A Comparative Crossover Study on the Safety, Efficacy, and Patient Quality of Life Comparing PureWick™ System With an Established Comparator in the Home Setting for Incontinence Overnight
Phase: NA
Conditions: Nocturnal Enuresis
Sponsor: C. R. Bard

Protocol Number: UCC-8007 
 
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Date:   16 Apr 2024 
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TITLE PAGE 
 
Protocol Title:  
A Comparative Crossover Study on the Safety, Efficacy, and Patient Quality of Life Comparing 
PureWick™ System with an Established Comparator in the Home Setting for Incontinence 
Overnight 
 
Protocol Number: UCC-8007 
 
Version Number: 5.0  
 
Investigational Device: PureWick™ System  
 
Study Type: Post-Market 
 
Short Title: PureWick™ At-Home Pilot Study 
 
Sponsor Name: C. R. Bard, Inc., a subsidiary of Becton, Dickinson and Company 
 
Legal Registered Address:  C. R. Bard, Inc. 
 
8195 Industrial Blvd. 
 
Covington, GA 30014 
 
Legal European Representative: 
BDI Benelux  
 
  
Hagelberg 2 
 
  
2250 Olen 
Belgium 
 
Sponsor Contact:  
SengDao VanMany 
Senior Clinical Project Manager 
75 N Fairway Drive 
Vernon Hills, IL 60061 
sengdao.vanmany@bd.com 
(847)362-9209 (w) 
(847)732-6839 (c) 
 
Regulatory Agency Identifier Number(s): NCT05710718 (USA), IDRCB: 2023-A01727-38 
(France)  
 
Overall Rationale for the protocol version 5.0: 
Protocol revised to incorporate new Quality of Life questionnaires (PROMIS Sleep Disturbance 
and End of Study Participant Preference Survey).  
 

Protocol Number: UCC-8007 
 
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Revision History 
Version Number 
Date 
Type 
1.0 
 30 Jan 2023 
Original 
2.0 
26 June 2023 
Protocol update to allow 
inclusion of up to two 
investigational sites in both 
France and the US; 
administrative updates to 
correct and clarify text. 
3.0 
14 August 2023 
Changes incorporated based 
on recommendations from the 
National Competent authority 
ANSM during their review: 
• Added Estimated start and 
end date of the study 
• Added IDRCB number 
4.0 
5 September 2023 
Changes incorporated based 
on recommendations from the 
leading French etic committee 
during their review: 
• Added an additional 
exclusion criteria:  
Participants under 
supervision of a legally 
authorized representative 
are excluded to participate 
in the UCC-8007 trial 
• Deletion of the possibility 
for the home nurses to 
conduct virtual visits 
instead of face-to-face 
visits at day 30 
5.0 
08 April 2024 
Changes incorporated based 
on recommendations to 
include the following 
questionnaires: 

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• Validated English and 
French version of the 
PROMIS Sleep 
Disturbance 
Questionnaire 
• End of Study 
Participant Preference 
Survey 
 
 

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SPONSOR PROTOCOL APPROVAL 
 
 
Signature below indicates approval of the protocol as written. 
Individual or 
function 
Name 
Signature 
Date 
Medical Affairs 
Team Representative 
Danielle Redmond 
Medical Science Liaison, 
Urology and Critical Care  
This document is signed 
electronically in the eTMF 
system 
Study Statistician 
Yanchang Zhang 
Statistician, Global Clinical 
Affairs 
This document is signed 
electronically in the eTMF 
system 
Regulatory Affairs 
Jenny McKinnon 
Manager, Regulatory Affairs 
Urology and Critical Care 
This document is signed 
electronically in the eTMF 
system 
Clinical Affairs 
SengDao VanMany 
Senior Clinical Project 
Manager 
Urology and Critical Care 
 
This document is signed 
electronically in the eTMF 
system 
Project Manager 
Winfried Huesmann 
Clinical Program Manager, 
EMEA 
This document is signed 
electronically in the eTMF 
system 
 
 
 

Protocol Number: UCC-8007 
 
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PROTOCOL SIGNATURE PAGE 
 
 
Investigator Responsibilities 
 
1. Prior to participation in this study, the Investigator or Institution must sign the Clinical 
Study Agreement (CSA) and obtain written approval from the appropriate Institutional 
Review Board (IRB)/Ethics Committee (EC). 
2. The Investigator must receive BD-sponsored training prior to site activation. The 
Investigator is responsible for ensuring that all Sub-Investigators and clinical staff are 
adequately trained prior to performing any data collection or study-related procedures.   
3. The Principal Investigator shall ensure that the study is conducted in accordance with the 
study protocol, any modifications as requested by the IRB/EC, the signed CSA, the 
ethical principles of the Declaration of Helsinki, Good Clinical Practice (ICH E6) / ISO 
14155), and applicable national/regional regulations and laws. 
4. If applicable, ensure that written informed consent is obtained from each participant prior 
to the conduct of any study procedure, using the current IRB/EC approved Informed 
Consent Form. 
 
I have read and understand the contents of this study protocol. I agree to follow and abide by the 
requirements set forth in this document. I agree to conduct the trial in accordance with 
the study protocol, the signed Clinical Study Agreement, the signed Investigator Agreement and 
Good Clinical Practice (GCP) as well as applicable FDA and ISO regulations (e.g., 21 CFR 
Parts 50, 54, 56 and 812; 21 CFR Part 812.28 (a) (1) (Good Clinical Practice); EU MDR (Council 
Regulation 2017/745 of 5 April 2017), MDCG guidelines, and applicable national and regional 
law and regulation. I agree to participate in BD-Sponsored training prior to performing any data 
collection or study-related procedures. 
 
Agreed to by (Investigator):  
  
 
_______________________________________________  
Printed Name – Investigator   
  
 
_______________________________________________  
Signature – Investigator  
 
 
______________________  
 Site Number 
 
 
_______________________________________________  
Date  
 

Protocol Number: UCC-8007 
 
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TITLE PAGE .................................................................................................................................. 1 
Abbreviations ................................................................................................................................ 10 
1.0 PROTOCOL SUMMARY .................................................................................................... 12 
1.1 Synopsis .............................................................................................................................. 12 
1.2 Schema ................................................................................................................................ 19 
1.3 Schedule of Activities ......................................................................................................... 20 
2.0 INTRODUCTION ................................................................................................................ 23 
2.1 Background ......................................................................................................................... 23 
2.3 Rationale.............................................................................................................................. 24 
2.4 Risk/Benefit Assessment ..................................................................................................... 24 
2.5 Risk Assessment .................................................................................................................. 25 
2.5.1 Benefit Assessment .......................................................................................................... 27 
2.5.2 Overall Benefit: Risk Conclusion .................................................................................... 28 
3.0 OBJECTIVES AND ENDPOINTS ...................................................................................... 28 
4.0 STUDY DESIGN.................................................................................................................. 29 
4.1 Overall Design..................................................................................................................... 29 
4.2 Scientific Rationale for Study Design ................................................................................. 30 
4.3 Participant Input into Design............................................................................................... 30 
4.4 End of Study Definition ...................................................................................................... 30 
5.0 STUDY POPULATION ....................................................................................................... 30 
5.1 Inclusion Criteria ................................................................................................................. 31 
5.2 Exclusion Criteria ................................................................................................................ 31 
5.3 Lifestyle Considerations ...................................................................................................... 31 
5.4 Screen Failures .................................................................................................................... 31 
6.0 STUDY INTERVENTION(S) .............................................................................................. 32 
6.1 Investigational/Test Device ................................................................................................. 32 
6.2 
Pre-placement Procedure ............................................................................................ 32 
6.3 Control Device/Standard of Care ........................................................................................ 33 
6.4 
Pre-placement Procedure ............................................................................................ 33 
6.5 Ancillary Devices/Products ................................................................................................. 34 
6.6 Device Labeling .................................................................................................................. 34 
6.7 Treatment Allocation and Measures to Minimize Bias ....................................................... 35 
6.8 
Randomization ............................................................................................................ 35 

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6.8.1 
Blinding/Masking ................................................................................................... 35 
7.0 STUDY PROCEDURES AND ASSESSMENTS ................................................................ 35 
7.2 Screening and Enrollment ................................................................................................... 36 
7.2.1 
Informed Consent.................................................................................................... 36 
7.2.2 
Eligibility ................................................................................................................ 36 
7.2.3 
Enrollment/ Assignment of Participant Number..................................................... 36 
7.2.4 
Randomization ........................................................................................................ 36 
7.2.5 Home Nurse Introduction ............................................................................................ 37 
7.2.7 Days 2-7 ........................................................................................................................... 38 
7.2.8 Day 8 ................................................................................................................................ 38 
7.2.9 Days 9-14 ......................................................................................................................... 38 
7.2.10 Day 15 ............................................................................................................................ 38 
7.2.11 Days 16-21 ..................................................................................................................... 38 
7.2.12 Day 22 ............................................................................................................................ 38 
7.2.13 Days 23-28 ..................................................................................................................... 39 
7.2.14 Day 29 ............................................................................................................................ 39 
7.2.15 Day 30 ............................................................................................................................ 39 
7.2.16 Days 29-42 (+14) Wash Out Period ............................................................................... 39 
7.2.17 Treatment Phase 2 .......................................................................................................... 39 
7.3 
Safety Assessments ........................................................................................................ 39 
7.3.1 Draize Scale ................................................................................................................. 39 
7.4 User Preference Questionnaire ............................................................................................ 40 
7.5 Participant Follow-Up ......................................................................................................... 41 
7.6 Replacement of Participants ................................................................................................ 41 
8.0 PARTICIPANT DISCONTINUATION/WITHDRAWAL.................................................... 41 
8.1 Discontinuation/Withdrawal ............................................................................................... 41 
8.2 Lost to Follow-Up ............................................................................................................... 41 
9.0 ADVERSE EVENTS AND DEVICE DEFICIENCIES ........................................................ 42 
9.1 Definitions of Events ........................................................................................................... 42 
9.1.1 Adverse Events (AEs) .................................................................................................. 42 
9.1.2 
Serious Adverse Events (SAEs).............................................................................. 42 
9.1.3 
Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) .............. 43 
9.1.4 
Unanticipated (Serious) Adverse Device Effect (UADE/USADE) ........................ 43 
9.2 Severity of Adverse Events ................................................................................................. 44 

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9.3 Relationship of Adverse Event to Device(s)/Procedure ...................................................... 44 
9.4 Reporting of Events ............................................................................................................. 46 
9.5 Serious Health Threats ........................................................................................................ 47 
9.6 Safety Committees .............................................................................................................. 48 
9.7 Device Deficiencies............................................................................................................. 48 
10.0 STATISTICAL METHODS ................................................................................................. 48 
10.1 Overview of Study Design ................................................................................................ 49 
10.2 Sample Size Considerations .............................................................................................. 49 
10.3 Analysis Population........................................................................................................... 49 
10.4 General Considerations .................................................................................................. 49 
10.4.1 Handling of Missing Data .......................................................................................... 49 
10.4.2 Poolability of Data ..................................................................................................... 50 
10.4.3 Multiplicity Control ................................................................................................... 50 
10.5 Primary Endpoint(s) .......................................................................................................... 50 
10.6 Secondary Endpoint(s) ................................................................................................... 50 
10.6.1 Questionnaire Nocturia Quality of Life (N-QoL) ...................................................... 50 
10.6.2 Questionnaire PROMIS Sleep Disturbance ............................................................ 51 
10.6.3 Tolerability - Number of days of actual use ........................................................... 51 
10.6.4 Tolerability - Discontinuation rate due to device discomfort or inconvenience ..... 51 
10.6.5 Comfort, Ease of Use and Confidence .................................................................... 51 
10.7 Tertiary/Exploratory Endpoint(s) ...................................................................................... 51 
10.8 Other Analyses .................................................................................................................. 51 
10.9 Interim Analyses ............................................................................................................... 51 
11.0 DATA COLLECTION AND RECORD MAINTENANCE ................................................ 51 
11.1 Case Report Forms ............................................................................................................ 51 
11.2 Source Documentation ...................................................................................................... 52 
11.3 Data Management ............................................................................................................. 52 
11.4 Record Retention ............................................................................................................... 52 
12.0 QUALITY CONTROL AND ASSURANCE ...................................................................... 53 
12.1 Control of Study Products ................................................................................................. 53 
12.2 Monitoring ......................................................................................................................... 53 
12.3 Audits and Inspections ...................................................................................................... 54 
12.4 Protocol Deviations ........................................................................................................... 54 
13.0 ADMINISTRATIVE REQUIREMENTS ............................................................................ 55 

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13.1 Investigator and Site Selection .......................................................................................... 55 
13.2 Training ............................................................................................................................. 55 
13.3 Required Documents ......................................................................................................... 55 
13.4 Publication Policy ............................................................................................................. 56 
13.5 Study Registration ............................................................................................................. 56 
13.6 Termination of Study ........................................................................................................ 56 
14.0 ETHICAL AND REGULATORY CONSIDERATIONS .................................................... 57 
14.1 IRB/EC Approval .............................................................................................................. 57 
14.2 Informed Consent and Confidentiality .............................................................................. 57 
14.3 
Confidentiality ........................................................................................................ 58 
14.4 Regulatory Status .............................................................................................................. 58 
14.5 Statement of Compliance .................................................................................................. 58 
15.0 REFERENCES ..................................................................................................................... 59 
16.0 APPENDICES ...................................................................................................................... 61 
Appendix 1 : Draize Scale for Skin Irritation ........................................................................... 61 
Appendix 2: Katz ADL assessment Score ................................................................................ 61 
Appendix 3: PureWick™ Female External Catheter Instructions for Use PWFX30 (US) ...... 61 
Appendix 4: PureWick™ Female External Catheter Instructions for Use PWFX30E (EU) .... 61 
Appendix 5: PureWick™ Urine Collection System Instructions for Use PW100 & PW 200 
(US) 61 
Appendix 6: PureWick™ Urine Collection System Instructions for Use PW200E (EU) ........ 61 
Appendix 7: Hollister® Female Urinary Pouch External Collection Device Instructions for 
Use 
61 
Appendix 8: N-QOL English .................................................................................................... 62 
Appendix 9: N-QOL French ..................................................................................................... 62 
Appendix 10: PROMIS English ................................................................................................ 62 
Appendix 11: PROMIS French ................................................................................................. 62 
Appendix 12 : Participant Comfort Questionnaire PureWick™ System (Sample) .................. 62 
Appendix 13 : Participant Comfort Questionnaire Hollister® Female Urinary Pouch External 
Collection Device (Sample) ...................................................................................................... 63 
Appendix 14 : PureWick™ System Participant Ease of Use Questionnaire (Sample) ............. 64 
Appendix 15: Hollister® Female Urinary Pouch External Collection Device Participant Ease 
of use Questionnaire (Sample) .................................................................................................. 65 
Appendix 16: End of Study Participant Preference Survey (Sample) ...................................... 66 
 

