An Open, Single-arm, Post-market Clinical Investigation to Verify the Ability of TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products in a Home Environment.
Phase: NA
Conditions: Urinary Incontinence
Sponsor: Essity Hygiene and Health AB

 
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CLINICAL INVESTIGATION PLAN (CIP) 
 
CLINICAL INVESTIGATION TITLE: 
An open, single-arm, post-market clinical investigation to verify the ability of TENA SmartCare 
Change Indicator to reduce the number of manual checks between changes of absorbing 
incontinence products in a home environment. 
CLINICAL INVESTIGATION CODE: 
POWER (NCT04846270) 
INVESTIGATIONAL DEVICE: 
TENA SmartCare Change Indicator 
PRINCIPAL INVESTIGATOR: 
Prof. Piotr Radziszewski 
Medical Concierge Centrum Medicine 
Ul. Polnej Rózy 6 lok. U2 
02-798 Warzaw 
Poland 
SPONSOR: 
Essity Hygiene and Health AB 
SE-405 03, Gothenburg 
Sweden 
DATE: 
07-Sep-2020  
 
 
Version 
Revision history 
A 
First release 
 
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 the latest 
version of the ISO 14155 standard, Medical Device Regulation (MDR) 2017/745 and applicable regional or 
national regulations. 
 
 
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. 
 

 
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1 
SYNOPSIS 
 
NAME OF THE SPONSOR: 
Essity Hygiene and Health AB 
 
CLINICAL INVESTIGATION TITLE: 
An open, single-arm, post-market clinical investigation to verify the ability of TENA SmartCare 
Change Indicator to reduce the number of manual checks between changes of absorbing 
incontinence products in a home environment. 
CLINICAL INVESTIGATION CODE: 
POWER 
INVESTIGATIONAL DEVICE: 
TENA SmartCare Change Indicator 
OBJECTIVES: 
Primary Objective 
To demonstrate performance through the ability to reduce the number of manual checks in-
between changes of absorbing incontinence products using the TENA SmartCare Change 
Indicator compared to Standard of Care.  
Secondary Objectives 
- 
Evaluate safety through analyzing device-related adverse events reported during the 
investigation.  
- 
Evaluate leakage into clothes and/or bed linen. 
- 
Evaluate change in skin redness and irritation. 
- 
Evaluate usability 
- 
Evaluate the number of fecal incidences 
OVERALL CLINICAL INVESTIGATION DESIGN: 
The purpose of this post market clinical investigation is to demonstrate the performance and 
safety of the TENA SmartCare Change Indicator. The TENA SmartCare Change Indicator is intended 
for use on individuals, dependent end user (DEU), suffering from Urinary Incontinence (UI) who 
are cared for in a home environment, by one or more caregivers (CGR). The TENA SmartCare 
Change Indicator is an accessory to TENA absorbing incontinence products. This clinical 
investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the 
ability to reduce the number of manual checks between daily changes of absorbing incontinence 
products. Secondarily, the investigation will evaluate number of leakages, skin redness, usability 
and fecal incidence. Furthermore, the safety will continuously be monitored through analyzing 
device-related adverse events reported during the investigation.  
Statistical calculations support the recruitment of 35 DEUs to account for an estimated premature 
withdrawal rate of 30%. To demonstrate the primary objective 24 evaluable subjects are needed 
to complete the investigation.  
Prior to initiation of any investigational procedures, applicable informed consents are to be 
obtained. Each DEU and CGR will meet with the investigator to give informed consent, see section 
18. 
The clinical investigation is designed to be conducted in the DEU’s home environment, for a 
duration of three (3) weeks + potential incontinence product training and visit window scheduling. 
The first week will establish an individual baseline for each DEU, during which the number of 
manual checks between changes of the TENA incontinence product are to be registered 
continuously in a diary by the CGR. During the second week the CGR will be provided with and 

 
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trained in the use of the TENA SmartCare Change Indicator. During the third week the TENA 
SmartCare Change Indicator is to be used as intended by the manufacturer, while the number of 
manual checks between changes of the TENA incontinence product are to be registered in a diary 
by the CGR. The resulting numbers are to be analyzed with regard to the individual baseline in 
order to evaluate the expected reduction of number of manual checks. In total, the clinical 
investigation involves eight visits out of which two are optional and conducted as deemed 
necessary. 
Summation of planned contacts/visits:  
Visit 0: Initial visit  
This visit will be the screening visit for subjects who have not previoulsy used TENA incontinence 
products. Only these subjects are to attend this visit, for other subjects this visit corresponds to visit 
1. During 7 days after the visit the subject and caregiver will develop familiarity with TENA 
incontinence products to ensure representative data collection during baseline week and the 
remainder of the investigation.  
 
At visit 0, the following assessments/procedures will be performed:  
- 
Performed by investigator and designated nurse. CGR, informed consent witness, and 
DEU visit site, or investigator and nurse visit DEU’s home.  
- 
Informed consent DEU and witness as applicable, legally designated representative in 
case DEU is considered unable to provide informed consent. 
- 
Informed consent CGR. 
- 
Eligibility verification (DEU and CGR). 
- 
Demography (DEU and CGR). 
- 
Medical and surgical history (DEU). 
- 
Relevant concomitant medication (DEU). 
- 
Evaluation of general cognitive function (DEU). 
- 
Physical examination (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Pregnancy test (DEU with childbearing potential). 
- 
Instruction and handover of single-use TENA incontinence products. 
- 
Scheduling of visit 1. 
 
Visit 1: Investigation initiation  
This will be the screening visit for subjects and CGRs who did not need to attend Visit 0.  
At visit 1, the following assessments/procedures will be performed for those who did not need to 
attend Visit 0:  
- 
Day 0  
- 
Performed by investigator and designated nurse. CGR, informed consent witness, and 
DEU visit site, or investigator and nurse visit DEU’s home.  
- 
Informed consent DEU and witness as applicable. 
- 
Informed consent CGR. 
- 
Eligibility verification (DEU and CGR). 
- 
Demography (DEU and CGR). 
- 
Medical and surgical history (DEU). 
- 
Relevant concomitant medication (DEU). 
- 
Evaluation of general cognitive function (DEU). 
- 
Physical examination (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Pregnancy test (DEU with childbearing potential). 

 
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- 
Instruction and handover of baseline week diary. 
- 
Instruction and handover of single-use TENA incontinence products. 
- 
Scheduling of visit 2. 
 
At visit 1, the following assessments/procedures will be performed for those who completed visit 
0:  
- 
Day 0 (+1-3 days) 
- 
Instruction and handover of baseline week diary. 
- 
Handover of single-use TENA incontinence products. 
- 
Relevant concomitant medication review (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Scheduling of visit 2. 
 
Baseline registrations are to be initiated on the first day following the enrollment, i.e. day 1.  
If required, additional support will be provided as needed during the course of the clinical 
investigation.  
 
Visit 2: Initiate baseline week. 
- 
Day 1 (+1-3 days)  
- 
Performed by designated nurse in DEU’s home, over phone or video call. 
- 
Confirmation of correct baseline week diary initiation.  
- 
Concomitant medication review (DEU). 
- 
Scheduling of visit 3. 
 
Visit 3: Initiate learning week.  
- 
Day 8 (+1-3 days). 
- 
Performed by designated nurse in DEU’s home.  
- 
Confirmation of correct baseline week diary registration. 
- 
Concomitant medication review (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Documentation of AE/ADE (DEU and CGR). 
- 
Handover of TENA SmartCare Change Indicator (including instruction/training/verification 
of understanding). 
- 
Instruction and handover of learning week diary. 
- 
Handover of single use TENA incontinence products. 
- 
Scheduling of Visit 4/5, as applicable. 
 
Visit 4: Assure correct learning and use as intended (optional visit) 
- 
1-3 days post visit 3.  
- 
Performed by designated nurse, as required based on need for additional support, e.g. 
visit/phone call/video call. 
In case the visit is conducted the following will be investigated: 
- 
Confirmation of correct learning week diary registration. 
- 
Concomitant medication review (DEU). 
- 
Correct use of TENA SmartCare Change Indicator. 
- 
Documentation of AE/ADE (DEU and CGR) and DD if applicable. 
- 
Scheduling of Visit 5. 
 
 

 
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Visit 5: Initiate investigation week.   
- 
Visit to be take place at ≥ 7 completed days post Visit 3, but ≤ 10 completed days after 
Visit 3   
- 
Performed by designated nurse in the DEU’s home. 
- 
Confirmation of correct learning week diary. 
- 
Concomitant medication review (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Documentation/follow-up of AEs/ADEs (DEU and CGR) and DDs as applicable. 
- 
Instruction and handover of investigational week diary. 
- 
Handover of single use TENA incontinence products. 
- 
Scheduling of visit 6/7, as applicable. 
- 
Questionnaire completion (CGR); 
o Usability 
 
Visit 6: Additional support, if needed (optional visit).  
- 
1-2 days post visit 5.  
- 
Performed by designated nurse, as required based on need for additional support, e.g. 
visit/phone call/video call 
In case the visit is conducted the following will be investigated: 
- 
Confirmation of correct investigational week diary registration. 
- 
Concomitant medication review (DEU). 
- 
Correct use of TENA SmartCare Change Indicator. 
- 
Documentation of AEs/ADEs (DEU and CGR) and DDs, or follow-up as applicable. 
- 
Scheduling of visit 7, as applicable. 
 
Visit 7: Investigation completion and termination.   
- 
≥ 7 completed days post Visit 5. 
- 
Performed by investigator and designated nurse in the DEU’s home or at site. 
- 
Confirmation of correct investigational week diary registration. 
- 
Concomitant medication review (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Documentation of AEs/ADEs (DEU and CGR) and DDs, or follow-up as applicable. 
- 
Finalization of study period. 
- 
Collection of investigational products. 
- 
Pregnancy test (DEU with childbearing potential). 
- 
Questionnaire completion (CGR); 
o Whether the TENA SmartCare Change Indicator facilitates the decision to change 
the TENA incontinence product  
o Likelihood of continued use of the TENA SmartCare Change Indicator. 
o Perceived wellbeing and comfort of DEU. 
o Usability 
  
INCLUSION AND EXCLUSION CRITERIA: 
Inclusion Criteria 
The DEUs and/or CGRs must meet all of the following criteria to be eligible for this clinical 
investigation: 
1. DEU is diagnosed with urinary incontinence managed with a tape-style incontinence 
product.  

