to be used 
according to normal procedures and intended use (15).  

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7 
JUSTIFICATION OF CLINICAL INVESTIGATION DESIGN 
During the ongoing marketing of the TENA product line of incontinence products the need for 
easy-to-use products and solutions to support caregivers were identified. Typically, an absorbing 
incontinence product is changed three to four times per day. Changing too early leads to 
unutilized products being discarded and changing too late implies a risk of leakages leading to a 
risk of reduced QoL for both the incontinent subject and the caregiver. To provide quality care 
and reassure that the incontinent individual is comfortable, a caregiver checks the saturation 
status of each pad on average 2-3 times between changes, including night-time. The saturation 
checking is a manual process involving touch-feel, looking, and/or asking that not only implies 
worry for the caregiver but also is an invasion of the privacy of the incontinent individual being 
cared for.  
The purpose of this exploratory clinical investigation is to evaluate safety and to collect real-life 
measurement data using the TENA Urine Sensor and Gateway. The collected data will be used to 
assess the involved mathematical algorithms of the TENA SmartCare Change Indicator. The 
mathematical algorithms are key parts of the complete system. The Urine Sensor is capturing 
impedance values, which are the result of an electromagnetic interaction of the electromagnetic 
irradiation from the sensor and the urine present in the absorbent product. The physical 
impedance values are not in its captured form usable in the daily routine to judge the amount of 
urine in the incontinence product. The mathematical algorithms translate the captured physical                           
val             values into amount of urine values which can be used for assessing the saturation 
status of the incontinence product. 
This exploratory clinical investigation will be conducted in a nursing home by professional and 
qualified nursing staff. By conducting this clinical investigation in a nursing home, sufficient 
number of suitable participants are estimated to be available and the measurements can be 
obtained under controlled conditions.  
Data from this exploratory clinical investigation are necessary to continue the TENA SmartCare 
Change Indicator development. However, the clinical investigation will only involve TENA Urine 
Sensor and Gateway. No comparator device will be involved in this single-arm clinical 
investigation. 

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8 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL INVESTIGATION 
When discussing risks and benefits of a new medical device, there are different aspects that 
have to be considered, including the potential risks and benefits for the subjects participating in 
the clinical investigation and for future subjects  with clinical use of the new device. 
Use of the device carries low risk. Risk management related to the device has been conducted in 
accordance with ISO 14971 and includes risk analysis and risk evaluation, risk control and pre-
production and post-production review. The risk management process and the residual risks are 
further described in the IB (13). 
8.1 Anticipated Clinical Benefits 
There are no direct anticipated clinical benefits of the investigational device for the participating 
subjects. However, the intended use demonstrates a clear clinical need in the target population.  
Anticipated benefits for the whole system (TENA SmartCare Change Indicator): 
The TENA SmartCare Change Indicator is intended to facilitate the decision to change an 
incontinence product. The clinical benefit is that this can reduce the number of unnecessary 
manual checks of the incontinence product and reduce the time the resident spend in an 
incontinence product near saturation.  The TENA SmartCare Change Indicator improves the 
residents’ privacy and well-being by minimizing unnecessary disruptions of their daily activities 
and sleep as well as skin exposure to urine and undignified leakages. 
8.2 Anticipated Adverse Device Effects 
Use of the device is considered to be associated with low risk and there are no anticipated 
adverse device effects. 
8.3 Residual Risks 
After the risk assessment (16) were performed, there were five residual risks remaining. Most of 
these risks are related to severe misuse of the device due to impaired cognitive and/or physical 
function, see table 1. For the FUEL exploratory clinical investigation, the study will be supervised 
thus reducing the risk of severe misuse even further. Considering the controlled setting and 
applied inclusion/exclusion criterias these risks are deemed unlikey to occur. Additional risk 
control has not been conducted as further design changes will infringe on the intended use and 
reduce the clinical benefit of the device. All individual risks (except the residual risks) where 
accepted in the risk assessment. After the risk/benefit analysis the residual risks were also 
accepted as it was evaluated that the benefit of the device outweighs the risks (16). 
8.4 Risks Associated with Participating in the Clinical Investigation 
This clinical investigation will be conducted in line with applicable regulations and ethical 
principles designed to safeguard study subjects. The PI will ensure that appropriate training 
relevant to the investigation is provided to the staff involved. 
According to the risk analysis report, if the device will not work or malfunction this will not pose 
a risk for the study subjects. Regular change of incontinence products will continue regardless of 
the functionality of the device. Furthermore, malfunctions will not be an issue for the clinical 
investigation as this will be part of the evaluation of the device within the scope of the  
investigation. 
TENA SmartCare Change Indicator is a novel device system, designed as an accessory to the CE-
marked TENA absorbent products (Class I) used in this clinical investigation. 
The reporting of adverse events and monitoring described in section 11 and 19 respectively, will 
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Except for the identified residual risks described above, no specific investigation related risk has 
been identified. 
8.5 Possible Interactions with Concomitant Medical Treatments 
No interactions with concomitant medication treatment have been identified. 
8.6 Risk Control 
A risk management plan has been implemented for the TENA SmartCare Change Indicator. 
Appropriate company procedures and systems are in place to obtain relevant production and 
post-production information. All risks have been reduced as far as possible, meaning that all 
safety principles have been applied where possible and where safety could be improved. See 
section 8.3 and the IB (13). 
8.7 Risk-to-Benefit Rationale 
The risks from all identified hazardous situations have been considered (17), for a summary of 
residual risks see table 1. It is concluded that the clinical benefit of using the device is greater 
than the residual risks, and the overall residual risk associated with the product are judged to be 
acceptable (16). Using the device adds no risk to the risk profile found for the absorbent 
incontinence products, which it is intended to be used in combination with, that have been on 
the market for many years. 
The risk management activities are in line with the risk management plan (18), the risk 
management procedure (19) and the requirements of the EN ISO 14971:2012 standard.  
The risk assessment (17) and the evaluation of the risk analysis (16) have been made with regard 
to the general safety and performance requirements of the Medical Device Regulation 
2017/745.  
Table 1: Summary of residual risks 
Risk ID 
Hazard 
Hazardous situation 
Risk/benefit analysis 
4.1 
Allergic reaction 
causing anaphylactic 
shock or other 
symptom with fatal 
outcome. 
Urine sensor in contact with skin 
The risk of having a 
hyper sensitive person 
among the users of the 
device are judged as 
very low.  
39.1 
Suffocation 
The dependent end user may ingest the 
transmitter 
The transmitter has 
been designed to be 
too large to easily 
ingest. This risk will also 
be present for 
dependent end users in 
a home or professional 
environment.  
39.2 
Suffocation 
The dependent end user winds the sensor 
strip around the neck 
The risks for the device 
are similar to that of 
any long thin object 
present in a home or 
professional 
environment. It is not 
possible to re-design 
the sensor strip without 
risking device 
performance. 

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Risk ID 
Hazard 
Hazardous situation 
Risk/benefit analysis 
39.4 
Burns, Indigestion 
The transmitter is opened and the battery 
swallowed 
The battery type is 
common in electric 
appliances in society 
and the risks are well 
known. Design 
measures have been 
included to secure the 
battery, but the 
presence of the battery 
is necessary to achieve 
intended use.  
39.7 
Suffocation 
Transmitter parts excluding battery may be 
ingested 
It is not possible to 
design the components 
of the urine sensor to 
mitigate this risk 
without risking device 
performance and 
intended use. 

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9 
OBJECTIVES AND HYPOTHESES OF THE CLINICAL INVESTIGATION 
9.1 Primary Objective 
The primary objective is to collect real-life measurement data using the Urine Sensor to assess 
the mathematical algorithms for wetness detection in TENA absorption products by urine 
volume quantification and                     measurements.  
9.2 Secondary Objectives 
The secondary objective is to evaluate safety through analyzing device-related adverse events 
reported during the investigation. 
9.3 Hypothesis 
Not applicable. A statistical hypothesis has not been considered relevant due to the exploratory 
nature of this clinical investigation.  
9.4 Claims and Intended Performance of the Investigational Device 
Not applicable as this exploratory clinical investigation will be limited to the TENA Urine Sensor 
and Gateway.  
9.5 Risks and Anticipated Device Effects 
There are no identified adverse risks or anticipated device effects. 

