A Prospective, Uncontrolled, Open-label Healthy Volunteer Study to Assess the Performance of the PureWick™ Male and PureWick™ Flex Female External Catheter Devices in Adolescents
Phase: NA
Conditions: Healthy Volunteers, Adolescent
Sponsor: C. R. Bard

 
Document Type: Global Clinical 
Title: Clinical Investigation Plan 
Study ID: UCC-23AC023 
Version No:  
1.0 
Template GFM-10095B 
 
Clinical Investigation Plan 
Study Title 
A prospective, uncontrolled, open-label healthy volunteer study to assess the 
performance of the PureWickTM Male and PureWickTM Flex Female external 
catheter devices in adolescents (PureWick Adolescent Study) 
Study ID 
UCC-23AC023 
CIP Version and Date 
V1.0 / August 9, 2024 
Registration Number(s) 
ClinicalTrials.gov 
Study Device 
PureWick™ Flex Female External Catheter (PWFXH30)  
PureWick™ Male External Catheter (PWMX30)  
PureWick™ Urine Collection System (PW100)  
Sponsor Name 
Becton, Dickinson and Company 
8195 Industrial Blvd. 
Covington, GA 30014 
Sponsor Contact 
Ajesh Raju  
Clinical Project Manager  
Ajesh.Raju@bd.com   
Principal Investigator 
Jesson Yeh, M.D 
Principal Investigator 
TKL Research Inc. 
One Promenade Boulevard  
Suite 1101/1201 
Fair Lawn, NJ 07410 
Participating Clinical Sites 
A list of participating clinical sites, Principal Investigators, and the relevant 
contact information is maintained in the Trial Master File (TMF). 
Funding 
This study is funded by Becton, Dickinson and Company as sponsor of the 
study. A clinical study agreement will be executed between the sponsor and 
participating clinical sites, which details obligations and responsibilities related 
to the study conduct, as well as the financial arrangements to reimburse for the 
efforts at the clinical site. 
Confidentiality Statement: This document contains information that is the confidential and proprietary property of 
Becton, Dickinson and Company (BD) or its affiliates. Neither this document nor the information therein may be 
reproduced, used, or disclosed to or for the benefit of any third party without the prior consent of BD. Investigators are 
cautioned that the information given in this document might be subject to change and revision. 
 
 
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CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
1. I have read the Clinical Investigation Plan including all appendices and agree to conduct this study as 
outlined herein.   
2. I agree to comply with ISO 14155, 21 CFR 812, ethical principles with their origin in the Declaration of 
Helsinki. 
3. I agree to ensure that the confidential information contained in this document will not be used for any 
purpose other than the evaluation conduct of the study without the prior written consent of Becton 
Dickinson (BD).  
4. I attest that I have signed the applicable clinical study agreement as a party or as having ‘read and 
acknowledged’ such agreement, and, by signing below, confirm that I accept the terms of such 
agreement as they relate to my activities and obligations as the study Principal Investigator and that 
such activities and obligations will not conflict with any contractual obligations I may have to my 
employer or others. 
 
Investigator Signature 
 
 
 
Printed Name  
Signature  
Date (DD/MMM/YYY): 
 
Clinical Site Name 
 
 
 
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Table of Contents 
1.0 SYNOPSIS .............................................................................................................................. 1 
2.0 ABBREVIATIONS ................................................................................................................ 2 
3.0 STUDY SCHEDULE ............................................................................................................. 4 
4.0 INTRODUCTION .................................................................................................................. 5 
4.1 
Background ...................................................................................................................... 5 
4.2 
Rationale........................................................................................................................... 6 
5.0 IDENTIFICATION AND DESCRIPTION OF THE STUDY DEVICE ............................... 6 
5.1 
Study Device(s) and Comparator(s) ................................................................................. 6 
5.2 
Equipment to be Used in Study ........................................................................................ 7 
6.0 OBJECTIVES AND HYPOTHESES ..................................................................................... 8 
6.1 
Objectives and Endpoints ................................................................................................. 8 
6.2 
Performance Goal ............................................................................................................. 9 
7.0 DESIGN OF THE STUDY ..................................................................................................... 9 
7.1 
Overall Design.................................................................................................................. 9 
7.2 
Justification for the Study Design .................................................................................... 9 
7.3 
Treatment Allocation and Measures to Minimize Bias .................................................... 9 
7.4 
Potential Influencing or Confounding Factors and Bias ................................................ 10 
7.5 
End of Study Definition ................................................................................................. 10 
7.6 
Clinical Sites .................................................................................................................. 10 
8.0 BENEFITS AND RISKS OF THE STUDY DEVICE, CLINICAL PROCEDURE(S), AND 
THE STUDY ................................................................................................................................ 10 
8.1 
Benefit Assessment ........................................................................................................ 10 
8.2 
Risk Assessment ............................................................................................................. 10 
8.3 
Risk / Benefit Analysis ................................................................................................... 13 
9.0 SUBJECTS ........................................................................................................................... 13 
9.1 
Inclusion Criteria ............................................................................................................ 13 
9.2 
Exclusion Criteria ........................................................................................................... 13 
9.3 
Vulnerable Subjects........................................................................................................ 14 
9.4 
Point of Enrollment ........................................................................................................ 14 
9.5 
Screen Failures and Replacement of Subjects................................................................ 14 
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9.6 
Study / Participation Duration ........................................................................................ 15 
9.7 
Subject Discontinuation / Withdrawal [and Discontinuation of Intervention] .............. 15 
10.0 Procedures ............................................................................................................................. 15 
10.1 
Screening and Enrollment Procedures ........................................................................ 15 
10.2 
Medical History / Baseline Assessments .................................................................... 16 
10.3 
Randomization ............................................................................................................ 16 
10.4 
Evaluation Procedures ................................................................................................ 16 
10.5 
Safety Assessments..................................................................................................... 18 
10.6 
Follow-up Procedures ................................................................................................. 18 
11.0 STATISTICAL METHODS ................................................................................................. 18 
11.1 
Sample Size Considerations ....................................................................................... 19 
11.2 
Analysis Population .................................................................................................... 19 
11.3 
General Considerations ............................................................................................... 19 
11.4 
Final Analysis ............................................................................................................. 19 
11.5 
Interim Analysis ......................................................................................................... 20 
12.0 DATA MANAGEMENT...................................................................................................... 20 
12.1 
Case Report Forms ..................................................................................................... 20 
12.2 
Source Documentation ............................................................................................... 20 
12.3 
Record Retention ........................................................................................................ 20 
13.0 MONITORING PLAN ......................................................................................................... 21 
14.0 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN .................................... 21 
15.0 DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN .................................. 22 
16.0 DEVICE ACCOUNTABILITY............................................................................................ 22 
17.0 STATEMENT OF COMPLIANCE ...................................................................................... 22 
18.0 INFORMED CONSENT PROCESS AND OTHER ETHICAL/REGULATORY 
CONSIDERATIONS .................................................................................................................... 23 
18.1 
Informed Consent ....................................................................................................... 23 
18.2 
IRB/EC Approval ....................................................................................................... 23 
18.3 
Confidentiality ............................................................................................................ 24 
19.0 ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE DEFICIENCIES 24 
19.1 
Definitions of Events .................................................................................................. 24 
19.2 
Relationship of Adverse Event to Device(s)/Procedure ............................................. 26 
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19.3 
Reporting of Events .................................................................................................... 28 
19.4 
Safety Committees ...................................................................................................... 29 
20.0 SUSPENSION OR PREMATURE TERMINATION OF THE STUDY............................. 29 
21.0 PUBLICATION POLICY .................................................................................................... 29 
22.0 STUDY REGISTRATION ................................................................................................... 29 
23.0 ADMINISTRATIVE REQUIREMENTS ............................................................................ 29 
23.1 
Audits and Inspections................................................................................................ 29 
23.2 
Investigator and Clinical Site Selection...................................................................... 30 
23.3 
Training ...................................................................................................................... 30 
23.4 
Required Documents .................................................................................................. 30 
23.5 
Regulatory Status ........................................................................................................ 31 
24.0 REFERENCES ..................................................................................................................... 31 
25.0 VERSION HISTORY ........................................................................................................... 32 
26.0 APPENDICES ...................................................................................................................... 33 
26.1 
Appendix 1 - PureWickTM Male External Catheter .................................................... 33 
26.2 
Appendix 2 - PureWickTM Flex Female External Catheter ........................................ 35 
26.3 
Appendix 3 - PureWickTM Urine Collection System .................................................. 37 
26.4 
Appendix 4 - Participant - Perception of Wetness Questionnaire (Both Male & 
Female) 54 
26.5 
Appendix 5 – Participant – Ease of use Questionnaire (Both Male & Female) ....... 55 
26.6 
Appendix 6 – Participant Ease of Use & Comfort Questionnaire (both Male and 
Female) 57 
26.7 
Appendix 7 – Participant IFU Evaluation Questionnaire (both Male and Female) . 58 
26.8 
Appendix 8 – HCP – Ease of use Questionnaire ........................................................ 59 
 