 
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2. DEU is unable to sufficiently communicate the need for an incontinence product to be 
changed.  
3. DEU is being cared for in a home environment and most of the care is provided by a main 
CGR. 
4. DEU is willing and able to provide informed consent and to participate in the clinical 
investigation or has a legally designated representative willing to provide informed consent 
on behalf of the DEU. Note, the legally designated representative and main CGR cannot be 
the same person.   
5. CGR is willing and able to provide informed consent to participate in the clinical 
investigation.  
6. The CGR frequently checks the saturation level of the incontinence product, manually 
and/or by a touch-feel process.  
7. If incontinence is managed by pharmaceuticals, the dose regime is stable. 
8. DEU and CGR ≥ 18 years of age. 
 
Exclusion Criteria 
DEUs and/or CGRs meeting any of the following criteria will not be permitted to participate in the 
clinical investigation: 
1. DEU is cared for in a professional establishment or is institutionalized. 
2. DEU has ≥ 4 fecal ”incidences” per week. 
3. DEU has severe incontinence product related skin problems, as judged by the investigator. 
4. DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence. 
5. The incontinence product is changed on a routine based on time (schedule) or device alert, 
without manual checks.  
6. Any other condition that may make participation in the clinical investigation inappropriate, 
as judged by investigator. 
7. CGR is incapable or unwilling to use the required smartphone application and/or the diary 
registration webpage required for the clinical investigation. 
8. Participation in an investigational study of a drug, biologic, or device within 30 days prior 
to entering the clinical investigation or planned during the course of the clinical 
investigation. 
9. DEU is pregnant or nursing.  
10. CGR or DEU with an alcohol or drug addiction 
 
PERFORMANCE AND SAFETY ENDPOINTS: 
Primary Endpoint  
- 
Change in the number of manual checks in-between the daily changes of the absorbing 
incontinence product at week 3 (investigational week) compared to week 1 (baseline week). 
Secondary Endpoints  
- 
Incidence of adverse events during week 2 (learning week) and week 3 (investigational 
week); adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), and 
serious adverse device effects (SADE), and device deficiency (DD).  
- 
Change in the number of leakages into the clothes and/or bed linen at week 3 
(investigational week) compared to week 1 (baseline week). 
- 
Evaluate change in skin redness and irritation, at week 3 (investigational week) compared 
to week 1 (baseline week). 
- 
Evaluate usability (questionnaire week 2 and 3). 
- 
Evaluate the number of fecal incidences. 

 
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STATISTICAL METHODS: 
Statistical analysis on variables of interest, including subject demographics, baseline 
characteristics, performance and safety endpoints will be collected. If nothing else is stated, 
descriptive statistics will be given for each variable in the investigation. This means number of 
subjects (n), mean, median, standard deviation (SD), minimum (min) and maximum (max) values 
will be presented for continuous data and frequencies and percentages for categorical data. The 
level of significance is set to 5% for all tested variables and specified in section 12.3. 
The primary variable is the percentage change of the number of manual checks between week 1 
and week 3 of the trial. A one-tailed paired t-test will be used to test if the number of manual 
checks have been reduced relative to week 1. If the variable is not normally distributed the non-
parametric Wilcoxon signed-rank test will be used and in case of a significant result, a one-sided 
95% confidence interval will be constructed for the percentage change in checks between week 1 
and week 3  to validate at least a 30% reduction. 
Performance Analysis 
The main analyses will be analyses of changes: investigation week compared to baseline week. 
Paired comparison will be conducted on the primary and secondary variables. T-test or non-
parametric tests will be used (if normality cannot be assumed). The significance level will be set to 
5%.   
Safety Analysis 
Data on incidence and severity of adverse events related to TENA SmartCare Change Indicator will 
be summarized in terms of AE, ADE, SAE, SADE and DD 
 
All safety variables will be tabulated for the Safety Population. 
 
 
 
 
 

 
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2 
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. 
 
 
 
 
______________________________  
______________________ 
Dr. Arne Böhling 
 
 
Date (dd-Mmm-yyyy) 
Clinical Affairs Director, Essity Hygiene and Health AB 
 
 
 
______________________________  
______________________ 
Dr. Fredrik Agholme 
 
 
Date (dd-Mmm-yyyy) 
Clinical Trials Manager, Essity Hygiene and Health AB 
 
 
 
 
 
The undersigned hereby confirms that they have read and understood the content of this 
Clinical Investigation Plan (CIP) and further approves its content. 
 
I will conduct the investigation according to the procedures specified herein.  
 
 
 
Site No.: 01  
 
 
 
______________________________  
______________________ 
Prof. Piotr Radziszewski 
 
 
Date (dd-Mmm-yyyy) 
Principal Investigator  
Medical Concierge Centrum Medyczne,  
Polnej Rózy 6/U2, 02-798 Warszawa 
 
 
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
1 
SYNOPSIS .................................................................................................................................................... 2 
2 
CIP APPROVAL PAGE .............................................................................................................................. 8 
3 
TABLE OF CONTENTS ............................................................................................................................. 9 
4 
ABBREVIATIONS AND ACRONYMS ................................................................................................. 12 
5 
INTRODUCTION ..................................................................................................................................... 13 
5.1 
Background .......................................................................................................................... 13 
6 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE ...................... 14 
6.1 
Manufacturer ....................................................................................................................... 14 
6.2 
Identification of clinical investigational medical device ...................................................... 14 
6.2.1 
Classification According to MDR ...................................................................................... 14 
6.2.2 
Device Labeling ................................................................................................................ 15 
6.3 
Device traceability ................................................................................................................ 15 
6.4 
Intended purpose ................................................................................................................. 15 
6.5 
Indication and population .................................................................................................... 16 
6.6 
Technical and Functional Features ...................................................................................... 16 
6.7 
Manufacturing and materials .............................................................................................. 17 
6.8 
Training and experience ....................................................................................................... 18 
6.9 
Installation and use .............................................................................................................. 18 
7 
JUSTIFICATION OF CLINICAL INVESTIGATION DESIGN ........................................................... 19 
8 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL 
INVESTIGATION ............................................................................................................................................. 20 
8.1 
Anticipated clinical benefits ................................................................................................. 20 
8.2 
Anticipated adverse device effects ...................................................................................... 20 
8.3 
Residual risks ........................................................................................................................ 20 
8.4 
Risks associated with participating in the clinical investigation .......................................... 21 
8.5 
Possible interactions with concomitant medical treatments .............................................. 22 
8.6 
Risk control........................................................................................................................... 22 
8.7 
Risk-to-benefit rationale ...................................................................................................... 22 
9 
OBJECTIVES AND HYPOTHESES OF THE CLINICAL INVESTIGATION .................................. 23 
9.1 
Primary Objective................................................................................................................. 23 
9.2 
Secondary Objectives ........................................................................................................... 23 
9.3 
Hypothesis ............................................................................................................................ 23 
9.4 
Claims and intended performance of the investigational device ........................................ 23 
9.5 
Risks and anticipated device effects .................................................................................... 23 
10 
DESIGN OF THE CLINICAL INVESTIGATION ........................................................................... 24 
10.1 
General ................................................................................................................................. 24 
10.1.1 
Primary Endpoint ......................................................................................................... 24 

 
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10.1.2 
Secondary Endpoints ................................................................................................... 24 
10.2 
Investigational device(s) and comparator(s) ....................................................................... 25 
10.3 
Subjects ................................................................................................................................ 25 
10.3.1 
Inclusion Criteria ......................................................................................................... 25 
10.3.2 
Exclusion Criteria ......................................................................................................... 25 
10.3.3 
Relationship of investigation population to target population ................................... 26 
10.3.4 
Number of Subjects ..................................................................................................... 26 
10.3.5 
Methods of Assigning Subjects to the different treatment arms ............................... 26 
10.3.6 
Subject withdrawal or discontinuation ....................................................................... 26 
10.4 
Clinical investigation duration ............................................................................................. 27 
10.5 
Clinical Investigation Procedures ......................................................................................... 27 
10.5.1 
Schedule of clinical investigation procedures/assessments ....................................... 27 
10.5.2 
Demographic Data and Baseline Measurements ........................................................ 33 
10.5.3 
Performance Variables and Measurements ................................................................ 34 
10.5.4 
Safety Variables and Measurements .......................................................................... 34 
10.5.5 
Activities performed by Sponsor ................................................................................. 34 
10.5.6 
Potential Confounding Factors .................................................................................... 35 
11 
MONITORING PLAN ........................................................................................................................ 36 
11.1 
Subject Records and Source Data ........................................................................................ 36 
11.2 
Access to Source Data and Documentation ......................................................................... 36 
12 
STATISTICAL CONSIDERATIONS................................................................................................ 37 
12.1 
Statistical design, method and analytical procedures ......................................................... 37 
12.2 
Sample size ........................................................................................................................... 37 
12.3 
Level of significance and power ........................................................................................... 37 
12.4 
Drop-out rates ...................................................................................................................... 38 
12.5 
Pass/fail criteria ................................................................................................................... 38 
12.6 
Interim analysis .................................................................................................................... 38 
12.7 
Criteria for termination on statistical grounds .................................................................... 38 
12.8 
Reporting of deviations from the original Statistical Analysis Plan (SAP)) .......................... 38 
12.9 
Subgroups for analysis ......................................................................................................... 38 
12.10 
Missing, unused or spurious data .................................................................................... 38 
12.11 
Exclusion of particular information from the testing of the hypothesis ......................... 38 
13 
DATA MANAGEMENT ..................................................................................................................... 39 
13.1 
Data Retention ..................................................................................................................... 39 
13.2 
Monitoring, Audits and Inspections ..................................................................................... 40 
14 
AMENDMENTS TO THE CIP .......................................................................................................... 41 
15 
DEVIATIONS FROM THE CIP ........................................................................................................ 42 

