Evaluating the Efficacy and Comfort of the PureWick Male External Catheter Against a Comparator in Healthy Volunteers
Phase: NA
Conditions: Non-invasive Urine Output Management
Sponsor: C. R. Bard

Protocol Number: UCC-23AC022 
 
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TITLE PAGE 
 
Protocol Title:  
Evaluating the efficacy and comfort of the PureWick™ Male External Catheter against a 
Comparator in Healthy Volunteers  
 
Protocol Number: UCC-23AC022  
Version Number: 1.0  
Study Device: BD PureWick™ Male External Catheter (PWM030) 
Study Type: Post-Market 
Short Title:  MECCE (Male External Catheters’ Comparison of Comfort & Efficacy) 
Sponsor Name: Becton, Dickinson and Company 
Legal Registered Address:  
Becton, Dickinson and Company 
8195 Industrial Blvd 
Covington, GA 30014 
Sponsor Contact: 
Ajesh Raju 
Clinical Project Manger 
Ajesh.Raju@bd.com  
 
Regulatory Agency Identifier Number(s): NCT number TBD 
National Principal Investigator:  TBD 
Version History 
Version Number 
Date 
Type 
1.0 
TBD 
Original 
 
 
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SPONSOR PROTOCOL APPROVAL  
 
Signature below indicates approval of the protocol as written. 
Individual or 
function 
Name 
Signature 
Date 
Medical Affairs 
Team Representative 
Danielle Redmond 
This document is 
signed 
electronically in the 
eTMF system 
 
Study Statistician 
Yanchang Zhang 
This document is 
signed 
electronically in the 
eTMF system 
 
Regulatory Affairs 
Jenny McKinnon 
This document is 
signed 
electronically in the 
eTMF system 
 
Clinical Affairs 
Kirsten Hammitt 
This document is 
signed 
electronically in the 
eTMF system 
 
UCC – Quality 
Engineering 
Michael Wolfe 
This document is 
signed 
electronically in the 
eTMF system 
 
 
 
 
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PROTOCOL SIGNATURE PAGE 
   
Investigator Responsibilities 
 
1. Prior to participation in this study, the Investigator or Institution must sign the Clinical 
Study Agreement (CSA) and obtain written approval from the appropriate Institutional 
Review Board (IRB)/Ethics Committee (EC). 
2. The Investigator must receive BD-sponsored training prior to site activation. The 
Investigator is responsible for ensuring that all Sub-Investigators and clinical staff are 
adequately trained prior to performing any data collection or study-related procedures.   
3. The Principal Investigator shall ensure that the study is conducted in accordance with the 
study protocol, any modifications as requested by the IRB/EC, the signed CSA, the 
ethical principles of the Declaration of Helsinki, Good Clinical Practice (ICH E6) / ISO 
14155), and applicable national/regional regulations and laws. 
4. If applicable, ensure that written informed consent is obtained from each participant prior 
to the conduct of any study procedure, using the current IRB/EC approved Informed 
Consent Form. 
 
I have read and understand the contents of this study protocol. I agree to follow and abide by the 
requirements set forth in this document. I agree to conduct the trial in accordance with 
the study protocol, the signed Clinical Study Agreement, and Good Clinical Practice (GCP) as 
well as applicable FDA and ISO regulations (e.g., 21 CFR Parts 812, 50, 54, 56; ISO 14155). I 
agree to participate in BD-Sponsored training prior to performing any data collection or study-
related procedures. 
 
 
Agreed to by (Investigator):  
  