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Abbreviations 
 
ADE 
Adverse Device Effect 
AE 
Adverse event 
Bard 
C. R. Bard, Inc. 
BD 
Becton Dickinson and Company 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CMP 
Clinical Monitoring Plan 
CRF 
Case Report/Record Form 
CRO 
Contract Research Organization 
CV 
Curriculum Vitae 
DMP 
Data Management Plan 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
FDAAA 
FDA Amendments Act of 2007 
FEC 
Female External Catheter 
FUP 
Female Urinary Pouch 
FR 
France 
GCP 
Good Clinical Practice 
HIPAA  
Health Insurance Portability and Accountability Act 
IAD 
Incontinence Associated Dermatitis 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IRB/EC 
Institutional or Independent Review Board/Ethics Committee 
MDCG 
Medical Device Coordination Group 
MDR 
Medical Device Regulation 
NDA 
Non-disclosure Agreement 
NSR 
Non-significant Risk 
OAB 
Overactive Bladder Syndrome 
PI 
Principal Investigator 
PUCS 
PureWick™ Urine Collection System 
PW  
PureWick™ Female External Catheter 
N-QOL 
Nocturia Quality of Life 
QOL 
Quality of Life 
RCT 
Randomized Control Trial 
RMV 
Routine Monitoring Visit 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SIV 
Site Initiation Visit 
SFTP 
Secure File Transfer Protocol 

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SoA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
TMF 
Trial Master File 
UADE 
Unexpected Adverse Device Effect 
UI 
Urinary Incontinence 
U.S. 
United States 
USADE 
Unexpected Serious Adverse Device Effect 

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1.0 PROTOCOL SUMMARY 
 
1.1 Synopsis 
 
Protocol Title 
A Comparative Crossover Study on the Safety, Efficacy, 
and Patient Quality of Life Comparing PureWick™ System 
with an Established Comparator Overnight in the Home 
Setting for Incontinence.  
Short Title 
PureWick™ At-Home Pilot Study 
Rationale 
The study will collect clinical and quality of life data from 
patients requiring urine output management overnight in the 
home setting, which will aid reimbursement in France and 
the United States (U.S.). This pilot will inform the sample 
size and the frequency of nursing visits for the future 
randomized control trial.  
Objectives and Endpoints 
 
Objective(s) 
Endpoint(s) 
Primary 
To compare efficacy 
and safety of 
PureWick™ System 
and Hollister® Female 
Urinary Pouch External 
Collection Device 
Primary 
• Efficacy – Daily capture 
rate via bed pad weights 
and captured volume. 
 
• Safety – Daily skin 
irritation score using the 
Draize Scale.  

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Secondary 
• To assess impact of 
PureWick™ System 
and Hollister® 
Female Urinary 
Pouch External 
Collection Device on 
Nocturnal 
Incontinence related 
Quality of Life and 
Sleep 
 
• Tolerability – To 
assess the tolerance 
of PureWick™ 
System and 
Hollister® Female 
Urinary Pouch 
External Collection 
Device over the 
expected duration of 
use  
 
• To assess participant 
comfort and ease of 
use of PureWick™ 
System and 
Hollister® Female 
Urinary Pouch 
External Collection 
Device  
 
• To assess participant 
preference between 
the PureWick™ 
System and 
Hollister® Female 
Urinary Pouch 
External Collection 
Device after study 
completion  
Secondary 
• Nocturia Quality of Life 
(N-QOL) score collected 
at baseline and every 2 
weeks during treatment 
• PROMIS Sleep 
Disturbance score at 
baseline and every 7th 
day during treatment. 
 
 
• Tolerability – Number of 
days of actual use of both 
devices & 
Discontinuation rate 
attributed to the device’s 
inconvenience or 
discomfort. 
 
 
 
• Overall comfort and ease 
of use scores on a 5-point 
Likert scale (brief 
questionnaire) collected at 
the end of each treatment 
phase. 
 
• Overall preference via end 
of study participant 
preference survey 
administered at study 
completion. 
 
 
 
Design and Overview 
In this prospective, open-label, crossover trial, 
approximately 30 women with Nocturnal Urinary 

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Incontinence requiring the use of diapers in bed will be 1:1 
randomized to a treatment sequence using two devices 
(PureWick™ System and Hollister® Female Urinary Pouch 
External Collection Device) and followed for approximately 
10 weeks through 2 treatment phases. For purposes of this 
study, the PureWick ™ System will be referenced to 
include the PureWick™ Female External Catheter used in 
conjunction with the PureWick™ Urine Collection System, 
including the tubing and the canister. 
At the start of the study, participants will be consented and 
screened against inclusion/exclusion criteria. All subjects 
that have met all eligibility criteria will be assigned a 
treatment order. Participants will view the training video for 
the applicable product at the beginning of each treatment 
phase and have access to the Instructions for Use (IFU) to 
review. Participants will use the device assigned in 
treatment phase 1 overnight while sleeping for 4 weeks (28 
days) before transitioning to the second assigned device in 
treatment phase 2.  
The primary endpoints will evaluate safety (skin injury) and 
efficacy (capture rate). Safety will be evaluated using the 
Draize Scale and efficacy will be measured based on daily 
capture rate.  
 Nurses will visit daily to measure urine capture rate and to 
assess for skin irritation using the Draize Scale.  
The secondary outcomes include participative evaluation of 
the therapy and self‐reported changes using questionnaires 
and preference surveys: Nocturia Quality of Life (N-QOL) 
assessment evaluated at baseline (previous treatment) and 
every 14 days through completion of each treatment phase 
(4 weeks/ 28 day period), PROMIS Sleep Disturbance 
measured at baseline and every 7 days through completion 
of each treatment phase, surveys (comfort & ease of use) 
completed by users at the end of each 4-week period, and 
end of study participant preference survey collected at study 
completion.   
Tolerability to be measured by number of days of actual use 
of both devices, and discontinuation rate attributed to the 
device’s discomfort or inconvenience. 
Investigational Device 
Test product(s):   
• PureWick™ Female External Catheter (PWFX30) 
(U.S.) and (PWFX30E) (EU) 

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Protocol Title 
A Comparative Crossover Study on the Safety, Efficacy, 
and Patient Quality of Life Comparing PureWick™ System 
with an Established Comparator Overnight in the Home 
Setting for Incontinence.  
• PureWick™ Urine Collection System (PW100, 
PW200) (U.S.) and (PW200E) (EU) 
For regulatory status, refer to Regulatory Status row 
below within this table.  
Reference/Comparator product(s):   
Marketed Device: Hollister® Female Urinary Pouch 
External Collection Device 
Ancillary Product(s):    
• PureWick™ replacement Kit (PWKIT03) (U.S.) and 
(PWKIT03E) (EU) 
• Absorbent under-pads 
• Medium/Large sealing plastic bags 
• Medical Triangular Graduated Cylinders, 1000mL 
• Weighing Scales 
• Urine Collection Bags for Hollister FUP 
• Urine Bag Holders 
• Mesh underwear 
• PPE (Gloves, Chux) 
• Barrier Paste 
• Wipes 
• Micropore tape 
• Hair trimmers/clippers 

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Participants 
Adult female participants currently using incontinence 
products at night (e.g., nocturnal enuresis, nocturia, 
mobility limitation) will be recruited for this study from the 
study site.  
To best mimic potential users of the PureWick™ System, 
participants >18 years of age will be enrolled. It is desired 
that at least 90% of participants are >65 years of age. This 
study will enroll approximately 30 participants. 
Inclusion Criteria 
In order to be eligible to participate in this study, an 
individual must meet all of the following criteria: 
1. Adult Female Participants >18 years of age at the 
time of signing the informed consent. 
2. Currently use diapers or equivalent at night for urine 
capture (“Change complet” (FR))  
3. Willing to comply with all study procedures in this 
protocol.  
4. Provision of signed and dated informed consent 
form.  
 
Exclusion Criteria 
Participants are excluded from the study if any of the 
following criteria apply: 
1. Has frequent episodes of bowel incontinence 
without a fecal management system in place; or 
2. Has moderate to heavy menstruation and cannot use 
a tampon or menstrual cup; or 
3. Has Urinary tract, vaginal or other chronic 
infections, active genital herpes; or 
4. Has Urinary retention; or 
5. Is agitated, combative, and/or uncooperative and 
may remove the external catheter or pouch; or 
6. Has any wound, open lesion or irritation on the 
genitalia, perineum, or sacrum; or 
7. Has any pre-existing neurological, psychiatric, or 
other condition that would confound quality of life 
assessment or would make it difficult to self-report 
on quality-of-life questionnaires in the opinion of 
the investigator; or 
8. Is known to be pregnant at time of enrollment (for 

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Protocol Title 
A Comparative Crossover Study on the Safety, Efficacy, 
and Patient Quality of Life Comparing PureWick™ System 
with an Established Comparator Overnight in the Home 
Setting for Incontinence.  
women of childbearing age); or 
9. Any other condition that, in the opinion of the 
investigator, would preclude them from participating 
in the study. 
10. Is under supervision of a legally authorized 
representative  
Intervention(s)/Procedure(s) 
The PI or designee/nurse defined by the Draize Skin Score 
will assess skin and determine readiness for each treatment 
phase. Participants assigned to both treatment arms will 
place and remove the FEC (female external catheter) or 
FUP (Female Urinary Pouch) after standardized teaching is 
completed on the first day of the treatment phase.  
Participants will use the device assigned in treatment phases 
1 and 2 overnight while sleeping for 4 weeks (28 days). 
There will be a minimum washout period of 2 weeks (not to 
exceed 4 weeks) between treatment phases. 
Investigational Sites 
Approximately 2 sites in France and approximately 2 sites 
in the U.S. 
Data Monitoring Committee 
N/A 
Regulatory Status 
Post-Market, Non-significant risk 
PureWick™ System 
• Class I, non-sterile device, CE marked, currently 
marketed in Europe 
• Class I, 510(k) exempt device currently marketed in 
the U.S. 
This investigation will use the PureWick™ System for its 
intended purpose. 
Trial Duration 
Estimated start date: (First Patient In): 19 Sep 2023 
Estimated end date (Final Clinical Study Report): October 
2024 

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Protocol Title 
A Comparative Crossover Study on the Safety, Efficacy, 
and Patient Quality of Life Comparing PureWick™ System 
with an Established Comparator Overnight in the Home 
Setting for Incontinence.  
Regulatory Agency Identifier 
Number(s):  
 
NCT05710718 (USA) 
IDRCB: 2023-A01727-38 (France)   

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1.2 Schema 
 
 
 
 

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1.3 Schedule of Activities 
Procedure 
Screening / 
Enrollment 
Daily Study Home Visits 
Ph 1 
Baseline 
Day 1 
Ph1 
Day 
2-14 
Ph1 
Day 15 
Ph1 
Day 
16-28 
Ph1 
Day 29 
Ph1 
Day 
30 
Washout 
Day 29-42 
(+14 days) 
Ph2 
Baseline 
Day 1 
 
Ph2 
Day 
2-14 
 
Ph2 
Day 
15 
 
Ph2 
Day 
16-28 
 
Ph2 
Day 
29 
 
Ph2 
Day 
30 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion and 
exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demography 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Katz ADL Index 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant ID 
Assignment and 
Randomization 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Introduction to 
Home Nurses 
(On site or Virtual) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Visual Skin 
Assessment & 
Draize Scoring 
(Both site and 
Nurses) 
 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Nurses Confirm 
Study Supplies 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
Nurses Have 
Participant 
Complete N-QOL 
 
X 
 
X* 
 
X* 
 
 
X 
 
X* 
 
X* 
 

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Procedure 
Screening / 
Enrollment 
Daily Study Home Visits 
Ph 1 
Baseline 
Day 1 
Ph1 
Day 
2-14 
Ph1 
Day 15 
Ph1 
Day 
16-28 
Ph1 
Day 29 
Ph1 
Day 
30 
Washout 
Day 29-42 
(+14 days) 
Ph2 
Baseline 
Day 1 
 
Ph2 
Day 
2-14 
 
Ph2 
Day 
15 
 
Ph2 
Day 
16-28 
 
Ph2 
Day 
29 
 
Ph2 
Day 
30 
Nurses Have 
Participant 
Complete 
PROMIS Sleep 
 
X 
X* 
Day 8 
X* 
Day 15 
X* 
Day 22 
X* 
Day 29 
 
 
X 
X* 
Day 8 
X* 
Day 15 
X* 
Day 22 
X* 
Day 29 
 
Nurses Conduct 
Device Training 
w/Participants 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
Nurses Pre-weigh 
urine canister or 
graduated cylinder 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
Nurses Pre-Weigh 
Overnight Pads 
and Mesh 
underwear  
(if applicable) 
 
X 
X 
X 
X 
 
 
 
X 
X 
X 
X 
 
 
Participants wear 
investigational 
device 
 
X 
X 
X 
X 
 
 
 
X 
X 
X 
X 
 
 
Nurses Measure 
Urine Output 
 
 
X 
X 
X 
X 
 
 
 
X 
X 
X 
X 
 
Nurses Post-Weigh 
Overnight Pads 
and Mesh 
Underwear  
(if applicable) 
 
 
X 
X 
X 
X 
 
 
 
X 
X 
X 
X 
 
Participant 
Completes 
Preference Survey 
 
 
 
 
 
X* 
 
 
 
 
 
 
X* 
 

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Procedure 
Screening / 
Enrollment 
Daily Study Home Visits 
Ph 1 
Baseline 
Day 1 
Ph1 
Day 
2-14 
Ph1 
Day 15 
Ph1 
Day 
16-28 
Ph1 
Day 29 
Ph1 
Day 
30 
Washout 
Day 29-42 
(+14 days) 
Ph2 
Baseline 
Day 1 
 
Ph2 
Day 
2-14 
 
Ph2 
Day 
15 
 
Ph2 
Day 
16-28 
 
Ph2 
Day 
29 
 
Ph2 
Day 
30 
Participant 
Completes End of 
Study Preference 
Survey 
 
 
 
 
 
 
 
 
 
 
 
 
X* 
 
AE review  
(If applicable) 
 
 
SAE review 
 (If applicable) 
 
 
Device 
Deficiencies  
(If applicable) 
 
 
*To be completed per treatment schedule or upon treatment discontinuation, whichever comes first.  