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SYNOPSIS 
 
Registration 
Clinicaltrials.gov  
Study Device 
PureWick™ Flex Female External Catheter (PWFXH30)  
PureWick™ Male External Catheter (PWMX30)  
PureWickTM Urine Collection System (PW100)  
Stage of Development 
Post-market expanded use  
Background and Rationale 
The purpose of this study is to evaluate the performance and intended use of 
PureWick™ Male External Catheter and PureWick™ Flex Female External Catheter in 
the adolescent patient population.  
Objectives and Endpoints 
Objective(s) 
Endpoint(s) 
Primary 
• 
To assess the performance of the 
PureWick™ Flex FEC and PureWick™ 
MEC in adolescents after HCP placement 
and participant (or guardian/parent) 
placement  
Primary 
• Capture rate following void 
(captured as % of urine captured 
by device and collected in canister 
measured by weight) 
• Perception of wetness following 
each void on a 5-point Likert scale 
(brief questionnaire)  
Secondary 
• 
To assess ease of use by HCP and 
participant 
• 
To assess participant comfort after using 
the PureWick™ Flex FEC and PureWick™ 
MEC  
• 
To evaluate the Instructions for Use in the 
adolescent population for PureWick™ Male 
External Catheter and PureWick™ Flex 
Female External Catheter 
Secondary 
• Ease of use score on a 5-point 
Likert scale (brief questionnaire)  
• Overall comfort score on a 5-point 
Likert scale (brief questionnaire) 
• IFU comprehension score on a 5-
point Likert scale (brief 
questionnaire) 
Study Design 
This is a prospective, uncontrolled, open-label, randomized healthy volunteer study to 
assess the performance of the PureWick™ Male External Catheter and the PureWick™ 
Flex Female External Catheter in adolescents following a void with HCP placement of 
the device and a void with participant (or guardian/parent) placement of the device.   
Number of Subjects 
40 participants (20 male and 20 female)  
Subject Population 
Adolescents aged 12 through 21 (up to but not including the 22nd birthday), Healthy 
Volunteers. 
This study will need to enroll, at a minimum, one male participant and one female 
participant 12 years of age, and one male participant and one female participant 21 
years of age.  Additionally, the study will aim to enroll 50% of the population in the 12-17 
year age range and 50% of the population in the 18-21 year age range. 
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Subject Inclusion/Exclusion Criteria 
Inclusion Criteria:  
1. 
Healthy Adolescent Male or Female aged 12 through 21 years old  
2. 
Able to independently and voluntarily void urine  
3. 
Ability to speak and understand English.  
4. 
Willing to comply with all study procedures in the protocol.  
5. 
Provision of signed and dated informed consent form.  
  
Exclusion Criteria:  
1. 
Has urinary retention  
2. 
Incontinent to feces  
3. 
Has any irritation, wound, open lesion at the device application site.  
4. 
For females: currently menstruating without use of an internal device, e.g. 
tampon or menstrual cup, during the execution of the study. 
5. 
For females: currently pregnant at time of consenting (self-reported) 
6. 
Currently enrolled in or has previously been enrolled in or has completed 
nursing or other clinical training and courses. 
7. 
Has ever been employed as a home health aide or homecare provider. 
8. 
Any other condition that, in the opinion of the investigator, would preclude them 
from participating in the study.  
Interventions / 
Measurements /  
Procedures 
Participants will evaluate the PureWick™ Male External Catheter (for males) or the 
PureWick™ Flex Female External Catheter (for females). Both devices are intended for 
non-invasive urine output management and utilize suction to pull voided urine away from 
the body through tubing into a collection canister.   
For each device evaluation, participants will have the device placed by a healthcare 
professional (HCP) for one void and will self-place the device for the other void. With the 
device in place, participants will urinate two separate times in this study to evaluate the 
performance of the device in the adolescent population. After each void, the device will 
be removed by the HCP or self-removed. Finally, the participants will be asked to 
complete brief questionnaires to assess comfort,  ease of use, ability to assemble device 
and IFU comprehension. HCPs will also be asked to complete questions about ease of 
use for the voids in which they place and remove the device.   
Duration of Study Participation  
Expected participation time is approximately 2-3 hours, divided across two voids. Prior to 
the first void, each participant will be consented and trained on device instructions for 
use.  
Clinical Sites  
1 US site  
Study Timeline  
Planned Enrollment Start: Approximately August 30, 2024  
Data Monitoring Committee  
N/A  - DMC not required for the study 
Clinical Events Committee  
N/A  - CEC not required for this study 
Regulatory Status  
Non-significant risk IDE. Study will evaluate legally marketed products in a new 
population for expanded indication.  
2.0 
ABBREVIATIONS 
Abbreviations 
Term 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
AFMEA 
Application Failure mode and Effects Analysis 
ASADE 
Anticipated Serious Adverse Device Effect 
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Abbreviations 
Term 
BD 
Becton, Dickinson and Company 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CIP 
Clinical Investigation Plan 
CRF 
Case Report/Record Form 
CRO 
Contract Research Organization 
EDC 
Electronic Data Capture 
FEC 
Female External Catheter 
FDA 
Food and Drug Administration 
FDAAA 
FDA Amendments Act of 2007 
GCP 
Good Clinical Practice 
HCP 
Healthcare Professional 
HIPAA  
Health Insurance Portability and Accountability Act 
ICH 
International Conference on Harmonization 
IFU 
Instructions for Use 
IRB/EC 
Institutional or Independent Review Board/Ethics Committee 
ISO 
International Organization for Standardization 
MEC 
Male External Catheter 
PI 
Principal Investigator 
PUCS 
PureWick™ Urine Collection System 
PW 
PureWick™ 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
TMF 
Trial Master File 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 
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3.0 
STUDY SCHEDULE 
Visit 
Study Activity 
Activity 
 
 
 
 
 
 
 
 
 
 
 
 
Visit 1 
Obtain Consent 
Obtain consent for study participants. For minor 
participants, consent will be obtained from the 
participant’s parent or guardian and assent provided by 
the minor participant. 
Screening & 
Randomization 
Screen potential participants against the inclusion and 
exclusion criteria. 
Randomly assign participants to placement sequence 
Baseline 
Collect participant demographic data including height 
and weight. HCP completes a visual assessment of the 
skin in the device application area. 
Device use and urine 
measurement collection 
After enrollment and randomization, train the participant 
to the device IFU. 
Prior to device placement, HCP assembles and sets up 
the PUCS. 
The study device will then be placed by the HCP, 
participant (or guardian/parent) per the assigned 
placement sequence. Placement will be confirmed by 
the HCP and then participant will void. 
Post-void, the device will be removed by the HCP, 
participant (or guardian/parent) and bed pad and 
canister weights will be captured. 
Above steps will be repeated for void 2.   
Questionnaires 
Participants complete the questionnaires below. 
• 
Perception of wetness 
• 
Ease of use 
• 
Comfort 
• 
IFU Evaluation 
After completion of all participants, each HCP completes 
this questionnaire once per device. 
Participant Completion 
Participants will be discharged from the study after 
completing all study activities. 
Study Completion 
End of study is when the last study participant is 
discharged. 
 
 
 
 
 
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4.0 
INTRODUCTION 
4.1 
Background 
Urinary incontinence increases the risk for complications such as incontinence-
associated dermatitis (IAD) and pressure ulcers1-4, and treatment can be difficult, time-
consuming, and costly4. Prolonged usage of an indwelling Foley catheter is a well-known 
risk factor for the development of catheter-associated urinary tract infections (CAUTI).  
The consequences of urinary tract infections (UTIs) can be serious as they have been 
found to increase mortality5,6, prolong hospitalization, and increase readmissions5.  UTIs 
are a leading cause of the development of bloodstream infections (BSIs) and sepsis, and 
the most severe infections are associated with increased morbidity, mortality, and costs.6 
As a result, hospitals are going to great lengths to limit indwelling catheter utilization and 
minimize the duration of catheterization when it must be used.  However, managing urine 
output without an indwelling catheter has been challenging given the limited device 
options recently available.  
For male patients, condom catheters are an option for external drainage that may allow 
for accurate urine output measurements and/or management of urinary incontinence. 
However, there are several disadvantages and challenges associated with sheath-style 
condom catheter types of devices.  First, appropriate sizing of condom catheters may be 
difficult; too large catheters may simply slip off the penis while too small catheters may 
cause pressure-associated tissue trauma.7 Second, adhesives used to hold the catheter 
sheath in place may fail; too little adhesion causes sheath slippage while too strong 
adhesion may lead to skin damage when the sheath is removed.7 Female patients, until 
recently, did not have widely available alternative options outside of traditional indwelling 
urinary catheters or diapers.  
Incontinence in adolescents is a neglected research topic in both acute care and home 
settings. The literature reports prevalence rates of 2.55- 5.41 per 1000 catheter days in 
the acute care setting 9-12 and 1.35 per 1000 catheter days in the ambulatory setting. 
There is an abundance of literature available on IAD in adult and infant populations; 
pediatric populations are a high-risk group for IAD, with diaper dermatitis accounting for 
20% of pediatric dermatology visits, IAD specifically is the most common presentation. 
However, no manuscripts could be found specifically addressing the adolescent 
prevalence of IAD, and there is limited consensus regarding the prevention of pediatric 
patients with IAD.  In the adolescent population, incontinence management can be 
challenging and unreliable; additional urine management solutions are needed to address 
the skin and infection problems associated with urinary incontinence. In addition to the 
clinical outcomes, urinary management may impact the quality of life in adolescent 
patients and their caregivers. For example, one study found that children with spina bifida 
experience incontinence as distressing and unpredictable.8 
The PureWick™ Urine Collection System (PUCS) is to be used with PureWick™ Flex 
Female External Catheters (FEC) or the PureWick™ Male External Catheter (MEC) 
which are intended for non-invasive urine output management and will be collectively 
referenced as the PureWick™ System throughout this study. 
 