_______________________________________________  
Printed Name – Investigator   
  
_______________________________________________  
Signature – Investigator  
 
_______________________________________________  
 Site Number 
 
_______________________________________________  
Date  
 
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TITLE PAGE .................................................................................................................................. 1 
Abbreviations .................................................................................................................................. 8 
1 
PROTOCOL SUMMARY ...................................................................................................... 9 
1.1 
Synopsis ........................................................................................................................... 9 
1.2 
Schema ........................................................................................................................... 15 
2 
INTRODUCTION ................................................................................................................ 16 
2.1 
Background .................................................................................................................... 16 
2.2 
Rationale......................................................................................................................... 17 
2.3 
Risk/Benefit Assessment ................................................................................................ 17 
2.3.1 
Risk Assessment ..................................................................................................... 17 
2.3.2 
Benefit Assessment ................................................................................................. 19 
2.3.3 
Overall Benefit: Risk Conclusion ........................................................................... 20 
3 
OBJECTIVES AND ENDPOINTS ...................................................................................... 20 
4 
STUDY DESIGN.................................................................................................................. 20 
4.1 
Overall Design................................................................................................................ 20 
4.2 
Scientific Rationale for Study Design ............................................................................ 22 
4.2.1 
Participant Input into Design .................................................................................. 23 
4.3 
End of Study Definition ................................................................................................. 23 
5 
STUDY POPULATION ....................................................................................................... 23 
5.1 
Inclusion Criteria ............................................................................................................ 23 
5.2 
Exclusion Criteria ........................................................................................................... 24 
5.3 
Lifestyle Considerations ................................................................................................. 24 
5.4 
Screen Failures ............................................................................................................... 24 
6 
STUDY INTERVENTION(S) .............................................................................................. 24 
6.1 
Investigational/Test Device ............................................................................................ 24 
6.2 
Control Device/Standard of Care ................................................................................... 24 
6.3 
Ancillary Devices/Products ............................................................................................ 25 
6.4 
Device Labeling ............................................................................................................. 25 
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6.5 
Treatment Allocation and Measures to Minimize Bias .................................................. 25 
6.5.1 
Randomization ........................................................................................................ 25 
6.5.2 
Blinding/Masking ................................................................................................... 26 
7 
STUDY PROCEDURES AND ASSESSMENTS ................................................................ 26 
7.1 
Subject Preparation – Prior to Arrival at Site ................................................................. 27 
7.2 
Screening and Enrollment .............................................................................................. 27 
7.3 
Medical History / Baseline Assessments ....................................................................... 27 
7.4 
Randomization ............................................................................................................... 27 
7.5 
Test Procedure ................................................................................................................ 28 
8 
PARTICIPANT DISCONTINUATION/WITHDRAWAL.................................................. 29 
8.1 
Discontinuation/Withdrawal .......................................................................................... 29 
8.2 
Lost to Follow-Up .......................................................................................................... 29 
9 
ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................... 29 
9.1 
Definitions of Events ...................................................................................................... 30 
9.1.1 
Adverse Events (AEs) ............................................................................................. 30 
9.1.2 
Serious Adverse Events (SAEs).............................................................................. 30 
9.1.3 
Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) .............. 30 
9.1.4 
Unanticipated (Serious) Adverse Device Effect (UADE/USADE) ........................ 31 
9.2 
Severity of Adverse Events ............................................................................................ 31 
9.3 
Relationship of Adverse Event to Device(s)/Procedure ................................................. 32 
9.4 
Reporting of Events ........................................................................................................ 32 
9.5 
Safety Committees ......................................................................................................... 33 
9.6 
Device Deficiencies........................................................................................................ 33 
10 STATISTICAL METHODS ................................................................................................. 34 
10.1 Overview of Study Design ............................................................................................. 34 
10.2 Sample Size Considerations ........................................................................................... 34 
10.3 Analysis Population........................................................................................................ 34 
10.4 General Considerations .................................................................................................. 35 
10.4.1 Handling of Missing Data ....................................................................................... 35 
10.4.2 Covariates ............................................................................................................... 35 
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10.4.3 Multiplicity Control ................................................................................................ 35 
10.5 Primary Endpoint(s) ....................................................................................................... 35 
10.6 Secondary Endpoint(s) ................................................................................................... 36 
10.7 Other Analyses ............................................................................................................... 36 
11 DATA COLLECTION AND RECORD MAINTENANCE ................................................ 36 
11.1 Case Report Forms ......................................................................................................... 36 
11.2 Source Documentation ................................................................................................... 37 
11.3 Data Management .......................................................................................................... 37 
11.4 Record Retention ............................................................................................................ 37 
12 QUALITY CONTROL AND ASSURANCE ...................................................................... 38 
12.1 Control of Study Products .............................................................................................. 38 
12.2 Monitoring ...................................................................................................................... 38 
12.3 Audits and Inspections ................................................................................................... 39 
12.4 Protocol Deviations ........................................................................................................ 40 
13 ADMINISTRATIVE REQUIREMENTS ............................................................................ 40 
13.1 Investigator and Site Selection ....................................................................................... 40 
13.2 Training .......................................................................................................................... 41 
13.3 Required Documents ...................................................................................................... 41 
13.4 Publication Policy .......................................................................................................... 41 
13.5 Study Registration .......................................................................................................... 42 
13.6 Termination of Study ..................................................................................................... 42 
14 ETHICAL AND REGULATORY CONSIDERATIONS .................................................... 42 
14.1 IRB/EC Approval ........................................................................................................... 43 
14.2 Informed Consent and Confidentiality ........................................................................... 43 
14.2.1 Confidentiality ........................................................................................................ 43 
14.3 Regulatory Status ........................................................................................................... 44 
14.4 Statement of Compliance ............................................................................................... 44 
15 REFERENCES ..................................................................................................................... 45 
16 APPENDICES ...................................................................................................................... 46 
16.1 Appendix 1: PureWick™ Male External Catheter Instructions for Use (IFU) .............. 46 
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16.2 Appendix 2: Sage PrimoFit™ Instructions for Use (IFU) ............................................. 48 
16.3 Appendix 3: Participant Comfort Scale Survey ............................................................. 50 
16.4 Appendix 4: Professional Ease of Use Questionnaire .................................................... 51 
 