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2.0 INTRODUCTION 
 
The PureWick™® Female External Catheter (PureWick™ FEC) is an external drainage 
device to address the need for an effective, non-invasive method of managing urine output 
in adult incontinent women.  The device utilizes suction to drain urine away from the patient 
through tubing that is connected to a collection canister.  PureWick™ FEC can use either 
wall suction (acute care setting) or a free-standing PureWick™ Urine Collection System 
(home setting/skilled nursing facility). In the U.S., PureWick™ FEC is a Class I, 510(k) 
exempt device. In Europe, the PureWick™ FEC is a Class I, CE marked, non-sterile device. 
 
2.1 Background 
 
Adult nocturnal enuresis, or nighttime urinary incontinence in the home setting has a 
significant impact on the individual, their family or caregiver, and the broader health 
system. Nocturnal enuresis in the adult population may be related to a multitude of causes, 
including but not limited to OAB (Overactive Bladder syndrome), dementia, mobility 
issues, and nocturia9. There is an apparent lack of research and focused attention on 
urinary incontinence management in people living at home.3 With an aging population and 
the emerging acceptance of open discussion of urinary management needs, there is an 
urgent need for both research and products tailored to those living in their home, where 
most adults with nighttime incontinence live.3 
 
Current literature supports that incontinence is under-reported.9,13 One qualitative study 
looking at those with dementia and incontinence reported, “Most carers reported 
protecting the person's dignity by not seeking health professionals help often until the 
point of a crisis”2  and incontinent women were less likely to seek care for their 
incontinence compared with incontinent men.7  Not only are patients and their caregivers 
embarrassed to discuss incontinence with their provider, but they’re also embarrassed 
about the multiple challenges with available toileting supplies,4 which has highlighted the 
need for urinary management solutions. In addition to being under-reported, older people 
frequently are not assessed and treated.13 
 
Although prevalence reports range, urinary incontinence (UI) rates among women are 
consistently high, especially in the elderly. The burden of UI amongst elderly people in 
the United States (U.S.) is immense, with UI prevalence estimates for elderly community-
dwelling women approximately 41% of Medicare beneficiaries11 ranging up to 55%.10 UI 
represents a similar public health burden in France, with 25% to 40% of women declaring 
suffering from UI and an increasing prevalence with age, with UI rates exceeding 45% 
among 75+ year-old women.28 
 
Quality of Life (QOL) is impacted in women with UI,13 including comorbidities and 
poorer health overall (despite education, poverty status, or smoking), including falls10 and 
positive bacterial cultures in those with UI in nursing homes5, physical and mental health 
(independent of demographic factors and comorbidities).8, and Incontinence Associated 
Dermatitis (IAD).12 These represent meaningful constraints in physical and social 

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activities, along with significant impacts on emotional well-being.6,8 One potential 
solution discussed by an older eleven-site European research project is to empower elderly 
individuals with incontinence to stay in their own homes with a better quality of life is that 
they would require caregiver assistance during toileting regularly1, which adds additional 
expense. A recent Conjoint Analysis survey revealed that getting a good night’s sleep and 
feeling rested were most important to individuals with nocturnal enuresis.24 
 
Finally, incontinence correlated with a considerable economic burden from both a patient 
perspective and in the community.14,16,17,18,19,20,21,22,23 In addition to direct costs, to be taken 
into consideration is the need to institutionalize loved ones because incontinence cannot 
be managed in the home setting. The ability to independently use the toilet and urinary 
incontinence appear to be independent predictors of the elderly and their families choosing 
admission to an institution.15 Considering OAB alone, a retrospective study among 
Medicare beneficiaries indicated that the cost of care for female patients in nursing homes 
is higher than for female patients in nursing homes without OAB.16  Estimates of the 
economic burden associated with OAB have been derived from community-dwelling 
populations. 9,12 
 
Further research is needed to determine if there’s an unmet need for current solutions to 
identified problems such as the need for additional caregivers or admission to institutions, 
Quality of Life solutions, or product alternatives that are safe and effective, and if there is 
potential to improve quality of life, or delay nursing home admissions with alternative 
home care solutions. A recently published patient and caregiver satisfaction survey with 
the PureWick™ System used in the home setting showed over 80% satisfaction, comfort, 
and ease of use using the product compared with their baseline incontinence solution 
despite over 70% reporting the PureWick™ System had a higher cost compared with their 
baseline direct costs.25 
 
The PureWick™ Urine Collection System (PUCS) is to be used with PureWick™ 
External Catheters (FEC) which are intended for non-invasive urine output management 
and will be collectively referenced as the PureWick™ System throughout this study. 
 
2.3 Rationale 
 
The study will collect clinical and quality of life data from patients requiring urine output 
management overnight in the home setting, which will aid reimbursement in France and 
the United States (U.S.). This pilot will inform the sample size and the frequency of 
nursing visits for the future home-setting, randomized control trial. 
  
2.4 Risk/Benefit Assessment 
 
Subjects participating in this study will be treated with approved, marketed devices and 
will use the investigational devices as intended. Therefore, subjects will be exposed to the 
same risks shared by all patients using these devices for urine output management in a real-
world setting. More detailed information about the known and expected benefits and risks 

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and reasonably expected adverse events of the PureWick™ Female External Catheter, 
PureWick Urine Collection System and the Hollister® Female Urinary Pouch External 
Collection Device may be found in the Instructions for Use for each product. 
 
2.5 Risk Assessment 
 
Potential Risk of Clinical Significance 
 
Summary of 
Data/Rationale for Risk 
 
Mitigation Strategy 
 
 
Study Intervention: PureWick™ System 
Potential adverse events: 
• Skin Injury 
• Skin Irritation 
• Allergic Reaction 
PureWick™ FEC is an 
external device placed 
between the separated 
gluteus and labia; it is in 
direct contact with skin 
and mucous membranes 
• To avoid potential skin 
injury, never push or 
pull the PureWick™ 
Female External 
Catheter against the skin 
during placement or 
removal. 
• Assess local area before 
device application/after 
device removal and 
periodically throughout 
use. 
• To monitor skin 
irritation, daily skin 
assessment will be 
performed using the 
Draize scale.  
• To avoid allergic 
reactions, study is using 
Non-latex PureWick™ 
FEC  
Potential adverse events: 
• 
Allergic Reactions 
• 
Choking 
• 
Strangulation 
• 
Electrical Shock 
• 
Injury from Explosion 
• 
Chemical Burns 
 
 The PureWick™ Urine 
Collection System is to be 
used with PureWick™ 
External Catheters which 
are intended for non-
invasive urine output 
management. 
•  Discontinue use if an 
allergic reaction occurs. 
Not recommended for 
users who are 
experiencing skin 
irritation or skin 
breakdown in device 
contact areas. 
• Keep small device parts, 
cords and tubing out of 
reach of children. 
• Always unplug 
PureWick™ Urine 
Collection System 

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before cleaning or when 
not in use. 
• DO NOT IMMERSE 
THE PUREWICK™ 
URINE COLLECTION 
SYSTEM IN WATER. 
As with most electrical 
devices, electrical parts 
in this system are 
electrically live even 
when the power is off. 
To reduce the risk of 
electric shock, if the 
PureWick™ Urine 
Collection System falls 
into water, unplug 
immediately. DO NOT 
REACH INTO THE 
WATER TO 
RETRIEVE IT. 
•  Do not use PureWick™ 
Urine Collection 
System in oxygen rich 
environments or in 
conjunction with 
flammable anesthetics. 
• For PW200: The battery 
cells used in this device 
may present a fire or 
chemical hazard. To 
minimize the risk of 
damaging the battery 
inside the PureWick™ 
Urine Collection 
System, do not use the 
device outside the 
indicated operating 
temperature range of 
41°F - 104°F (5°C - 
40°C). The battery is 
not intended to be 
replaced; replacement 
could result in a hazard. 
Study Intervention: Hollister® Female Urinary Pouch External Collection Device 
Potential adverse events: 
• 
Irritation 
• 
Broken skin 
• 
Rash 
• 
Severe Redness 
• 
Swelling 
Hollister® Female Urinary 
Pouch External Collection 
Device is a urinary 
collection pouch with a 
skin barrier suitable for 
frequent pouch changes or 
• 
To avoid potential 
adverse events, while 
using the Hollister® 
Female Urinary Pouch 
External Collection 
Device, it is advised 

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• 
Itching or pain in vulva/perineal area 
• 
Fever 
• 
Abnormal Discharge 
use on fragile skin. It is in 
direct contact with the 
vulva or perineal area. 
the product should not 
reuse the pouch after 
use. Reprocessing, 
cleaning, disinfection, 
and sterilization may 
comprise the product. 
• 
Urinary pouch should 
only be used under 
supervision of 
healthcare 
professional. 
• 
Urinary pouch should 
not be used on patients 
with any 
contraindications per 
IFU. 
Study Procedures 
Potential loss of confidentiality of 
information 
Study data, including 
photographs when 
applicable, will be 
collected in the home 
setting and transferred to 
the investigational site for 
collection in the clinical 
database.  
• 
Access controlled 
Secure File Transfer 
Protocol (SFTP) 
software will be used 
to transfer data to 
investigational site  
 
 
2.5.1 Benefit Assessment 
 
Potential benefits to participants using the PureWick™ System may include: 
• 
The PureWick™ System can help make better sleep possible for women with 
incontinence and their caregivers.24  
• 
The PureWick™ System may help reduce the need for multiple changes at 
night, or trips to the bathroom.  
• 
The PureWick™ System is easy to set up, and the PureWick™ Female 
External Catheter can be placed in a few easy steps.  
• PureWick™ FEC can decrease risk of moisture-associated skin damage 
compared to the use of absorbent products such as adult briefs, pads, or sheets. 
 
Other potential benefits of study participation include:   
• Participants receive enhanced follow up, including daily skin assessments and 
urine output management by a nurse.  
• Participants contribute to the process of generating clinical evidence for urine 
output management solution in the home setting.  
• Potential to benefit from future reimbursement of the PureWick system.  
 

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2.5.2 Overall Benefit: Risk Conclusion 
 
Taking into consideration the measures to minimize risk to participants in this study, the 
potential risks identified in association with the PureWick™ System and the Hollister® 
Female Urinary Pouch External Collection Device are justified by the anticipated benefits 
that may be afforded to participants with urinary incontinence. 
 
3.0 OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary 
 
To compare efficacy and safety of 
PureWick™ System and Hollister® Female 
Urinary Pouch External Collection Device 
• Efficacy – Daily capture rate via bed pad 
weights and captured volume. 
• Safety – Daily skin irritation score using 
the Draize Scale. 
 
Secondary 
 
To assess impact of PureWick™ System and 
Hollister® Female Urinary Pouch External 
Collection Device on Nocturnal Incontinence 
related Quality of Life. 
• Nocturia Quality of Life (N-QOL) score 
collected at baseline and every 2 weeks 
during treatment. 
• PROMIS Sleep Disturbance score 
collected at baseline and every 7 days 
during treatment. 
Tolerability – To assess the tolerance of 
PureWick™ System and Hollister® Female 
Urinary Pouch External Collection Device 
over the expected duration of use  
Tolerability – Number of days of actual use 
of both devices & Discontinuation rate 
attributed to the device’s inconvenience or 
discomfort 
To assess participant device preference, 
comfort, and ease of use of PureWick™ 
System and Hollister® Female Urinary Pouch 
External Collection Device  
To assess participant preference between the 
PureWick™ System and Hollister® Female 
Urinary Pouch External Collection Device 
after study completion 
• Overall comfort and ease of use scores on 
a 5-point Likert scale (brief questionnaire) 
collected at the end of each treatment 
phase. 
 
• Overall preference via end of study 
participant preference survey 
administered at study completion  
Tertiary/Exploratory  
 
N/A 
N/A 
 
 
 

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4.0 STUDY DESIGN 
 
4.1 Overall Design 
 
In this prospective, post-market, multi-site, open-label, crossover trial, women with 
urinary incontinence requiring the use of diapers (changes complets (Fr)) at night will be 
1:1 randomized to a treatment sequence using two devices (PureWick™ System and 
Hollister® Female Urinary Pouch External Collection Device) and followed for 
approximately 10 weeks through 2 treatment phases.  
Approximately 30 female participants from 2 sites will be enrolled into the study. Those 
meeting eligibility criteria will be treated according to the treatment sequence assigned 
during randomization. Participants will be trained by the nurses for the applicable product 
at the beginning of each treatment phase and have access to the IFU to review during each 
treatment phase. The total expected duration of subject participation is approximately 10 
weeks. Participants will use the device assigned in treatment phase 1 overnight while 
sleeping for 4 weeks (28 days) before transitioning to the second assigned device in 
treatment phase 2. There will be a minimum washout period of 2 weeks (not to exceed 4 
weeks) between treatment phases and a re-screening of eligibility criteria before the 
second phase. Participants assigned to both treatment arms will place and remove the FEC 
(female external catheter) or FUP (Female Urinary Pouch) after standardized teaching is 
completed on the first day of the treatment phase. 
The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). 
Safety will be assessed using the Draize Scale and efficacy will be measured based on 
daily urine capture rate. Nurses will visit participants’ homes daily to perform a skin 
assessment and collect urine measurements during the treatment phases. Participants will 
be withdrawn from the treatment phase if grade 4 is achieved in any category on the 
Draize skin irritation scale. 
The secondary objectives are to assess quality of life, tolerability, preference, comfort and 
ease of use. Quality of life will be measured using self-reported changes in quality of life 
via the validated Nocturia Quality of Life (N-QOL) and PROMIS Sleep Disturbance 
assessments. Preference, comfort and ease of use will be measured using subjective 
evaluations of the therapy via participant surveys. Tolerability will be measured by 
number of days of actual use of both devices, and discontinuation rate attributed to the 
device’s discomfort or inconvenience. 
 