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10 DESIGN OF THE CLINICAL INVESTIGATION 
10.1 General 
This is an exploratory clinical investigation to evaluate safety and to collect real-life measurement 
data using the TENA Urine Sensor and Gateway. The collected data will be used to evaluate and 
assess the device related algorithms. The primary algorithms have been established and evaluated 
in a laboratory environment. However, several parameters differ between real-life and laboratory 
settings and can be hard to predict. Consequently, real-life measurement data has been 
determined necessary to continue the product development.  
To assess the mathematical algorithms the urine volume needs to be quantified (ml urine) and 
the                      values from the Urine Sensor captured. Data such as; date and time of 
application, date and time of removal, Urine Sensor ID, absorbent product information (type, 
absorption level and size), leakage outside product, presence of feces, and the subject’s main 
position since last absorbent product change will be recorded by the caregiver on a label located 
on a plastic bag. The absorbent product is thereafter placed in the plastic bag and provided to a 
Sponsor’ representative. The plastic bag is weighed on a calibrated scale by the Sponsor’ 
representative in the Essity lab and the weight documented in the eCRF. The urine spreading in 
the absorbent product is documented by taking a photo of the absorbent area of the product. 
The photo is uploaded in the eCRF system. All data documented by the caregiver on the plastic 
bag label are transferred to the eCRF by the Sponsor’ representative, and the label is detached 
from the plastic bag and placed on a paper and returned to site. The paper is considered source 
data and will be stored in a study specific binder for quality assurance and archiving. 
In total 9 types of absorbent products will be tested; 
•
TENA Slip
•
TENA Flex
•
TENA Pants
Each TENA absorbent product type exists in three different absorption levels, Plus, Super and 
Ultima, to meet different incontinence needs of the user. The lower absorption level is designed 
for users suffering from moderate incontinence needs and the higher absorption level is designed 
for users with higher incontinence need. In the FUEL  clinical investigation, both absorption levels 
for each TENA absorbent product type will be included. The TENA absorbent products come in 
four different sizes; small, medium, large and extra large. All subjects will be allocated to the most 
appropriate size. Note, the size is not believed to affect the registrations and are not considered 
different product types.  
Approximately 15 subjects diagnosed with UI will be recruited from the nursing home Tre 
Stiftelser in Gothenburg, Sweden. 
The clinical investigation is designed to be conducted in a professional environment, for a duration 
of 8 weeks (approximately 6 weeks registration per subject + enrollment time). Two visits are 
planned for each subject during the duration of the clinical investigation; screening visit and 
follow-up visit. Absorption product registrations will be collected as specified above between 
these visits.  
The overall duration of the investigation is estimated to 8 weeks, including a 2-week recruitment 
period.  
10.1.1 Primary Endpoint 
Summarize the individual differences (predicted urine volume* - true urine volume**) using 
descriptive statistics. The data*** will later be used to assess mathematical algorithms for the 
TENA SmartCare Change Indicator. 

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*Prediction calculated from urine sensor values
** Urine volume determined from absorbent product weights
***Data is the combination of urine sensor values and absorbent product weights.
10.1.2 Secondary Endpoints 
Incidence of adverse events and device deficiencies; AEs, ADEs, SAEs, SADEs and DDs. 
10.2 Investigational Device(s) and Comparator(s) 
This is a single-arm clinical investigation. Thus, no comparator device will be used. 
Each participating subject will be provided with one Urine Sensor, as well as absorbent products 
for the duration of the investigation. Eight types of absorbent products will be tested in the 
FUEL clinical investigation, and each participating subject will be allocated to the type(s) that are 
considered most suitable. What type(s) are most suitable will be decided during the screening 
visit depending on previous absorption product use and the subject’s physiology. 
Gateways will be placed                                                                                                to enable full 
measurement registration.  
Within the scope of this clinical investigation, no other additional medical device or medication 
is required.  
10.3 Subjects 
10.3.1 Inclusion Criteria 
The subject must meet all of the following criteria to be eligible for this clinical investigation: 
1.
The subject is willing and able to provide informed consent and to participate in the
clinical investigation.
2.
The subject is  18 years of age.
3.
The subject is diagnosed with urinary incontinence.
4.
The subject is being cared for at Tre Stiftelser.
10.3.2 Exclusion Criteria 
Subjects meeting any of the following criteria will not be permitted to participate in the clinical 
investigation: 
1.
The subject has  4 fecal ”incidences” per week.
2.
The subjecthas severe absorbent product related skin problems, as judged by the
investigator.
3.
The subject is hyper sensitive related to allergic reaction to any of the included
materials, as judged by the investigator.
4.
The subject has  2 intermittent urinary catheters per day.
5.
The subject has a pacemaker or an implantable cardioverter-defibrillator.
6.
The subject removes the incontinence product.
7.
The subject demonstrates responsive behavior towards sensors.
8.
The subject has any other condition that may make participation in the clinical
investigation inappropriate, as judged by investigator.
9.
The subject is not cared for at Tre Stiftelser.
10. The subject is pregnant or lactating.
10.3.3 Number of Subjects 
The investigation population will be comprised of approximately 15 subjects suffering from UI, 
cared for at the nursing home Tre Stiftelser, and that are fulfilling all of the inclusion criteria and 
none of the exclusion criteria for the clinical investigation.  

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10.3.4 Methods of Assigning Subjects to the Different Treatment Arms 
Not applicable as this is a non-randomized single-arm clinical investigation. For allocation to 
suitable incontinence products, see section 10.1. 
10.3.5 Subject Withdrawal or Discontinuation 
Subjects are free to discontinue participation in the clinical investigation at any time and are not 
required to give a reason for their decision. However, subjects who discontinue the investigation 
should always be asked about the reason(s) for their discontinuation and about the presence of 
any AE/ADE and, if possible, be assessed by an investigator. Discontinuation from the clinical 
investigation will not affect the future treatment/care of the subject. 
If the subject withdraw his/her consent no further data will thereafter be recorded. Data collected 
up to the date of withdrawal of informed consent will be used in the data analysis and for the 
Clinical investigation Report (CIR), provided that the subject do not actively request all data to be 
removed. 
Participants may be withdrawn from the clinical investigation and assessments at any time, if 
deemed necessary by the investigator. 
Specific reasons for withdrawal of participants from this clinical investigation are: 
•
The decision of a subject to withdraw from the investigation.
•
The investigator deems the subject unfit for the investigation or suspects poor CIP
compliance.
In case of withdrawal, all AEs/ADEs should be followed up and applicable documentation should 
be returned to the Sponsor.  
Incorrectly enrolled subjects will be withdrawn from further investigation and assessments. A 
subject may, however, continue the clinical investigation under exceptional circumstances (i.e. if 
continuation of investigation or follow-up are necessary for the subject’s safety and well-being, 
or if only a follow-up period remain, and the continuation of the investigation is not expected to 
be associated with any risk or discomfort for the subject). 
10.4  Clinical Investigation Duration 
Table 2. Overview of clinical investigation duration. 
Point of enrolment: 
End Aug/beginning Sep 2019 
Total expected duration of the clinical investigation: 
8 weeks 
Expected duration of each subject’s participation: 
6 weeks 
Enrolment period: 
2 weeks 
10.5  Clinical Investigation Procedures 
10.5.1 Schedule of Clinical Investigation Procedures/Assessments 
The assessments and procedures that will be performed during the clinical investigation is 
illustrated in table 3 below. Further information is provided in the sections below. 