 
 
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Abbreviations 
 
AE 
Adverse event 
Bard 
C. R. Bard, Inc. 
BD 
Becton Dickinson and Company 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CRF 
Case Report/Record Form 
CRO 
Contract Research Organization 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
FDAAA 
FDA Amendments Act of 2007 
GCP 
Good Clinical Practice 
HCP 
Health Care Professional 
HIPAA  
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IFU 
Instructions for use 
IRB/EC 
Institutional or Independent Review Board/Ethics Committee 
MEC 
Male external catheter 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SoA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
TMF 
Trial Master File 
WHO 
World Health Organization 
 
 
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1 
PROTOCOL SUMMARY 
 
1.1 Synopsis 
 
Protocol Title 
Evaluating the efficacy and comfort of the PureWick™ male external 
catheter against a comparator in Healthy Volunteers 
Short Title 
MECCE (Male External Catheters’ Comparison of Comfort & Efficacy) 
Rationale 
The purpose of this study is to provide clinical evidence to compare the 
effectiveness and comfort of PureWick™ Male against a comparator for 
non-invasive urine output management in patients with varying male 
anatomy. 
Objectives and Endpoints 
 
Objective(s) 
Endpoint(s) 
Primary 
• 
To assess the 
performance of the 
PureWick™ Male 
(System) against an 
established comparator 
(Stryker/ Sage 
PrimoFit™) 
Primary 
• 
Capture rate following void 
(captured as % of urine 
captured by device and 
collected in canister, 
measured by weight) 
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Protocol Title 
Evaluating the efficacy and comfort of the PureWick™ male external 
catheter against a comparator in Healthy Volunteers 
Secondary Objective (with 
Hypothesis Test): 
• 
To assess the 
performance of the 
PureWick™ Male 
(System) in patients that 
are unable to use 
traditional sheath style 
condom catheters.  
 
Secondary Objective (without 
Hypothesis test): 
• 
To assess participant 
comfort after using the 
MEC 
 
• 
To assess ease of use by 
HCP in placing the MEC  
Secondary 
• 
Capture rate following void 
(captured as % of urine 
captured by device and 
collected in canister, 
measured by weight). 
 
 
 
 
• 
Overall Comfort score on a 
5-point Likert scale (brief 
questionnaire) 
 
• 
Ease of use score on a 5-
point Likert scale (brief 
questionnaire) 
Design and Overview 
This is a Prospective, Randomized, Crossover, Single-blind, Single 
Center Healthy Volunteer Study conducted over 1 day, with 2 voids 
using the PW Male external catheter vs. comparator Sage PrimoFit™. 
This study is designed to assess the performance, comfort, and ease of 
use of the PW Male external catheter as compared to the comparator 
product.  
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Protocol Title 
Evaluating the efficacy and comfort of the PureWick™ male external 
catheter against a comparator in Healthy Volunteers 
Study Device 
Test product(s):  BD PureWick™ Male (PWM030) 
The PureWick™ Male External Catheter (MEC) is intended for non-
invasive urine output management in male patients. The PureWick™ 
Male External Catheter is a commercially available device which is 
Class I, 510(K) exempt. 
Reference/Comparator product(s): Sage PrimoFit™ (5404) 
The Sage PrimoFit™ is a commercially available device which is Class 
I, 510(K) exempt. 
Ancillary Product(s): 
• 
Standard suction tubing and cannister 
• 
BBS Revolution: Bladder Scanner + Display (PD0100002) 
• 
Absorbent under-pads 
• 
Commercially available scales 
• 
Clippers/trimmers 
• 
Wipes/towels for peri-care 
• 
Turning wedge (45-degree foam wedge) 
• 
PPE 
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Protocol Title 
Evaluating the efficacy and comfort of the PureWick™ male external 
catheter against a comparator in Healthy Volunteers 
Participants 
Adult male healthy volunteers with a target of 50% of subjects in each 
of the following cohorts: 
o Cohort A: Non morbidly obese men: BMI <40  
o Cohort B: Morbidly Obese men: BMI ≥40 
o  
Inclusion Criteria: 
 