 

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4.2 Scientific Rationale for Study Design 
 
This study will assess the performance of and user experience with PureWick™ System in 
a home setting. The endpoints chosen for the study were selected based on peer-reviewed 
research and feedback from expert consultants, Centers for Medicare & Medicaid 
Services, applicable health authorities and urology key opinion leaders. 
 
To best mimic potential users of the PureWick™ System, participants >18 years of age 
will be enrolled with a target of at approximately 90% of participants >65 years of age. 
The treatment duration of 4 weeks for each investigational device was selected to allow 
sufficient time for a potential impact to quality of life. For this study, the baseline quality 
of life scores will be compared to mid-treatment scores and to post-treatment scores. 
 
The PureWick™ System may provide improvements to urine output management, 
specifically in the home-setting. Additionally, the PureWick™ At-Home study is required 
to provide the needed information to properly execute a future global randomized control 
trial (RCT) with confidence of success. 
 
 
4.3 Participant Input into Design 
 
Not applicable.  
 
4.4 End of Study Definition 
 
A participant is considered to have completed the study after she has completed both 
treatment phases and all required questionnaires.  
 
The end of the study is defined as the date of completion of the last participant in the 
study. 
 
 
5.0 STUDY POPULATION 
 
Adult female participants requiring urine output management overnight in the home setting will 
be recruited for this study by the study site from their current patient list.  Study sites may 
advertise and recruit new patients if eligible participants from the patient list have been 
exhausted.   
 
To best mimic potential users of the PureWick™ System, participants >18 years of age will be 
enrolled. It is desired that at approximately 90% of participants are >65 years of age. This study 
will enroll approximately 30 participants. 
 

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5.1 Inclusion Criteria 
 
In order to be eligible to participate in this study, an individual must meet all of the 
following criteria: 
 
1. Adult Female Participants >18 years of age at the time of signing the informed 
consent. 
2. Currently use diapers or equivalent at night for urine capture (“Change complet” 
(FR))  
3. Willing to comply with all study procedures in this protocol.  
4. Provision of signed and dated informed consent form.  
 
5.2 Exclusion Criteria 
 
Participants are excluded from the study if any of the following criteria apply: 
 
1. Has frequent episodes of bowel incontinence without a fecal management system in 
place; or 
2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or 
3. Has Urinary tract, vaginal or other chronic infections, active genital herpes; or 
4. Has Urinary retention; or 
5. Is agitated, combative, and/or uncooperative and may remove the external catheter or 
pouch; or 
6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or 
7. Has any pre-existing neurological, psychiatric, or other condition that would 
confound quality of life assessment or would make it difficult to self-report on 
quality-of-life questionnaires in the opinion of the investigator; or 
8. Is known to be pregnant at time of enrollment (for women of childbearing age); or 
9. Any other condition that, in the opinion of the investigator, would preclude them 
from participating in the study. 
10. Is under supervision of a legally authorized representative.  
 
5.3 Lifestyle Considerations 
 
No restrictions are required. 
 
5.4 Screen Failures 
 
Screen failures are defined as participants who consent to participate in the clinical study 
but do not subsequently meet eligibility criteria prior to treatment. Data collected for 
screen failures will include consent, randomization, criteria leading to exclusion, and AEs.  
 
Individuals who do not meet the criteria for participation in this study (screen failure) may 
be rescreened if the exclusionary criteria are temporary in nature and may resolve over 

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time (e.g., active infection, open wound, etc.). Rescreened participants will receive a new 
participant number.  
 
 
6.0 STUDY INTERVENTION(S) 
 
6.1 Investigational/Test Device 
 
The PureWick™ System includes the PureWick™ Female External Catheter and the 
PureWick™ Urine Collection System. The PureWick™ Female External Catheter 
(PureWick™ FEC) is marketed in both the United States and Europe. In the U.S. 
PureWick™ FEC is a Class I, 510(k) exempt device. In Europe, the PureWick™ FEC is a 
Class I, CE marked, non-sterile device. 
 
The PureWick™ FEC is intended for non-invasive urine output management in female 
patients. The PureWick™ FEC (Figure 1) is a flexible, contoured external catheter that is 
positioned against the area where urine exits the female body.  The PureWick™ FEC will 
be connected to the PureWick™ Urine Collection System (PUCS) via connector tubing.  
The PUCS uses suction (not felt by the user) to pull voided urine through the device. 
Urine continues through vinyl tubing until it reaches a collection canister, away from the 
body. The PureWick™ FEC and PUCS will be used according to the IFU.  
  
6.2 Pre-placement Procedure 
 
Prior to placing the PureWick ™ FEC, perineal care should be performed, and skin 
should be assessed for integrity. 
 
Figure 1:  PureWick™ Female External Catheter 
 
 

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Figure 2:  PureWick™ Urine Collection System 
 
 
All PureWick™ FECs and PUCS will be shipped directly to the study site from regular 
commercial stock.  Access to the devices will be limited to study staff and will only be 
used by study participants who have provided written informed consent. 
 
6.3 Control Device/Standard of Care 
 
The Hollister® Female Urinary Pouch External Collection Device will be used as a 
comparator for this study. The urinary collection pouch with a skin barrier is suitable for 
non-ambulatory females with urinary incontinence. It is designed to be emptied and should 
be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and 
polymer/copolymer plastics. 
 
6.4 Pre-placement Procedure 
 
To prepare the skin prior to placing the Hollister® FUP, the genital area should be 
washed with a mild soap and water and pubic hair trimmed. After drying the area 
thoroughly, the skin that will be in contact with the skin barrier may be wiped with a skin 
protective wipe if desired. 
  
The pre-cut opening on the skin barrier can be modified so that it will encompass the 
urinary and vaginal orifices by cutting the opening with scissors.  
 
If desired, barrier paste may be placed on the edge of the skin barrier that will adhere to 
areas where the skin surface is creased or uneven prior to placement. 
 
 
 

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Figure 3: Hollister® Female Urinary Pouch One-System and Bedside Drainage Bag 
 
 
All Hollister® Female Urinary Pouch External Collection Devices will be shipped directly 
to the study site from regular commercial stock.  Access to the devices will be limited to 
study staff and will only be used by study participants who have provided written informed 
consent. 
 
6.5 Ancillary Devices/Products 
 
• PureWick™ replacement kit (PWKIT03) (US) and (PWKIT03E) (EU) 
• Absorbent under-pads will be used to collect and measure urine leakage.  
• Medium/Large sealing plastic bags 
• Medical triangular graduated cylinders, 1000mL  
• Commercially available scales will be used to weigh under-pads and mesh underwear.  
both before and after use to calculate urine capture rates. 
• Bedside urine collection bags to capture outputs from the Hollister FUP 
• Bedside urine bag holder 
• Mesh Underwear 
• PPE (gloves, chux) 
• Barrier Paste 
• Wipes 
• Micropore tape 
• Hair trimmers/clippers 
 
6.6 Device Labeling 
 
Commercial products will be supplied as labeled by the manufacturer. The test device and 
comparator products shall be labeled in accordance with regulatory requirements, including 
the following statement, "CAUTION - Investigational Device. Limited by Federal (or 
United States) law to investigational use." for the products used in the US, and with the 
following statement “exclusively for clinical investigation” for the devices used in France.   

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6.7 Treatment Allocation and Measures to Minimize Bias 
 
Known foreseeable factors that could potentially compromise the outcome of the 
investigation or interpretation of the results or introduce bias into the study are delineated 
in this section. 
 
This is an open label, cross-over study in which each subject acts as her own control and 
therefore, the difference in treatments is derived from a within-subject comparison. This 
allows for better control of potential confounders and removes the inter-subject 
variability from the comparison between treatment groups. In addition, the study design 
includes a required washout period between treatment phases to minimize the impact of 
carry-over effect. 
 
Standardized questionnaires and data collection tools will be used to assess participant 
preference and to document study findings, respectively. As training level and device 
experience could be a foreseeable factor that could impact study outcomes, standardized 
instructional videos will be used to train all participants on device use.  
 
6.8 Randomization 
 
Subjects will be randomized 1:1 to the two sequences of treatment (using PureWick™ 
FECs in phase 1 and Hollister® Female External Pouch in phase 2, or the reversed order). 
This design allows the evaluation of elements such as the carryover effect, period effect, 
and sequence effect. To begin treatment phase in either the U.S. or France, using a prepared 
randomization schedule participants will be randomized 1:1 to use either PureWick™ FEC 
in phase 1 and Hollister® FUP in phase 2, or vice versa. Block randomization will be 
carried out using a fixed block size and stratified by investigational site and geography.  
 
6.8.1 Blinding/Masking 
 
Not applicable. This is an open-label study. 
 
6.8.2  Procedures for Unblinding 
 
 
 
 
 
Not applicable. 
 
 
7.0 STUDY PROCEDURES AND ASSESSMENTS 
 
Study procedures and their timing are summarized in the Schema (Section 1.2). Protocol 
waivers or exemptions are not allowed. Adherence to the study design requirements, 
including those specified in the SoA, is essential and required for study conduct. 
 

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All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
 
7.2 Screening and Enrollment 
 
7.2.1 Informed Consent 
 
The Principal Investigator or their designee will explain the study to the participant, 
answer all the participant’s questions, and obtain written or electronic informed consent 
before the collection of any study data or performance of any study procedures in 
accordance with article 63 of the European Medical Device Regulations respectively 
CFR Parts 50 and 56 and any other applicable laws and regulations.  The original copy of 
the consent will be retained with the participant records and a copy will be provided to 
the participant. 
 
7.2.2 Eligibility 
 
The participant’s eligibility (inclusion/exclusion criteria) for study participation will be 
confirmed by the PI or designee (via on site or virtual visit (U.S. only)) per 
investigational site policy) and documented on the appropriate electronic case report form 
(eCRF). Participant baseline and demographic information, including, but not limited to 
age, sex assigned at birth, primary diagnosis, medical history, Katz ADL Index score and 
incontinence-specific information will be collected and recorded after informed consent 
is obtained prior to device use.  
 
Participants who fail to meet eligibility criteria due to an exclusionary criterion that is 
temporary in nature and may resolve over time (e.g., active infection, open wound, etc.) 
can be rescreened at the PI’s discretion. 
 
7.2.3 Enrollment/ Assignment of Participant Number 
 
Participants who sign an informed consent will be considered enrolled in this study.   
A unique identification number will be given to study participants. Participant numbers 
will be assigned in sequential order. The participant number will consist of six digits. The 
first three digits will designate the site number and the last three digits will designate the 
participant number in sequential order.  
 
7.2.4 Randomization 
Investigational sites will receive the randomization envelopes that are numbered in 
sequential orders. Within each randomization envelope, a treatment assignment card will 
be enclosed indicating which device to be used for each treatment phase. The 

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randomization envelope will be opened when all eligibility criteria are confirmed, and 
consent has been obtained. Randomization envelopes should be opened in sequential 
order. The treatment assignment card will be filed in the participant’s record to serve as 
documentation. Participant randomization numbers will be captured in EDC. 
7.2.5 Home Nurse Introduction 
 
The Principal Investigator or their designee will introduce enrolled participants to the 
nurse that will conduct daily home visits (either in person or virtually).  
 
Nurse and participant will arrange the baseline visit. Once a baseline visit has been 
scheduled, the site coordinator/Pharmacist will reach out to Marken and setup study 
device shipment from clinical site to the Participant’s home. 
 
7.2.6 Day 1 - Baseline Assessments 
 
This part of the study is to assess if the participants are eligible to begin treatment per 
assigned treatment schedule. During the baseline assessment urine output measurements 
will not be taken. 
 
The nurse will collect nighttime routine (e.g., sleep position) and visually assess for any 
existing signs of irritation in the perineal area, using the Draize Scale Skin Scoring system. 
 
If Skin Score is Greater than 0: 
1. Participant is not eligible to begin treatment on that day. 
2. Baseline visit can be rescheduled at the nurse’s discretion within 2-4 weeks. 
3. If the skin score of 0 is not achieved within 4 weeks from the original baseline visit, the 
participant will not be eligible for treatment. 
4. Nurse will notify PI and Site staff will complete appropriate eCRFs. 
 
If Skin Score is 0: 
1. Nurse will have participant complete Baseline N-QOL & PROMIS Sleep Disturbance 
assessment. 
2. Nurse will confirm treatment assignment. 
3. Nurse will provide device and procedure training via standardized product training 
video.  
4. Once training is completed, nurse will ensure the participant have all the supplies 
prepped for the first night of device wear. 
5. Nurse will pre-weigh and document weight of sealed bed pad in bag  
6. If assigned to PureWick™ treatment phase, nurse will pre-weigh and document weight 
of canister before use. 
7. If assigned to Hollister FUP treatment phase, nurse will pre-weigh and document 
weight of the graduated cylinder. 
8. If applicable, nurse will pre-weigh and document weight of mesh underwear in bag.  

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9. Nurse will confirm next day visit with participant. 
 