 
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DEVICE ACCOUNTABILITY ........................................................................................................... 43 
17 
STATEMENTS OF COMPLIANCE .................................................................................................. 44 
17.1 
Institutional Ethics Review ................................................................................................... 44 
17.2 
Insurance .............................................................................................................................. 44 
18 
INFORMED CONSENT PROCESS .................................................................................................. 45 
19 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES .............. 46 
19.1 
Definitions ............................................................................................................................ 46 
19.2 
Methods for discovering and documenting AE/ADE ........................................................... 47 
19.2.1 
Severity ........................................................................................................................ 48 
19.2.2 
Causality ...................................................................................................................... 48 
19.3 
Methods for discovering and documenting Device Deficiencies ......................................... 50 
19.4 
Reporting of SAE/SADE and Device Deficiencies with SADE potential ................................ 50 
19.5 
Data Monitoring Committee ................................................................................................ 51 
20 
VULNERABLE POPULATION ........................................................................................................ 51 
21 
SUSPENSION OR EARLY TERMINATION OF THE CLINICAL INVESTIGATION ............. 52 
21.1 
Criteria for breaking the blinding code ................................................................................ 52 
21.2 
Subject follow-up ................................................................................................................. 52 
22 
PUBLICATION POLICY ................................................................................................................... 53 
23 
REFERENCES ..................................................................................................................................... 54 
24 
APPENDICES ...................................................................................................................................... 55 
24.1 
Appendix A – Clinical Investigation Contact List .................................................................. 55 
24.2 
Appendix B – Declaration of Helsinki ................................................................................... 57 
 
 
 

 
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ABBREVIATIONS AND ACRONYMS 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
App 
Application  
ASADE 
Anticipated Serious Adverse Device Effect 
BMI 
Body Mass Index 
CA 
Competent Authority 
CER 
Clinical Evaluation Report 
CGR 
Care Giving Relative, synonymous with “caregiver”  
CIP 
Clinical Investigation Plan 
CIR 
Clinical Investigation Report 
CRF 
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 
EEA 
European Economic Area 
EU 
European Union 
GCP 
Good Clinical Practice 
GDPR 
EU General Data Protection Act 
GLOBIAD 
Ghent Global IAD Categorisation Tool 
IAD 
Incontinence associated dermatitis 
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 
Legally 
designated 
representative 
Individual, judicial, or other body authorized under applicable law to consent, on behalf 
of a prospective subject, to the subject’s participation in the clinical investigation 
MDD 
Medical Device Directive – Council Directive 93/42/EEC 
MDR 
Medical Device Regulation – Regulation (EU) 2017/745 
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 
TENA incontinence 
products 
TENA tape style incontinence product with absorbing core longer than 40 cm and a textile-
like back sheet. 
UI 
Urinary Incontinence 
USADE 
Unanticipated Serious Adverse Device Effect 
 

 
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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 
(UTI), 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, β3-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] [6-12]. 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 
absorbing 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 family 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 family caregiver checks the 
saturation status of each pad on average 2-3 times between changes, 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 [13].  
 

 
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The aim of this interventional, post-market clinical investigation is to demonstrate the 
performance and safety of the TENA SmartCare Change Indicator as an accessory to TENA 
incontinence products. The primary objective is to demonstrate that use of TENA SmartCare 
Change Indicator has the ability to reduce the number of manual checks by informing the CGR 
about increasing saturation of the absorbing core. The target population for this clinical 
investigation is individuals suffering from UI (DEU) who are cared for in a home environment, by 
one “main” CGR. The clinical investigation will be conducted in compliance with Declaration of 
Helsinki and the most current version of ISO 14155, and all approvals (i.e. Independent Ethical 
Committee (IEC) approval and Competent Authority (CA) approval) will be retrieved before study 
initiation.  
The clinical data retrieved from this clinical investigation will be evaluated and incorporated in 
the product Clinical Evaluation Report (CER).  
 
6 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
TENA SmartCare Change Indicator is a medical device accessory that has been developed and 
marketed by Essity Hygiene and Health AB. TENA SmartCare Change Indicator is an assortment of 
wetness indicators to be used as an accessory to an absorbing hygiene product. These absorbing 
products are intended to be used by individuals suffering from light to heavy incontinence 
problems. The products can be used in a home-care environment or at institutions. 
TENA SmartCare Change Indicator is a system that consists of a reusable electronic sensor and an 
application installed on one or more smart devices. The TENA SmartCare Change Indicator 
monitors the saturation level of the absorbing incontinence product by using a sensor placed on 
the outside of the absorbing incontinence product.  
The TENA SmartCare Change Indicator user interface shows the urine saturation level of the 
absorbing incontinence product. Information about saturation level aids in decision support for 
Caregivers to know when it is time to change their Dependent End User’s (DEU) absorbing 
incontinence product, complementing a manual check routine.  
 
6.1 
Manufacturer 
Essity Hygiene and Health AB is the legal manufacturer of the TENA Smartcare Change Indicator.  
Address: 
Essity Hygiene and Health AB 
SE-405 03 Göteborg 
Sweden 
 
6.2 
Identification of clinical investigational medical device 
6.2.1 Classification According to MDR 
Absorbing Incontinence products are class I medical devices and TENA SmartCare Change 
Indicator is considered an non-invasive accessory to the Incontinence product.  
The TENA SmartCare Change Indicator is CE-marked as a Medical Device and classified as Class I 
according to rule 1 and 11 of Annex VIII Medical Devices Regulation (EU) 2017/745. 
The TENA SmartCare Change indicator is a Class A software product according to IEC 62304 and 
the Level of Concern for the software is minor according to FDA regulation.  
 

 
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6.2.2 Device Labeling 
For this investigation marketed devices will be used. The devices will labelled with “exclusively for 
clinical investigation” (Figure 1).   
English  
Polish  
Product: TENA SmartCare Change Indicator™ 
Produkt: TENA SmartCare Change Indicator™ 
Study Code: POWER 
Kod badania: POWER 
Description of content: The TENA SmartCare 
Change Indicator is an accessory to TENA absorbing 
incontinence products. 
Opis zawartości:  
TENA SmartCare Change Indicator to wskaźnik 
zmian, dodatkiem do produktów wchłaniających 
TENA na nietrzymanie moczu. 
  
  
Follow instructions provided by your study doctor 
and refer to the INSTRUCTIONS FOR USE.  
Należy przestrzegać instrukcji przekazanych przez 
swojego lekarza prowadzącego badanie i zapoznać 
się z INSTRUKCJĄ UŻYCIA.  
Exclusively for clinical investigation 
 
Wyłącznie do użytku w badaniach klinicznych.   
Keep out of reach of children  
Przechowywać w miejscu niedostępnym dla dzieci.  
Figure 1. Labeling of the TENA SmartCare Change Indicator (not to scale). The labeling will be 
present as stickers put clearly visible on the SmartCare Change Indicator. 
 
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(s). The device accountability log at site will include the following 
information: 
- 
Date, Lot No and Expiry date for each delivered device. 
- 
Date and subject No 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 
storage conditions in the Instructions For Use (IFU) [14]. Returned and unused investigational 
devices are accounted when returned to the Sponsor.  
 
The monitor will verify the accountability process at each site during the site monitoring visits.  
6.4 
Intended purpose 
The TENA SmartCare Change Indicator is an accessory to absorbing incontinence products, 
intended for use on individual(s) suffering from urinary incontinence in a home or professional 
environment who are dependent on one or more caregivers to change the absorbing incontinence 
products. The TENA SmartCare Change Indicator estimates the degree of urine saturation in the 
absorbing incontinence product and notifies the care giver(s). This facilitates the care giver 
decision regarding when to change the absorbing incontinence product.  

 
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In this investigation the TENA SmartCare change Indicator will be used according to the its 
intended use and in accordance with the IFU for home care users [14].  
6.5 
Indication and population 
The TENA SmartCare Change Indicator is intended to be used in adult patients (DEU) diagnosed 
with urinary incontinence, who are unable to sufficiently communicate the need to change an 
incontinence product to a caregiver. For this investigation the caregiver is a care giving relative 
(CGR) that will use the device in a home environment. Subjects participating in the investigation 
are to be part of the intended user population and will meet specific eligibility criteria, see section 
10.3. 
6.6 
Technical and Functional Features 
The TENA SmartCare Change Indicator System (system) is described in figure 1. The system 
consists of the TENA SmartCare Transmitter (transmitter) and the TENA SmartCare Sensor Strip 
(sensor strip). When the transmitter is combined with a sensor strip they form a reusable 
electronic sensor, the change indicator (Figure 2). The change indicator is attached to the outside 
of the absorbing incontinence product and estimates the impedance in the absorbing 
incontinence product. The transmitter then sends the impedance data wirelessly to the TENA 
SmartCare Gateway (gateway).  
The gateway communicates with the TENA SmartCare Backend Services which is a cloud based 
solution consisting of the Device Backend Service and the Application Backend Service. The device 
backend acts as the communication path between the Gateway and the TENA SmartCare 
Applications using public cellular networks and internet infrastructure. The application Backend 
services are used to handle application specific services such as logins and handling of personal 
data used by the TENA SmartCare Change Indicator Application (app). In the application backend 
the saturation level is calculated using the impedance data. 
In the final part of the system the user receives saturation level notifications in the user interface 
of the app. This notification aid the caregiver in deciding if it is time to change the absorbing 
incontinence product. 

 
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Figure 2. The TENA SmartCare Change Indicator System 
 
Figure 3. The transmitter and sensor strip is combined to a change indicator 
6.7 
Manufacturing and materials 
Manufacturing and packaging of the TENA SmartCare Change Indicator are all conducted by or for 
Essity. The TENA SmartCare Change Indicator will be manufactured according to ISO 13485:2016 
quality management system.  
 

 
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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 absorbing 
incontinence products used during the clinical investigation. These products will be of the TENA 
brand, are CE-marked Class I medical devices and will be used according to their intended use. As 
for TENA SmartCare Change Indicator, the absorbing products do not contain any medicinal 
products, human or animal tissues or their derivates or other biological active substances.  
 
6.8 
Training and experience 
Investigators and designated nurses will receive investigational device related training according 
to approved IFU prior to clinical investigation initiation to ensure that the TENA SmartCare Change 
Indicator 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 investigators and nurses will receive applicable 
investigational training(s), e.g. CIP content, safety reporting procedures and timelines, informed 
consent process and forms, regulatory requirements including Good Clinical Practice (GCP), Case 
Report Form (CRF) content, and content/logs etc. of the Investigator’s Site File (ISF) etc. The 
training is conducted to ensure patient safety, compliance to approved CIP and applicable 
regulations/guidelines, and accuracy of obtained clinical data. The principal investigator 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.  
 