 
 
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4.2 
Rationale 
The purpose of this study is to understand if external catheters are an effective 
alternative in the adolescent population in both male and female adolescents  in the 
setting where the external catheter is placed by a healthcare professional as well as in 
the outpatient or home setting where the external catheter is self-placed or placed by 
guardian/parent, and to provide data to support potential labeling for an expanded 
population use. Specifically, the study will collect data about how the external catheters 
perform in terms of capture rate when participants are voiding after self-placement of the 
device, if the adolescent participant can use the device independently or with the help of 
a guardian/parent and collect any adverse events that are reported. 
 
5.0 
IDENTIFICATION AND DESCRIPTION OF THE STUDY DEVICE 
5.1 Study Device(s) and Comparator(s) 
Study participants will be evaluating the PureWick™ Male External Catheter (male 
participants) or the PureWick™ Flex Female External Catheter (female participants). Both 
study devices will be used with the PureWick™ Urine Collection System, a 510(k) exempt 
device currently marketed in the United States. All study devices will have a lot number for 
product traceability.  
 
PureWick™ Male External Catheter 
The PureWick™ Male External Catheter (Figure 1) is intended for non-invasive urine output 
management in users with male anatomy. This device is a Class I, 510k exempt device 
which is marketed in the United States. The device Instructions for Use (IFU) can be found 
in Appendix 1. Male participants will void two times using the PureWick™ MEC. The study 
will utilize approximately 40 PureWickTM MECs, 2 per male participant. 
 
Figure 1 
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PureWick™ Flex Female External Catheter 
The PureWick™ Flex Female External Catheter is intended for non-invasive urine output 
management in adult users with female anatomy. The PureWick™ Flex FEC (Figure 2) is a 
non-sterile single use device. The device is a flexible, contoured external catheter (a “Wick”) 
that is positioned between the separated gluteus and labia, against the urethra. The wick is 
connected to the free-standing PureWick™ Urine Collection System (PUCS) via tubing. The 
PUCS uses suction (not felt by the user) to pull voided urine through the wick, regardless of 
the urine flow rate. Urine continues quickly through PVC tubing, away from the body until it 
reaches the collection canister. 
 
The PureWickTM Flex FEC is currently on the market. The device is composed of  
silicone, polyester non-woven foam, bamboo mid-layer sheet, polypropylene top sheet,  
PVC dual lumen tubing; all materials common in medical devices. The device also  
consists of an aluminum wire inside of the dual lumen PVC tubing that allows the FEC to  
hold its shape when formed.  
 
The device Instructions for Use (IFU) can be found in Appendix 2. Female participants will 
void two times using the PureWick™ Flex FEC. The study will utilize approximately 40 
PureWickTM Flex FECs, 2 per female participant. 
 
Figure 2 
 
5.1.1 
Device Labeling 
All study devices are commercially available and will be supplied as labeled by the 
manufacturer. Copies of the study device’s labeling will be maintained under a 
separate cover. 
 
5.2 Equipment to be Used in Study 
 
PureWick™ Urine Collection System 
The PureWick™ Urine Collection System (PUCS) (Figure 3) is to be used with PureWick™ 
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Male External Catheters and PureWick™ Flex FEC which are intended for non-invasive 
urine output management. The device pulls voided urine through tubing that is connected to 
a collection canister. Urine is stored in the collection canister for proper disposal (see Figure 
3). The system may be used in both home environments and professional care facilities. In 
this study, the device will be used according to the current IFU (Appendix 3). 
 
Figure 3 
 
6.0 
OBJECTIVES AND HYPOTHESES 
6.1 Objectives and Endpoints 
 
Objective 
Type 
Objective 
Endpoint 
Primary 
• 
To assess the 
performance of the 
PureWick™ Flex FEC and 
PureWick™ MEC in 
adolescents after HCP 
placement and participant 
(or guardian/parent) 
placement  
• 
Capture rate following 
void (captured as % of 
urine captured by device 
and collected in canister 
measured by weight)  
• 
Perception of wetness 
following each void on a 
5-point Likert scale (brief 
questionnaire) 
Secondary 
• 
To assess ease of use by 
HCP and participant  
• 
To assess participant 
comfort after using the 
PureWick™ FEC or 
PureWick™ MEC 
• 
Ease of use score on a 
5-point Likert scale (brief 
questionnaire) 
• 
Overall comfort score on 
a 5-point Likert scale 
(brief questionnaire) 
  
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• 
To evaluate the 
Instructions for Use in the 
adolescent population 
• 
IFU comprehension 
score on a 5-point Likert 
scale (brief 
questionnaire) 
6.2 
Performance Goal 
Not applicable.  
7.0 
DESIGN OF THE STUDY 
7.1 
Overall Design 
This prospective, uncontrolled, open-label, single-center, healthy volunteer study will 
assess the performance of the PureWickTM System in adolescents following a void with 
HCP placement of the device and a void with participant (or guardian/parent) placement 
of the device. Male participants will evaluate the PureWick™ Male External Catheter and 
female participants will evaluate the PureWick™ Flex Female External Catheter.  
The expected participation time is approximately 2-3 hours, divided across two voids. 
Prior to the first void, each participant will be consented and trained on device 
instructions for use.  
For each device evaluation, participants will have the device placed by a healthcare 
professional (HCP) for one void and will self-place the device for the other void. The 
participant may have a guardian or parent place the device only if the participants is 
unable or unwilling to self-place the device. With the device in place, participants will 
urinate two separate times during the study to evaluate the performance of the device in 
the adolescent population. After each void, the device will be removed by the HCP or 
self-removed (a guardian or parent may remove the device if the participant is unable or 
unwilling to remove the device). Finally, the participants will be asked to complete brief 
questionnaires to assess perceived wetness, IFU comprehension, comfort and ease of 
use. HCPs will also be asked to complete questions about ease of use for the voids in 
which they placed and removed the device. 
Approximately 40 healthy participants (20 male and 20 female) will be enrolled into the 
study. The study will be conducted at one clinical site.  
7.2 
Justification for the Study Design 
This non-significant risk IDE study will evaluate device safety and performance in the 
adolescent population. Evidence generated from this study will be used to support 
indication expansion.  
7.3 
Treatment Allocation and Measures to Minimize Bias 
This is an open-label study in which participants will be randomized to a device 
placement sequence. All male participants will evaluate the PureWick™ Male External 
Catheter and all female participants will evaluate the PureWick™ Flex Female External 
Catheter. Standardized questionnaires and data collection tools will be used to assess 
capture performance, safety, participant comfort and ease of use.  
7.3.1 
Randomization 
Participants will be randomized 1:1 to one of two placement sequences. A 
randomization list will be provided by the sponsor.  
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7.3.2 
Blinding/Masking 
Not applicable. This is an open label study.  
7.3.2.1 Procedures for Unblinding 
Not applicable – This is an open label study 
7.4 
Potential Influencing or Confounding Factors and Bias 
This is an open-label, healthy volunteer study where participants will be randomized to a 
device placement sequence. All male participants will evaluate the PureWick™ Male 
External Catheter and all female participants will evaluate the PureWick™ Flex Female 
External Catheter. As such, no confounding factors are anticipated. 
7.5 
End of Study Definition 
A subject is considered to have completed the study if they have completed all study 
procedures shown in Section 10.0. 
The end of the study is defined as the date of the last visit of the last participant in the 
study. 
7.6 
Clinical Sites 
This study will have one site, TKL Research Inc., located in Fair Lawn, NJ.  
8.0 
BENEFITS AND RISKS OF THE STUDY DEVICE, CLINICAL PROCEDURE(S), AND 
THE STUDY 
Participants in this study will be treated with either PureWick™ Male External Catheter or the 
PureWick™ Flex Female External Catheter which are Class I Exempt devices that will be used as 
intended. Therefore, participants will be exposed to the same risks shared by all patients using 
these devices.  
Application failure mode and effects analysis (AFMEA) documents (PureWick™ Flex FEC 
RA0301999, PureWick™ MEC RA0301920 and PUCS RA0301678) were generated to 
summarize the risk analysis process and provide documented evidence that the risks associated 
with the study device are acceptable. Prior to study participation, the Investigator must explain to 
each subject the risks and benefits of this clinical study. 
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events/adverse device effects of the PureWick™ Male External Catheter and 
PureWick™ Flex Female External Catheter may be found in the IFU for each device product. 
 
8.1 
Benefit Assessment 
This is a healthy volunteer study in which the participants are not known to suffer from any 
of the conditions/indications for use of the PureWickTM Male External Catheter or 
PureWickTM Flex Female External Catheter. As such, there is likely to be no direct benefit 
for study participants. Data gathered through this study could benefit future patients utilizing 
the study devices. Study participants may contribute to the process of generating clinical 
evidence for urine output management in male and female adolescent patients. 
 