7.2.7 Days 2-7 
 
1. Prior to nurse visit, participants are expected to have placed the used night pads and 
mesh underwear (if applicable) in their respective labeled, pre-weighed sealed bag upon 
completion of sleep.  
2. Nurse will weigh and document weight of night pads and mesh underwear (if 
applicable). 
3. The nurse will weigh and document the captured urine. 
• For PureWick™ Treatment Phase the captured urine volume in the PW urine 
collection canister will be weighed and documented. 
• For Hollister® FUP Treatment Phase the captured urine volume in the bedside urine 
bag will be emptied into a graduated cylinder, then weighed and documented. 
4. The nurse will note any signs of skin irritation or injury and document the Draize Scale 
score* 
5. If during the skin assessment a Draize score of 4 is documented on the skin irritation 
scale in any category, this must be recorded as an AE and will require participants to 
discontinue from the treatment phase; participant will immediately begin wash out 
period and complete N-QoL. 
6. Nurse will pre-weigh and document weight of study supplies for next night use. 
7. The nurse will confirm the next day visit. 
 
* For safety assessment, see section 7.3 
 
7.2.8 Day 8 
1. Same procedures as days 2-7. 
2. Participant to complete Day 8 PROMIS Sleep Disturbance assessment. 
7.2.9 Days 9-14 
1. Same procedures as days 2-7. 
7.2.10 Day 15 
1. Same procedures as days 2-7. 
2. Participant to complete 2-week N-QOL assessment. 
3. Participant to complete Day 15 PROMIS Sleep Disturbance assessment. 
7.2.11 Days 16-21 
1. Same procedures as days 2-7. 
7.2.12 Day 22 
1. Same procedures as days 2-7. 
2. Participant to complete Day 22 PROMIS Sleep Disturbance assessment. 

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7.2.13 Days 23-28 
1. Same procedures as days 2-7. 
7.2.14 Day 29 
1. Same procedures as days 2-7 with the exception of steps 6 and 7. 
2. Participant to complete 4-week N-QOL assessment. 
3. Participant to complete Day 29 PROMIS Sleep Disturbance assessment. 
4. Participant to complete comfort and ease of use questionnaires. 
5. If this day is the last day of phase 1 treatment for the participant, they will begin 
washout and prepare for phase 2 treatment. 
6. If this day is the last day of phase 2 treatment for the participant, they will complete the 
study.  Participant is to complete the End of Study Preference Survey. 
7.2.15 Day 30 
The participant will be asked to report any discomfort or voiding issues occurring within 
the first 24 hours after treatment phase completion or discharge from the study to the PI or 
sponsor. Skin assessments will also be conducted 24 hours after the participant completes 
the treatment phase and/or the study. 
 
7.2.16 Days 29-42 (+14) Wash Out Period 
Participant begins washout period of 2 weeks (not to exceed 4 weeks) between treatment 
phase 1 and treatment phase 2. At the completion of washout, the nurse will perform a re-
screening of eligibility criteria before phase 2 treatment begins. 
 
7.2.17 Treatment Phase 2 
Same procedures as outline in sections 7.2 – 7.11. 
 
7.3 Safety Assessments 
 
7.3.1 Draize Scale 
 
For each daily visit (described in 7.2-7.7), skin condition will be evaluated by nurses 
using the Draize scale (Table 1). Skin assessments will also be conducted 24 hours after 
the participant completes the study, either in person or virtually. 
   
If during the skin assessment a Draize score of 4 is documented on the skin irritation 
scale in any category, it must be recorded as an AE and will require participants to 
discontinue from the treatment phase. Any other score on the skin irritation scale in any 
category may be recorded as an AE based on PI discretion. 
 

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To assess a potential AE identified during the home visit, the nurse will contact the PI or 
designee. The site will document the AE assessment on the appropriate CRF from and 
follow the AE until resolution. If the PI requests a follow up visit with the participant, 
this can be conducted on site or virtually per investigational site policy. 
 
However, if the AE is not resolved during the treatment phase(s) within 4 weeks from the 
AE start date, the participant will be discontinued from the study. 
Also, if during the skin assessment a Draize score of 2 or greater is documented for the 
device placement site, a photograph may need to be taken of the skin in the anatomical 
area of device application. The photo will be sent in a pseudonymized matter to the site, 
only the subject ID and the date when the picture was taken will be collected. These 
photographs will be shared with the Principal Investigator / Sub-Investigator, the 
Sponsor, and the study staff only and will be used for the Principal Investigator / Sub-
Investigator’s review and assessment of the skin reactions. 
 
Table 1:  Draize Scale for Skin Irritation 
Score 
Erythema (redness) 
Edema (swelling) 
Bleeding 
0 
None 
None 
None 
1a 
Very slight (barely 
perceptible) erythema 
Very slight (barely 
perceptible) skin surface rise 
Just a visible spot of red 
2a 
Well-defined erythema 
Well-defined skin surface rise 
(edges of area well-defined by 
definite raising) 
A drop of red blood 
3a 
Moderate erythema 
Moderate skin surface rise 
A continuing ooze of red 
blood 
4b 
Severe (beet red) or 
damage to skin (eschar 
formation) 
Severe skin surface rise 
Significant bleeding from 
the sight 
a = Represents irritation in any category and may require participant’s removal from the study based on PI 
decision. 
Note: a rating of 1-3 on the skin irritation scale in any category may be recorded as an AE based on PI 
discretion. 
 
b = A rating of 4 on the skin irritation scale in any category must be recorded as AE and will require 
participant’s removal from the treatment phase and/or study. 
 
7.4 User Preference Questionnaire 
Prior to each treatment phase completion, the participant will be asked to complete a short 
questionnaire on their experience with the PureWick™ System or the Hollister® FUP. The 
questionnaire is designed to assess the following: 

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• Comfort with PureWick™ FEC/PureWick™ Urine Collection System or the 
Hollister® Female Urinary Pouch External Collection Device 
• Ease of use in placing and removing the PureWick™ FEC and the Hollister® 
Female Urinary Pouch External Collection Device 
After completing both treatment phases for the study, the participant will complete the 
preference questions on their experience with the PureWick™ System and the Hollister® FUP. 
The survey is designed to assess the following: 
• The participants preferred device after using both the PureWick™ 
FEC/PureWick™ Urine Collection System and the Hollister® Female Urinary 
Pouch External Collection Device.  
 
 7.5 Participant Follow-Up 
 
After all procedures are complete in both treatment phases, the participant will be discharged 
from the study.  The participant will be asked to report any discomfort or voiding issues 
occurring within the first 24 hours after discharge from the study to the PI or sponsor. 
 
7.6 Replacement of Participants 
A participant that discontinues from the study will be replaced when feasible.  
 
 
8.0 PARTICIPANT DISCONTINUATION/WITHDRAWAL  
   
8.1 Discontinuation/Withdrawal 
 
• A participant may withdraw from the study at any time at his/her own request or may 
be withdrawn at any time at the discretion of the investigator or sponsor for safety, 
behavioral, compliance, or administrative reasons. This is expected to be uncommon. 
• At the time of discontinuing from the study, no further assessments will be performed. 
• If the participant withdraws consent for disclosure of future information, the sponsor 
may retain and continue to use any data collected before such a withdrawal of consent. 
• Participants who withdraw or discontinue the study early may be replaced. 
 
8.2 Lost to Follow-Up 
 
A participant will be considered lost to follow-up if she repeatedly fails to keep the visit 
schedule or is unable to be contacted by the study site or nurses. 
 
The following actions must be taken if a participant fails to keep the visit schedule or is 
unable to be contacted: 
 

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• The site and nurse must attempt to contact the participant and reschedule the 
missed visit as soon as possible and counsel the participant on the importance of 
maintaining the assigned visit schedule and ascertain whether or not the participant 
wishes to and/or should continue in the study. 
• Before a participant is deemed lost to follow up, the investigator or designee must 
make every effort to regain contact with the participant.  Where possible, 3 
telephone calls and, if necessary, a certified letter to the participant’s last known 
mailing address or local equivalent methods. These contact attempts should be 
documented in the participant’s study record. 
• Should the participant continue to be unreachable, she will be considered to have 
withdrawn from the study. 
 
9.0 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
 
9.1 Definitions of Events 
 
9.1.1 Adverse Events (AEs) 
 
An AE is defined as any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in 
participants, users or other persons, whether or not related to the investigational device 
and whether anticipated or unanticipated (ISO14155:2020).  This definition includes 
events related to the investigational device, the comparator or the procedures involved. 
 
Pre-existing conditions should be considered as part of the participant’s medical history 
and should not be reported as an AE unless there is a substantial increase in severity or 
frequency of the condition, which has not been attributed to natural history. Likewise, 
planned hospital visits and/or hospital stays should not be considered as adverse events.  
Exacerbation of an existing condition should be reported as an AE if the event meets the 
protocol definition of an AE. 
 
The clinical course of the event will be followed according to accepted standards of 
medical practice until the event resolves, stabilizes, or in the opinion of the Investigator, 
is no longer considered clinically significant.  The Investigator must supply the Sponsor 
with information concerning the follow up and/or resolution of the AE. 
 
9.1.2 Serious Adverse Events (SAEs) 
 
A serious adverse event is defined by ISO 14155 and/or 21 CFR 803.3 as an adverse 
event that led to:  
a. Death, 
b. Serious deterioration in the health of the participant, 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. Fetal distress, fetal death, a congenital abnormality, or birth defect including 
physical or mental impairment. 
 
NOTE: Planned hospitalizations for a preexisting condition, or a procedure required by this 
trial without serious deterioration in health, is not considered an SAE. 
 
9.1.3 Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) 
 
An adverse device effect is defined as any adverse event that is considered to be related 
to the use of an investigational medical device. This definition includes any event 
resulting from insufficiencies or inadequacies in the instructions for use, deployment, 
implantation, or operation or any malfunction of the investigational device and includes 
any event that is a result of a user error, intentional misuse of the investigational medical 
device and/or comparator if the comparator is a medical device. 
 
A serious adverse device effect (SADE) is defined as an ADE that has resulted in any of 
the consequences characteristic of an SAE. An anticipated serious adverse device effect 
(ASADE) is an effect which by its nature, incidence, severity or outcome has been 
identified in the risk assessment. 
 
9.1.4 Unanticipated (Serious) Adverse Device Effect (UADE/USADE) 
 
An unanticipated (serious) adverse device effect (UADE/USADE) is any (serious) 
adverse device effect on health or safety or any life-threatening problem or death 
caused by, or associated with, an investigational device, which by its nature, incidence, 
severity, or outcome has not been identified in the current instructions for use and/or 
current version of the risk analysis report, or any other unanticipated serious problem 
associated with a device that relates to the rights, safety or welfare of participants. 
 
Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk assessment. 
 
A sponsor shall immediately conduct an evaluation of any unanticipated adverse device 
effect. 
 
UADEs/USADEs will be reported to FDA as required by 21 CFR Part 812 and ISO 
14155:2020 and will be reported to the appropriate governing body per ISO 14155:2020. 

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9.2 Severity of Adverse Events 
 
Each AE shall be assessed for its severity, or the intensity of an event, experienced by the 
participant according to the criteria below. 
 
Severity Rating 
Description 
Mild 
Event, signs, or symptoms that do not interfere with the participant’s 
daily activity, are usually considered self-limiting, can be treated 
with non-prescription type medications, and do not require medical 
intervention 
Moderate 
Event may interfere or cause low level inconvenience with the 
participant’s daily activity. Requires medical intervention and/or 
treatment; however, unlikely to require hospitalization or be 
considered potentially life-threatening in nature 
Severe 
Event may cause significant discomfort to the participant and/or 
interferes with the participant’s daily activity. Requires medical 
intervention and/or treatment to preclude a permanent impairment; 
may be life threatening and/or require hospitalization 
 
 
9.3 Relationship of Adverse Event to Device(s)/Procedure 
 
Each AE will be assessed for its relationship to the investigational device or procedure according 
to the following guidelines. 
 
A.  Assess each AE for its relationship to the device or procedure. 
 
• Device Related: This category should be restricted to AEs directly attributable to 
the PureWick™ System and Hollister® Female Urinary Pouch External 
Collection Device during the urine capture assessments. 
 
• Procedure:  A procedure includes any study-related activity performed during the 
set-up or application of the PureWick™ System and Hollister® Female Urinary 
Pouch External Collection Device and/or urine capture assessment procedure.  
 
B.  To assess the causality, clinical judgement should be used and the relevant study 
documentation, such as the study protocol should be consulted. The presence of 
confounding factors, such as concomitant medication/treatment, underlying diseases, 
other concurrent illness or risk factors should also be considered. The above 
considerations apply also to the serious adverse events occurring in the comparison 
group.  
Each SAE will be classified according to four different levels of causality:  

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1. 
Not Related  
2. 
Possible  
3. 
Probable 
4. 
Causal Relationship 
 
Relatedness 
Description 
Not Related 
Relationship to the device, comparator or procedures can be 
excluded when:  
• the event has no temporal relationship with the use of the 
investigational device, or the procedures related to 
application of the investigational device;  
• the serious adverse 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 level 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 adverse event;  
• the event involves a body-site or an organ that cannot be 
affected by the device or procedure;  
• the serious adverse 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;  
 
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 adverse event. 
 
Possible 
The relationship with the use of the investigational device or 
comparator, or the relationship with procedures, 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 where relatedness cannot be assessed, or no 
information has been obtained should also be classified as 
possible.  
Probable 
The relationship with the use of the investigational device or 
comparator, or the relationship with procedures, seems 

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relevant and/or the event cannot be reasonably explained by 
another cause. 
 
Causal 
Relationship 
the serious adverse event is associated with the investigational 
device, comparator or with procedures beyond reasonable 
doubt when: 
• the event is a 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 involves a body-site or organ that  
o the investigational device or procedures are applied 
to;  
o the investigational device or procedures have an 
effect on;  
• the serious adverse 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 the level of 
activation/exposure), impact on the serious adverse event 
(when 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 adverse event. 
 
 
9.4 Reporting of Events 
 
For all adverse events, all sections of the appropriate electronic Case Report Form (eCRF) must 
be completed including AE start and end date, outcome of AE, severity, seriousness, relationship 
to device and relationship to the procedure. All AEs shall be promptly reported to the Sponsor. 
 