• 
Adult Male Patients >18 years old 
• 
Male anatomy at time of enrollment  
• 
Ability to speak and understand English 
• 
Willing to comply with all study procedures in this protocol 
• 
Able to independently void urine 
• 
Provision of signed and dated informed consent form 
 
Exclusion Criteria: 
 
• 
Urinary incontinence which does not allow the subject to 
spontaneously void 
• 
Frequent episodes of bowel incontinence 
• 
Has Urinary Retention 
• 
Has any irritation, wound, open lesion, at the application site, on 
the genitalia, perineum, or sacrum 
• 
Recent surgery of the external urogenital tract, penis, or pubic 
area 
• 
Not able to comply with study procedures independently 
without required assistance 
• 
Any other condition that, in the opinion of the investigator, 
would preclude them from participating in the study 
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Intervention(s)/Procedure(s) Prior to arrival, participants will be instructed to consume fluids and to 
come to the test site with a full bladder. Upon arrival at the test site, 
participants will be consented and screened against inclusion/exclusion 
criteria. Those meeting eligibility criteria will be assigned a treatment 
order. Participants will be divided into two cohorts.  
Cohort A: Non morbidly obese men: BMI <40 
Cohort B: Morbidly obese men: BMI ≥40 
Participants will be placed in the test area, instructed to undress, and put 
on a gown. The Health Care Professional (HCP) will complete a visual 
assessment of the participant’s pubic/ genital region to ensure that the 
participant is trimmed and assess the anatomy. Trimmers can be 
provided if the participant did not arrive to the site trimmed. The HCP 
will then assess for a buried penis and/or anatomical compatibility with 
traditional sheath style condom catheters for each participant. “A buried 
penis refers to a normal-sized phallus encompassed by either skin, 
subcutaneous tissue, and/or fat in the prepubic area” causing a reduced 
visible and/or functional length of the phallus.11 
Void 1: 
The bed in the test area will be set with a pre-weighed absorbent pad and 
a pre-weighed urine collection canister (with the lid).  Once the 
participant feels the need to void, the Health Care Professional (HCP) 
will place either the PureWick™ MEC (Device A) or the Sage 
PrimoFit™ (Device B) (depending on randomized treatment order) 
according to the device instructions for use (IFU) and confirm the 
correct placement prior to the voiding episode. The participant will be 
placed in a semi-fowler position (head of bed elevated approximately 30 
degrees) in a hospital bed and turned to one side using a turning wedge 
prior to the voiding episode. Participants will be monitored for 
approximately 2 hours from the time of the device application, through 
one void. (The skin needs to be assessed at least every two hours while 
wearing a MEC.) After the void, the pre-weighed absorbent pad and 
urine collection canister will be weighed (with the lid), and weights 
documented in the source. The Pure Wick MEC or Sage PrimoFit™ will 
be removed by the HCP. After removal, the HCP will note any signs of 
irritation/injury in the perineal area. Any unresolved erythema (redness), 
erythema (swelling), bleeding, injury, or rash should be recorded as an 
Adverse Event. 
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Protocol Title 
Evaluating the efficacy and comfort of the PureWick™ male external 
catheter against a comparator in Healthy Volunteers 
The participant will be asked to complete a brief survey to assess device 
comfort immediately after the completed void. 
The HCP will be asked to complete a brief survey to assess device ease 
of use for the participant just treated.  
Void 2:   
Participants will be asked to not void and to drink approximately 16 
fluid ounces of liquid. When the participant feels the need to void (a 
second time), the HCP will confirm via bladder scanning procedure that 
the bladder volume is ≥125mL If the volume is determined to be 
inadequate, the participant will be asked if they can wait to void, drink 
additional fluids as tolerated and be re-assessed in approximately 30 
minutes. If the participant does not feel comfortable waiting to void, 
they will be allowed to proceed with void 2. 
Void 2 will be repeated per the Void 1 procedure using the 2nd device 
assigned per randomization. 
The participant will complete a brief survey (for the second device 
sequence) immediately following the void to assess device comfort and 
will then be discharged from the study. 
The HCP will complete a brief survey to assess device ease of use for 
the participant just treated. 
Investigational Sites 
1 site in the US  
Data Monitoring 
Committee 
Not Applicable 
Regulatory Status 
Post-Market   
The investigation will use both the PureWick™ Male External Catheter 
and Sage PrimoFit™ for its intended purpose. 
 