CGRs participating in the trial will receive brief instructions regarding the use of the investigational 
devices and basic functionality. This training will take part in visit 2. Any instructions will be in line 
of what is given in the IFU. 
6.9 
Installation and use 
The device does not need to be formally installed or maintained. It is to be setup and used 
according to its intended use as specified in the IFU for home care users [14]. In the setup of the 
system a gateway needs to be connected to a power outlet and an app needs to be downloaded 
and installed on a smartphone. In this investigation a smartphone will be provided to the subjects 
by the sponsor.  
 
 

 
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7 
JUSTIFICATION OF CLINICAL INVESTIGATION DESIGN 
 
This post-market clinical investigation explores topics that are important to the patient but are 
beyond the already established performance and safety topics for the device. Since the intended 
use of the device in its target population occurs in a homecare environment with the presence of 
at least two individuals, the family caregiver (CGR) and dependent end user (DEU), there is a need 
for a clinical investigation to explore the objectives of the investigation. CGRs spend considerable 
time and effort caring for DEUs suffering from urinary incontinence. 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 and skin 
irritation and redness leading to a risk of reduced quality of life for both DEU and CGR. To provide 
quality care and reassure that the DEU is comfortable, a CGR checks the saturation status of each 
incontinence product on average 2-3 times between changes, 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 DEU being cared for.  
To meet the objectives the investigation has a single arm, prospective and interventional design. 
The DEU will act as its own control, and outcome variables for an investigational week (week 3) 
will be compared to the Standard of Care during a baseline week (week 1). The time period of 3 
weeks is to allow for a sufficient number of product changes, to occur. The design with internal 
controls offers the benefit of requiring fewer DEUs to be subjected to investigation. The 
underlying incontinence condition is not affected by introduction of the study device. Hence, a 
sequential measurement series should suffice to meet study objectives.  
 
 
 
 
 
 

 
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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 patients with clinical use of the new device. 
 
The risk management related to the device has been conducted in accordance with ISO 
14971:2019 and the manufactures procedure for risk management. The risk management 
included risk analysis and risk evaluation, risk control and pre-production and post-production 
review.  
 
8.1 
Anticipated clinical benefits 
The anticipated benefit of the TENA SmartCare Change Indicator is that the urine saturation of an 
incontinence product can be monitored. Furthermore, the following clinical benefits are 
anticipated: 
- 
A reduction in manual checks is anticipated which will increase the quality of life for DEU 
and CGR due to the reduced stress for CGR to monitor the saturation of the incontinence 
product. Further, the anticipated reduction in manual checks leads to decrease in 
disturbance and will increase the dignity for the DEU. 
- 
Reduction in DEU skin redness and irritation due to incontinence products being changed 
when saturated, which limits the time spent in a saturated product. 
- 
Reduction in leakages increases dignity and quality of life for CGR and DEU. 
8.2 
Anticipated adverse device effects 
No adverse device effects are anticipated. During the previous clinical investigation (FUEL) no 
such effects were observed. 
8.3 
Residual risks 
After the risk assessment [15] 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 POWER clinical investigation, the study will be supervised thus 
reducing the risk of severe misuse even further. Considering the controlled setting and applied 
inclusion/exclusion criteria these risks are deemed unlikely to occur. Risks have been reduced as 
far as possible and additional risk control measure are judged to 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 as documented in 
the risk management report for the device [16].  
 
 

 
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Table 1: Summary of residual risks for the TENA SmartCare Change Indicator 
Risk ID 
Hazard 
Hazardous situation 
Risk/benefit analysis 
4.1 
Allergic reaction 
causing anaphylactic 
shock or other 
symptom with fatal 
outcome. 
Change indicator 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. 
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. 
 
8.4 
Risks associated with participating in the clinical investigation 
The overall risk of using absorbing incontinence products with the accessory TENA SmartCare 
Change Indicator is considered low. Except for the identified residual risks described in section 
8.3, no specific investigation related risk has been identified.  
 

 
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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.  
The reporting of adverse events and monitoring described in section 11 and 19 respectively, will 
assure early detection of any increased risk or unanticipated subject safety concerns. 
8.5 
Possible interactions with concomitant medical treatments 
No interactions with concomitant medication treatment have been identified. 
8.6 
Risk control 
From the possible hazards, foreseeable sequences of events and possible harms were identified, 
evaluated and mitigated. The following risk control measures have been used in the priority order 
listed: 
1. Eliminate or reduce risks as far as possible (inherent safety by design). 
2. Protective measures in the medical device itself or in the manufacturing process. 
3. Information to the user of the residual risk due to any shortcomings of the protection 
measures adopted. 
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. 
 
8.7 
Risk-to-benefit rationale 
The risks from all identified hazardous situations have been considered [15]. 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 extra 
risk to the risk found for the absorbing incontinence products. The device is intended to be used 
in combination with these products. Absorbing incontinence products have been on the market 
for many years and showed to be low risk devices with a clear clinical benefit. 
 
The risk management activities are in line with the risk management plan  [17], the risk 
management procedure [18] and the requirements of the EN ISO 14971:2019 standard. The risk 
management have been made with regard to the general safety and performance requirements 
of the Medical Device Regulation 2017/745. 
 
 
 

 
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9 
OBJECTIVES AND HYPOTHESES OF THE CLINICAL INVESTIGATION 
9.1 Primary Objective 
The primary objective of this clinical investigation is to demonstrate performance through the 
ability to reduce the number of manual checks in-between the daily changes of absorbing 
incontinence products using the TENA SmartCare Change Indicator compared to Standard of Care.  
 
9.2 Secondary Objectives 
The secondary objectives are to: 
- 
Evaluate safety through analyzing device-related adverse events reported during the 
investigation.  
- 
Evaluate leakage into clothes and/or bed linen. 
- 
Evaluate change in skin redness and irritation. 
- 
Evaluate usability. 
- 
Evaluate the number of fecal incidences. 
 
9.3 Hypothesis 
The null hypothesis (H0) is that there is no difference in the mean number of checks performed 
during the investigation week compared to the baseline week. 
 
The alternate hypothesis (H1) is that there is a reduction in the mean number of checks 
performed during the investigation week compared to the baseline week. 
 
9.4 Claims and intended performance of the investigational device  
The device has no specific claim for performance other than what is stated in its intended use and 
indication. 
- 
The TENA SmartCare Change Indicator estimates the degree of urine saturation in the 
absorbing incontinence product and notifies the care giver. It is to be use on individual(s) 
suffering from urinary incontinence in a home or professional environment who are 
dependent on one or more caregivers to change the individual´s absorbing incontinence 
products. 
 
The device has no specific claim for safety other than that it is safe to use when used as intended.  
9.5 Risks and anticipated device effects 
There are no anticipated device effects, the device is used in combination with an absorbing 
incontinence product which have the primary function to alleviate the incontinence issues 
suffered by the DEU. There are no unacceptable risks connected to participating in the 
investigation besides the residual risks reported in section 8.3.   
 

 
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10 DESIGN OF THE CLINICAL INVESTIGATION 
10.1 General 
This is a prospective, interventional, post-market clinical investigation with the aim to 
demonstrate the performance and safety of the TENA SmartCare Change Indicator when used as 
intended in subjects affected with UI compared to Standard of Care. The outcome will be 
evaluated and incorporated in the product specific CER and serve as a base for continuous 
investigations.  
 
Thirty-five (35) DEUs with UI cared for in a home environment mainly by one CGR will be recruited 
in Poland.  
 
The clinical investigation is designed to be conducted in the individuals home environment, for a 
duration of three (3) weeks + potential incontinence product training week (one) and potential 
additional days depending on the visit window scheduling. Eight visits are planned for each subject 
during the duration of the clinical investigation. However, two of the visits are optional and 
conducted as needed. If considered necessary by the investigator, nurse, or CGR, additional 
contacts (e.g. visits/phone calls/video calls) can be arranged. The first week will establish an 
individual baseline for each EDU, during which the number of manual daily checks between 
changes of the TENA incontinence product are to be registered by the CGR. During the second 
week the CGR will be provided the TENA SmartCare Change Indicator and learn how to set up and 
use it as intended by the manufacturer. During the third week the TENA SmartCare Change 
Indicator will be used as intended by the manufacturer, while the number of additional manual 
checks between changes of the TENA incontinence product are to be registered by the CGR. The 
number of manual checks will be analyzed with regard to the individual baseline in order to 
evaluate the reduction of manual checks.  
 
The overall duration of the investigation is estimated to 8 months, including a 6-month 
recruitment period. Expected duration of each subject’s participation is 3-6 weeks depending on 
potential incontinence product training week and potential additional days depending on the visit 
window scheduling.  
10.1.1 Primary Endpoint 
- 
Change in the number of manual checks in-between the daily changes of the absorbing 
incontinence product at week 3 (investigational week) compared to week 1 (baseline week). 
10.1.2 Secondary Endpoints 
- 
Incidence of adverse events during week 2 (learning week) and week 3 (investigational week); 
adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), and serious 
adverse device effects (SADE), and device deficiency (DD).  
- 
Change in the number of leakages into the clothes and/or bed linen at week 3 (investigational 
week) compared to week 1 (baseline week). 
- 
Evaluate change in skin redness and irritation, at week 3 (investigational week) compared to 
week 1 (baseline week). 
- 
Evaluate usability (questionnaire week 2 and 3). 
- 
Evaluate the number of fecal incidences. 
 
 
 

 
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10.2 Investigational device(s) and comparator(s) 
This is a single arm clinical investigation. The DEU will act as its own control and documented 
checks during the investigational week will be compared to the Standard of Care during the 
baseline week.  
 
Each participating CGR will be provided with the investigational product; TENA SmartCare Change 
Indicator (sensor and app), as well as single use TENA incontinence products. The single use TENA 
incontinence products will be used during the entire study period. CGR will receive enough 
products throughout the clinical investigation. TENA SmartCare Change Indicator is a re-usable 
medical device accessory to be used with single use TENA incontinence products. TENA SmartCare 
Change Indicator will be provided to each participating CGR/EDU, with the assumption that one 
product per subject will be needed. In case of malfunction, the investigational product will be 
replaced. To ensure this is made in a timely manner the CGR will be provided with an extra set of 
transmitter and sensor strips. These will be accounted for and traced similar to all other study 
devices. 
 