8.2 
Risk Assessment 
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8.2.1 
Anticipated Adverse Device Effects 
Potential Risk of 
Clinical 
Significance 
Summary of 
Data/Rational for Risk 
Mitigation Strategy 
PureWickTM Flex Female External Catheter 
• 
Skin Injury 
• 
Skin Irritation 
• 
Allergic reaction 
• 
Inflammation 
• 
Infection 
• 
Discomfort 
 
The PureWickTM Flex is 
a flexible, contoured 
external catheter (a 
“Wick” that is positioned 
between the separated 
gluteus and labia, 
against the urethra.  
• 
To avoid potential skin injury, 
never push or rub the product 
against the skin during 
placement or removal. 
• 
Assess local area before 
application/after device removal 
and periodically throughout use.  
• 
Participants are allowed to 
discontinue use if they feel any 
pain or discomfort. 
• 
IFU (warning, contraindications, 
instructions) 
• 
Study Exclusion criteria 
• 
Tissue injury or 
possible minor 
bleeding 
The device sites against 
the skin, sticking and 
possible minor bleeding 
is a potential risk. 
• 
Top layer of wicking material has 
been selected to minimize the 
possibility of sticking to skin.  
• 
Exposure to 
Biohazard or 
bloodborne 
pathogens 
Device is intended to 
capture urine, may lead 
to transmission of 
bloodborne pathogens. 
• 
HCP will wear gloves when 
handling devices and will dispose 
of used devices per the IFU 
• 
Injuries 
Device is labeled MRI 
conditional. Potential 
interference with other 
medical devices or 
treatments under 
specific operating 
conditions.  
• 
IFU (warnings) 
• 
No MRI included in the study 
procedures.  
PureWickTM Male External Catheter 
• 
Skin injury 
• 
Skin Irritation  
• 
Allergic reaction 
• 
Infection 
• 
Discomfort 
 
• 
PureWick™ MEC is 
an external device 
placed around the 
base of the penis 
and adhered to the 
pelvic skin. 
• 
To avoid potential skin injury, 
never pull the device directly 
away from the patient. Always 
peel in the direction from head to 
foot. 
• 
Perform perineal care using the 
included wipes and assess skin 
integrity before device 
application. 
• 
Assess the device placement 
and patient’s skin at least every 2 
hours. 
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• 
Monitor for pulling and tension on 
the device after turning the 
patient. 
• 
Replace the device every 24 
hours or if soiled with feces, 
blood, or semen. 
• 
Remove the device prior to 
ambulation. 
• 
Exposure to 
biohazard or 
blood borne 
pathogens 
• 
Device is intended to 
capture urine, may 
lead to transmission 
of bloodborne 
pathogens. 
• 
HCP will wear gloves when 
handling devices and will dispose 
of used devices per the IFU 
PureWickTM Urine Collection System 
• 
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. 
• 
Keep small device parts, cords 
and tubing out of reach of 
children. 
• 
Always unplug PureWick™ Urine 
Collection System 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. 
 
• 
Exposure to 
biohazard or 
blood borne 
pathogens. 
• 
Device is intended to 
capture urine, may 
lead to transmission 
of bloodborne 
pathogens. 
• 
HCP will wear gloves when 
handling devices and will dispose 
of used devices per the IFU 
 
8.2.2 
Anticipated Procedure-related Adverse Events 
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Potential Risk of 
Clinical 
Significance 
Summary of 
Data/Rational for Risk 
Mitigation Strategy 
• 
Potential 
discomfort due to 
full bladder.  
• 
Participants will be 
asked to drink fluids 
in between voids to 
ensure a full second 
void. 
• 
Participants who meet the 
eligibility criteria and follow study 
instructions should not have a 
bladder that is uncomfortably full. 
• 
Potential 
biohazard 
exposure after 
use 
• 
Device is intended to 
capture urine, may 
lead to transmission 
of bloodborne 
pathogens. 
• 
Participants will be provided 
gowns and offered gloves during 
study participation 
 
8.2.3 
Additional Risks Associated with Study Participation 
No additional risks associated with participation in this study have been identified. 
 
8.3 
Risk / Benefit Analysis 
Taking into consideration the measures to minimize risk to subjects in this study, the 
potential risks identified in association with PureWickTM Male External Catheter and 
PureWickTM Flex Female External Catheter are justified by the anticipated benefits that may 
be afforded to subjects with requiring a non-invasive urine output management solution. 
 
9.0 
SUBJECTS 
Adolescent male and female healthy participants will be recruited by the clinical site, TKL 
Research Inc. Participants will be recruited from the site’s existing pool of volunteers in a 
database owned by the study site and with advertisements. It is anticipated to have 20 enrolled 
male and 20 enrolled female healthy volunteers aged 12-21 years old, with a target of 50% 
between 12-17 and 50% between 18-21. At least one male participant and one female participant 
must be the minimum age of 12, and at least one male participant and one female participant 
must be the maximum age of 21 to ensure representativeness across the target age range. 
9.1 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the 
following criteria: 
1. Healthy Adolescent Male or Female aged 12 through 21 years old 
2. Able to independently and voluntarily void urine 
3. Ability to speak and understand English 
4. Willing to comply with all study procedures in the protocol 
5. Provision of signed and dated informed consent form. 
9.2 
Exclusion Criteria 
Subjects are excluded from the study if any of the following criteria apply: 
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1. Has urinary retention 
2. Incontinent to feces 
3. Has any irritation, wound, open lesion at the device application site 
4. For females: currently menstruating without use of an internal device, e.g. 
tampon or menstrual cup, during the execution of the study 
5. For females: currently pregnant at time of consenting (self-reported) 
6. Currently enrolled in or has previously been enrolled in or has completed nursing 
or other clinical training and courses 
7. Has ever been employed as a home health aide or homecare provider 
8. Any other condition that, in the opinion of the investigator, would preclude them 
from participating in the study. 
9.3 
Vulnerable Subjects 
Human subject regulations consider pediatric subjects a vulnerable population. This 
study will require IRB review and approval prior to the start of the study. Prior to approval, 
the IRB must determine that no greater than minimal risk to children is presented in the 
study. Written informed consent using the IRB approved consent form will be obtained 
from all subjects or their parent/guardian prior to participating in the study. The IRB will 
determine if assent of the adolescent participants is required in addition to 
parent/guardian consent. No medical care will be provided to the study participants once 
the study has been completed.  
9.4 
Point of Enrollment 
The point of enrollment is the time at which, following recruitment and before any clinical 
investigation-related procedures are undertaken, a subject signs and dates the informed 
consent form. 
9.4.1 
Point of Treatment 
Once the participant meets all the eligibility criteria and signs the ICF, the 
participant is considered enrolled and study activities will begin as outlined in 
section 10.  
9.4.2 
Point of Randomization 
Randomization assignment should occur only when all eligibility criteria are met 
and consent has been obtained. The point of randomization is after enrollment 
when the site assigns a subject to a device placement order per the Sponsor 
provided randomization list.   
9.5 
Screen Failures and Replacement of Subjects 
Screen failures are defined as subjects who consent to participate in the clinical study but 
are not subsequently randomized into the study. Demographic information may be 
captured for screen failures. Screen failures will not be allowed to re-screen.  
The Principal Investigator will maintain a screening log to record details of all subjects 
screened and to confirm eligibility or record reasons for screening failure, as applicable. 
9.5.1 
Replacement of Subjects 
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Not Applicable – This study will not have replacement participants.  
9.6 
Study / Participation Duration 
9.6.1 
It is expected to take approximately 2-3 weeks to complete subject enrollment.  The 
total duration of the study is expected to be 2-3 weeks (last subject, last visit). 
9.6.2 
The duration of study participation for an individual subject is expected to be 
approximately 2-3 hours (enrollment through last study assessment). 
9.7 
Subject Discontinuation / Withdrawal [and Discontinuation of Intervention] 
9.7.1 
Discontinuation / Withdrawal 
9.7.1.1 A subject may withdraw from the study at any time at their own request 
or may be withdrawn at any time at the discretion of the Principal 
Investigator (PI) or sponsor for safety, behavioral, compliance, or 
administrative reasons. This is expected to be uncommon. 
9.7.1.2 At the time of discontinuing from the study, no further assessments will 
be performed. 
9.7.1.3 If the subject withdraws consent for disclosure of future information, the 
sponsor may retain and continue to use any data collected before such a 
withdrawal of consent. 
9.7.1.4 If a subject withdraws from the study, they may request destruction of 
any samples taken and not tested, and the Principal Investigator must 
document this in the clinical site study records.  
9.7.1.5 Once the study has ended, there will be no additional care for study 
participants.  
9.7.1.6 There will be no additional procedures/parameters in the study.  
9.7.2 
Lost to Follow-Up 
The study only has one visit with two voids. There are no follow-up visits.  
10.0 
PROCEDURES 
Adherence to the study design requirements, including those specified in the CIP, is essential and 
required for study conduct. 
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. 
10.1 Screening and Enrollment Procedures 
All participants will be screened against the inclusion and exclusion criteria (see section 
9.1 & 9.2). Participants who fail to meet eligibility criteria must not have a study device 
placed. 
The Investigator or their designee will explain the study to the participant, answer all of 
the participant’s questions, and obtain written informed consent (and assent, as 
applicable) before the collection of any study data or performance of any study 
procedures.  
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10.2 Medical History / Baseline Assessments 
Participants demographic information including age, race, ethnicity, sex, height, and 
weight (for BMI calculation) will be collected at baseline. 
10.3 Randomization 
The site will receive a randomization list of placement sequence numbers. Participants 
can only be randomized when all eligibility criteria are met, and consent has been 
obtained. 
10.4 Evaluation Procedures 
Once participants meet all the inclusion, none of the exclusion criteria and are 
randomized, participants will go through the activities below.  
 