 
 
 
 
 
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1.2 Schema 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening and 
Enrollment 
Obtain informed consent. Screen potential participants by inclusion and exclusion criteria, 
obtain history, document.   
Randomize (Sequence 1 or Sequence 2) 
Void #1 
The HCP will place either the Pure Wick MEC (Device A) or the Sage Primo Fit (Device B) 
(depending on randomized sequence order) according to the device instructions for use (IFU) 
and confirm the correct placement prior to the voiding episode. The HCP will remove the 
device once void is completed.  
Participant 
Questionnaire 
The participant will be asked to complete a brief survey to assess device comfort.  
Void #2 
Void 2 will be repeated similarly to void 1. Participant will be asked not to void and to drink 
approximately 16 ounces of fluid prior to the second void. HCP will place the second device. 
Bladder scanner will be used to confirm amount of fluid in bladder prior to the voiding 
episode. 
HCP 
Questionnaire 
The HCP will be asked to complete a brief survey to assess device ease of use. 
The participant will be asked to complete a brief survey to assess device comfort. Once 
completed, they will be discharged from the study.  
Participant 
Questionnaire 
Participants will be placed in the test area, instructed to undress, and put on a gown. The 
Health Care Professional (HCP) will complete a visual assessment of the participant’s pubic/ 
genital region to ensure that the participant is trimmed and assess the anatomy. Trimmers can 
be provided if the participant did not arrive to the site trimmed. The HCP will then assess for 
a buried penis and/or anatomical compatibility with traditional sheath style condom catheters 
for each participant. 
Randomization 
HCP Assessment 
The HCP will be asked to complete a brief survey to assess device ease of use. 
HCP 
Questionnaire 
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2 
INTRODUCTION 
The PureWick™ MEC is intended for non-invasive urine output management in male 
patients. The PureWick™ MEC is a single use nonsterile device. It is composed of the 
following elements: a flexible polyurethane shell, a patient-contacting adhesive intended 
for up to 24 hours of wear, a spacer fabric layer to function as a fluid pathway, a drainage 
fitting to connect to standard hospital suction, and vents to allow for air intake. To 
capture voided urine, the catheter is connected to a wall vacuum system.  This vacuum 
(not felt by the user) is intended to pull urine through the catheter, regardless of the urine 
flow rate. Urine continues quickly through vinyl tubing until it reaches a collection 
canister, away from the body. 
The PureWick™ MEC does not require a doctor’s order, is a commercially available and 
marketed device commonly used in the hospital setting, and is an FDA 510(k) Exempt, 
Class I device.  See Appendix 1 for the Instructions for Use (IFU). 
 
2.1 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 
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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 Lastly, condom catheters 
can only be used for males with normal anatomy and cannot be used with men with 
buried/hidden penis. “A buried penis refers to a normal-sized phallus encompassed by 
either skin, subcutaneous tissue, and/or fat in the prepubic area” causing a reduced visible 
and/or functional length of the phallus11; buried penis is an acquired deformity secondary 
to obesity8,9. Obesity is increasing in our society, with a prevalence of up to 40.8% in 
middle-aged men.8 This condition is also commonly seen in the acute care setting in 
critically ill patients with third spacing and generalized gross edema. Although no 
published data are available that could be found regarding the specific incidence of the 
hidden penis in morbidly obese men, acquired buried penis is increasing in incidence in 
adult men as morbid obesity becomes more prevalent.10 
The PureWick™ Male External Catheter (MEC) is a new external drainage device to 
address the need for an effective, non-invasive method of managing urine output in male 
patients.   
 