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 DEUs and/or CGRs must meet all of the following criteria to be eligible for this clinical 
investigation: 
1. DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.  
2. DEU is unable to sufficiently communicate the need for an incontinence product to be 
changed.  
3. DEU is being cared for in a home environment and most of the care is provided by a main 
CGR. 
4. DEU is willing and able to provide informed consent and to participate in the clinical 
investigation or has a legally designated representative willing to provide informed consent 
on behalf of the DEU. Note, the legally designated representative and main CGR cannot be 
the same person.   
5. CGR is willing and able to provide informed consent to participate in the clinical investigation.  
6. The CGR frequently checks the saturation level of the incontinence product, manually and/or 
by a touch-feel process.  
7. If incontinence is managed by pharmaceuticals, the dose regime is stable. 
8. DEU and CGR ≥ 18 years of age. 
10.3.2 Exclusion Criteria 
DEUs and/or CGRs meeting any of the following criteria will not be permitted to participate in the 
clinical investigation: 
1. DEU is cared for in a professional establishment or is institutionalized. 
2. DEU has ≥ 4 fecal ”incidences” per week. 
3. DEU has severe incontinence product related skin problems, as judged by the investigator. 
4. DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence. 
5. The incontinence product is changed on a routine based on time (schedule) or device alert, 
without manual checks.  

 
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6. Any other condition that may make participation in the clinical investigation inappropriate, as 
judged by investigator. 
7. CGR is incapable or unwilling to use the required smartphone application and/or the diary 
registration webpage required for the clinical investigation. 
8. Participation in an investigational study of a drug, biologic, or device within 30 days prior to 
entering the clinical investigation or planned during the course of the clinical investigation. 
9. DEU is pregnant or nursing.  
10. CGR or DEU with an alcohol or drug addiction 
 
10.3.3 Relationship of investigation population to target population 
The TENA SmartCare Change Indicator is intended to be used in adults diagnosed with urinary 
incontinence, who are unable to sufficiently communicate the need to change an incontinence 
product to a caregiver. For this investigation the caregiver is a care giving relative (CGR) that will 
use the device in a home environment.  
10.3.4 Number of Subjects 
The investigation population will be comprised of 35 DEUs suffering from UI, cared for in a home 
environment mainly by one CGR, and that are fulfilling all of the inclusion criteria and none of the 
exclusion criteria for the clinical investigation. For details linked to sample size calculations, see 
section 12.2. 
10.3.5 Methods of Assigning Subjects to the different treatment arms 
Not applicable as this is a non-randomized single arm clinical investigation.  
10.3.6 Subject withdrawal or discontinuation 
DEUs and/or CGRs are free to discontinue participation in the clinical investigation at any time 
and are not required to give a reason for their decision. However, DEUs and/or CGRs 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 DEU 
or the CGR. In case a CGR withdraw from the study, the respective DEU can not participate in the 
study anymore. 
 
If the DEU/CGR 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 and or CGR 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 DEU/CGR to withdraw from the investigation.  
- 
The investigator deems the DEU/CGR unfit for the investigation or suspects poor CIP 
compliance. 
- 
DEU/CGR lost to follow-up. 
 
In case of withdrawal, all AEs/ADEs should be followed up until the event is resolved or judged as 
stabel by the sponsor, if possible.  Applicable documentation should be returned to the Sponsor.  

 
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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 wellbeing, 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 1. Overview of clinical investigation duration.  
Point of enrolment: 
Q1 2021 
Total expected duration of the clinical investigation: 
8 months 
Expected duration of each subject’s participation: 
3-6 weeks depending on potential 
incontinence product training 
weekand potential additional days 
depending on the visit window 
scheduling 
Enrolment period: 
6 months 
 
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 2 below. Further information is provided in the sections below. 

 
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Table 2. Clinical investigation schedule for assessments and procedures.  
Clinical Investigation Visit: 
Visit 01 
Visit 1 
Visit 2  
Visit 3 
Visit 42 
Visit 5 
Visit 62 
Visit 7 
Visit time window:  
Day -7 
Day 0 
(+1-3 days) 
Day 1 
(+1-3 days) 
Day 8 
(+1-3 
days) 
1-3 days 
post Visit 3  
≥ 7 completed days 
post Visit 3, 
 but ≤ 10 completed 
days after Visit 3) 
1-2 days 
post Visit 5. 
≥7 completed days 
post Visit 5 
Visit conducted by: 
Investigator 
and nurse 
Investigator 
and nurse 
Nurse 
Nurse 
Nurse 
Nurse 
Nurse 
Investigator and 
nurse 
Assessments and procedures: 
 
 
 
 
 
 
 
 
Informed consent DEU and witness 
X 
X3 
 
 
 
 
 
 
Informed consent CGR 
X 
X3 
 
 
 
 
 
 
Eligibility verification (DEU and CGR) 
X 
X3 
 
 
 
 
 
 
Demography (DEU and CGR) 
X 
X3 
 
 
 
 
 
 
Concomitant Medication review (DEU) 
X 
X 
X 
X 
X 
X 
X 
X 
Medical and surgical history (DEU) 
X 
X3 
 
 
 
 
 
 
Evaluation of general cognitive function (DEU) 
X 
X3 
 
 
 
 
 
 
Physical examination (DEU) 
X 
X3 
 
 
 
 
 
 
Visual assessment and GLOBIAD scoring of skin redness/irritation in the 
body region covered by the absorbing incontinence product (DEU) 
X 
X 
 
X 
 
X 
 
X 
Pregnancy test for women of childbearing potential (DEU) 
X 
X3 
 
 
 
 
 
X 
Instruction and handover of baseline week diary 
 
X 
 
 
 
 
 
 
Instruction and handover of single use TENA incontinence products, as 
required 
X 
X 
 
X 
 
X 
 
 
Confirmation of correct baseline week diary registration 
 
 
X 
X 
 
 
 
 
Handover of TENA SmartCare Change Indicator and instructions 
 
 
 
X 
 
 
 
 
Instruction and handover of learning week diary 
 
 
 
X 
 
 
 
 
Confirmation of correct use of TENA SmartCare Change Indicator 
 
 
 
 
X 
 
X 
 
Confirmation of correct learning week diary registration 
 
 
 
 
X 
X 
 
 
Instruction and handover of investigational week diary 
 
 
 
 
 
X 
 
 
Additional support as required 
 
 
 
 
X 
 
X 
 
Confirmation of correct investigational week diary registration 
 
 
 
 
 
 
X 
X 
Questionnaire completion (CGR) 
 
 
 
 
 
X 
 
X 
Adverse Event (DEU and CGR)/Device deficiency documentation/Follow-
up 
 
 
 
X 
X 
X 
X 
X 
Collection of investigational products 
 
 
 
 
 
 
 
X 
Finalization of study period 
 
 
 
 
 
 
 
X 
1 Earlier investigation initiation for subjects not previoulsy used to TENA Incontinence products.  
2Optional visits conducted if considered required. 
3 Will not be completed during Visit 1 for subjects who completed Visit 0. 

 
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10.5.1.1 Visit 0 (Day -7) 
This visit will only be completed for subjects who have not previously used TENA incontinence 
products. During 7 days the subject and caregiver will develop familiarity with TENA Incontinence 
products to ensure representative data collection during baseline week and the remainder of the 
investigation. This will be the screening and baseline visit for these subjects. 
 
The screening visit is conducted by the investigator and the designated nurse, either at the site or 
in the DEU’s home, as considered most appropriate. The investigator will introduce the clinical 
investigation and explain the CIP, procedures and objectives to the potential DEU, his/her 
witnesses and the CGR (Note, the CGR can act as one of the DEU’s witnesses. If so the CGR and 
one of the witnesses is the same person). The investigator will verbally inform about the 
investigation and provide written patient information describing the clinical investigation, 
potential discomforts, risks and benefits of participation. Potential DEUs, their witnesses, and 
their CGRs will be given adequate time for review of the patient information and time to discuss 
the investigation and ask questions to the investigator. Any queries that a potential 
DEU/witness/CGR may have regarding the investigation will be addressed appropriately by the 
investigator. Potential DEU and their CGR will be instructed that they are free to withdraw their 
consent and to discontinue their participation in the investigation at any time without prejudice. 
In case a DEU is considered unable to provide informed consent, e.g. due to intellectual 
challenges, a legally designated representative must be available and willing to provide informed 
consent on behalf of the subject. If the DEU and the CGR are willing to participate in the 
investigation, they need to sign and date the Informed Consent Form (ICF) together with the 
investigator who gave the verbal and written information. The original ICF will be retained in the 
Investigator Site File (ISF) and a copy provided to the DEU and CGR. 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 DEU and CGR are considered to be enrolled 
in the clinical investigation. The DEU be allocated to a unique subject identification number.  
 
After enrollment, relevant medical/surgical history will be collected together with a review of 
current medication and information on the subject’s (DEU) demographics. The DEU’s general 
cognitive function will be evaluated. A physical examination will be performed on the DEU and 
DEUs with childbearing potential will conduct a pregnancy test. Visual assessment and GLOBIAD 
scoring of skin redness/irritation in the body region covered by the absorbing incontinence 
product will be performed on the DEU. After confirmation of the inclusion and exclusion criteria 
the caregiver will be provided with instructions and single use TENA incontinence products 
sufficient to cover the one week-training period. 
 
At visit 0, the following assessments/procedures will be performed:  
- 
Informed consent DEU and witness as applicable, legally designated representative in case 
DEU is considered unable to provide informed consent. 
- 
Informed consent CGR. 
- 
Eligibility verification (DEU and CGR). 
- 
Demography (DEU and CGR). 
- 
Medical and surgical history (DEU). 
- 
Relevant concomitant medication (DEU). 
- 
Evaluation of general cognitive function (DEU). 
- 
Physical examination (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Pregnancy test (DEU with childbearing potential). 

 
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- 
Instruction and handover of single-use TENA incontinence products. 
- 
Scheduling of visit 1. 
10.5.1.2 Visit 1 (Day 0 (+ 1-3 days if V0 completed)) 
This will be the screening visit for subjects and CGRs who did not complete visit 0.  
Subjects and CGRs who completed visit 0 will at this visit receive the baseline week diary, 
instructions for diary completion and additional single-use incontinence products as required. 
Further, visual assessment and GLOBIAD scoring of skin redness/irritation in the body region 
covered by the absorbing incontinence product will be performed on the DEU, relevant 
concomitant medication will be reviewed and scheduling of Visit 2 will be performed. 
 