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Table 3. Clinical investigation schedule for assessments and procedures. 
Clinical Investigation Visit: 
Visit 1 – Screening 
Visit 2 – Follow-up 
Assessments and procedures: 
Subject  information and informed 
consent 
X 
Eligibility verification 
X 
Enrollment 
X 
Demography 
X 
Concomitant medication review 
X 
X 
Relevant medical and surgical 
history 
X 
General health status 
X 
Pregnancy test in subjects with 
childbearing potential 
X 
Allocation to suitable absorbent 
product type(s) and size(s) 
X 
Verification of eCRF completion 
X 
AE/ADE/SAE/SADE/DD 
documentation/Follow-up 
X 
10.5.1.1 Visit 1 – Screening, day 0 
The screening visit is conducted by the PI. The PI will introduce the clinical investigation and 
explain the CIP, procedures and objectives to the potential subject. The PI will verbally inform the 
subject about the investigation and provide written subject  information describing the clinical 
investigation, potential discomforts, risks and benefits of participation. Potential subjects will be 
given adequate time for review of the subject  information and time to discuss the investigation 
and ask questions to the PI. Any queries that a potential subject may have regarding the 
investigation will be addressed appropriately by the PI. Potential subjects will be instructed that 
they are free to withdraw their consent and to discontinue their participation in the investigation 
at any time without prejudice. If the subject is willing to participate in the investigation, he/she 
needs to sign and date the ICF together with the investigator who gave the verbal and written 
information. The original ICF will be retained in the ISF and a copy provided to the subject. The 
investigator must obtain written informed consent before any clinical investigation related 
procedures are performed on the subject, for further details on the informed consent process 
please see section 18.  
After written informed consent has been obtained the subject is considered to be enrolled in the 
clinical investigation. The subject will be allocated to the next available subject identification 
number, a unique number, used for the identification of the subject in the investigation. For FUEL 
clinical investigation the subject identification number will consist of the letter F (FUEL) and four 
digits. The first digit is the site number. As only one site is expected in the upcoming clinical 
investigation number 1 is currently the first number for all subjects. The remaining three digits 
are consecutive numbering. For example, the first subject will be allocated to subject No. F1001. 
After enrollment, relevant medical/surgical history and relevant concomitant medication(s) will 
be collected and listed in the study specific eCRF. The general health status will be evaluated and 
for subjects with childbearing potential a urine pregnancy test obtained. Information on the 
subject’s demographics will be documented in the eCRF and all inclusion and exclusion criteria 
reviewed (eligibility verification). If eligible, the subject will be allocated to the most suitable 
absorbent product type(s) to be tested (eight types in total) and size. 
At visit 1, the following assessments/procedures will be performed: 
•
Subject  information and informed consent

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•
Eligibility confirmation
•
Enrollment
•
Demographic data and baseline information; year of birth, gender, incontinence
product(s) of use previous 6 months, bedridden/not bedridden
•
Documentation of relevant concomitant medication(s)
•
Documentation of relevant medical and surgical history
•
Evaluation of general health status
•
Urine pregnancy test in subjects with childbearing potential
•
Allocation to suitable absorbent product type(s) and size
10.5.1.2 Visit 2 – Follow-up, after approximately 6 weeks of absorbent product registration 
At the follow-up visit concomitant medications will be reviewed and completion of eCRF 
registrations confirmed. All AEs/ADEs/SAEs/SADEs and/or DDs will be documented and followed-
up, as applicable. After completion of visit 2 the subject will be terminated from further 
participation in the clinical investigation.  
At visit 2, the following assessment/procedures will be performed: 
•
Documentation and/or follow-up on AE/ADE/SAE/SADE/DD
•
Concomitant medication review
•
Verification of eCRF completion
•
Study termination
10.5.1.3 Unscheduled Visits/Contacts 
If deemed necessary for any reason, e.g. AE/ADE/SAE/SADE, unscheduled visits may be 
conducted within the course of the clinical investigation. All unscheduled visits shall be 
documented in the eCRF and medical notes, as applicable*.  
* Any unscheduled examination between visit 1 and visit 2 will be considered an unscheduled visit.
10.5.2 Demographic Data and Baseline Measurements 
10.5.2.1 Demographic Data 
At the screening visit the following demographic data are to be collected; year of birth, gender, 
incontinence product(s) of use the previous 6 months, bedridden/not bedridden.  
The following information linked to incontinence product(s) of use the previous 6 months is 
expected to be recorded in the eCRF: 
•
Name/product type
•
Absorption level
•
Size
•
Current/past use
•
Night time use/day time use/both
10.5.2.2 Relevant Concomitant Medication 
Relevant concomitant medication will be listed in the eCRF. At follow-up (visit 2) the listed 
concomitant medications will be reviewed, and eventual changes recorded. 
10.5.2.3 Relevant Medical and Surgical History 
During visit 1 relevant medical and surgical history will be elicited for each subject and listed in 
the eCRF. Relevant medical history will include specification whether the event is past or 
current. Relevant medical history will include date of surgical intervention. The medical history 
will assess the subject for any disqualifying medical conditions.  

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10.5.2.4 Evaluation of General Health Status 
Based on available medical record data and recorded health status at screening, the PI will 
evaluate the general health status of the subject i.e.: poor, fair, good, or very good. Based on 
the above information the PI will determine whether the health status of the subject is sufficient 
for participation in the clinical investigation.  
10.5.2.5 Urine Pregnancy Test 
All women of childbearing potential will conduct a pregnancy test at visit 1. The following is to 
be recorded in the eCRF: 
•
Was a urine pregnancy test obtained? Yes/No/Not applicable
•
If not applicable, reason.
•
Result of conducted test? Positive/Negative
10.5.2.6 Allocation to Suitable Absorbent Products 
The absorbent product allocation will be documented in the eCRF. The absorbent product 
type(s), absorbent level, size and time of use will be specified in a table. 
10.5.3 Performance Variables and Measurements 
10.5.3.1 Registration of Absorbent Product Information 
Between visit 1 and visit 2 the following information are to be documented; date and time of 
application, date and time of removal, Urine Sensor ID, absorbent product information (type, 
absorption level and size), leakage outside product, presence of feces, and subject’s main 
position since last absorbent product change will be recorded by the caregiver on a label located 
on a plastic bag. The absorbent product is thereafter placed in the plastic bag and provided to a 
Sponsor’ representative. The plastic bag is weighed on a calibrated scale by the Sponsor’ 
representative in the Essity lab and the weight documented in the eCRF. The urine spreading in 
the absorbent product is documented by taking a photo of the absorbent area of the product. 
The photo is uploaded in the eCRF system. All data documented by the caregiver on the plastic 
bag label are transferred to the eCRF by the Sponsor’ representative. The label is thereafter 
detached from the plastic bag and placed on a paper and the paper is returned to site. The 
paper is considered source data and will be stored in a study specific binder for quality 
assurance and archiving. 
10.5.4  Safety Variables and Measurements 
All incidences of AEs and DDs will be documented and reported during the course of the clinical 
investigation. Adverse events will be documented as adverse events AE, ADE, SAE, and SADE. 
For details related to adverse event definitions or reporting see section 19. 
All events will be followed up until resolved or judged as clinically stable according to the PI, if 
possible.  
10.5.5  Activities Performed by Sponsor 
•
The Sponsor is responsible for device training of involved personnel. Device training will
be documented in applicable training logs.
•
The Sponsor is responsible for weighting and photographing absorbent products and
transfer of data into eCRF according to section 10.5.3.
•
The Sponsor is responsible for reporting of SAEs according to section 19.4.
10.5.6 Potential Confounding Factors 
•
Concomitant medications that could potentially affect urination.
•
Subjects with regular fecal incidents.
•
Illnesses occurring during the investigational period.

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All the above identified potential confounding factors have been mitigated by study specific 
exclusion criterion.  

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11 MONITORING PLAN 
A detailed description of the monitoring activities will be explained in investigation specific 
monitoring manual.  
11.1 Subject Records and Source Data 
Subject data recorded directly in the eCRF, and not into the medical record, will be considered as 
source data. It is the responsibility of the PI to record essential information in the medical records, 
in accordance with national regulations and requirements. The origin of the source data in this 
clinical investigation will be further specified in a separate document (“Origin of Source Data”).  
In general, the following information shall be recorded in the medical records: 
• 
Clinical investigation code/title. 
• 
Subject identification number. 
• 
That informed consent for participating in the clinical investigation was obtained and date 
of consent. 
• 
Diagnosis. 
• 
All visits during the investigation period. 
• 
All AEs/ADEs/SAEs/SADEs/DDs. 
• 
Treatments and medications. 
The PI is responsible for ensuring the accuracy; completeness, legibility and timeliness of the data 
recorded in the eCRFs. Completed sections of eCRFs will be monitored on a regular basis.  
11.2 Access to Source Data and Documentation 
The PI and site should guarantee access to source documents for the monitor and auditors as well 
as for inspection by appropriate Competent Authorities (CA), Regulatory Agencies, and the IEC, if 
required. 
 