For European site(s): 
 
• All SAEs, SADEs, UADEs/USADEs, and Serious Health Threats must be 
reported to the Sponsor via completion of the appropriate eCRF no later than 3 

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calendar days of the site/investigator becoming aware of the event. If the study 
team is unable to access the electronic data capture system, the event may be 
reported to the Sponsor by emailing UCC.ClinicalSafety@bd.com. 
 
• De-identified copies of all requested relevant documentation should be submitted 
to the Sponsor within 72 hours of knowledge, as appropriate. 
 
For U.S. site(s): 
• All SAEs, SADEs, UADEs/USADEs, and Serious Health Threats must be 
reported to the Sponsor via completion of the appropriate eCRF within 1 working 
day of the site/investigator becoming aware of the event. If the study team is 
unable to access the electronic data capture system, the event may be reported to 
the Sponsor by emailing UCC.ClinicalSafety@bd.com.   
 
• De-identified copies of all requested relevant documentation should be submitted 
to the Sponsor within 72 hours of knowledge, as appropriate. 
 
In the US, it is the responsibility of the Investigator to report adverse events to individual 
Institutional Review Boards (IRBs) and/or regulatory authorities according to the local 
regulations. 
 
In Europe, it is the responsibility of the Sponsor to report adverse events to individual 
Ethics Committees (ECs) and/or regulatory authorities according to the local regulations 
in each participating country. 
• 
For the purpose of this guidance and based on the definitions above, the following 
events are considered sponsor reportable events in accordance with MDR Art. 
80(2):  
a) any serious adverse event that has a causal relationship with the 
investigational device, the comparator or the investigation procedure or 
where such causal relationship is reasonably possible; 
b) any device deficiency that might have led to a serious adverse event if 
appropriate action had not been taken, intervention had not occurred, or 
circumstances had been less fortunate;  
c) any new findings in relation to any event referred to in points a) and b). 
 
9.5 Serious Health Threats 
Serious Health Threats are a 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.  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 
(ISO14155:2020) 
 

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9.6 Safety Committees 
Not applicable.  
 
9.7 Device Deficiencies 
The Investigator will record a device deficiency if a device used in the study procedure failed to 
meet its performance specifications in the identify, quality, durability, reliability, usability, safety 
or performance, including malfunction, use errors or in adequacy in information supplied by the 
manufacturer, mechanical failure, malfunction, or defect.  Device deficiencies also include use 
errors and inadequate labeling.  This applies to: devices used to treat the participant, or devices in 
which the package was opened, but the device was not used for treatment, or devices with which 
treatment was attempted, but the device did not remain through the entire study 
procedure/period. 
 
All device deficiencies will be recorded on the appropriate Case Report Form and will be 
promptly reported to the Sponsor. All sections of the appropriate eCRF must be completed 
including date of deficiency, time of deficiency, device identifiers (i.e. lot number, serial 
number). The device(s) should be returned to the Sponsor as outlined in the site’s regulatory 
binder. 
 
If the device deficiency was associated with an AE, the reporting provisions for AEs, 
ADEs, SAEs, SADEs and UADEs/USADEs apply. If the device deficiency was not associated 
with an AE, an assessment of whether the device deficiency could have led to a SADE if suitable 
action had not been taken, if intervention had not been made or if circumstances had been less 
fortunate should be reported.  
 
Reported deficiencies will be investigated and reported under 21 CFR part 803 Medical Device 
Reporting and ISO 14155:2020 by the Sponsor if necessary.  The site may be contacted to 
provide additional information to allow the Sponsor to conduct a thorough investigation. 
 
It is the responsibility of the Investigator for the U.S. and Sponsor for France to notify the 
IRB/EC of such device deficiencies in accordance with the IRB/EC and/or the Competent 
Authority’s local regulations. 
 
 
10.0 STATISTICAL METHODS 
 
The statistical analysis plan will be finalized prior to database lock and will include a more 
technical and detailed description of the statistical analyses described in the following sections. 
Analyses will be performed per protocol and statistical analysis plan. Any deviation from 
planned analyses will be described in the clinical study report along with justification of change. 
This section includes a summary of the planned statistical analyses of the most important 
endpoints including primary and key secondary endpoints. 
 

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10.1 Overview of Study Design 
 
This is a prospective, open-label, 2 by 2, crossover trial to evaluate the safety, efficacy, 
and patient quality of life of PureWick™ System in comparison with Hollister® Female 
Urinary Pouch. Participants are randomized 1:1 to use PureWick™ System in phase 1 
and Hollister® Female External Pouch in phase 2, or to use Hollister® Female Urinary 
Pouch in phase 1 and PureWick™ System in phase 2. Each phase lasts 4 weeks, with a 2-
4 week washout period between phase 1 and phase 2. Capture rates and Draize Scale are 
assessed daily during both phases. Quality of life is assessed at baseline and every 14 
days during phases 1 and 2. User preference questionnaires are completed at the 
completion of each treatment phase. The primary efficacy endpoint is the mean of daily 
capture rate. The primary safety endpoint is the mean of daily assessments of Draize 
Scale. 
 
10.2 Sample Size Considerations 
 
Approximately 30 participants will be enrolled. The sample size is planned based on 
operational and practical considerations and is adequate for the purpose of this pilot 
study. 
 
10.3 Analysis Population 
 
The following populations are defined: 
 
Population 
Description 
Enrolled  
Subjects who signed ICF. 
Intent-to-Treat (ITT) 
Subjects who signed ICF and randomized to a treatment 
sequence. 
As-Treated (AT) 
ITT subjects, grouped by actual treatment sequence, if different 
from planned treatment sequence. 
Per-Protocol (PP) 
ITT subjects without major protocol deviation. 
 
ITT population will be used for the analyses of endpoints. Sensitivity analyses may be 
carried out using AT or PP population. 
 
10.4 General Considerations 
 
10.4.1 Handling of Missing Data 
 
Endpoint data may be missing due to reasons including lost to follow-up or 
withdrawal of consent. Reason for missing endpoints will be reported. For the 
primary efficacy endpoint, if capture rate assessments are missing for part of a 
treatment phase, derivation of the primary efficacy endpoint will be based on 

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available data. For the primary safety endpoint, the main analysis will be based on 
evaluable data. Sensitivity analyses may be performed for the primary safety endpoint 
where missing data is imputed using methods including linear interpolation or last-
observation-carry-forward. 
 
10.4.2 Poolability of Data 
 
The effect of investigational site will be evaluated using regression models, with 
primary endpoint as the dependent variable, and treatment, investigational site, and 
the interaction term between treatment and investigational site as fixed effects.  
 
10.4.3 Multiplicity Control 
 
No formal hypothesis test is planned for this pilot study. P values and confidence 
intervals may be provided for exploratory purposes and are unadjusted for 
multiplicity. 
 
10.5 Primary Endpoint(s) 
 
10.5.1 Primary Efficacy Endpoint 
 
Capture rates is evaluated daily during participant phase 1 and phase 2. Daily capture rate is 
defined as:  
 
captured urine weight / (captured urine weight + leaked urine weight) 
 
The primary efficacy endpoint is derived by computing the mean of daily capture rate during 
each phase. Descriptive statistics of the primary efficacy endpoint, including mean, standard 
deviation, median, and range will be provided by treatment. The paired difference in mean 
daily capture rate between treatments will be provided.  
 
10.5.2 Primary Safety Endpoint 
 
The primary safety endpoint is derived by computing the mean of Draize Scale assessed 
daily during each phase. Descriptive statistics of the primary safety endpoint, including 
mean, standard deviation, median, and range will be provided by treatment. Paired 
difference in mean daily Draize Scale between treatment will be provided.  
 
10.6 Secondary Endpoint(s) 
10.6.1 Questionnaire Nocturia Quality of Life (N-QoL) 
 
The questionnaire consists of 13 items with a total score ranging from 0 to 52 higher score 
indicating greater impact of nocturia on quality of life). Descriptive statistics will be 
provided by treatment and by visit. Mixed effect linear regression model may be used, with 
treatment and sequence as the fixed effect, and participant as the random effect. 

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10.6.2 Questionnaire PROMIS Sleep Disturbance 
 
Items in the questionnaire will be summarized both as categorical variable (using 
frequency count and percentage) and as continuous variables (using mean, standard 
deviation, median, and range) by treatment. 
 
10.6.3 Tolerability - Number of days of actual use 
 
Number of days of actual use will be summarized using descriptive statistics by 
treatment. Paired difference between treatment will be provided. 
 
10.6.4 Tolerability - Discontinuation rate due to device discomfort or inconvenience 
 
Rate of not completing a treatment phase due to device discomfort or inconvenience will 
be summarized using descriptive statistics. 
  
10.6.5 Comfort, Ease of Use and Confidence 
 
Items in the questionnaire will be summarized both as categorical variable (using 
frequency count and percentage) and as continuous variables (using mean, standard 
deviation, median, and range) by treatment. 
 
10.7 Tertiary/Exploratory Endpoint(s) 
Not applicable. 
 
10.8 Other Analyses 
Not applicable. 
 
10.9 Interim Analyses 
Not applicable. 
 
 
11.0 DATA COLLECTION AND RECORD MAINTENANCE 
 
11.1 Case Report Forms 
The Investigator is responsible for ensuring the completeness and accuracy of all study 
documentation. 
 
All required clinical data will be collected/documented in sponsor-provided web-based 
electronic Case Report Forms (eCRFs). The eCRFs are designed to accommodate the 
specific elements of this clinical investigation and it is the responsibility of the Investigator 
to confirm that the data is completely and accurately entered in the appropriate sections of 

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the eCRF. Data reported on the eCRFs shall be derived from, and be consistent with, source 
documents and will be approved by the Investigator. An audit trail of changes or corrections 
to eCRFs will be maintained. Discrepancies between the source documents and the eCRFs 
shall be explained in writing. FDA 21 CFR 11 and ISO 14155:2020, 7.8.3 are followed as 
well as other applicable legislation on the handling of electronic data. Modification of the 
CRFs will only be made if deemed necessary by the Sponsor and/or the appropriate 
regulatory body. 
 
Site numbers and Participant numbers will be used to track participant information 
throughout the study.  Participant personal information will be de-identified. 
 
11.2 Source Documentation 
Original or certified copies of all relevant clinical findings, observations, and other activities 
throughout the clinical investigation must be recorded and maintained in the study file of 
each enrolled participant.  
 
11.3 Data Management 
Data management is the responsibility of the Sponsor.  Data from completed CRFs will be 
managed in a secured, controlled database. A Data Management Plan (DMP) will be 
developed that outlines the procedures used for database design and testing, database 
security, data review, database cleaning and issuing/resolving data queries. Procedures for 
validations, database finalization and data storage will also be contained within the DMP. 
Observation data will be collected prospectively at the time of each urine output monitoring 
event.  As such, any missing data or inconsistent data cannot be retrieved from an alternate 
source. Particular care must be taken to ensure that all data are recorded in a clear and 
complete manner.   
 
11.4 Record Retention 
       For United States: The Investigator shall retain all study records for a minimum of two (2)  
years after the later of the following two dates: the date on which the study is 
terminated/completed or the date that the records are no longer required for purposes of 
supporting a pre-market approval application or a notice of completion of a product 
development protocol (21 CFR Part 812.140). The data for some of these records may be 
available in computerized form but the final responsibility for maintaining study records 
remains with the Investigator. 
 
For European sites: Documentation shall be kept for a period of at least 10 years after the 
clinical investigation with the device in question has ended, or, in the event that the device is 
subsequently placed on the market, at least 10 years after the last device has been placed on 
the market. 
 
The Investigator may withdraw from the responsibility to maintain records for the period 
required by transferring custody of the records to any other person who will accept 
responsibility for retaining them. Notice of a transfer shall be given to the Sponsor and 

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FDA, if applicable, not later than ten (10) working days after the transfer occurs. 
 
 
12.0 QUALITY CONTROL AND ASSURANCE 
 
12.1 Control of Study Products 
Investigational study products will be released only for use by Investigators who have 
obtained written IRB/EC approval (as required) for participation in this study, who have 
completed all required study documentation, and who have been qualified by the Sponsor.  
Investigators must maintain control over all study products, and ensure they are used in 
accordance with this protocol.  Failure to do so may result in the Sponsor suspending or 
terminating the study at the Investigator’s site.  
  
The Investigator will ensure that study products are only dispensed to participants (or used 
for specimens) properly enrolled in the study. The Investigator must maintain records of 
receipt, disposition, return and/or destruction of all study products. All investigational study 
products released to the site must be accounted for at the unit level prior to study close out, 
regardless of disposition.  The Sponsor-Monitor will regularly review all records regarding 
study product accountability.  
 
The Sponsor will maintain records that document the shipment, receipt, disposition, return 
and/or destruction of study products. A Study Supply Plan will be developed that contains 
study material traceability information and labeling requirements. Study product handling 
and accountability procedures will be outlined in the Clinical Monitoring Plan (CMP). 
 
12.2 Monitoring 
       The Sponsor will designate trained and qualified personnel to monitor the progress of this  
       clinical study in accordance with established standard operating procedures and the study- 
       specific Monitoring Plan.   
 
      Prior to study start, a site initiation visit (SIV) will be conducted to review with the  
      Investigator(s) and staff the provisions and proper conduct of this study. This visit will  
      include a detailed review of this protocol, verification that all necessary documents are on    
      file at the investigational site and confirmation of IRB/EC approvals.   
 
      During the study, routine monitoring visits (RMVs) will be conducted to assure the site  
      continues to adhere to the protocol, the investigator agreement, and regulations regarding  
      conduct of clinical studies.  The Sponsor-Monitor will confirm that the ICF to be used is the  
      version approved by the IRB/EC, confirm the applicable national privacy laws have been 
      followed, verify that all necessary documents are on file at the investigational site and  
      confirm that there are provisions to continue and maintain all documents and records  
      throughout the study as required by applicable regulations. These monitoring visits will      
      assess continued protocol compliance, adequate participant enrollment, accurate data       
      reporting, monitoring of participant safety through identification and/or review of any    
      device-related AEs, UADEs, or SAEs, device accountability, continued maintenance and  

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     calibration of study-specific equipment (if applicable), and continued IRB/EC acceptance of 
     the study. 
 