The screening visit is conducted by the investigator and the designated nurse, either at the site or 
in the DEU’s home, as considered most appropriate. The investigator will introduce the clinical 
investigation and explain the CIP, procedures and objectives to the potential DEU, his/her 
witnesses and the CGR (Note, the CGR can act as one of the DEU’s witnesses. If so the CGR and 
one of the witnesses is the same person). The investigator will verbally inform about the 
investigation and provide written patient information describing the clinical investigation, 
potential discomforts, risks and benefits of participation. Potential DEUs, their witnesses, and 
their CGRs will be given adequate time for review of the patient information and time to discuss 
the investigation and ask questions to the investigator. Any queries that a potential 
DEU/witness/CGR may have regarding the investigation will be addressed appropriately by the 
investigator. Potential DEU and their CGR will be instructed that they are free to withdraw their 
consent and to discontinue their participation in the investigation at any time without prejudice. 
In case a DEU is considered unable to provide informed consent, e.g. due to intellectual 
challenges, a legally designated representative must be available and willing to provide informed 
consent on behalf of the subject. If the DEU and the CGR are willing to participate in the 
investigation, they need to sign and date the Informed Consent Form (ICF) together with the 
investigator who gave the verbal and written information. The original ICF will be retained in the 
Investigator Site File (ISF) and a copy provided to the DEU and CGR. 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 DEU and CGR are considered to be enrolled 
in the clinical investigation. The DEU be allocated to a unique subject identification number.  
 
After enrollment, relevant medical/surgical history will be collected together with a review of 
current medication and information on the subject’s (DEU) demographics. The DEU’s general 
cognitive function will be evaluated. A physical examination will be performed on the DEU and 
DEUs with childbearing potential will conduct a pregnancy test. Visual assessment and GLOBIAD 
scoring of skin redness/irritation in the body region covered by the absorbing incontinence 
product will be performed on the DEU. After confirmation of the inclusion and exclusion criteria 
the CGR will be instructed in how to fill in the baseline week diary. Before the visit is completed 
the CGR will receive the baseline week diary and instruction, as well as single use TENA 
incontinence products (sufficient to cover at least the baseline registration period) and 
instructions as needed.  
 
At visit 1, the following assessments/procedures will be performed for those who did not 
complete visit 0:  
- 
Informed consent DEU and witness as applicable, legally designated representative in case 
DEU is considered unable to provide informed consent. 

 
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- 
Informed consent CGR. 
- 
Eligibility verification (DEU and CGR). 
- 
Demography (DEU and CGR). 
- 
Medical and surgical history (DEU). 
- 
Relevant concomitant medication (DEU). 
- 
Evaluation of general cognitive function (DEU). 
- 
Physical examination (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Pregnancy test (DEU with childbearing potential). 
- 
Instruction and handover of baseline week diary. 
- 
Instruction and handover of single-use TENA incontinence products. 
- 
Scheduling of visit 2. 
 
At visit 1, the following assessments/procedures will be performed for those who completed 
visit 0:  
- 
Instruction and handover of baseline week diary. 
- 
Handover of single-use TENA incontinence products. 
- 
Relevant concomitant medication review (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Scheduling of visit 2. 
 
10.5.1.3 Visit 2 (Day 1 (+ 1-3 days)) 
Visit 2 is conducted by the designated nurse either in the DEU’s home or over the phone (as 
agreed during visit 1). The aim of the visit is to verify that the baseline diary is correctly filled in, 
single-use TENA incontinence products used as intended, and all eventual questions are answered 
satisfactory. To avoid systematic queries, visit 2 is to be conducted as early during the baseline 
registration as possible, preferably during the first day of baseline registrations.  
 
At visit 2, the following assessment/procedures will be performed: 
- 
Confirmation of correct baseline week diary registration. 
- 
Concomitant medication review (DEU). 
- 
Scheduling of visit 3. 
10.5.1.4  Visit 3 (Day 8 (+ 1-3 days)) 
Visit 3 is conducted by the designated nurse in the DEU’s home. Correctness of baseline week 
diary registrations will be confirmed. Visual assessment and GLOBIAD scoring of skin 
redness/irritation in the body region covered by the absorbing incontinence product will be 
performed on the DEU. All AEs/ADEs and/or DDs will be documented and followed-up. The TENA 
SmartCare Change Indication (sensor and app) and applicable instruction (IFU), learning week 
diary, and additional single use TENA incontinence products will be provided. 
Before completion of visit 3, the designated nurse shall assure that the CGR understands how to 
install and use the investigational product.  
 
At visit 3, the following assessment/procedures will be performed: 
- 
Confirmation of correct baseline week diary registration. 
- 
Concomitant medication review (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Documentation of AE/ADE (DEU and CGR). 

 
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- 
Handover of TENA SmartCare Change Indicator (including instruction/training/verification of 
understanding). 
- 
Instruction and handover of learning week diary. 
- 
Handover of single use TENA incontinence products. 
- 
Scheduling of Visit 4/5, as applicable. 
 
10.5.1.5 Visit 4 (1-3 days post Visit 3) 
Visit 4 is an optional visit conducted as required with the aim to provide additional support to 
involved participants. The visit is conducted by the designated nurse either in the DEU’s home or 
over the phone/video call. The study nurse shall verify that the TENA SmartCare Change Indicator 
is used as intended and provide support as needed. If conducted the nurse will also verify that the 
learning week diary is correctly filled in.  
 
At visit 4, the following assessment/procedures will be performed: 
- 
Additional support as required. 
In case the visit is conducted the following will also be investigated: 
- 
Confirmation of correct learning week diary registration. 
- 
Concomitant medication review (DEU). 
- 
Correct use of TENA SmartCare Change Indicator. 
- 
Documentation of AE/ADE and DD if applicable 
- 
Scheduling of Visit 5. 
 
10.5.1.6 Visit 5 (≥ 7 completed days post Visit 3, but ≤ 10 completed days after Visit 3) 
Visit 5 is conducted by the designated nurse in the DEU’s home. Correctness of learning week 
diary registrations will be confirmed. Visual assessment and GLOBIAD scoring of skin 
redness/irritation in the body region covered by the absorbing incontinence product will be 
performed on the DEU. All AEs/ADEs and/or DDs will be documented and followed-up. 
Investigational week diary and instruction, and additional single use TENA incontinence products 
provided as applicable.  
 
At visit 5, the following assessment/procedures will be performed: 
- 
Confirmation of correct learning week diary. 
- 
Concomitant medication review (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Documentation/follow-up of AEs/ADEs (DEU and CGR) and DDs as applicable. 
- 
Instruction and handover of investigational week diary. 
- 
Handover of single use TENA incontinence products. 
- 
Scheduling of visit 6/7, as applicable. 
- 
Questionnaire completion (CGR); 
o Usability 
 
10.5.1.7 Visit 6 (1-2 days post visit 5) 
Visit 6 is an optional visit conducted as required with the aim to provide additional support to 
involved participants. The visit is conducted by the designated nurse either in the DEU’s home or 
over the phone/video call. If conducted the nurse will verify that the TENA SmartCare Change 
Indicator is used as intended and provide support as needed. The nurse will also verify that the 
investigational week diary is correctly filled in. 
 

 
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At visit 6, the following assessment/procedures will be performed: 
- 
Additional support as required. 
In case the visit is conducted the following will also be investigated: 
- 
Confirmation of correct investigational week diary registration. 
- 
Concomitant medication review (DEU). 
- 
Correct use of TENA SmartCare Change Indicator. 
- 
Documentation of AEs/ADEs (DEU and CGR) and DDs, or follow-up as applicable. 
- 
Scheduling of visit 7, as applicable. 
 
10.5.1.8 Visit 7 (≥7 completed days post Visit 5) 
Visit 7 is conducted by the investigator and nurse in the DEU’s home or at site. Correctness of 
investigational week diary registrations and applicable questionnaires filled in by the CGR, will be 
confirmed. Visual assessment and GLOBIAD scoring of skin redness/irritation in the body region 
covered by the absorbing incontinence product will be performed on the DEU. All AEs/ADEs 
and/or DDs will be documented and followed-up, as applicable. After completion of visit 7 the 
DEU and CGR will finish the clinical investigation.  
 
At visit 7, the following assessment/procedures will be performed: 
- 
Confirmation of correct investigational week diary registration. 
- 
Concomitant medication review (DEU). 
- 
Skin redness/irritation assessment (DEU). 
- 
Documentation of AEs/ADEs (DEU and CGR) and DDs, or follow-up as applicable. 
- 
Finalization of study period. 
- 
Collection of investigational products. 
- 
Pregnancy test (DEU with childbearing potential). 
- 
Questionnaire completion (CGR); 
o Whether the TENA SmartCare Change Indicator facilitates the decision to change 
the TENA incontinence product  
o Likelihood of continued use of the TENA SmartCare Change Indicator. 
o Usability 
 