 

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12 STATISTICAL CONSIDERATIONS 
12.1  Statistical Design, Method and Analytical Procedures 
As this is an exploratory clinical investigation results will be summarized using relevant 
descriptive statistics such as means, Standard Deviation (SD), median, minimum and maximum 
values and frequency tables. The data will later be used to assess the mathematical algorithms 
for the TENA SmartCare Change Indicator. 
12.2  Sample Size 
No formal sample size calculation has been performed. Instead, it has been assumed that     
l             .. measurement points (absorptions product registrations) will be required per product 
type to be in an accuracy range similar to the lab verified urine sensor accuracy (20). Included in 
the assumptions for the         measurement points are also that each subject uses 3 absorbent 
products each day and that .................. absorbent products will be disregarded . 
In total 9 product types will be evaluated .............................................................................. It is 
estimated that at least 12 subjects are considered appropriate to adapt for individual spreading 
during the test. However, to compensate for drop-outs or non-compliance (see 12.4) 15 subjects 
are appropriate to include in the investigation. In the screening phase, a detailed product test 
plan will be made for each subject with the ambition to match test absorbent product type with 
the subject’s current absorbent product type. However, it cannot be assumed that the subject is 
using the specific TENA absorbent products in scope of this clinical investigation for their 
incontinence need, so a different product type might be assigned each subject. Product 
absorption level as well as product size will however remain the same.  
12.3 Level of Significance and Power 
Not applicable as no formal statistical analyses will be performed for this clinical investigation. 
12.4  Drop-out Rates 
It is estimated that 20% of subjects will drop-out or not complete the investigation. See section 
12.2 for further details. 
12.5  Pass/fail Criteria 
Not applicable as this clinical investigation does not contain a statistical hypothesis. 
12.6  Interim Analysis 
No interim analysis is currently planned. 
12.7  Criteria for Termination on Statistical Grounds 
Not applicable as no formal statistical analyses will be performed for this clinical investigation. 
12.8  Reporting of Deviations from the Original Statistical Analysis Plan (SAP) 
Any deviation(s) from the original SAP will be described and justified in a CIP Amendment 
and/or in a revised SAP and/or in the final report, as appropriate.  
12.9  Subgroups for Analysis 
No subgroup analyses are planned. 
12.10 Procedures that Take into Account All the Data 
Not applicable. 

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12.11 Missing, Unused or Spurious Data 
Outliers will be included in summary tables and listings and will not be handled separately. 
Available data from prematurely withdrawn subjects will be included in the summaries as far as 
possible.  
12.12 Exclusion of Particular Information from the Testing of the Hypothesis 
Not applicable as this clinical investigation does not contain a statistical hypothesis. 

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13 DATA MANAGEMENT 
The Data Management process includes all activities related to data handling, e.g.: 
•
Establishment of Data Management Plan (DMP)
•
eCRF and database set-up
•
Specification of on-line checks
•
Data and database validation
•
Export of data from Viedoc to Excel / SAS
•
Creation of post-entry checks and listings
•
Reconciliation of ADEs, SAEs, SADEs, and DDs
•
Clean-file process including execution of post entry checks and listings
•
Post clean-file tasks
•
Establishment of Data Management Report (DMR)
Data management and handling will be conducted according to the investigation specific DMP in 
accordance with applicable guidelines and CRO’s Standard Operating Procedures (SOPs). Any 
deviations, i.e. discrepancies and additions from the process defined in the DMP, will be described 
in an investigation specific DMR.  
Data will be collected in an eCRF specifically designed for this clinical investigation. The PI or an 
authorized person (Essity employee or sponsor representative) will record and upload subject 
data in the eCRF in a precise and accurate manner. Abbreviations should not be used. The 
investigator is responsible for the data entered and sign off the eCRF at the end of the clinical 
investigation. The data should be recorded as soon as they are generated.  
Data validation/ data cleaning procedures are designed to assure validity and accuracy of clinical 
data. These procedures consist of computerized edit checks and queries for identifying data 
values that are outside the allowed range, CIP deviations, incomplete or inconsistent. The Data 
Validation Plan (DVP) specifies the checks that are to be performed on subject data for the clinical 
investigation. All investigation-specific and standard data validation programming will be tested 
in a separate testing environment prior to use on production data.  
When all data from all endpoints of all study participants have been entered, discrepancies 
solved and all reconciliation with the safety database is complete, the database will be locked, 
and the data will be analyzed.   
13.1 Electronic Data Capture (EDC) 
Viedoc a web-based EDC system, will be used to capture data in this investigation; eCRF. The EDC 
system complies with FDA Title 21 CFR part 11 (ER/ES) requirement and is validated according 
GAMP 5. eCRF training will be given to appropriate personnel before/at initiation of the 
investigation site(s). Data entry will be done by the PI and other authorized personnel (Essity 
employee or sponsor representative). For the FUEL clinical investigation authorized personnel for 
eCRF data entry will be both personnel at site and authorized Sponsor’ representatives (absorbent 
product weight, photo and data entry of plastic bag label data). An Essity employee will enter the 
predicted value of each incontinence product into the eCRF. This person will not be able to see 
the actual weight of the product in the eCRF. To achieve this, a separate user will be created in 
the Viedoc database for this person. When entering data on-line checks are incorporated for 
consistency and validation. When data has been entered authorized personnel at Sponsor and 
CRO can immediately view the data, send queries if necessary and lock eCRF pages when they 
have been validated. The physical database will be stored using redundant enterprise level 
storage area networks (SAN) on separate data centers at separate geographic locations within the 
European Union. Programs for post-entry checks and data listings will be created and executed 
for validation of data. Completeness will be checked by authorized personnel at CRO so that there 

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are no unexplainable empty fields. This is done in order to prevent that data have been 
overlooked by personnel entering the data. 
A clean-file meeting will be held prior to database lock. All decisions on the evaluability of the 
data from each individual subject for the statistical analysis and final definition of Intention To 
Treat (ITT), Per Protocol (PP) and safety populations must be made and documented before 
locking the database. 
13.2 Data Retention 
The medical files of clinical investigation subjects must be retained in accordance with local 
legislation and in accordance with the maximum period of time permitted by site practice. 
The PI/investigational site shall retain all clinical investigation records during the investigation and 
for the period required by the applicable regulatory requirements or for at least 10 years after 
the premature termination or completion of the clinical investigation, whichever is the longer. 
The PI must take measures to prevent accidental or premature destruction of these documents. 
The PI should contact the Sponsor prior to destruction of any records or reports pertaining to the 
clinical investigation in order to ensure they no longer need to be retained. In addition, if the PI 
leaves the site, he/she should provide the Sponsor with the name and address of the person who 
will look after and be responsible for the clinical investigation-related records. If the records will 
be transferred to another person/party, the transfer will be documented at the investigation site 
and/or at the Sponsor.  
As the Investigators do not normally work at Tre Stiftelser, a contact person at site will be 
appointed and documented in the delegation log located in the ISF.  
13.3 Monitoring, Audits and Inspections 
During the investigation, the monitor will have regular contacts with the investigation site. These 
contacts will include visits to confirm that the facilities remain adequate to specified standards 
and that the investigation team is carrying out the procedure stated in the CIP. All data must be 
accurately recorded in the eCRF. Source Data Verification (SDV), a comparison of data in the eCRF 
with the subject’s medical records and other records at the investigation site, will also be 
performed. The source documents and records must be made accessible during the visit.  
The monitor or other Sponsor personnel will be available between visits if the PI or other 
investigation staff at the site needs information and/or advise.  Authorized representatives of the 
Sponsor and/or international Regulatory Agencies/CAs may visit the site to perform 
audits/inspections, including SDV.  

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14 AMENDMENTS TO THE CIP 
Any change to the approved clinical investigation documents will be documented and include a 
written justification. Any effects of the implemented changes on other clinical investigation 
documents shall be evaluated and documented. If deemed necessary, affected documents shall 
be properly updated and relevant parties notified. The version number and date of amendments 
shall be documented. 
Proposed amendments to the CIP shall be agreed upon between the Sponsor and the PI. The 
amendments to the CIP shall be notified to, or approved by, the IEC and CA, if required. 
All amendments to the CIP will be documented in an amendment log and communicated to 
relevant parties. 
 