    At the completion of the study, the Sponsor-Monitor will conduct a final close-out visit or  
    COV. The purpose of this visit may include but is not limited to collecting all outstanding  
    study data documents, confirming that the Investigator’s files are accurate and complete,  
    reviewing the record retention requirements with the Investigator, providing for the return of  
    unused devices to the Sponsor, reviewing records which account for device shipments and  
    ensuring that all applicable requirements for closure of the study are met.  
 
12.3 Audits and Inspections 
    If the study is selected for audit by the Sponsor or if there is an inspection by the appropriate  
    Health Authorities, the Investigator and his team will make themselves available during the  
    visit.  The Investigator must agree to the inspection of all study related records and give the  
    auditor/inspector direct access to source documents for verification of data on CRFs.  The  
    participant’s anonymity must be ensured, and data checked during the audit must remain 
    confidential. 
 
    As soon as the Investigator is aware of an upcoming inspection/audit by the Health  
    Authorities, he/she will promptly inform the Sponsor.  As agreed with the Investigator,  
    Sponsor personnel may be present at the site during the inspection. 
 
12.4 Protocol Deviations 
     A protocol deviation is defined as an event where the Investigator or site personnel did 
     not conduct the study according to the protocol. 
 
     Except when necessary to protect the life or physical well-being of a participant, protocol    
     deviations are not permitted.  The Sponsor and the investigational site’s IRB/EC must be  
     notified immediately if an emergency situation arises in which the safety of a participant may  
     require immediate intervention different than that defined in the protocol.  This must be  
     followed by written confirmation that describes the emergency action and outcomes, within  
     five (5) working days from the date of the emergency action in accordance with the governing  
     IRB/EC’s requirement.   
 
     It is the Investigator’s responsibility to ensure that there are no deviations from the Protocol.   
     Except in an emergency, when a protocol deviation is planned or anticipated, the Sponsor  
     should be contacted for approval.  Any and all deviations must be recorded on the appropriate  
     CRF regardless of whether medically justifiable or sponsor approved.  Upon evaluation by the  
     Sponsor, actions may be required to prevent additional deviations, such as retraining of the  
     site, implementation of additional site procedures, and more frequent monitoring.  If these  
     steps fail, more serious measures, up to and including termination of enrollment at the site. 
 
 
 

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13.0 ADMINISTRATIVE REQUIREMENTS 
 
13.1 Investigator and Site Selection 
The Investigator must be of good standing as an Investigator and knowledgeable in relevant 
areas of clinical research to ensure adherence to the requirements of this 
protocol, including the protection of human participants.  Other site personnel must have 
appropriate research experience and infrastructure to ensure adherence to this protocol 
and enrollment of sufficient numbers of evaluable participants. The curriculum vitae (CV) of 
the Investigator(s), Sub-Investigator(s) and Study Coordinator(s) will be maintained in the 
Sponsor’s files as documentation of qualification by training and experience. 
 
The Principal Investigator will sign the Investigator Agreement pages of this protocol, 
agreeing to comply with all applicable regulations and the requirements of this study as 
per the clinical study agreement.  Federal databases will be searched to ensure that the 
Investigator(s) and/or the site are not prohibited from engaging in federally sponsored 
clinical research.  
 
Any site that is deactivated prior to initial enrollment, either by the Sponsor or by the 
individual site itself, may be replaced. 
 
13.2 Training 
       In addition to each Investigator and appropriate site personnel being trained on this 
       protocol and study procedures during the Site Initiation Visit, product training will be 
       provided by the Sponsor or designee and is required for each Investigator. Additional study 
       staff (e.g., Sub-Investigator(s)) will also require device training provided from the Sponsor  
       or proctoring by the PI. All training will be documented and filed at the investigational site 
      and with the Sponsor. 
 
13.3 Required Documents 
      An Investigator may not screen or enroll participants until authorized to do so by the 
      Sponsor. At a minimum, the following documentation should be received by the Sponsor 
      prior to the commencement of study activities: 
• Fully executed Non-disclosure Agreement (NDA) between PI/site and Sponsor; 
• CVs, signed and dated within 2 years of study start for the PI and Sub-
Investigator(s); 
• CVs for Study Coordinator(s); 
• Signed CSA by PI/site (or designee); 
• Signed Investigator Agreement Page by PI and Sub-Investigator(s); 
• Signed Financial Disclosure Statement by PI and Sub-Investigator(s); 
• Completed and Signed Training Log by PI and Sub-Investigator(s); 
• Study Personnel Identification list; 
• Written approval from the IRB/EC of both the protocol and ICF, and any other  
applicable protocol specific material; and 

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• IRB/EC Membership List, Assurance of Compliance Form (for US only), or 
equivalent. 
 
13.4 Publication Policy 
The sponsor believes that results of applicable clinical studies should be published in peer-
reviewed literature in a timely, accurate, complete and balanced manner, regardless of study 
outcomes, whenever possible.  As such, at the conclusion of this study, an article may be 
prepared for publication in a reputable scientific journal.  Formal presentation(s) or 
publication(s) of data collected from this study will be considered as a joint publication by 
the investigator(s) and the appropriate personnel of the Sponsor. Authorship will be based on 
generally accepted criteria of the ICMJE (International Committee of Medical Journal 
Editors) and determined by mutual agreement. 
 
The publication of the principal results from any single-center experience within the study is 
not allowed until the preparation and publication of the multicenter results. Exceptions to 
this rule require the prior approval of the Sponsor. The analysis of other pre-specified and 
non-pre-specified endpoints will be performed by the Sponsor or its designee. Such 
analyses, as well as other proposed investigations or manuscripts will require the approval of 
the Sponsor. 
 
13.5 Study Registration 
In compliance with Title VIII of Public Law 110-85, known as FDA Amendments Act of 
2007 (FDAAA), the Sponsor will register this study studies and disclose study results in a 
publicly accessible database (i.e., ClinicalTrials.gov).  This study will be registered no later 
than 21 days after commencing enrollment.  Study results will be posted to the website 
within 12 months of the last participant visit for collection of primary outcome data.   
 
In accordance with the Declaration of Helsinki, a description of the clinical investigation 
will be registered in a publicly accessible database before the start of recruitment activities 
and the content shall be updated throughout the conduct of the clinical investigation and the 
results entered at completion of the clinical investigation (ISO14155:2020). 
 
13.6 Termination of Study 
The Sponsor reserves the right to suspend enrollment or terminate the study at any time 
for any reason.  The Sponsor may suspend enrollment or terminate the study at a 
specific investigational site for reasons including, but not limited to, inadequate data 
collection, low participant enrollment rate, achievement of the total enrollment, conditions 
imposed by the reviewing IRB/EC and/or non-compliance with this protocol or other clinical 
research requirements. Written notice will be submitted to the Investigator in advance of 
such termination.  
 
In the event of study suspension or termination, the Sponsor will send a report outlining 
the circumstances to the IRB/EC, and all Investigators and Regulatory Authorities as 

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required by regulation. If the study was terminated, resumption would be done according to 
21 CFR Part 812.  
 
14.0 ETHICAL AND REGULATORY CONSIDERATIONS 
 
14.1 IRB/EC Approval 
Investigators or designees must submit the study protocol, Informed Consent Form (if 
applicable), and all other locally required documentation to an appropriate IRB/EC and 
obtain study-specific written approval (favorable opinion) before being allowed to 
participate in the study. Before commencement of the study, the Investigator or designee 
must provide the Sponsor with written documentation of such approval.  If applicable, the 
IRB/EC must give written renewal of the original approval at least annually to continue the 
study. A copy of the written renewal must be provided to the Sponsor. 
 
The IRB/EC will be notified of any amendments to the protocol, as well as possible 
associated information and consent form changes, where applicable, and written approval 
(favorable opinion) will be obtained prior to implementation, as applicable. 
The Investigator or designee is responsible for fulfilling any conditions of approval imposed 
by the IRB/EC, such as regular safety reporting, study timing, etc. The Investigator or 
designee will provide the Sponsor with copies of such reports. 
 
14.2 Informed Consent and Confidentiality 
 
Prior to any study procedure, the Investigator (or designee) must explain to each participant 
in layman’s terms, the nature of the study, its purpose, expected duration, and the risks and 
benefits of study participation. Also, participant will be informed of uses and disclosures of 
their medical information for research purposes, and their rights to access information about 
them. All applicable national privacy laws (e.g., HIPAA requirements in the U.S., General 
Data Protection Regulation [GDPR] requirements in the EU) will be followed in this study. 
The participants must be informed of their right to withdraw from the study at any time and 
for any reason without sanction, penalty, or loss of benefits to which they are otherwise 
entitled, and that withdrawal from the study will not jeopardize their future medical care. 
Participants will be informed of their right to new information and/or findings relating to the 
clinical study, and the process by which this information is made available. After this 
explanation, given sufficient time to decide whether to participate, before any study 
procedure is conducted, and before entering the study, the participant must voluntarily 
provide consent in accordance with 21 CFR Parts 50 and 56 and ISO 14155:2020(E). The 
participant will receive a copy of his/her signed ICF. 
 
 

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14.3 Confidentiality 
 
Participant confidentiality must be strictly held in trust by the Investigator, study staff, and 
the Sponsor.  Participant confidentiality and anonymity will be maintained by removal of 
identifiers from any data, documentation, or clinical samples submitted to the Sponsor. 
 
Any data collected meeting the definition of protected/confidential health information or 
personal identifying information will be collected and maintained using the designated 
authorizations and following privacy procedures as specified in the applicable health 
authority regulations.   
 
The Sponsor-Monitor, authorized representatives of the sponsor, and/or applicable Health 
Authorities may inspect all documents and records required to be maintained by the 
Investigator.  The Investigator/Site will permit access to such records.  
 
14.4 Regulatory Status 
       The PureWick™ System, comprised of the PureWick™ Female External Catheter and the  
        PureWick™ Urine Collection System, is a Class I, 510(k) exempt device currently  
       marketed in the United States and will be evaluated for its approved indication. The  
       investigational device is CE marked and will be studied in a post-market fashion in Europe. 
 
The Sponsor has determined this to be a non-significant risk study. Institutional Review 
Board (IRB) or Ethics Committee (EC) submission of this study plan along with IRB/EC 
study approval or waiver is required. The study will comply with the abbreviated IDE 
requirements under CFR 812.2 (b). 
  
14.5 Statement of Compliance 
       This clinical investigation will be conducted in compliance with the investigator agreement,  
       protocol and following regulatory requirements: 
• 21 CFR 50, 54, 56 and 812; 
• 21 CFR 812 (Good Clinical Practice); 
• ISO14155:2020 (Good Clinical Practice); 
• EU MDR (Council Regulation 2017/745 of 5 April 2017) 
• MDCG guidelines 
• Ethical principles that have their origin in the Declaration of Helsinki; and 
• Applicable sections of the national laws and regulations. 
 
The clinical investigation will not commence at a clinical site until approval (favorable 
opinion) from the respective IRB/EC has been received. All additional requirements 
imposed by the IRB/EC(s) will be followed. Involvement of the national competent 
authorities (e.g. by notification, seeking authorization) will be accomplished as required by 
national laws and regulations. 
 
 

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15.0 REFERENCES 
 
1. Sørbye, L. W., Finne‐Soveri, H., Ljunggren, G., Topinkova, E., Garms‐Homolova, V., 
Jensdóttir, A. B., ... & AdHOC Project Research Group. (2009). Urinary incontinence 
and use of pads–clinical features and need for help in home care at 11 sites in Europe. 
Scandinavian journal of caring sciences, 23(1), 33-44. 
2. Drennan, V. M., Cole, L., & Iliffe, S. (2011). A taboo within a stigma? A qualitative 
study of managing incontinence with people with dementia living at home. BMC 
geriatrics, 11(1), 1-7. 
3. Drennan, V. M., Greenwood, N., Cole, L., Fader, M., Grant, R., Rait, G., & Iliffe, S. 
(2012). Conservative interventions for incontinence in people with dementia or cognitive 
impairment, living at home: a systematic review. Bmc Geriatrics, 12(1), 1-10. 
4. Beer, J. M., McBride, S. E., Mitzner, T. L., & Rogers, W. A. (2014). Understanding 
challenges in the front lines of home health care: a human-systems approach. Applied 
Ergonomics, 45(6), 1687-1699. 
5. Kuil, S. D., Hidad, S., Fischer, J. C., Visser, C. E., van Leth, F., de Jong, M. D., & 
Schneeberger, C. (2021). Diapers as Promising Alternative Collection Method for Urine 
Specimens in Nursing Home Residents: A Noninferiority Study. Journal of the American 
Medical Directors Association, 22(6), 1222-1227. 
6. Hawkins, K., Pernarelli, J., Ozminkowski, R. J., Bai, M., Gaston, S. J., Hommer, C., ... & 
Yeh, C. S. (2011). The prevalence of urinary incontinence and its burden on the quality 
of life among older adults with medicare supplement insurance. Quality of life research, 
20(5), 723-732. 
7. Li, Y., Cai, X., Glance, L. G., & Mukamel, D. B. (2007). Gender differences in 
healthcare-seeking behavior for urinary incontinence and the impact of socioeconomic 
status: a study of the Medicare managed care population. Medical care, 1116-1122. 
8. Mardon, R. E., Halim, S., Pawlson, L. G., & Haffer, S. C. (2006). Management of urinary 
incontinence in Medicare managed care beneficiaries: results from the 2004 Medicare 
Health Outcomes Survey. Archives of internal medicine, 166(10), 1128-1133. 
9. Samuelsson, E., Victor, A., & Tibblin, G. (1997). A population study of urinary 
incontinence and nocturia among women aged 20‐59 years. Acta obstetricia et 
gynecologica Scandinavica, 76(1), 74-80. 
10. Bresee, C., Dubina, E. D., Khan, A. A., Sevilla, C., Grant, D., Eilber, K. S., & Anger, J. 
T. (2014). Prevalence and correlates of urinary incontinence among older, community-
dwelling women. Female pelvic medicine & reconstructive surgery, 20(6), 328. 
11. Goode PS, Burgio KL, Redden DT, et al. Population based study of incidence and 
predictors of urinary incontinence in black and white older adults. J Urol. 
2008;179:1449–1453. discussion 1453–1444. 
12. Beeckman, D. (2017). A decade of research on incontinence-associated dermatitis (IAD): 
evidence, knowledge gaps and next steps. Journal of tissue viability, 26(1), 47-56. 
13. Coyne, K. S., Wein, A., Nicholson, S., Kvasz, M., Chen, C. I., & Milsom, I. (2014). 
Economic burden of urgency urinary incontinence in the United States: a systematic 
review. Journal of Managed Care Pharmacy, 20(2), 130-140. 