Steps 
Activity 1 (Prior to placing the device) 
1.1 
After enrollment and completion of baseline data collection, the participant will 
be escorted to a test room. Participant will be asked to remove all clothing and 
change into a gown. The participants may leave on a shirt if desired.  
• 
Female participants may keep on a bra if desired 
• 
Male participants – Unless the participant arrives to the clinical site 
with their pubic hair pre-trimmed, the participant’s pubic hair will be 
clipped by themselves (or guardian/parent) or the HCP.  
1.2 
Prior to the participant’s arrival to the test room, the bed will be prepared 
with clean sheets. A pre-weighed absorbent pad will be placed in the 
middle of the bed. A pre-weighed canister (weighed with lid) will be 
will be available for the participant to connect. 
Note 
to site 
Make sure top of mattress and PUCS height remains the same for all 
participants in the study.  
1.3 
The participant will be trained on device use per the Instructions for Use and a 
training video. The participant will be allowed to refer to any of the training 
materials that are available and provided to them throughout the study 
procedures. 
1.4 
The HCP will set-up the PUCS per the IFU.  
The HCP will confirm proper assembly by performing the following:  
• 
check that the PUCS lid is securely snapped.  
• 
check that all tubing and elbow connections on the lid are secure.  
• 
confirm power connections are secure.  
• 
ensure the Green LED light on the power switch is on. 
The HCP will adjust the PUCS as needed prior to continuing to next steps.  
1.5 
The participant will be asked to lie on their back on the bed and to leave 
their hands resting on their stomach, when possible, while they are lying 
on their back. For participant comfort, the head of the bed will be slightly 
elevated. 
1.6 
The participant (or guardian/parent) or HCP will clean the participant’s 
anatomy with the provided wipes. The HCP will confirm the participant 
cleaned their anatomy.  
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1.7 
The HCP will perform a skin integrity check and note any existing signs or 
symptoms of irritation in the perineal area. If the participant’s skin is 
compromised, the HCP will consult the site staff before proceeding with 
placement of study device and/or withdraw the participant.  
HCP will confirm if no signs or symptoms of irritation in the perineal area was 
noted.  
Steps 
Activity 2 (Placement of device) 
2.1 
The participant will be given either the PureWickTM Male External Catheter 
(male participants only) or PureWickTM Flex Female External Catheter (female 
participants only).  
2.2 
For female participants only: The participant (or guardian/parent) or HCP 
will curve the PW Flex to fit the participant’s anatomy per the IFU. 
2.3 
The PW MEC or PW Flex will be connected to the canister via collector tubing 
per the IFU. Tubing connection to be done by the participant (or 
guardian/parent) for the self-placed void and by the HCP for the HCP-placed 
void. The HCP will confirm and record if the tubing connection was made 
correctly for the self-placed void. If the connection was not done correctly, the 
HCP will capture the reason: 
1. The participant did not understand how to make the connection 
2. The participant connected the device to the wrong tubing port 
3. The participant was not physically able to make the connection with 
sufficient force 
4. Other, specify 
The HCP will adjust tubing connection prior to void if it was not done correctly.  
2.4 
Based off the randomization of placement sequence, the participant will self-
place (or guardian/parent) the device or the HCP will place the device.  
2.5 
If device was self-placed (or guardian/parent), the HCP will confirm the 
placement of the PureWickTM Male External Catheter (male participants only) 
or PureWickTM Flex Female External Catheter (female participants only). If the 
device is not placed correctly, the HCP will ask the participant to 
reposition/adjust the device. The HCP will record if any adjustments were 
made. 
Even when placed correctly, participants may adjust the device as needed for 
comfort. The HCP will record if any adjustments were made. 
Steps 
Activity 3 (Void #1) 
3.1 
The HCP will confirm that the absorbent bed pad is appropriately positioned 
under the participant. 
3.2 
The participant will be asked to void in the supine position. The participant will 
be instructed not to strain or attempt to regulate their urine flow. 
Steps 
Activity 4 (Removing the device) 
4.1 
After the completion of the void the participant (or guardian/parent) or HCP 
(based off placement sequence) will carefully remove the device per the 
instructions for use.  
• 
For female participants, HCP will record if the device has dislodged 
after the void prior to device removal 
4.2 
The HCP will record whether they observed any urine leak from the device 
upon removal.  
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4.3 
The HCP will lift the catheter and tubing to make sure all the liquid flows into 
the canister.  
4.4 
The HCP will perform a skin integrity check and note any signs of irritation in 
the perineal area or adverse reactions. 
HCP will confirm if no signs or symptoms of irritation in the perineal area were 
noted.  
4.5 
The HCP will turn the PUCS suction OFF by flipping the black switch on the 
PUCS.  
4.6 
The used absorbent pad will be weighed by the HCP, and the value 
documented on the appropriate CRF. The canister (with lid) with urine will be 
weighed by the HCP and documented. The used catheter will be 
disconnected from the tubing and discarded.  
4.7 
The participant will be asked to complete all applicable questionnaires. 
Steps 
Activity 5 (Void #2) 
5.1 
After completion of void 1, the participant will be instructed to drink fluids in 
preparation for void 2.  
5.2 
Approximately 30 minutes after void 1 or when the participant feels the need 
to void again, the participant will proceed with void 2 (the participant will not 
use the same wetted device but a new clean device). Steps in Activities 1-4 
will be repeated for the 2nd void based off the placement sequence.   
Steps 
Activity 6 (After Completion of Both Voids) 
6.1 
Once the participant has completed both voids, the participant will be asked to 
complete the remaining required questionnaire.  
6.2 
Each HCP will complete the ease-of-use questionnaire after completing all 
study activities. 
 
Questionnaires to be completed 
Person to complete 
questionnaire 
Questionnaire to complete 
When to complete 
Participant 
Perception of wetness 
After each void 
Participant 
Ease of use 
After self-placement void 
Participant 
Comfort 
After completion of all voids 
Participant 
IFU Evaluation 
After self-placement void 
HCP 
Ease of use 
After completion of all participants. 
Each HCP completes this 
questionnaire once per device.  
 
10.5 Safety Assessments 
All AEs will be captured and summarized. 
10.6 Follow-up Procedures 
After all study assessments and procedures are complete, 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.   
 
11.0 
STATISTICAL METHODS 
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There is no formal hypothesis testing, and no formal statistical test will be conducted. Participants 
responses will be complied and analyzed using descriptive statistics.  
11.1 Sample Size Considerations 
The study sample size requires a minimum of 20 males and 20 female healthy 
participants. This is considered adequate to assess the primary objective.  
11.2 Analysis Population 
The analysis populations will be defined as follows for this study: 
Population 
Description 
Enrolled  
All participants who sign the ICF 
Intent-to-Treat (ITT) 
All participants who have device placed for at least one void. 
Per-Protocol (PP) 
ITT subjects without any major protocol deviations 
11.3 General Considerations 
As there is no formal hypothesis testing, no formal statistical analysis will be conducted. 
Endpoints will be summarized using descriptive statistics.  
11.4 Final Analysis 
11.4.1 Primary Endpoint(s) 
 
Capture Rate 
 
Capture rate is defined as: 
 
𝑤𝑒𝑖𝑔ℎ𝑡 𝑜𝑓 𝑐𝑎𝑝𝑡𝑢𝑟𝑒𝑑 𝑢𝑟𝑖𝑛𝑒 × 100%
𝑤𝑒𝑖𝑔ℎ𝑡 𝑜𝑓 𝑐𝑎𝑝𝑡𝑢𝑟𝑒𝑑 𝑢𝑟𝑖𝑛𝑒+ 𝑤𝑒𝑖𝑔ℎ𝑡 𝑜𝑓 𝑢𝑟𝑖𝑛𝑒 𝑙𝑒𝑎𝑘 
 
Voids with a total volume (captured urine + urine leak) of 10 mL is considered 
evaluable for this endpoint. Summary statistics such as mean, standard 
deviation, median, and range will be used for the analysis of capture rate. 
Separate summary may be provided by gender and by placement (HCP or self). 
 
Perception of Wetness 
 
Response to the questionnaire will be summarized as categorical variable and as 
continuous variable. Summary statistics such as frequency count, mean, 
standard deviation, median, and range will be provided. Separate summary may 
be provided by gender and by placement (HCP or self). 
 
11.4.2 Secondary Endpoint(s) 
 
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Secondary endpoints will be summarized as categorical variable and as 
continuous variable. Summary statistics such as frequency count, mean, 
standard deviation, median, and range will be provided. 
 
Ease of use score 
Summary statistics will be provided for subjects and for HCPs separately. 
Overall comfort score  
Overall summary and summary by gender will be provided.  
IFU comprehension score 
Overall summary will be provided. 
 