 
 
 

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15 DEVIATIONS FROM THE CIP 
A CIP deviation is a failure to follow, intentionally or unintentionally, the requirements of the CIP. 
Every effort should be made to comply with the requirements of the CIP and the PI is not allowed 
to deviate from the CIP. 
As required by national regulations or guidelines, requests for deviations and reports of deviations 
will be provided to the IEC if the deviation affects subject’s rights, safety and well-being, or the 
scientific integrity of the clinical investigation. 
Under emergency circumstances deviations from the CIP may proceed without prior approval by 
the Sponsor and favorable opinion of the IEC if the rights, safety and well being of human subjects 
need to be protected. Such deviations will be documented and reported to the Sponsor and IEC 
as soon as possible in accordance with national regulations. 
When the monitor or Sponsor identifies that the PI is out of compliance, this will be notified to 
the PI in writing, with a request to correct the source of the deviation immediately. Corrective 
action will be implemented to avoid repeated non-compliance, which will usually include re-
training and may include termination of the clinical investigation at the site. 
The Sponsor is responsible for analyzing deviations and assessing their significance. Corrective 
actions will be implemented to avoid repeated deviations, which may include suspending the 
clinical investigation, or disqualifying the PI. 
 
 

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16 DEVICE ACCOUNTABILITY 
The Sponsor and the PI will keep records documenting the location of all investigational devices 
from shipment of investigational devices to the investigation sites until return. This will be 
documented by a shipment log stored at the Sponsor and in a device accountability log at the 
investigation site. The device accountability log at site will include information on: date, device ID 
No no, list of delivered devices, date and subject identification for used devices, and date and 
device ID No of devices returned. 
The monitor will verify the accountability process during the site monitoring visits. 

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17 STATEMENTS OF COMPLIANCE 
This clinical investigation will be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki (Appendix C). Furthermore, the clinical investigation will 
be conducted in compliance with ISO 14155:2011 and applicable regional or national regulations. 
17.1 Institutional Ethics Review 
The final CIP, including the final version of the ICF, must be approved or given favorable opinion 
in writing by an IEC, and CA, before enrolment of any subject into the clinical investigation. The PI 
is responsible for informing the IEC of any amendment to the CIP as per local requirements.  
Any additional requirements imposed by the IEC or CA shall be followed. 
17.1.1 IEC Submission 
In Sweden, the IEC application is to be submitted to the Swedish Ethical Review Authority through 
the web portal Prisma. The application is to be submitted by the PI who needs a Prisma account. 
17.1.2 CA Submission 
In Sweden, the CA application is to be submitted to the Swedish Medical Products Agency 
through their e-portal. No specific account is needed to submit the application.  
17.2 Insurance 
The Sponsor will be responsible for ensuring adequate insurance covering any injuries to the 
subject caused by the investigational medical device. The nursing home have a private patient 
insurance through the insurance company Länsförsäkringar, the insurance is equivalent to the 
public insurance provided by the Swedish Patient Injury policy (LÖF). 

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18 INFORMED CONSENT PROCESS 
All subjects will receive written and verbal information regarding the investigation prior to any 
investigation-related procedures. This information will emphasize that participation in the 
investigation is voluntary and that the subject may withdraw from the investigation at any time 
and for any reason. If any new important information occurs during the clinical investigation the 
subject will be informed both orally and in writing. All subjects will be given the opportunity to 
ask questions about the investigation and will be given sufficient time to decide whether to 
participate in the investigation or not. 
The written subject information explains that the data will be stored in a computer database, 
maintaining confidentiality in accordance with national data legislation, and that authorized 
representatives of the Sponsor, international Regulatory Agencies, a Competent Authority or an 
IEC may require direct access to those parts of the medical records relevant to the investigation, 
including medical history, for verification of data. Additionally, the written subject information 
specifies that data will be recorded, collected, processed and may be transferred (to either EEA 
countries and/or non-EEA countries). In accordance with the General Data Protection Regulation 
(GDPR) 2016/679, the data will not identify any subjects taking part in the investigation. 
Before any investigation-related procedures, the informed consent will be signed and dated by 
the subject (or their legally acceptable representative and/or witness, as applicable) and by the 
Investigator who gave the subject the verbal and written information. 

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19 ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES 
The definitions and procedures for reporting Adverse Events (AE), Adverse Device Effects (ADE), 
Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE) and Unanticipated Serious 
Adverse Device Effects (USADE) are presented in the subsections below. It is of utmost 
importance that all staff involved in the investigation is familiar with the definitions and 
procedures and it is the responsibility of the PI to ensure this. 
19.1 Definitions 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs 
(including an abnormal laboratory finding) in subjects, users or other persons whether or not 
related to the investigational medical device. 
Note 1: This definition includes events related to the investigational 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. 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical device. 
Note 1: This includes any adverse event resulting from insufficiencies or inadequacies in the 
instructions for use, the deployment, the implantation, the installation, the operation, or any 
malfunction of the investigational medical device. 
Note 2: This includes any event that is a result of a use error or intentional abnormal use of the 
investigational medical device. 
Device Deficiency (DD) 
Inadequacy of an investigational medical device related to its identity, quality, durability, 
reliability, safety or performance. This may include malfunctions, use error, or inadequacy in the 
information supplied by the manufacturer. 
Serious Adverse Event (SAE) 
Adverse event that: 
a)
Led to a death, injury or permanent impairment to a body structure or a body function.
b) Led to a serious deterioration in health of the subject, that either resulted in:
-
A life-threatening illness or injury, or
-
A permanent impairment of a body structure or a body function, or
-
In-patient hospitalization or prolongation of existing hospitalization, or
-
In medical or surgical intervention to prevent life threatening illness.
c)
Led to foetal distress, foetal death or a congenital abnormality or birth defect.
Note: Planned hospitalization for pre-existing condition, or a procedure required by the CIP, 
without a serious deterioration in health, is not considered a serious adverse event. 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event. 

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Unanticipated Serious Adverse Device Effect (USADE) 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report. 
Note: Anticipated SADE (ASADE): an effect which by its nature, incidence, severity or outcome has 
been previously identified in the risk analysis report. 
19.2  Methods for Discovering and Documenting AE/ADE 
All subjects will be carefully monitored for the occurrence of AEs throughout the clinical 
investigation, from enrollment to completion the clinical investigation. Events prior to enrollment 
will be considered medical history. The investigator will collect safety information using non-
leading questions such as “have you experienced any new health problems or worsening of 
existing conditions?” Events directly observed or spontaneously volunteered by subjects will also 
be recorded throughout the clinical investigation. 
Clearly related signs, symptoms and abnormal diagnostic procedure results should be grouped 
together and reported as a single diagnosis or syndrome whenever possible. 
All AEs, including but not limited to events reported by the subject or reported in response to an 
open question by the PI or member of the investigation team, which fall into any of the previously 
defined definitions must be recorded as an AE in the eCRF and should include the following 
information: 
-
Brief description of the event (diagnosis).
-
Date of event onset (and time, if relevant).
-
Date of event resolution (and time, if relevant).
-
Severity.
-
Seriousness.
-
Causality assessment (i.e. relationship to medical device and/or procedure).
-
Event treatment.
-
Event outcome.
If the AE meets seriousness criteria it should be subject to expedited reporting as described in 
section 19.4. 
19.2.1 Severity 
Severity describes the intensity of an AE and will be assessed as: 
1.
Mild: asymptomatic or mild symptoms; clinical or diagnostic observations only;
intervention not indicated.
2.
Moderate: minimal, local or non-invasive intervention indicated, limiting age-
appropriate instrumental activities of daily living.
3.
Severe or medically significant but not immediately life-threatening: hospitalization or
prolongation of hospitalization indicated; disabling; limiting self care activities of daily
living.
4.
Life-threatening consequences; urgent intervention indicated.
5.
Death related to AE.
If an AE changes in severity, it should be reported as an AE of new severity but with the same 
description and identifier. 
19.2.2 Causality 
Causality is the relationship between the use of the medical device (including the investigational 
device and the medical – surgical procedure) and the occurrence of each AE.  