2.2 Rationale 
The purpose of this study is to provide clinical evidence to compare the effectiveness and 
comfort of PureWick™ Male against a comparator for non-invasive urine output 
management in patients with varying male anatomy. Specifically, the study will collect 
data about how the male external catheters perform when participants are positioned on 
their side using a turning wedge with the head of the bed elevated, mimicking common 
patient positioning in the hospital setting.  
 
2.3 Risk/Benefit Assessment 
Participants in this study will be treated with approved, marketed devices and will use the 
investigational devices as intended. Therefore, participants will be exposed to the same 
risks shared by all patients using these devices for urine output management in a real-
world setting. More detailed information about the known and expected benefits and risks 
and reasonably expected adverse events of the PureWick™ MEC and the Sage 
PrimoFit™ may be found in the Instructions for Use of each product. 
 
 
2.3.1 Risk Assessment 
 
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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Mitigation Strategy 
Study Intervention: PureWick™ Male External Catheter 
Potential adverse events: 
 
• 
Skin injury 
• 
Skin irritation 
• 
Allergic reaction 
 
 
 
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. 
• 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. 
Study Intervention: Sage PrimoFit™ 
Potential adverse events:  
 
• Skin injury 
• Skin irritation 
 
Sage PrimoFit™ is an 
external urine management 
device for the male anatomy 
that adheres to the pelvic and 
abdominal skin.  
• Clean, prep, and dry 
patient’s genital area 
before device 
application 
• Perform skin 
assessment every 2 
hours 
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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Mitigation Strategy 
• Assess device 
periodically to ensure 
proper placement, 
particularly after 
turning or 
repositioning patient. 
• Device can be left on 
skin for up to 24 
hours. Replace device 
if soiled with stool or 
bodily fluids other 
than urine. 
• Discontinue use 
during patient 
ambulation. 
Study Procedures 
Discomfort due to full 
bladder 
Participants will be asked to 
refrain from voiding until 
bladder volume reaches 
>125mL 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. 
 
 
 
2.3.2 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 PureWick™ MEC or Sage 
PrimoFit™. 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 patients.  
 
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2.3.3 Overall Benefit: Risk Conclusion 
Taking into consideration the measures to minimize risk to participants in this 
study, the potential risks identified in association with both the PureWick™ Male 
External Catheter and the Sage PrimoFit™ are minimal. Both products are 
commercially available for use. This is a post-market, non-significant risk study.  
 
3 
OBJECTIVES AND ENDPOINTS 
 
 
Objectives 
Endpoints 
Primary 
 
• 
To assess the performance of the PureWick™ 
Male (System) against an established 
comparator (Stryker/ Sage PrimoFit™)  
• 
Capture rate following void (captured as % of 
urine captured by device and collected in 
canister, measured by weight) 
Secondary (With Hypothesis Test) 
 
• 
To assess the performance of the PureWick™ 
Male (System) in patients that are unable to 
use traditional sheath style condom catheters  
• 
Capture rate following void (captured as % of 
urine captured by device and collected in 
canister, measured by weight) 
Secondary (Without Hypothesis Test) 
 
• 
To assess participant comfort after using the 
MEC 
• 
Overall Comfort score on a 5-point Likert 
scale (brief questionnaire) 
• 
To assess ease of use by HCP in placing and 
removing the MEC 
• 
Ease of use score on a 5-point Likert scale 
(brief questionnaire) 
 