11.4.3 Tertiary/Exploratory Endpoint(s) 
Not Applicable – There are no tertiary or exploratory endpoint 
11.4.4 Other Analyses 
Not Applicable – No other analyses will be performed outside of the statistical 
analysis plan 
11.5 Interim Analysis 
Not Applicable – The study does not have any interim analysis planned 
12.0 
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 end-to-end process of data collection, data processing and reconciliation, and 
database lock.  Procedures for validations and data storage will also be contained within the 
DMP. 
12.1 Case Report Forms 
The Principal Investigator is responsible for ensuring the completeness and accuracy of 
all study documentation. 
All required clinical data will be collected/documented in sponsor-provided electronic 
Case Report Forms (CRFs).  Corrections should be made using the principles of Good  
Documentation Practice. FDA 21 CFR 11 is followed as well as other applicable 
legislation on the handling of electronic data.  
Clinical site numbers and subject numbers will be used to track subject information 
throughout the study. Participants personal information will be de-identified.  
12.2 Source Documentation 
Source documentation is required to be maintained by the clinical site. Original or 
certified copies of all relevant clinical findings, observations, and other activities 
throughout the study must be recorded and maintained by the clinical site. 
12.3 Record Retention 
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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 clinical product development protocol. 
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. 
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 
FDA, if applicable, not later than ten (10) working days after the transfer occurs. 
13.0 
MONITORING PLAN 
The Sponsor will designate trained and qualified personnel to monitor the progress of this study in 
accordance with established procedures and the study-specific Clinical Monitoring Plan.   
Prior to study start, a Site Initiation Visit (SIV) will be conducted to review with the Investigator(s) 
and clinical site personnel the provisions and proper conduct of this study. This visit will include a 
detailed review of the study’s CIP, verification that all necessary documents are on file at the 
clinical site and confirmation of IRB/EC approvals.   
During the study, Interim Monitoring Visits (IMVs) will be conducted to assure the clinical site 
continues to adhere to the CIP, the investigator agreement, and regulations regarding conduct of 
clinical studies.  The Monitor will confirm that the ICF to be used is the IRB/EC approved version, 
confirm the applicable national privacy laws have been followed, verify that all necessary 
documents are on file at the clinical 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, at a minimum, continued CIP compliance, adequate subject 
enrollment, accurate data reporting (that is, source data verification according to the Clinical 
Monitoring Plan), monitoring of subject safety through identification and/or review of any device-
related AEs, U(S)ADEs, Serious Health Threats, DDs or SAEs, device accountability, continued 
maintenance and 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 (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. 
14.0 
AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
A CIP amendment is required when there is a change which will impact study conduct and/or 
subject safety, including changes of study objectives, study design, subject population, sample 
size, study procedures, or significant administrative aspects. 
All amendments will be reviewed and approved by the Sponsor according to their procedures.  
Related documents, including but not limited to, ICF, IB, CRFs, and SAP will be reviewed and 
revised to align with the amended CIP, as required. 
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Amendments and affected related documents will be communicated to each clinical site as soon 
as possible and submissions made to their corresponding IRB/EC for review and approval.  
Amended CIPs will only be instituted at clinical sites after IRB/EC approval has been received. 
15.0 
DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN 
A protocol deviation is defined as an event where the PI or clinical site personnel did not conduct 
the study according to the CIP, applicable regulations and standards, or requirements imposed by 
the IRB/EC. 
CIP deviations are not permitted except when necessary to protect the life or physical well-being 
of a subject.  The Sponsor and the clinical site’s IRB/EC must be notified immediately if an 
emergency situation arises in which the safety of a subject may require immediate intervention 
different than that defined in the CIP.  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 Principal Investigator’s responsibility to ensure that there are no deviations from the CIP. 
Any and all deviations must be recorded on the appropriate CRF regardless of whether medically 
justifiable.  Upon evaluation by the Sponsor, actions may be required to prevent additional 
deviations, such as retraining of the clinical site, implementation of additional clinical site 
procedures, and more frequent monitoring.  If these steps fail, in accordance with Sponsor 
procedures, additional corrective and preventative actions may be taken, up to and including 
termination of enrollment at the clinical site and/or disqualification of the PI. 
16.0 
DEVICE ACCOUNTABILITY 
Clinical 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 clinical products, and ensure they are used in accordance with this CIP.  Failure to do so 
may result in the Sponsor suspending or terminating the study at the Investigator’s site.  
The PI will ensure that clinical products are only dispensed to subjects properly enrolled in the 
study. The PI must maintain records of receipt, disposition, return and/or destruction of all clinical 
products. All clinical products released to the clinical 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 clinical product accountability, in accordance with the study-specific Clinical 
Monitoring Plan. 
The Sponsor will maintain records that document the shipment, receipt, disposition, return and/or 
destruction of clinical products. 
17.0 
STATEMENT OF COMPLIANCE 
The study will not commence at a clinical site until approval (favorable opinion) from the 
respective IRB/EC has been received. This study will be conducted in compliance with the 
following: 
• 
The study’s Clinical Investigation Plan, 
• 
Any signed study agreements with the study Sponsor, 
• 
Any IRB requirements, 
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• 
Food and Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21 Parts 11, 
50, 54, 56 and 812, 
• 
International Organization for Standardization (ISO) 14155:2020 – Clinical Investigations of 
Medical Devices for Human Subjects – Good Clinical Practice, 
• 
Ethical principles that have their origin in the Declaration of Helsinki, 
• 
Applicable sections of the local laws and regulations. 
18.0 
INFORMED CONSENT PROCESS AND OTHER ETHICAL/REGULATORY 
CONSIDERATIONS 
18.1 Informed Consent 
18.1.1 Prior to any study procedure, the PI (or designee) must explain to each subject in 
layman’s terms, the nature of the study, its purpose, expected duration, and the 
risks and benefits of study participation. Also, subjects 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 (for example, 
HIPAA requirements in the U.S.) will be followed in this study. The subjects 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. 
Subjects 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 subject must 
voluntarily provide consent. The subject will receive a copy of their signed ICF. 
Failure to obtain informed consent prior to the conduct of any protocol-specific 
procedures should be reported to the Sponsor within five (5) days of site 
awareness.  
18.1.2 The ICF may be modified, with Sponsor approval, to suit the requirements of the 
individual clinical site. 
18.2 IRB/EC Approval 
18.2.1 Investigators or designees must submit the CIP, 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.   
18.2.2 The IRB/EC will be notified of any amendments to the CIP, 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. 
18.2.3 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. 
Upon study completion, a copy of the final IRB site close-out report should be 
provided to the Sponsor. If the IRB withdraws approval of the study prior to 
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completion, the Sponsor should be notified immediately, followed by a copy of the 
IRB/EC notification within five (5) working days of withdrawal. 
A list of IRB/EC names, locations, and chairpersons will be maintained under a 
separate cover. 
18.3 Confidentiality 
18.3.1 Subject confidentiality must be strictly held in trust by the PI, study staff, and the 
Sponsor.  Subject confidentiality and anonymity will be maintained by removal of 
identifiers from any data, documentation, or clinical samples submitted to the 
Sponsor. 
18.3.2 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.   
18.3.3 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/Clinical Site will permit access to 
such records.  
19.0 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE DEFICIENCIES 
19.1 Definitions of Events 
19.1.1 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 
subjects, users, or other persons, whether or not related to the investigational 
medical device and whether anticipated or unanticipated. This definition includes 
events related to the investigational medical device or the comparator. This 
definition includes events related to the procedures involved. For users or other 
persons, this definition is restricted to events related to the use of investigational 
medical devices. 
19.1.2 Serious Adverse Events (SAEs) 
A serious adverse event is defined as an adverse event that led to any of the 
following: 
a) Death, 
b) Serious deterioration in the health of the subject, users, or other persons as 
defined by one or more of the following:  
1) A life-threatening illness or injury,  
2) A permanent impairment of a body structure or a body function including 
chronic diseases,  
3) In-patient or prolonged hospitalization,  
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4) 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 hospitalization for a pre-existing condition, or a procedure 
required by the CIP, without serious deterioration in health, is not considered a 
serious adverse event. 
19.1.3 Adverse Device Effect (ADE) 
An adverse device effect (ADE) is defined as an adverse event related to the use 
of an investigational medical device. This definition includes adverse events 
resulting from insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the investigational 
medical device. This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device. This includes 
‘comparator’ if the comparator is a medical device. 
19.1.4 Serious Adverse Device Effect (SADE) 
A SADE is defined as an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
19.1.5 Unanticipated (Serious) Adverse Device Effect (UADE/USADE) 
An UADE/USADE is defined as a (serious) adverse device effect which by its 
nature, incidence, severity or outcome has not been identified in the current risk 
assessment. Anticipated serious adverse device effect (ASADE) is an effect 
which by its nature, incidence, severity or outcome has been identified in the risk 
assessment. 
19.1.6 Serious Health Threat 
A serious health threat is defined as 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. 
19.1.7 Device Deficiency 
A device deficiency is defined as inadequacy of a medical device with respect to 
its identity, quality, durability, reliability, usability, safety or performance. Device 
deficiencies include malfunctions, use errors, and inadequacy in the information 
supplied by the manufacturer including labelling. This definition includes device 
deficiencies related to the investigational medical device or the comparator. 
This applies to: devices used to treat the subject, 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.  
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The Principal Investigator will record all device deficiencies for both the study 
device and the comparator, if the comparator is a medical device, on the 
appropriate CRF.  Device deficiencies will be reported to the Sponsor. 
If the device deficiency was associated with an AE, the reporting provisions for 
AEs, ADEs, SAEs, SADEs and UADEs/USADEs apply. 
It is the responsibility of the Investigator to notify the IRB/EC of such device 
deficiencies in accordance with the IRB/EC and/or the Competent Authority’s 
local regulations. 
19.1.8 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. 
 