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During causality assessment activity, clinical judgment shall be used and the relevant documents, 
such as the Investigator Brochure (IB), the CIP or the risk analysis report shall be consulted, as all 
the foreseeable serious adverse events and the potential risks are listed and assessed there. The 
presence of confounding factors, such as concomitant medication/treatment, the natural history 
of the underlying disease, other concurrent illness or risk factors shall also be considered.  
For the purpose of harmonizing reports, each SAE will be classified according to five different 
levels of causality. The sponsor and the investigator will use the following definitions to assess the 
relationship of the SAE to the investigational medical device or procedures: 
a) Not related: relationship to the device or procedures can be excluded when: 
- 
The event is not a known side effect of the product category the device belongs to or of 
similar devices and procedures; 
- 
The event has no temporal relationship with the use of the investigational device or the 
procedures; 
- 
The serious event does not follow a known response pattern to the medical device (if 
the response pattern is previously known) and is biologically implausible; 
- 
The discontinuation of medical device application or the reduction of the levels of 
activation/exposure – when clinically feasible – and reintroduction of its use (or increase 
of the level of activation/exposure), do not impact on the serious event; 
- 
The event involves a body-site or an organ not expected to be affected by the device or 
procedure; 
- 
The serious event can be attributed to another cause (e.g. an underlying or concurrent 
illness/clinical condition, an effect of another device, drug, treatment or other risk 
factors); 
- 
The event does not depend on a false result given by the investigational device used for 
diagnosis when applicable; 
- 
Harms to the subject are not clearly due to use error; 
- 
In order to establish the non-relatedness, not all the criteria listed above might be met 
at the same time, depending on the type of device/procedures and the serious event. 
b) Unlikely: the relationship with the use of the device seems not relevant and/or the event 
can be reasonably explained by another cause, but additional information may be obtained. 
c) Possible: the relationship with the use of the investigational device is weak but cannot be 
ruled out completely. Alternative causes are also possible (e.g. an underlying or concurrent 
illness/clinical condition or/and an effect of another device, drug or treatment). Cases were 
relatedness cannot be assessed or no information has been obtained should also be 
classified as possible. 
d) Probable: the relationship with the use of the investigational device seems relevant and/or 
the event cannot reasonably be explained by another cause, but additional information may 
be obtained. 
e) Causal relationship: the serious event is associated with the investigational device or with 
procedures beyond reasonable doubt when: 
- 
The event is known side effect of the product category the device belongs to or of 
similar devices and procedures; 
- 
The event has a temporal relationship with investigational device use/application or 
procedures; 
- 
The event involved a body-site or organ that 
f) The investigational device or procedures are applied to; 
g) The investigational device or procedures have an effect on; 
- 
The serious event follows a known response pattern to the medical device (if the 
response pattern is previously known); 

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The discontinuation of medical device application (or reduction of the level of
activation/exposure) and reintroduction of its use (or increase of activation/exposure),
impact on the serious event (when a clinically feasible);
-
Other possible causes (e.g. an underlying or concurrent illness/clinical condition or/and
an effect of another device, drug or treatment) have been adequately ruled out;
-
Harm to the subject is due to error in use;
-
The event depends on a false result given by the investigational device used for
diagnosis, when applicable;
-
In order to establish the relatedness, not all the criteria listed above might be met at the
same time, depending on the type of device/procedures and the serious event.
The Sponsor and the investigator will distinguish between the AEs related to the investigational 
device and those related to the procedures (any procedure specific to the clinical investigation). 
An AE can be related to both the procedures and the device. Complications of procedures are 
considered not related if the said procedures would have been applied to the subjects also in the 
absence of device use/application. 
Particular attention shall be given to the causality evaluation of USADE, since the occurrence of 
USADE could suggest that the clinical investigation places subjects at increased risk of harm than 
was expected beforehand. 
In case of disagreement between the Sponsor and the PI assessments of the AE, both opinions 
shall be communicated to concerned parties. 
19.3 Methods for Discovering and Documenting Device Deficiencies 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 
performance shall be reported as a device deficiency without unnecessary delay to the Sponsor 
by using the device deficiency form. It is the PI’s responsibility to record every observed device 
deficiency together with an assessment. The Sponsor shall review all DDs and determine and 
document in writing whether they could have led to a SADE. Device Deficiencies that are assessed 
to or have SADE potential should be subjected to expedited reporting as described in section 19.4. 
19.4  Reporting of SAE/SADE and Device Deficiencies with SADE Potential 
The following events are considered reportable events in according with the Medical Device 
Directive (MDD) 93/42/EEC, Medical Device Regulation (MDR) 2017/745, and ISO 14155:2011: 
a)
Any SAE,
b)
Any Device Deficiency that might have led to a SAE if:
-
Suitable action had not been taken or,
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Intervention had not been made or,
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If circumstances had been less fortunate.
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New findings/updates in relation to already reported events.
All SAEs/SADEs and DDs that could have led to a SADE must be reported to the Sponsor 
immediately, but not later than 3 calendar days according to MEDDEV 2.7/3 after investigational 
site investigation personnel’s awareness of the event, regardless of the time that may have 
elapsed from the time the event occurred. 
The initial report should contain as much information as possible, but as a minimum the following 
information: 
-
Subject identification.
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Site contact information.
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Date of procedure/first use.
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Date of event onset.

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Event type (i.e. SAE or DD with SADE potential).
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Description of event.
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Action/treatment/subject outcome.
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Relationship to investigation procedure.
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Relationship to medical device.
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Unanticipated SADE (Yes/No).
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Treatment Arm.
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Event status.
The Sponsor must also promptly receive a completed report. All SAEs have to be reported whether 
or not they are considered causally related to the investigational medical device. 
SAE/SADE EMERGENCY CONTACT DETAILS 
Name: Romana Stefek 
Phone: +46 31 746 10 24 
Email: romana.svensson@essity.com 
In accordance with MEDDEV 2.7/3, the Sponsor must report to the CA where the clinical 
investigation has commenced: 
-
For all reportable events as described above, which indicate an imminent risk of death,
serious injury, or serious illness and that requires prompt remedial action for other
patients/subjects, users or other persons or a new finding to it: immediately, but not
later than 2 calendar days after awareness by sponsor of a new reportable event or of
new information in relation with an already reported event.
-
Any other reportable events as described above or new finding/update to it:
immediately, but not later than 7 calendar days following the date of awareness by the
sponsor of the new reportable event or of new information in relation with an already
reported event.
The Sponsor should inform the IEC and CA about reportable events as per local requirements. 
The summary tabulation featured in the appendix of MEDDEV 2.7/3 shall be used. The report 
format (excel) for reporting of all reportable events is also available on: 
http://ec.europa.eu/growth/sectors/medical-devices/guidance/index_en.htm 
19.5 Data Monitoring Committee 
Establishment of a Data Monitoring Committee (DMC) is not considered necessary for this 
clinical investigation. The reason is that the risk analysis indicates no need for a DMC. In case 
data retrieved during the clinical investigation contradicts the risk analysis and suggests a need, 
this decision might be reconsidered.  

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20 VULNERABLE POPULATION 
No subjects considered vulnerable will be enrolled in the FUEL clinical investigation. 

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21  SUSPENSION OR EARLY TERMINATION OF THE CLINICAL INVESTIGATION 
If the investigation is terminated early or suspended due to reasons of safety, the Sponsor will 
promptly inform the PI and the investigation site of the termination or suspension and the 
reason(s) thereof. The IEC will also be informed promptly and provided with the reason(s) for the 
termination or suspension by the Sponsor or by the PI/investigation site. 
In addition, CIP violations may result in termination of the clinical investigation at a site. CIP 
violations are deviations made without permission as a result of error or fraud/misconduct. 
Where the monitor or Sponsor identifies that the PI is out of compliance, this will be noted to the 
PI in writing, with a request to correct the source of the deviation immediately. Corrective actions 
will be implemented to avoid repeated non-compliance, including re-training. However, in case 
of repeated non-compliance despite implemented corrective actions, the clinical investigation will 
be terminated at the site. 
21.1 Criteria for Breaking the Blinding Code 
Not applicable, as this is a non-randomized single-arm clinical investigation. 
21.2 Subject Follow-up 
If the clinical investigation is prematurely terminated, the Sponsor and the PI will assure that 
adequate consideration is given to the protection of subjects’ interest, including subject follow-
up, e.g. ongoing AEs/ADEs, or subjects becoming pregnant during the course of the clinical 
investigation (if applicable). 

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22 PUBLICATION POLICY 
The clinical investigation will be registered in a publicly accessible database before recruitment 
of the first subject. 
A final report of the investigation, a Clinical Investigation Report (CIR), will be completed, even if 
the investigation is prematurely terminated. The report will be prepared by the Sponsor according 
to the guideline presented in Annex D of ISO 14155:2011. All publications and presentations must 
be based upon the CIR. 
All information supplied by the Sponsor in connection with this investigation will remain the sole 
property of the Sponsor and is to be considered confidential information. No confidential 
information will be disclosed to others without obtaining prior written consent from the Sponsor 
and will not be used except in the performance of this investigation. 
The Sponsor may choose to publish or present data from this investigation. If a PI is offered first 
authorship, he/she will be asked to comment and approve the publication. The Sponsor has the 
right to use the results for registration and internal presentation and for promotion. 
 