10.5.1.9 Unscheduled visits/contacts 
If deemed necessary for any reason, e.g. additional support or AEs/ADEs, unscheduled visits may 
be conducted within the course of the clinical investigation. Unscheduled visits may be conducted 
at site or in the home of the DEU. In addition, unscheduled telephone/skype contacts may be 
conducted as required. All unscheduled visits shall be documented in the CRF and medical notes, 
as applicable.  
10.5.2 Demographic Data and Baseline Measurements 
10.5.2.1 Demographic data 
At screening visit the following demographic data is to be collected for DEU and CGR: date of birth 
(documented according to country specific requirements, if any) and gender. 
10.5.2.2 Medical and surgical history 
During visit 1 relevant medical and surgical history will be elicited for each DEU. The medical 
history will assess the DEU for any disqualifying medical conditions as specified in the exclusion 
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10.5.2.3 Evaluation of general cognitive function  
During Visit 1 the PI will evaluate the general cognitive function of the DEU i.e.: no cognitive 
impairment, mild cognitive impairment or severe cognitive impairment. 
10.5.2.4 Physical examination 
A comprehensive physical examination will be obtained for the DEU at visit 1.  
10.5.2.5 Pregnancy test for women of childbearing potential 
At visit 1 pregnancy test will be obtained for all women of childbearing potential judged by the 
investigator. In case a potential DEU is pregnant, the subject is considered ineligible and will be 
exited from further participation in the clinical investigation. 
10.5.3 Performance Variables and Measurements 
10.5.3.1 Diary completion 
Three different diaries will be filled out and completed by the CGR; Baseline diary, learning week 
diary, and investigational week diary. Number of manual checks in-between the daily changes of 
the absorbing incontinence product are to be documented continuously throughout the day. The 
investigational week diary will be compared to the baseline week diary.  
The following data will be documented in the diary:  
• 
Number of manual checks in-between the daily changes of the absorbing incontinence 
product 
• 
Leakage into clothes and/or bed linen 
• 
Fecal incidences  
• 
Concomitant medication  
10.5.3.2 Questionnaires 
Questionnaires are to be completed by the CGR at visit 5 and 7 and will evaluate the following: 
• 
Whether the TENA SmartCare Change Indicator facilitates the decision to change the 
TENA incontinence product (V7) 
• 
Likelihood of continued use of the TENA SmartCare Change Indicator (V7) 
• 
Perceived wellbeing and comfort of DEU (V7) 
• 
Usability (V5 and V7) 
10.5.3.3 Visual assessment and scoring of skin redness/irritation in the body region covered by the absorbing 
incontinence product 
During visit 0, 1, 3, 5 and 7 visual assessment and GLOBIAD scoring of skin redness/irritation in 
the body region covered by the absorbing incontinence product will be performed for the DEU 
[19].  
10.5.4 Safety Variables and Measurements 
All incidences of adverse events (DEU and CGR ) and device deficiencies 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 11. 
All events will be followed up until resolved or judged as clinically stable according to the 
investigator, 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. 
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Reporting of SAEs according to section 19.4. 
10.5.6 Potential Confounding Factors 
- 
Use of TENA single-use incontinence product prior to the clinical investigation. 
- 
Concomitant medications that could potentially affect urination. 
- 
Subjects with regular fecal incidents. 
- 
Illnesses occurring during the investigational period. 
 
 

 
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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, eDiaries, and eQuestionnaires 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. 
- 
Subject identification number. 
- 
That informed consent for participating in the clinical investigation was obtained and when. 
- 
Diagnosis. 
- 
All visits during the investigation period. 
- 
All AEs/ADEs/DDs. 
- 
Treatments and medications. 
 
The PI is responsible for ensuring the accuracy; completeness, legibility and timeliness of the data 
recorded in the eCRFs, while the CGR is responsible for the data recorded in the eDiaries, and 
eQuestionnaires. Completed sections of eCRFs, eDiaries, and eQuestionnaires will be monitored 
on regular basis.  
11.2 Access to Source Data and Documentation 
The PI should guarantee access to source documents for the monitor and auditors as well as for 
inspection by appropriate regulatory agencies, and the IEC, if required. 
 
 

 
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12 STATISTICAL CONSIDERATIONS 
12.1  Statistical design, method and analytical procedures 
If nothing else is stated, descriptive statistics will be given for each variable in the trial. This means 
number of subjects (n), mean, median, standard deviation (SD), minimum (min) and maximum 
(max) values will be presented for continuous data and frequencies and percentages for 
categorical data. The level of significance is similar for all variables and specified in section 12.3. 
The primary variable is the percentage change of the number of manual checks between week 1 
and week 3 of the trial. A one-tailed paired t-test will be used to test if the number of manual 
checks have been reduced relative to week 1. If the variable is not normally distributed the non-
parametric Wilcoxon signed-rank test will be used and in case of a significant result, a one-sided 
95% confidence interval will be constructed for the percentage change in checks between week 
1 and week 3  to validate at least a 30% reduction. 
 
For the secondary variable change in number of leakages between week 1 and week 3. The The 
analysis is to determine if there is a significant difference in leakages. A paired t-test will be used 
for comparison. If the variable is not normally distributed a non-parametric Wilcoxon signed rank 
test will be used. 
 
The secondary variable change in skin redness/irritation between week 1 and 3. This variable is 
evaluated using the Ghent Global IAD Categorisation Tool (GLOBIAD) [19]. GLOBIAD is a 
categorisation tool to monitor IAD prevalence and incidence. IADs can be scored as 1A, 1B, 2A 
and 2B. The analysis is to determine if there is a significant difference in scoring between the time 
points. A paired t-test will be used for comparison. If the variable is not normally distributed a 
non-parametric Wilcoxon signed rank test will be used. For this variable it is possible we cannot 
detect any difference due to the short time period.   
 
For the secondary variable number of fecal incidences per week in the trial, the analysis is to 
determine if there is significant difference in incidences per week. A non-parametric Wilcoxon 
signed rank test will be used for comparison. 
 
There are also safety and usability endpoints in the trial however these are only to be covered by 
descriptive and summary statistics.  
 
12.2  Sample size 
The sample size calculation is based on the assumption of a reduction of the number of manual 
checks in-between incontinence product changes by 30%. Based on data from [20] and the 
statistical power in section 12.3 this give a sample size of 24 subjects. Assuming a 30% dropout 
rate, the investigation will include up to 35 subjects. If for any reason the dropout rate should be 
higher than this, additional subjects might be enrolled in the investigation to reach a total of 24 
completed subjects.  
 
12.3 Level of significance and power 
The level of statistical significance is set to 0.05  The level of statistical power is set to 90% for the 
primary endpoint. 
 

 
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12.4  Drop-out rates 
A drop-out rate of 30% as been assumed based on previous experience. However, due to limited 
knowledge, actual dropout rate is difficult to estimate.  
 
12.5  Pass/fail criteria 
To reduce the number of manual checks by more than 30% between the daily change of 
absorbing incontinence products using the TENA SmartCare Change Indicator compared to 
Standard of Care. Checks will be documented in diaries completed by the CGR. 
 
12.6  Interim analysis 
No interim analysis is currently planned in the clinical investigation. 
 
12.7  Criteria for termination on statistical grounds 
Study termination based on statistical reason is not foreseen.  
 
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 
Subgroup analysis is not possible due to the low number of subjects included in this clinical 
investigation. 
 
12.10 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 analysis as far as 
possible. Missing data will not be analyzed.  
 
12.11 Exclusion of particular information from the testing of the hypothesis 
No exclusions of this kind is planned to be performed.  
 
 

 
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13 DATA MANAGEMENT 
 
Data management and handling will be conducted according to the investigation specific Data 
Management Plan (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 investigations specific Data Management Report (DMR).  
 
Data will be collected in eCRFs specifically designed for this clinical investigation. The PI or an 
authorized person will record subject data in the CRF in a precise and accurate manner. 
Abbreviations should not be used. The investigator is responsible for the data entered and sign 
off the CRF at the end of the clinical investigation. The data should be recorded as soon as they 
are generated.  
 
The person entering data into the database is not allowed to attempt any personal interpretation 
or to make any decisions on the data other than self-evident corrections as listed in the Data Entry 
Instructions or Data Handling Report. Single data entry type will be applied. Data required to 
determine eligibility for investigation participation will be collected in the database for screening 
failures.  
 
Data validation / data cleaning procedures are designed to assure validity and accuracy of clinical 
data. These procedures consist of manual reviewing during data entry and 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 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 the hospital, 
institution or private practice. 
 
The investigator 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 hospital, 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.  
 

 
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13.2 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 eCRF and source documents and records must be made accessible during the 
visit.  
 
The monitor or other Sponsor personnel/representatives 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 Competent Authority (CA) 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 investigator 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 
As also specified in section 6.3 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, lot no, list of delivered devices, date and subject identification for used 
devices, and date and lot 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 B). Furthermore, the clinical investigation will 
be conducted in compliance with the latest version of the ISO 14155 standard, Medical Device 
Regulation (MDR) 2017/745 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 if applicable, 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.  
17.2 Insurance 
The Sponsor will be responsible for ensuring adequate insurance covering any injuries to the 
subject caused by the investigational medical device.  
 
 
 

 
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18 INFORMED CONSENT PROCESS 
 
All DEUs and CGRs 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 it is possible to withdraw from the investigation at any time 
and for any reason. If any new important information occurs during the clinical investigation the 
DEU and CGR will be informed both orally and in writing. All DEUs and CGRs 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. For subjects able to understand the procedures 
and give verbally consent, but have difficulties to sign the form, presence of two impartial 
witnesses is required. The two witnesses shall be present during the informed concent process 
and sign off and verify that the DEU has received sufficient information and responses to eventual 
questions related to the clinical investigation. One of the witnesses is usually a family member. In 
this clinical investigation the CGR can act as witness for the DEU and thereby sign off both as 
witness and as CGR. The other witness is usually a non-study team medical professional from the 
investigational site. For subjects incapable to sign off on the informed consent, e.g. due to 
intellectual challenges, a legally designated representative must be available and sign off on 
behalf of the subject. If no legally designated representative is available, the vulnerable subject 
cannot participate in the clinical investigation.  
 
The written subject information explains that the data will be stored in a computer database 
(located within the EU), maintaining confidentiality in accordance with national data legislation, 
and that authorized representatives of the Sponsor, CA or any 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 information specifies that data will be recorded, collected, processed 
and may be transferred (to either EEA countries and/or non-EEA countries). If data is transferred 
to a non-EEA country, it will be confirmed that the country has an adequate level of data 
protection according to decision by the EU Commission or through referring to appropriate 
safeguards. In accordance with the EU General Data Protection Regulation (GDPR), the data will 
not identify any persons taking part in the investigation.  
 
Before any investigation-related procedures are initiated, informed consents will be signed and 
dated by the DEU, the witnesses or legally designated representative as applicable, the CGR, and 
the investigator who gave 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 
The definitions below originate from the ISO/FDIS 14155(E).  
Adverse Event (AE) 
Untoward medical occurrence, unintended disease or injury, or any untoward clinical signs 
(including an abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device and whether anticipated or unanticipated 
 
Note 1: This definition includes events related to the investigational medical device or the 
comparator. 
 
Note 2: This definition includes events related to the procedures involved. 
 
Note 3: For users or other persons, this definition is restricted to events related to the use of 
investigational medical devices. 
 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical device. 
 
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment,  implantation, installation, or operation, or any malfunction of 
the investigational medical device. 
 
Note 2: This definition includes any event resulting from use error or from intentional misuse of 
the investigational medical device. 
 
Note 3: This includes comparator if the comparator is a medical device. 
 