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14. Dramé, M., Fierobe, F., Lang, P. O., Jolly, D., Boyer, F., Mahmoudi, R., ... & Novella, J. 
L. (2011). Predictors of institution admission in the year following acute hospitalisation 
of elderly people. The journal of nutrition, health & aging, 15(5), 399-403. 
15. Sura, S., Shiozawa, A., Ng, D., & Aparasu, R. R. (2021). Higher resource utilization and 
costs in long-term nursing home residents with overactive bladder: a retrospective study 
of medicare beneficiaries. Journal of the American Medical Directors Association, 22(6), 
1300-1306. 
16. T.W. Hu, T.H. Wagner, J.D. Bentkover, et al. Costs of urinary incontinence and 
overactive bladder in the United States: A comparative study. Urology, 63 (2004), pp. 
461-465 
17. M.L. Ganz, A.M. Smalarz, T.L. Krupski, et al. Economic costs of overactive bladder in 
the United States. Urology, 75 (2010), pp. 526-532.e1–18 
18. A. Yehoshua, M. Chancellor, S. Vasavada, et al. 
19. Health resource utilization and cost for patients with incontinent overactive bladder 
treated with anticholinergics. J Manag Care Spec Pharm, 22 (2016), pp. 406-413 
20. E.O. Caplan, I.M. Abbass, B.T. Suehs, et al. Impact of coexisting overactive bladder in 
medicare patients with osteoporosis. Arch Gerontol Geriatr, 75 (2018), pp. 44-50 
21. E. Durden, D. Walker, S. Gray, et al. The direct and indirect costs associated with 
overactive bladder within a commercially-insured population in the United States. J 
Occup Environ Med, 60 (2018), pp. 847-852 
22. E. Durden, D. Walker, S. Gray, et al. The economic burden of overactive bladder (OAB) 
and its effects on the costs associated with other chronic, age-related comorbidities in the 
United States. Neurourol Urodyn, 37 (2018), pp. 1641-1649 
23. Welk, B., & Kennelly, M. (2022). The relative importance of different consequences of 
nocturnal enuresis among older women: A conjoint analysis experiment. Neurourology 
and Urodynamics, 41(6), 1451-1457. 
24. Khosla, L., Sani, J. M., & Chughtai, B. (2022). Patient and caretaker satisfaction with the 
PureWick system. The Canadian Journal of Urology, 29(4), 11216-11223. 
25. Abraham, L., Hareendran, A., Mills, I. W., Martin, M. L., Abrams, P., Drake, M. J., ... & 
Noble, J. G. (2004). Development and validation of a quality-of-life measure for men 
with nocturia. Urology, 63(3), 481-486. 
26. Mock, L. L., Parmelee, P. A., Kutner, N., Scott, J., & Johnson II, T. M. (2008). Content 
validation of symptom-specific nocturia quality-of-life instrument developed in men: 
issues expressed by women, as well as men. Urology, 72(4), 736-742. 
27. Takao, T., Tsujimura, A., Kiuchi, H., Takezawa, K., Okuda, H., Yamamoto, K., ... & 
Nonomura, N. (2013). Correlation between overactive bladder symptoms and quality of 
life in Japanese male patients: focus on nocturia. Urology, 82(1), 189-193. 
28. Incontinence urinaire. (n.d.-b). Urofrance. https://www.urofrance.org/patient/pathologies-
urologiques/incontinence-urinaire/ 
29. Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse 
D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, 
Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The 
Patient-Reported Outcomes Measurement Information System (PROMIS) developed and 
tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin 
Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 
Aug 4. PMID: 20685078; PMCID: PMC2965562. 
 

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16.0 APPENDICES 
 
Appendix 1 : Draize Scale for Skin Irritation 
 
Draize Scale for Skin Irritation 
 
 
 
Reference:  Draize J.H., Woodward G., Calvery H.O. Method for the study of irritation and 
toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp 
Ther. 1944; 82: 377-390 
 
Appendix 2: Katz ADL assessment Score 
Appendix 3: PureWick™ Female External Catheter Instructions for Use PWFX30 (US) 
Appendix 4: PureWick™ Female External Catheter Instructions for Use PWFX30E (EU) 
Appendix 5: PureWick™ Urine Collection System Instructions for Use PW100 & PW 200 
(US) 
Appendix 6: PureWick™ Urine Collection System Instructions for Use PW200E (EU) 
Appendix 7: Hollister® Female Urinary Pouch External Collection Device Instructions for 
Use  
 
Score 
Erythema (redness) 
Edema (swelling) 
Bleeding 
0 
None 
None 
None 
1 
Very slight (barely 
perceptible) erythema 
Very slight (barely 
perceptible) skin surface rise 
Just a visible spot of red 
2 
Well-defined erythema 
Well-defined skin surface rise 
(edges of area well-defined by 
definite raising) 
A drop of red blood 
3 
Moderate erythema 
Moderate skin surface rise 
A continuing ooze of red 
blood 
4 
Severe (beet red) or 
damage to skin (eschar 
formation) 
Severe skin surface rise 
Significant bleeding from 
the sight 

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Appendix 8: N-QOL English 
Appendix 9: N-QOL French 
Appendix 10: PROMIS English 
Appendix 11: PROMIS French 
Appendix 12 : Participant Comfort Questionnaire PureWick™ System (Sample) 
 
Participant Number: 
Visit#: 
Now that you have experienced the use of each device as well as voiding with the device in 
place, please answer the following questions. 
1.  On a scale of 1 to 5 where 1 is very uncomfortable and 5 is very comfortable, how 
comfortable was the placement of the PureWick™ Female External Catheter? 
1 
Very 
uncomfortable 
2 
Uncomfortable 
3 
Neither 
comfortable nor 
uncomfortable 
4 
Comfortable 
5 
Very 
Comfortable 
Comments:  
 
2.  On a scale of 1 to 5 where 1 is very uncomfortable and 5 is very comfortable, how 
comfortable was the PureWick™ System during sleep? 
1 
Very 
uncomfortable 
2 
Uncomfortable 
3 
Neither 
comfortable nor 
uncomfortable 
4 
Comfortable 
5 
Very  
Comfortable 
Comments:  
 
3.  On a scale of 1 to 5 where 1 is very uncomfortable and 5 is very comfortable, how 
comfortable was the removal of the PureWick™ Female External Catheter? 
1 
Very 
uncomfortable 
2 
Uncomfortable 
3 
Neither 
comfortable nor 
uncomfortable 
4 
Comfortable 
5 
Very 
Comfortable 
Comments: 
 

Protocol Number: UCC-8007 
 
CONFIDENTIAL 
Version: 5.0 
Date:   16 Apr 2024 
Page 63 of 67 
 
 
4.  On a scale of 1 to 5 where 1 is very unlikely and 5 is very likely, how likely would you be to 
recommend the PureWick™ System to one of your loved ones? 
1 
Very unlikely 
2 
Unlikely 
3 
Neither likely 
nor unlikely 
4 
Likely 
5 
Very Likely 
Comments:  
 
 
 
 
 
Appendix 13 : Participant Comfort Questionnaire Hollister® Female Urinary Pouch 
External Collection Device (Sample) 
 
Participant Number: 
Visit#: 
Now that you have experienced the use of each device as well as voiding with the device in 
place, please answer the following questions. 
1.  On a scale of 1 to 5 where 1 is very uncomfortable and 5 is very comfortable, how 
comfortable was the placement of the Hollister® Female Urinary Pouch External Collection 
Device? 
1 
Very 
uncomfortable 
2 
Uncomfortable 
3 
Neither 
comfortable nor 
uncomfortable 
4 
Comfortable 
5 
Very 
Comfortable 
Comments:  
 
2.  On a scale of 1 to 5 where 1 is very uncomfortable and 5 is very comfortable, how 
comfortable was the Hollister® Female Urinary Pouch External Collection Device during 
sleep? 
1 
Very 
uncomfortable 
2 
Uncomfortable 
3 
Neither 
comfortable nor 
uncomfortable 
4 
Comfortable 
5 
Very  
Comfortable 

Protocol Number: UCC-8007 
 
CONFIDENTIAL 
Version: 5.0 
Date:   16 Apr 2024 
Page 64 of 67 
 
Comments:  
 
3.  On a scale of 1 to 5 where 1 is very uncomfortable and 5 is very comfortable, how 
comfortable was the removal of the Hollister® Female Urinary Pouch External Collection 
Device? 
1 
 
Very 
uncomfortable 
2 
 
Uncomfortable 
3 
 
Neither 
comfortable nor 
uncomfortable 
 
4 
 
Comfortable 
5 
 
Very 
Comfortable 
Comments: 
 
 
4.  On a scale of 1 to 5 where 1 is very unlikely and 5 is very likely, how likely would you be to 
recommend the Hollister® Female Urinary Pouch External Collection Device to one of your 
loved ones? 
1 
Very unlikely 
2 
Unlikely 
3 
Neither likely 
nor unlikely 
4 
Likely 
5 
Very Likely 
Comments:  
 
 
 
 
Appendix 14 : PureWick™ System Participant Ease of Use Questionnaire (Sample) 
 
Participant Number: 
 
Visit #: 
1. On a scale of 1 to 5 where 1 is very difficult and 5 is very easy, how easy was the set up 
and placement of the PureWick™ System? 
1 
Very difficult 
2 
Somewhat 
difficult 
3 
Average 
difficulty 
4 
Somewhat easy 
5 
Very easy 
Comments:  
 
2. On a scale of 1 to 5 where 1 is very difficult and 5 is very easy, how easy was 
the removal of the PureWick™ FEC? 
1 
2 
3 
4 
5 

Protocol Number: UCC-8007 
 
CONFIDENTIAL 
Version: 5.0 
Date:   16 Apr 2024 
Page 65 of 67 
 
Very difficult 
Somewhat 
difficult 
Average 
difficulty 
Somewhat easy 
Very easy 
Comments: 
 
3. How would you describe the dryness experienced with the PureWick™ System during 
sleep? 
1 
Never Dry 
(unacceptable) 
2 
Sometimes Dry 
(unacceptable) 
3- 
Usually Dry 
(acceptable) 
4 
Always Dry to 
mostly always dry 
(acceptable) 
Comments: 
 
 
Appendix 15: Hollister® Female Urinary Pouch External Collection Device Participant 
Ease of use Questionnaire (Sample) 
 
Participant Number: 
 
Visit #: 
1. On a scale of 1 to 5 where 1 is very difficult and 5 is very easy, how easy was 
the placement of the Hollister® Female Urinary Pouch External Collection Device? 
1 
Very difficult 
2 
Somewhat 
difficult 
3 
Average 
difficulty 
4 
Somewhat easy 
5 
Very easy 
Comments:  
 
2. On a scale of 1 to 5 where 1 is very difficult and 5 is very easy, how easy was 
the removal of the Hollister® Female Urinary Pouch External Collection Device? 
1 
Very difficult 
2 
Somewhat 
difficult 
3 
Average 
difficulty 
4 
Somewhat easy 
5 
Very easy 
Comments: 
 

Protocol Number: UCC-8007 
 
CONFIDENTIAL 
Version: 5.0 
Date:   16 Apr 2024 
Page 66 of 67 
 
3. How would you describe the dryness experienced with the Hollister® Female Urinary 
Pouch External Collection Device during sleep? 
1 
Never Dry 
(unacceptable) 
2 
Sometimes Dry 
(unacceptable) 
3 
Usually Dry 
(acceptable) 
4 
Always Dry to 
mostly always dry 
(acceptable) 
Comments: 
 
Appendix 16: End of Study Participant Preference Survey (Sample) 
 
Participant Number:  
 
 
 
Thank you for participating in this study. Now that you have experienced the use of two urine 
collection devices, please answer a few questions about your experiences with the devices. 
 
As a reminder, during the study, you used two devices overnight while sleeping:  
During the first part of the study, you used the PureWick™ Urine Collection System/Hollister 
Female Urinary Pouch External Collection Device. 
 
During the second part of the study, you used the PureWick™ Urine Collection 
System/Hollister Female Urinary Pouch External Collection Device. 
 
 
 
1. Do you remember using each of these devices? 
__________ Yes 
__________ No  
<If No or if there is significant difficulty in differentiating the 2 study phases, discontinue the 
interview.> 
 
 

Protocol Number: UCC-8007 
 
CONFIDENTIAL 
Version: 5.0 
Date:   16 Apr 2024 
Page 67 of 67 
 
 
2. Which device did you prefer?  
__________ PureWick™ Urine Collection System 
__________ Hollister® Female Urinary Pouch External Collection Device 
 
3. What made you choose the <PureWick/Hollister> device? Why did you prefer that 
device? 
________________________________________________________________________ 
 
<Ask follow-up questions, as much as practical, to better understand the participant’s 
preference> 
 
4. Please think about how your skin felt when using each device. Which caused you to feel 
LESS skin irritation, the PureWick™ device or Hollister® device? 
__________ PureWick™ Urine Collection System 
__________ Hollister® Female Urinary Pouch External Collection Device 
__________ No difference 
__________ Do not recall 
 
Why did you choose the PureWick/Hollister? 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________ 
 
 
Thank you for taking the time to answer these questions!