 
4 
STUDY DESIGN 
 
4.1 Overall Design 
 
In this prospective, post-market, crossover, single-blind, single center healthy volunteer 
study, healthy males will be randomized 1:1 to a treatment sequence using two devices 
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(PureWick™ Male External Catheter and Sage PrimoFit™) and followed for 1 day 
through 2 voids. Approximately 50 participants will be enrolled in this study to obtain 44 
evaluable subjects. This study is designed to assess the performance, comfort, and ease of 
use of the PW Male external catheter. 
Prior to arrival, participants will be instructed to consume fluids and to come to the study 
site with a full bladder. Upon arrival at the site, participants will be consented and 
screened against inclusion/exclusion criteria. Participants meeting eligibility criteria will 
be assigned a treatment cohort. Participants will be divided into two cohorts. 
A. Non-morbidly obese men: BMI <40 or; 
B. Morbidly Obese men: BMI ≥40.  
Prior to any study activities, participants will be asked to review the Informed Consent 
Form and will have an opportunity to ask the Principal Investigator (PI) any questions. 
Participants will be considered enrolled after the PI determines they meet the inclusion 
criteria and receive a signed copy of the Informed Consent Form. 
Participants will be placed in the test area, instructed to undress, and put on a gown. The 
Health Care Professional (HCP) will complete a visual assessment of the participant’s 
pubic/ genital region to ensure that the participant is trimmed and assess the anatomy. 
Trimmers can be provided if the participant did not arrive to the site trimmed.  The HCP 
will assess for a buried penis and/or anatomical compatibility with traditional sheath style 
condom catheters for each participant. “A buried penis refers to a normal-sized phallus 
encompassed by either skin, subcutaneous tissue, and/or fat in the prepubic area” causing 
a reduced visible and/or functional length of the phallus.11 
 
Void 1: 
The bed in the test area will be set with a pre-weighed absorbent pad and a pre-weighed 
urine collection canister (with the lid).  Once the participant feels the need to void, the 
Health Care Professional (HCP) will place either the PureWick™ MEC or the Sage 
PrimoFit™ device (depending on randomized treatment order) according to the device 
instructions for use (IFU) and confirm the correct placement prior to the voiding episode. 
The participant will be placed in a semi-fowler position (head of bed elevated 
approximately 30 degrees) in a hospital bed and turned to one side using a turning wedge 
prior to the voiding episode. Participants will be monitored for approximately 2 hours 
from the time of the device application, through one void. The skin needs to be assessed 
at least every two hours while wearing a MEC. After the void, the pre-weighed absorbent 
pad and urine collection canister will be weighed (with the lid), and weights documented 
in the source. The Pure Wick MEC or Sage PrimoFit™ will be removed by the HCP. 
After removal, the HCP will note any signs of irritation/injury in the perineal area. Any 
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unresolved erythema (redness), erythema (swelling), bleeding, injury, or rash should be 
recorded as an Adverse Event. The participant will be asked to complete a brief survey to 
assess device comfort immediately after the completed void. 
The HCP will complete a brief survey to assess device ease of use for the participant just 
treated. 
Void 2:   
Participants will be asked to not void and to drink approximately 16 fluid ounces of 
liquid. When the participant feels the need to void (a second time), the HCP will confirm 
via bladder scanning procedure that the bladder volume is ≥125mL. If the volume is 
determined to be inadequate, the participant will be asked to drink fluids as tolerated and 
re-assessed in approximately 30-60 minutes.  
Void 2 will be repeated per the Void 1 procedure using the 2nd device assigned per 
randomization. 
The participant will be asked to complete a brief survey (for the second device sequence) 
immediately following the void to assess device comfort and will then be discharged 
from the study. 
The HCP will complete a brief survey to assess device ease of use for the participant just 
treated. 
4.2 Scientific Rationale for Study Design 
This study will assess the performance of and user experience with PureWick™ Male 
External Catheter when compared with a marketed comparator, Sage PrimoFit™ Male 
External Catheter. To best mimic potential users of the study devices, male participants 
>18 years of age will be enrolled. Additionally, enrollment will target approximately 50% 
of the sample size of men in two different BMI cohorts so that potential differences based 
on anatomy can be characterized. As such, participants in this study adequately represent 
the patients who would use the device in the hospital setting. 
In the critical care setting or with patients that have limited mobility, it is commonly 
ordered for patients to be repositioned and turned on their side every two hours. A turning 
wedge is a device used by hospitals to prop the patient onto their side. Additionally, the 
patient is commonly ordered to elevate the head of the bed. The Primary endpoint 
provides a reliable and valid measurement of the efficacy related to the function of the 
device by capturing and weighing all urine output per void, including leakage, and 
dividing by the captured amount of urine in the canister. A higher captured rate 
constitutes a more meaningful effect. Questionnaires using a 5-point Likert scale will be 
administered to each participant to assess comfort, and to each HCP to assess ease of use. 
A higher Likert score, such as a 4 or 5, constitutes a more meaningful effect on these 
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secondary endpoints. Furthermore, this study seeks to understand if the PureWick™ 
MEC will perform effectively in male anatomy that is not compatible with traditional 
sheath-style condom catheters in a controlled setting. 
 