 

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23 REFERENCES 
1. EAU Guidelines on Urinary Incontinence. Burkhard, F.C, et al. Arnhem, The Netherlands.  :
EAU Guidelines Office, , 2019. EAU Guidelines. Edn. presented at the EAU Annual Congress
Barcelona 2019.
2. Absorbent products for moderate-heavy urinary and/or faecal incontinence in women and
men. Fader, M, Cottenden, A.M and Getliffe, K. 2008, The Cochrane Database of Systematic
Reviews, p. (4).
3. Prevalence of urinary incontinence among community-dwelling adults receiving home care.
Du Moulin, M.F, et al. 2008, Research in Nursing and Health, p. 31(6).
4. Urinary incontinence in a community sample of older adults: prevalence and impact on quality
of life. Sims, J, et al. 2011, Disability and Rehabilitation, pp. 33(15-16).
5. Clinical Burden and Nonpharmacologic Management of Nursing Facility Residents with
Overactive Bladder and/or Urinary Incontinence. Zarowitz, B.J, et al. 2015, The Consult
Pharmacist, p. 30(9).
6. Open retropubic colposuspension for urinary incontinence in women. Lapitan, M.C.M and
Cody, J.D. 2, 2016, Cochrane Database of Systematic Reviews.
7. Laparoscopic colposuspension for urinary incontinence in women. Dean, N, et al. 3, 2006,
Cochrane Database of Systematic Reviews.
8. Mid-urethral sling operations for stress urinaryincontinence in women. Ford, A.A, et al. 7,
2015, Cochrane Database of Systematic Reviews.
9. Traditional suburethral sling operations for urinary incontinence in women. Rehman, H, et al.
1, 2011, Cochrane Database of Systematic Reviews.
10. Bladder neck needle suspension for urinary incontinence in women. Glazener, C.M.A and
Cooper, K. 12, 2014, Cochrane Database of Systematic Reviews.
11. Urethral injection therapy for urinary incontinence in women. Kirchin, V, Page, T and
Keegan, P.E. 2, 2012, Cochrane Database of Systematic Reviews.
12. The current role of the artiﬁcial urinary sphincter in male and female urinary incontinence.
Islah, M, Cho, S.Y and Son, H. 1, 2013, The World Journal of Men’s Health, Vol. 31.
13. (LUCY-054) FUEL Investigator Brochure.
14. (Lucy-019) System Description.
15. (Mary-003) IFU Smart Care change indicator Professional.
16. (Lucy-024) Risk Managment Report Lucy and Mary.
17. (Lucy-017) Risk Assessment Lucy and Mary.
18. (LUCY-047) Risk managment plan Lucy and Mary.
19. PRO-00122 Risk Managment Procedure.
20. (ENG-333) Sensor verification and wetness detection report.

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24 APPENDICES 
24.1 Appendix A – Clinical Investigation Plan Agreement Form 
Investigation code: FUEL 
CIP Version: A 
I agree to the terms of this CIP. I will conduct the investigation according to the procedures 
specified herein.  
Principal Investigator 
Name: Ulla Molander 
Signature: _____________________ 
Date (dd-Mmm-yyyy): ______________ 

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24.2 Appendix B – Clinical Investigation Contact List 
PRINCIPAL INVESTIGATOR 
Name: Ulla Molander  
Address: Enheten för geriatrik, Avdelningen för Invärtes medicin och klinisk nutrition, Högsbo 
sjukhus, Tunnlandsgatan 2A, 400 43 Göteborg  
Phone: +46 (0)70-4383470 
Fax: -  
E-mail: ulla.molander@vgregion.se
SUB-INVESTIGATOR 
Name: Jan Faergemann 
Address: - 
Phone: +46 (0)70-5462360 
Fax: -  
E-mail: jan.faergemann@derm.gu.se
CLINICAL INVESTIGATION SITE(S) 
Tre Stiftelser, Gothenburg, Sweden 
SPONSOR REPRESENTATIVE 
Name: Arne Böhling 
Address:  Essity / BSNmedical GmbH, Quickbornstraße 24, 21147 Hamburg, Germany 
Phone +49 40 4909 6049 
Mobile +49 152 21425063 
Fax: - 
E-mail: arne.boehling@essity.com
OTHER SPONSOR REPRESENTATIVE 
Name: Sofia Hagman 
Address: Essity Hygiene and Health AB, 405 03 Göteborg, Sweden 
Phone: +46 (0)31-7460972  
Fax: +46 (0)31-7461900  
E-mail: sofia.hagman@essity.com
CONTRACT RESEARCH ORGANIZATION 
Name: Devicia AB 
Address: Argongatan 2C, 431 53 Mölndal, Sweden 
Phone: +46 (0)72-3611968 
BIOSTATISTICIAN 
Name: Anders Ljungström 
Address: Devicia AB, Brunnsgatan 6, 111 38 Stockholm, Sweden 
Phone: +46 (0)707-590260 
E-mail: anders.ljungstrom@devicia.se
SAFETY OFFICER 
Name: Romana Stefek 
Address: Essity Hygiene and Health AB, 405 03 Göteborg, Sweden 
Phone: +46 31 746 10 24 
E-mail: romana.svensson@essity.com

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CLINICAL INVESTIGATION PLAN AUTHOR(S) 
Name: Ada Saltarski 
Address: Devicia AB, Brunnsgatan 6, SE-111 38 Stockholm, Sweden 
Phone: +46(0)-725568088 
Fax: -  
E-mail: ada.saltarski@devicia.se
Name: Arne Böhling 
Address:  Essity / BSNmedical GmbH, Quickbornstraße 24, 21147 Hamburg, Germany 
Phone +49 40 4909 6049 
Mobile +49 152 21425063 
Fax: - 
E-mail: arne.boehling@essity.com

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24.3 Appendix C – Declaration of Helsinki 
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI 
Ethical Principles for Medical Research Involving Human Subjects 
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 
29th WMA General Assembly, Tokyo, Japan, October 1975 
35th WMA General Assembly, Venice, Italy, October 1983 
 41st WMA General Assembly, Hong Kong, September 1989 
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 
52nd WMA General Assembly, Edinburgh, Scotland, October 2000  
53rd WMA General Assembly, Washington, DC, USA, October 2002 (Note of Clarification added) 
55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 
59th WMA General Assembly, Seoul, Republic of Korea, October 2008 
64th WMA General Assembly, Fortaleza, Brazil, October 2013 
PREAMBLE 
1.
The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement
of ethical principles for medical research involving human subjects, including research on
identifiable human material and data.
The Declaration is intended to be read as a whole and each of its constituent paragraphs should 
be applied with consideration of all other relevant paragraphs. 
2.
Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians.
The WMA encourages others who are involved in medical research involving human subjects to
adopt these principles.
GENERAL PRINCIPLES 
3.
The Declaration of Geneva of the WMA binds the physician with the words, “The health of my
patient will be my first consideration,” and the International Code of Medical Ethics declares
that, “A physician shall act in the patient's best interest when providing medical care.”
4.
It is the duty of the physician to promote and safeguard the health, well-being and rights of
patients, including those who are involved in medical research. The physician's knowledge and
conscience are dedicated to the fulfillment of this duty.
5.
Medical progress is based on research that ultimately must include studies involving human
subjects.
6.
The primary purpose of medical research involving human subjects is to understand the causes,
development and effects of diseases and improve preventive, diagnostic and therapeutic
interventions (methods, procedures and treatments). Even the best proven interventions must
be evaluated continually through research for their safety, effectiveness, efficiency, accessibility
and quality.
7.
Medical research is subject to ethical standards that promote and ensure respect for all human
subjects and protect their health and rights.
8.
While the primary purpose of medical research is to generate new knowledge, this goal can
never take precedence over the rights and interests of individual research subjects.
9.
It is the duty of physicians who are involved in medical research to protect the life, health,
dignity, integrity, right to self-determination, privacy, and confidentiality of personal