Device Deficiency (DD) 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, 
safety or performance.  
Note 1: Device deficiencies include malfunctions, use errors, and inadequacy in the information 
supplied by the manufacturer including labelling. 
 
Note 2: This definition includes device deficiencies related to the investigational medical device 
or the comparator. 
 
Serious Adverse Event (SAE) 
Adverse event that led to any of the following: 
a) death,  
b) serious deterioration in the health of the subject, users, or other persons as defined by one 
or more of the following: 

 
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- 
a life-threatening illness or injury, or 
- 
a permanent impairment of a body structure or a body function including chronic 
diseases, or 
- 
in-patient or prolonged hospitalization, or 
- 
medical or surgical intervention to prevent life-threatening illness or injury, or permanent 
impairment to a body structure or a body function, 
c) foetal distress, foetal death, congenital abnormality, or birth defect including physical or 
mental impairment. 
 
Note 1: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without 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. 
Serious health threat 
Signal from any adverse event or device deficiency that indicates an imminent risk of death or a 
serious deterioration in the health in subjects, users or other persons, and that requires prompt 
remedial action for other subjects, users or other persons. 
Note 1: This would include events that are of significant and unexpected nature such that they 
become alarming as a potential serious health hazard or possibility of multiple deaths occurring 
at short intervals. 
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 risk assessment 
 
Note 1: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk assessment. 
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 CRF and should include the following 
information: 
 
- 
Brief description of the event (diagnosis). 
- 
Date of event onset (and time, if relevant). 

 
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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.  
 
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 
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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); 
- 
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. 
 

 
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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 will monitor the devices used in the 
investigation in order to discover DDs that may not be noticable to the PI och subjects. 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. As determined by sponsor, the devices subjected 
to DDs are to be replaced with new devices. 
19.4  Reporting of SAE/SADE and Device Deficiencies with SADE potential 
All SAEs, whether or not related to the investigational medical device or procedure involved 
shall be entered into the eCRF. 
 
The following events are considered reportable events according to MDR 2017/745: 
a) Any SAE that has a causal relationship with the investigational device, the comarator or the 
investigation procedure or where such causal relationship is reasonably possible; 
b) Any Device Deficiency that might have led to a SAE if: 
a. appropriate action had not been taken, or 
b. intervention had not occurred, or 
c. circumstances had been less fortunate. 
c) Any new findings in relation to any event referred to in points a) and b). 
 
The above must be reported to the Sponsor immediately, without unneccary delay, 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. 
- 
Site contact information. 
- 
Date of procedure/first use. 
- 
Date of event onset. 
- 
Event type (i.e. SAE or DD with SADE potential). 
- 
Description of event. 
- 
Action/treatment/subject outcome. 
- 
Relationship to investigation procedure. 
- 
Relationship to medical device. 
- 
Unanticipated SADE (Yes/No). 
- 
Treatment Arm. 
- 
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. 
 
 
 

 
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SAE/SADE EMERGENCY CONTACT DETAILS 
Name: Romana Stefek 
Address: Essity Hygiene and Health AB, SE-405 03 Göteborg, Sweden 
Phone:  
E-mail:  
 
Since this is a post-market clinical investigation all reportable events will be handled according to 
the Sponsors vigilance system and in accordance with MDR 2017/745. 
 
19.5 Data Monitoring Committee 
Establishment of a Data Monitoring Committee (DMC) is not considered necessary for this post-
market clinical investigation as 1) the investigation duration for the subjects are short 2) there will 
be only one investigational site and 3) the risk analysis indicates no need for a DMC. In case data 
retrieved during the clinical investigation contradicts this decision, it might be reconsidered.  
 
20 Vulnerable population 
In this clinical investigation DEUs unable to give informed consent, e.g. due to intellectual 
challenges may be included. This vulnerable group of subjects can only be included in the clinical 
investigation if they have a legally designated representative available and willing to sign off on 
behalf of the DEU. In case any DEU unable to sign off on informed consent is included in the clinical 
investigation, the DEU shall receive sufficient information related to the clinical investigation up 
to the level of the DEUs understanding. The DEUs reluctancy to participate should as much as 
possible be respected. A specific Patient Information Sheet and Informed Consent Form for sign 
off by legally designated representatives will be developed. 
 
No specific additional medical care will be provided to the study subjects (DEUs) after completion 
of the 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 14155:2020. 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. 
Burkhard, F.C., et al., Urinary incontinence. Guideline. European Association of Urology, 
http://uroweb.org/guideline/urinary-incontinence/, Editor. 2020. 
2. 
Fader, M., A.M. Cottenden, and K. Getliffe, Absorbent products for moderate-heavy urinary 
and/or faecal incontinence in women and men. Cochrane Database Syst Rev, 2008(4): p. 
Cd007408. 
3. 
Du Moulin, M.F., et al., Prevalence of urinary incontinence among community-dwelling adults 
receiving home care. Res Nurs Health, 2008. 31(6): p. 604-12. 
4. 
Sims, J., et al., Urinary incontinence in a community sample of older adults: prevalence and 
impact on quality of life. Disabil Rehabil, 2011. 33(15-16): p. 1389-98. 
5. 
Zarowitz, B.J., et al., Clinical Burden and Nonpharmacologic Management of Nursing Facility 
Residents with Overactive Bladder and/or Urinary Incontinence. Consult Pharm, 2015. 30(9): 
p. 533-42. 
6. 
Lapitan, M.C. and J.D. Cody, Open retropubic colposuspension for urinary incontinence in 
women. Cochrane Database Syst Rev, 2016. 2: p. Cd002912. 
7. 
Dean, N., et al., Laparoscopic colposuspension and tension-free vaginal tape: a systematic 
review. Bjog, 2006. 113(12): p. 1345-53. 
8. 
Ford, A.A., et al., Mid-urethral sling operations for stress urinary incontinence in women. 
Cochrane Database Syst Rev, 2017. 7: p. Cd006375. 
9. 
Saraswat, L., et al., Traditional suburethral sling operations for urinary incontinence in 
women. Cochrane Database Syst Rev, 2020. 1: p. Cd001754. 
10. 
Glazener, C.M., K. Cooper, and A. Mashayekhi, Bladder neck needle suspension for urinary 
incontinence in women. Cochrane Database Syst Rev, 2017. 7: p. Cd003636. 
11. 
Kirchin, V., et al., Urethral injection therapy for urinary incontinence in women. Cochrane 
Database Syst Rev, 2017. 7: p. Cd003881. 
12. 
Islah, M., S.Y. Cho, and H. Son, The current role of the artificial urinary sphincter in male and 
female urinary incontinence. World J Mens Health, 2013. 31(1): p. 21-30. 
13. 
Essity, SCA and Ipsos MORI Care Giving Relatives Research - Internal and Client Use - 30.10.17 
– v1. 
14. 
Essity, (ENG-127-19) Instructions For Use (IFU). 
15. 
Essity, (LUCY-017-06) Risk Assessment Lucy and Mary. 
16. 
Essity, (LUCY-024-04) Risk Management Report TENA SmartCare Change Indicator. 
17. 
Essity, (LUCY-047-03) TENA SmartCare - Risk Management Plan. 
18. 
Essity, PRO-00122-v.5.0 Risk Management for Medical Device. 
19. 
The Ghent Global IAD Categorisation Tool (GLOBIAD) 2017, Skin Integrity Research Group-
Ghent University. www.UCVVGent.be. 
20. 
Essity, FORM-0728 Product Classification, ver.3. 
 
 

 
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24 APPENDICES 
24.1 Appendix A – Clinical Investigation Contact List 
 
PRINCIPAL INVESTIGATOR 
Name: Piotr Radziszewski 
Address: Medical Concierge Centrum Medyczne, Polnej Rózy 6/U2, 02-798 Warszawa, Poland 
Phone:  
E-mail:  
 
CLINICAL INVESTIGATION SITE(S) 
Medical Concierge Centrum Medyczne, Warszawa 
 
SPONSOR REPRESENTATIVE 
Name: Åke Hillman 
Address: Essity Hygiene and Health AB, SE-405 03 Göteborg, Sweden 
Phone:  
E-mail:  
 
SPONSOR REPRESENTATIVE 
Name: Arne Böhling 
Address: Essity / BSN medical GmbH, Haykenaukamp 10, 21147 Hamburg, Germany 
Phone : 
E-mail:  
 
SPONSOR REPRESENTATIVE 
Name: Fredrik Agholme 
Address: Essity Hygiene and Health AB, SE-405 03 Göteborg, Sweden 
Phone:  
E-mail:  
 
CONTRACT RESEARCH ORGANIZATION 
Name: Devicia AB 
Address: Argongatan 2C, SE-43153 Mölndal, Sweden 
Phone: +46 (0) 723-611968 
 
PROJECT MANAGER: 
Name: Åsa Nilsson 
Address: Argongatan 2C, SE-43153 Mölndal, Sweden 
Phone:  
E-mail:  
 
BIOSTATISTICIAN 
Name: Anders Ljungström 
Address: Devicia AB, Brunnsgatan 6, 111 38 Stockholm, Sweden 
Phone:  
E-mail:  
 
 
 

 
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SAFETY OFFICER 
Name: Romana Stefek 
Address: Essity Hygiene and Health AB, SE-405 03 Göteborg, Sweden 
Phone:  
E-mail:  
 
CLINICAL DATA MANAGER: 
Name: Matina Starck 
Address: Devicia AB, Argongatan 2C, SE-43153 Mölndal, Sweden 
Phone:  
 
CLINICAL INVESTIGATION MONITOR 
Designated monitor(s): Anna Rosowicz-Lipowczan 
Address: ul. Grodzka 62/4a 31-044 Kraków, Poland 
Phone:  
E-mail:  
 
CLINICAL INVESTIGATION PLAN AUTHOR(S) 
Name: Åsa Nilsson 
Address: Devicia AB, Argongatan 2C, SE-43153 Mölndal, Sweden 
Phone:  
E-mail:  
 
Name: Fredrik Agholme 
Address: Essity Hygiene and Health AB, SE-405 03 Göteborg, Sweden 
Phone:  
E-mail:  
 
 
 
 

 
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24.2 Appendix B – 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. 
 

 
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All vulnerable groups and individuals should receive specifically considered protection. 
 
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 
 
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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 
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 

 
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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. 
 
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.