19.2 Relationship of Adverse Event to Device(s)/Procedure 
Each AE will be assessed for its relationship to the study device or procedure according 
to the following guidelines. 
19.2.1 Assess each AE for its relationship to the device or procedure. 
• 
Device Related: This category should be restricted to AEs directly 
attributable to the study device used. 
• 
Procedure:  A procedure includes any study-related activity performed. 
19.2.2 The following categories shall be used for assigning the certainty of the 
relatedness. An event is considered to be related if a relatedness category other 
than "Not Related" is assigned. 
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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 AE/SAE 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 AE/SAE,  
- 
The event involves a body-site or an organ that cannot be affected 
by the device or procedure,  
- 
The AE/SAE can be attributed to another cause (for example, 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 (for 
example, 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 relevant and/or 
the event cannot be reasonably explained by another cause. 
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Relatedness 
Description 
Causal 
Relationship 
The AE/SAE is associated with the investigational device, comparator 
or with procedures beyond reasonable doubt when:  
- 
The event is a known side effect of the clinical 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  
• 
the investigational device or procedures are applied to;  
• 
the investigational device or procedures have an effect on, 
- 
the AE/SAE 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 (for example, 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. 
19.3 Reporting of Events 
An event (for example, AE, SAE, DD) will not be considered reported to the Sponsor until 
the clinical site has entered the event into the study database.  
19.3.1 Report by Investigator to Sponsor and IRB/EC 
For all adverse events, all sections of the appropriate Case Report Form (CRF) 
must be completed.  
• 
All SAEs, SADEs, UADEs/USADEs, and Serious Health Threats must be 
reported to the Sponsor no later than 1 calendar days of the clinical 
site/investigator becoming aware of the event.  
• 
All AEs must be reported to the Sponsor no later than 1 calendar days. 
• 
All device deficiencies must be report to the Sponsor no later than 1 calendar 
days. 
• 
De-identified copies of all requested relevant documentation should be 
submitted to the Sponsor within 72 hours of the Sponsor’s request. 
• 
The Principal Investigator must report adverse events to individual 
Institutional Review Boards (IRBs)/Ethics Committees (ECs) per the IRB/EC 
requirements. 
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19.4 Safety Committees 
19.4.1 Medical Monitor 
19.5 
The medical monitor is responsible for providing medical expertise and 
safety oversight for the study. The medical monitor is to ensure the welfare and 
safety of participants.  
19.5.1 Clinical Events Committee 
19.6 
Not Applicable – This study will not utilize a clinical event committee as 
this is a non-significant risk IDE study.   
19.6.1 Data Monitoring Committee  
19.7 
Not Applicable – This study will not utilize a data monitoring committee 
as there is no major morbidities studied.   
20.0 
SUSPENSION OR PREMATURE TERMINATION OF THE 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 clinical site for 
reasons including, but not limited to, inadequate data collection, low subject enrollment rate, 
achievement of the total enrollment, conditions imposed by the reviewing IRB/EC and/or non-
compliance with this Clinical Investigation Plan 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 required by 
regulation.  
21.0 
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. 
22.0 
STUDY REGISTRATION 
In compliance with Title VIII of Public Law 110-85, known as FDA Amendments Act of 2007 
(FDAAA), and/or national regulations, the Sponsor will register this study and disclose study 
results in a publicly accessible database (for example, ClinicalTrials.gov). This study will be 
registered no later than 21 days after commencing enrollment.  Study results will be posted 
website within 12 months of the last subject visit for collection of primary outcome data. 
23.0 
ADMINISTRATIVE REQUIREMENTS 
23.1 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 their team will make themselves 
available during the visit.  The Investigator must agree to the inspection of all study 
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related records and give the auditor/inspector direct access to source documents for 
verification of data on CRFs.  The subject’s anonymity must be ensured, and data 
checked during the audit must remain confidential. 
As soon as the PI is aware of an upcoming inspection/audit by the Health Authorities, 
they will promptly inform the Sponsor.  As agreed with the PI, Sponsor personnel may be 
present at the clinical site during the inspection. 
23.2 Investigator and Clinical Site Selection 
Investigators must be of good standing and knowledgeable in relevant areas of clinical 
research to ensure adherence to the requirements of this CIP, including the protection of 
human subjects.  Other clinical site personnel must have appropriate research 
experience and infrastructure to ensure adherence to this CIP and enrollment of sufficient 
numbers of evaluable subjects. The curriculum vitae (CV) of the PI(s) and Sub-
Investigator(s) will be maintained in the Sponsor’s files as documentation of qualification 
by training and experience. 
Government databases will be searched to ensure that the Investigator(s) and/or the site 
are not prohibited from engaging in clinical research. 
Any clinical site that is deactivated prior to initial enrollment, either by the Sponsor or by 
the individual clinical site itself, may be replaced. 
23.3 Training 
In addition to each Principal Investigator and appropriate clinical site personnel being 
trained on this CIP and its procedures during the Site Initiation Visit, clinical product 
training will be provided by the Sponsor or designee and is required for each PI. 
Additional study personnel (for example, 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 clinical site and with the Sponsor. 
23.4 Required Documents 
An Investigator may not screen or enroll subjects 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 Confidentiality Disclosure Agreement, 
• 
Fully executed Work Order/Mast Clinical Trial Agreement, 
• 
Investigator(s) signed CIP signature page, 
• 
Signed Investigator Agreement(s), 
• 
Signed Financial Disclosure Form(s), 
• 
CVs, current, signed, and dated for all clinical site personnel, 
• 
Debarment screening acceptable, 
• 
Delegation of Authority is complete and signed, 
• 
Study-specific Clinical Site Training Log is complete and signed for applicable clinical 
site personnel, 
• 
IRB/EC approval of CIP, ICF and other applicable subject facing material, 
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• 
IRB roster/EC membership list. 
23.5 Regulatory Status 
The Sponsor has determined and documented this to be a non-significant risk device 
study based on congruency with 21 CFR 812.3.  This determination is based on the 
following assessment of the study device: 
• 
Is not intended as an implant, 
• 
Is not purported or represented to be for a use in supporting or sustaining human life, 
• 
Is not intended for a use of substantial importance in diagnosing, curing, mitigating, 
or treating disease, or otherwise preventing impairment of human health, 
• 
Does not present a potential for serious risk to the health, safety, or welfare of a 
subject. 
• 
Classification of NSR is documented in the Study Risk Assessment Form. 
24.0 
REFERENCES  
1. 
Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J et al. (2016) 
Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane 
Database Syst Rev 11 CD011627.  
2. 
Bender JK, Faergemann J, Skold M (2017) Skin Health Connected to the Use of 
Absorbent Hygiene Products: A Review. Dermatol Ther (Heidelb)  
3. 
Beeckman D, Van Lancker A, Van Hecke A, Verhaeghe S (2014) A systematic review 
and meta-analysis of incontinence-associated dermatitis, incontinence, and moisture as risk 
factors for pressure ulcer development.  Res Nurs Health 37 (3): 204-218.  
4. 
Beeckman D, et al. (2015) Proceedings of the Global IAD Expert Panel. Incontinence 
associated dermatitis: moving prevention forward. Wounds International Available to download 
from www.woundsinternational.com. 
5. 
Chant C, Smith OM, Marshall JC, Friedrich JO (2011) Relationship of catheter-associated 
urinary tract infection to mortality and length of stay in critically ill patients: a systematic review 
and meta-analysis of observational studies.  Crit Care Med 39 (5): 1167-1173. 
6. 
Tandogdu Z, Bartoletti R, Cai T, Cek M, Grabe M et al. (2016) Antimicrobial resistance in 
urosepsis: outcomes from the multinational, multicenter global prevalence of infections in urology 
(GPIU) study 2003-2013. World J Urol 34 (8): 1193-1200. 
7.  
Szymanski, K. M., Carroll, A. E., Misseri, R., Moore, C. M., Hawryluk, B. A., & Wiehe, S. 
E. (2023). A patient-and parent-centered approach to urinary and fecal incontinence in children 
and adolescents with spina bifida: understanding experiences in the context of other competing 
care issues. Journal of pediatric urology, 19(2), 181-189. 
8.  
CATHETER, U. C. M. E. (2008) Good Practice in Healthcare: Male External Catheters, 
Condom Catheter Urinary Sheath. EAUN MEC Guidelines Szymanski, K. M., Carroll, A. E., 
Misseri, R., Moore, C. M., Hawryluk, B. A., & Wiehe, S. E. (2023). A patient-and parent-centered 
approach to urinary and fecal incontinence in children and adolescents with spina bifida: 
understanding experiences in the context of other competing care issues. Journal of pediatric 
urology, 19(2), 181-189. 
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9. 
Foster, C. B., Ackerman, K., Hupertz, V., Mustin, L., Sanders, J., Sisson, P., & Wenthe, 
R. E. (2020). Catheter-associated urinary tract infection reduction in a pediatric safety 
engagement network. Pediatrics, 146(4). 
10. 
Rinke, M. L., Oyeku, S. O., Heo, M., Saiman, L., Zachariah, P., Rosenberg, R. E., ... & 
Bundy, D. G. (2020). Pediatric ambulatory catheter-associated urinary tract infections (CAUTIs): 
Incidence, risk factors, and patient outcomes. Infection Control & Hospital Epidemiology, 41(8), 
891-899. 
11. 
Snyder, M. D., Priestley, M. A., Weiss, M., Hoegg, C. L., Plachter, N., Ardire, S., & 
Thompson, A. (2020). Preventing catheter-associated urinary tract infections in the pediatric 
intensive care unit. Critical care nurse, 40(1), e12-e17. 
12. 
Davis, K. F., Colebaugh, A. M., Eithun, B. L., Klieger, S. B., Meredith, D. J., Plachter, N., 
... & Coffin, S. E. (2014). Reducing catheter-associated urinary tract infections: a quality-
improvement initiative. Pediatrics, 134(3), e857-e864 
13.  
Center for Devices and Radiological Health. (2019). Pediatric medical devices. U.S. Food 
and Drug Administration. https://www.fda.gov/medical-devices/products-and-medical-
procedures/pediatric-medical-devices 
 