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information of research subjects. The responsibility for the protection of research subjects must 
always rest with the physician or other health care professionals and never with the research 
subjects, even though they have given consent. 
10. Physicians must consider the ethical, legal and regulatory norms and standards for research
involving human subjects in their own countries as well as applicable international norms and
standards. No national or international ethical, legal or regulatory requirement should reduce or
eliminate any of the protections for research subjects set forth in this Declaration.
11. Medical research should be conducted in a manner that minimises possible harm to the
environment.
12. Medical research involving human subjects must be conducted only by individuals with the
appropriate ethics and scientific education, training and qualifications. Research on patients or
healthy volunteers requires the supervision of a competent and appropriately qualified
physician or other health care professional.
13. Groups that are underrepresented in medical research should be provided appropriate access to
participation in research.
14. Physicians who combine medical research with medical care should involve their patients in
research only to the extent that this is justified by its potential preventive, diagnostic or
therapeutic value and if the physician has good reason to believe that participation in the
research study will not adversely affect the health of the patients who serve as research
subjects.
15. Appropriate compensation and treatment for subjects who are harmed as a result of
participating in research must be ensured.
RISKS, BURDENS AND BENEFITS
16. In medical practice and in medical research, most interventions involve risks and burdens.
Medical research involving human subjects may only be conducted if the importance of the
objective outweighs the risks and burdens to the research subjects.
17. All medical research involving human subjects must be preceded by careful assessment of
predictable risks and burdens to the individuals and groups involved in the research in
comparison with foreseeable benefits to them and to other individuals or groups affected by the
condition under investigation.
Measures to minimise the risks must be implemented. The risks must be continuously
monitored, assessed and documented by the researcher.
18. Physicians may not be involved in a research study involving human subjects unless they are
confident that the risks have been adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of
definitive outcomes, physicians must assess whether to continue, modify or immediately stop
the study.
VULNERABLE GROUPS AND INDIVIDUALS
19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of
being wronged or of incurring additional harm.
All vulnerable groups and individuals should receive specifically considered protection.

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20. Medical research with a vulnerable group is only justified if the research is responsive to the 
health needs or priorities of this group and the research cannot be carried out in a non-
vulnerable group. In addition, this group should stand to benefit from the knowledge, practices 
or interventions that result from the research 
 
SCIENTIFIC REQUIREMENTS AND RESEARCH PROTOCOLS 
 
21. Medical research involving human subjects must conform to generally accepted scientific 
principles, be based on a thorough knowledge of the scientific literature, other relevant sources 
of information, and adequate laboratory and, as appropriate, animal experimentation. The 
welfare of animals used for research must be respected. 
 
22. The design and performance of each research study involving human subjects must be clearly 
described and justified in a research protocol. 
 
The protocol should contain a statement of the ethical considerations involved and should 
indicate how the principles in this Declaration have been addressed. The protocol should include 
information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, 
incentives for subjects and information regarding provisions for treating and/or compensating 
subjects who are harmed as a consequence of participation in the research study. 
 
In clinical trials, the protocol must also describe appropriate arrangements for post-trial 
provisions 
 
RESEARCH ETHICS COMMITTEES 
 
23. The research protocol must be submitted for consideration, comment, guidance and approval to 
the concerned research ethics committee before the study begins. This committee must be 
transparent in its functioning, must be independent of the researcher, the sponsor and any 
other undue influence and must be duly qualified. It must take into consideration the laws and 
regulations of the country or countries in which the research is to be performed as well as 
applicable international norms and standards but these must not be allowed to reduce or 
eliminate any of the protections for research subjects set forth in this Declaration.  
 
The committee must have the right to monitor ongoing studies. The researcher must provide 
monitoring information to the committee, especially information about any serious adverse 
events. No amendment to the protocol may be made without consideration and approval by the 
committee. After the end of the study, the researchers must submit a final report to the 
committee containing a summary of the study’s findings and conclusions.  
 
PRIVACY AND CONFIDENTIALITY 
 
24. Every precaution must be taken to protect the privacy of research subjects and the 
confidentiality of their personal information. 
 
INFORMED CONSENT 
 
25. Participation by individuals capable of giving informed consent as subjects in medical research 
must be voluntary. Although it may be appropriate to consult family members or community 
leaders, no individual capable of giving informed consent may be enrolled in a research study 

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unless he or she freely agrees. 
26. In medical research involving human subjects capable of giving informed consent, each potential
subject must be adequately informed of the aims, methods, sources of funding, any possible
conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and
potential risks of the study and the discomfort it may entail, post-study provisions and any other
relevant aspects of the study. The potential subject must be informed of the right to refuse to
participate in the study or to withdraw consent to participate at any time without reprisal.
Special attention should be given to the specific information needs of individual potential
subjects as well as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, the physician or 
another appropriately qualified individual must then seek the potential subject’s freely-given 
informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-
written consent must be formally documented and witnessed.      
All medical research subjects should be given the option of being informed about the general 
outcome and results of the study. 
27. When seeking informed consent for participation in a research study the physician must be
particularly cautious if the potential subject is in a dependent relationship with the physician or
may consent under duress. In such situations the informed consent must be sought by an
appropriately qualified individual who is completely independent of this relationship.
28. For a potential research subject who is incapable of giving informed consent, the physician must
seek informed consent from the legally authorised representative. These individuals must not be
included in a research study that has no likelihood of benefit for them unless it is intended to
promote the health of the group represented by the potential subject, the research cannot
instead be performed with persons capable of providing informed consent, and the research
entails only minimal risk and minimal burden.
29. When a potential research subject who is deemed incapable of giving informed consent is able
to give assent to decisions about participation in research, the physician must seek that assent
in addition to the consent of the legally authorised representative. The potential subject’s
dissent should be respected.
30. Research involving subjects who are physically or mentally incapable of giving consent, for
example, unconscious patients, may be done only if the physical or mental condition that
prevents giving informed consent is a necessary characteristic of the research group. In such
circumstances the physician must seek informed consent from the legally authorised
representative. If no such representative is available and if the research cannot be delayed, the
study may proceed without informed consent provided that the specific reasons for involving
subjects with a condition that renders them unable to give informed consent have been stated
in the research protocol and the study has been approved by a research ethics committee.
Consent to remain in the research must be obtained as soon as possible from the subject or a
legally authorised representative.
31. The physician must fully inform the patient which aspects of their care are related to the
research. The refusal of a patient to participate in a study or the patient’s decision to withdraw
from the study must never adversely affect the patient-physician relationship.
32. For medical research using identifiable human material or data, such as research on material or
data contained in biobanks or similar repositories, physicians must seek informed consent for its
collection, storage and/or reuse. There may be exceptional situations where consent would be
impossible or impracticable to obtain for such research. In such situations the research may be
done only after consideration and approval of a research ethics committee.

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USE OF PLACEBO 
33. The benefits, risks, burdens and effectiveness of a new intervention must be tested against
those of the best proven intervention(s), except in the following circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
Where for compelling and scientifically sound methodological reasons the use of any
intervention less effective than the best proven one, the use of placebo, or no intervention is
necessary to determine the efficacy or safety of an intervention
and the patients who receive any intervention less effective than the best proven one, placebo,
or no intervention will not be subject to additional risks of serious or irreversible harm as a
result of not receiving the best proven intervention.
Extreme care must be taken to avoid abuse of this option
POST-TRIAL PROVISIONS
34. In advance of a clinical trial, sponsors, researchers and host country governments should make
provisions for post-trial access for all participants who still need an intervention identified as
beneficial in the trial. This information must also be disclosed to participants during the
informed consent process.
RESEARCH REGISTRATION AND PUBLICATIONS AND DISSEMINATION OF RESULTS
35. Every research study involving human subjects must be registered in a publicly accessible
database before recruitment of the first subject.
36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to
the publication and dissemination of the results of research. Researchers have a duty to make
publicly available the results of their research on human subjects and are accountable for the
completeness and accuracy of their reports. All parties should adhere to accepted guidelines for
ethical reporting. Negative and inconclusive as well as positive results must be published or
otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of
interest must be declared in the publication. Reports of research not in accordance with the
principles of this Declaration should not be accepted for publication.
UNPROVEN INTERVENTIONS IN CLINICAL PRACTICE
37. In the treatment of an individual patient, where proven interventions do not exist or other
known interventions have been ineffective, the physician, after seeking expert advice, with
informed consent from the patient or a legally authorised representative, may use an unproven
intervention if in the physician's judgement it offers hope of saving life, re-establishing health or
alleviating suffering. This intervention should subsequently be made the object of research,
designed to evaluate its safety and efficacy. In all cases, new information must be recorded and,
where appropriate, made publicly available.