 
25.0 
VERSION HISTORY 
Ver. # 
Date 
 (DD-MMM-YYYY) 
Change Owner 
Description and Justification of Change 
1.0 
09-AUG-2024 
Ajesh Raju 
Original 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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26.0 
APPENDICES 
26.1 Appendix 1 - PureWickTM Male External Catheter 
 
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26.2 Appendix 2 - PureWickTM Flex Female External Catheter 
 
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26.3 Appendix 3 - PureWickTM Urine Collection System 
 
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26.4 Appendix 4 - Participant - Perception of Wetness Questionnaire (Both Male & Female) 
Participant Number: 
 
 
 
Device:  
            
                        
 
             PureWick Male                       PureWick Flex Female 
              External Catheter                   External Catheter 
After HCP Placement Void 
  
  
Extremely 
wet 
Very wet 
Somewhat 
wet 
Slightly 
wet but 
acceptably 
dry 
Dry (not 
at all 
wet) 
  
Question 
1 
2 
3 
4 
5 
1 
On a scale of 1-5 where 1 is 
‘Extremely wet’ and 5 is ‘Dry, (not at 
all wet)’, how wet or dry did you feel 
after your urination (pee)? 
  
  
  
  
  
1a 
If you selected 1, 2 or 3, please 
provide comments to tell us why you 
answered as you did (free text) 
 
 
Question 
Yes 
No 
  
  
  
2 
Did you feel leakage while urinating  
during use of the device? 
  
  
  
  
  
After Self-Placement Void 
  
  
Extremely 
wet 
Very wet 
Somewhat 
wet 
Slightly 
wet but 
acceptably 
dry 
Dry (not 
at all 
wet) 
  
Question 
1 
2 
3 
4 
5 
1 
On a scale of 1-5 where 1 is 
‘Extremely wet’ and 5 is ‘Dry, (not at 
all wet)’, how wet or dry did you feel 
after your urination (pee)? 
  
  
  
  
  
1a 
If you selected 1, 2 or 3, please 
provide comments to tell us why you 
answered as you did (free text) 
 
 
Question 
Yes 
No 
  
  
  
2 
Did you feel leakage while urinating 
during use of the device? 
  
  
  
  
  
 
 
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26.5 Appendix 5 – Participant – Ease of use Questionnaire (Both Male & Female) 
 Participant Number: 
Device:   
                 
                  
 
                PureWick Male                    PureWick Flex Female 
                 External Catheter                 External Catheter  
After Self-Placement Void 
 
 
Very 
difficult 
Somewh
at 
difficult 
Average 
difficulty 
Somewh
at easy 
Very easy 
  
Question 
1 
2 
3 
4 
5 
1 
On a scale of 1-5, where 1 is Very 
difficult, and 5 is Very Easy, How 
easy was the placement of the device?  
 
 
 
 
 
2 
On a scale of 1-5, where 1 is Very 
difficult, and 5 is Very Easy, How 
easy was the removal of the device?  
 
 
 
 
 
 
**The following questions are applicable for FEMALE participants only.** 
 
Please respond to the following questions regarding the PureWick™ Flex Female External Catheter on a scale of 1-5, 
where 1 is Strongly Disagree, and 5 is Strongly Agree. 
 
 
Strongly Disagree 
Disagree 
Neutral 
Agree 
Strongly 
Agree 
  
Question 
1 
2 
3 
4 
5 
3 
I was able to connect the device  
PureWick™ Flex FEC tubing to the 
suction tubing on the PureWick™ 
Urine Collection System 
  
  
  
  
  
3a 
If you selected 1, 2 or 3, please 
provide comments to tell us why you 
answered as you did (free text). 
  
   
  
  
4 
I was able to locate the vent hole on 
the PureWick™ Flex FEC and make 
sure it was not blocked. 
  
  
  
  
  
4a 
If you selected 1, 2 or 3, please 
provide comments to tell us why you 
answered as you did (free text). 
  
  
  
  
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5 
I would be able to tell if the 
PureWick™ Flex FEC came out of 
place. 
  
  
  
  
  
5a 
If you selected 1, 2 or 3, please 
provide comments to tell us why you 
answered as you did (free text). 
 
6 
I would be able to tell if the 
PureWick™ Flex FEC was in the 
correct orientation (i.e. tubing pointed 
toward the belly button). 
  
  
  
  
  
6a 
If you selected 1, 2 or 3, please 
provide comments to tell us why you 
answered as you did (free text). 
  
  
   
  
7 
I was able to curve the PureWick™ 
Flex FEC to fit my body. 
  
  
  
  
  
7a 
If you selected 1, 2 or 3, please 
provide comments to tell us why you 
answered as you did (free text). 
   
  
  
  
 
 
 
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26.6 Appendix 6 – Participant Comfort Questionnaire (Both Male and Female) 
 Participant Number: 
  
  
Device: 
                                  
                        
 
                                  PureWick Male                       PureWick Flex Female 
                                   External Catheter                   External Catheter 
After Completion of All Voids 
 
Please respond to the following questions regarding device comfort on a scale of 1-5, where 1 is Very 
Uncomfortable, and 5 is Very Comfortable 
 
  
 
Very 
uncomfortable 
Uncomfortable 
Neither 
Comfortable 
nor 
Uncomfortable 
Comfortable 
Very 
Comfortable 
 
  
Question 
1 
2 
3 
4 
5 
 
1 
How comfortable was the 
placement of the 
PureWick™ External 
Catheter?  
  
  
  
  
  
 
2 
How comfortable was the 
device while you were 
voiding? 
  
  
  
  
  
 
3 
How comfortable was the 
removal of the PureWick™ 
External Catheter?  
  
  
  
  
  
 
  
 
Very Unlikely  
Unlikely 
Neither Likely 
nor Unlikely 
Likely 
Very Likely 
 
 
Question 
1 
2 
3 
4 
5 
 
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™ External 
Catheter to someone else?  
  
  
  
  
  
 
 
 
 
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26.7 Appendix 7 – Participant IFU Evaluation Questionnaire (Both Male and Female) 
 Participant Number: 
  
Device:  
                     
                        
 
                         PureWick Male                       PureWick Flex Female 
                          External Catheter                   External Catheter 
After Self-Placement Void 
 
Please respond to the following questions regarding the PureWick™ External Catheter on a scale of 1-5, where 1 is 
Strongly Disagree, and 5 is Strongly Agree. 
  
Strongly 
Disagree 
Disagree 
Neutral 
Agree 
Strongly 
Agree 
  
Questions 
1 
2 
3 
4 
5 
 
1 
I was able to understand and follow 
the written instructions in the 
PureWick™ External Catheter 
instructions for use so that I could 
perform the steps myself. 
  
  
  
  
  
 
1a 
If you selected 1, 2 or 3, please 
provide comments to tell us why 
you answered as you did (free text). 
  
  
  
 
2 
I was able to understand the pictures 
in the PureWick™ External 
Catheter instructions for use so that 
I could perform the steps myself. 
  
  
  
  
  
 
2a 
If you selected 1, 2 or 3, please 
provide comments to tell us why 
you answered as you did (free text). 
  
   
 
3 
I was able to place the PureWick™ 
external catheter on myself. 
  
  
  
  
  
 
3a 
If you selected 1, 2 or 3, please 
provide comments to tell us why 
you answered as you did (free text). 
  
  
  
 
 
 
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26.8 Appendix 8 – HCP – Ease of use Questionnaire 
HCP Initials: 
  
  
Device:  
                      
                        
 
                         PureWick Male                       PureWick Flex Female 
                          External Catheter                   External Catheter 
PUREWICK™ MALE - After Completion of All Participants 
  
 
Very Difficult 
Somewhat 
Difficult 
Average 
Difficulty 
Somewhat 
Easy 
Very Easy 
  
Question 
1 
2 
3 
4 
5 
 
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 device?  
  
  
  
  
  
 
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 device?  
  
  
  
  
  
 
PUREWICK™ FEMALE - After Completion of All Participants 
 
  
 
Very Difficult 
Somewhat 
Difficult 
Average 
Difficulty 
Somewhat 
Easy 
Very Easy 
 
  
Question 
1 
2 
3 
4 
5 
 
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 device?  
  
  
  
  
  
 
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 device?  
  
  
  
  
  
 
 
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