4.2.1 Participant Input into Design 
There was no participant involvement in the design of this study.  
 
4.3 End of Study Definition 
A participant is considered to have completed the study if he has completed both voids 
and the corresponding questionnaires. 
The end of the study is defined as the date of completion of the last participant in the 
study. 
 
5 
STUDY POPULATION 
 
Adult male healthy volunteers will be recruited for this study with a target of 50% of 
participants in each of the two BMI cohorts. Participants will be recruited from an existing 
pool of volunteers in a database owned by a third-party research vendor.  Basic screening 
questions will be used to identify potential participants and full screening against 
inclusion/exclusion criteria will be completed on the day of enrollment.  
 
5.1 Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the 
following criteria: 
1. Adult Male Patient ≥ 18 years old 
2. Male anatomy at time of enrollment 
3. Ability to speak and understand English 
4. Willing to comply with all study procedures in this protocol 
5. Able to independently void urine 
6. Provision of signed and dated informed consent form 
 
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5.2 Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Urinary incontinence which does not allow the subject to spontaneously void 
2. Frequent episodes of bowel incontinence 
3. Has Urinary Retention 
4. Has any irritation, wound, open lesion, at the application site, on the genitalia, 
perineum, or sacrum 
5. Recent surgery of the external urogenital tract, penis, or pubic area 
6. Not able to comply with study procedures independently without required 
assistance 
7. Any other condition that, in the opinion of the investigator, would preclude them 
from participating in the study 
 
5.3 Lifestyle Considerations 
No restrictions are required. 
 
5.4 Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study 
but are not subsequently randomized into the study. Demographic information may be 
captured for screen failures. Screen failures will not be allowed to re-screen. 
 
6 
STUDY INTERVENTION(S) 
   
6.1 Investigational/Test Device 
The PureWick™ MEC is a commercially available device. It is a Class I, 510(k) exempt 
device. The device is intended for non-invasive urine output management in male 
patients. The PureWick™ MEC is a single-use, non-sterile device. The IFU for the 
PureWick™ MEC can be found in Appendix 1. 
 
6.2 Control Device/Standard of Care 
The Sage PrimoFit™ is a commercially available device. It is a Class I, 510(K) exempt 
device. The device is intended for non-invasive external collection of urine for adult 
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patients with male anatomy who require urine management. The Sage PrimoFit™ is a 
single -use, non-sterile device. The IFU for the Sage PrimoFit™ can be found in 
Appendix 2.  
 
6.3 Ancillary Devices/Products 
Ancillary products for this study are listed below.  
• Standard suction tubing and canisters 
• BBS Revolution: Bladder Scanner + Display (PD0100002) 
• Absorbent under-pads 
• Commercially available scales 
• Clippers/trimmers 
• Wipes/towels for peri-care 
• Turning wedge (45-degree foam wedge) 
• PPE 
 
6.4 Device Labeling 
All commercial products will be supplied as labeled by the manufacturer. The study site 
will document all study devices and products received. 
6.5 Treatment Allocation and Measures to Minimize Bias 
Known foreseeable factors that could potentially compromise the outcome of the 
investigation or interpretation of the results or introduce bias into the study are delineated 
in this section. 
This is a single-blind, cross-over study in which each subject acts as his own control and 
therefore, the difference in treatments is derived from a within-subject comparison. This 
allows for better control of potential cofounders and removes the inter-subject variability 
from the comparison between treatment groups.  
Standardized questionnaires will be used to assess participant comfort and HCP ease of 
use. As training level and device experience could be a foreseeable factor that could 
impact ease of use outcomes, HCPs will all be trained using standardized instructional 
videos and device IFUs.  
6.5.1 Randomization 
Participants will be randomized 1:1 to one of the two treatment sequences. 
Subjects randomized to Sequence 1 will use PureWick™ MEC first, followed by 
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Sage PrimoFit™. Subjects randomized to Sequence 2 will use Sage PrimoFit™ 
first, followed by PureWick™ MEC. Randomization will be stratified by cohorts 
(non-morbidly obese men: BMI <40 or morbidly obese men: BMI ≥40). This 
design allows for the evaluation of elements such as carryover effect, period 
effect, and sequence effect. 
The study site will receive randomization envelopes for each cohort that are 
numbered in sequential order. Within each randomization envelope, a treatment 
sequence assignment card will be enclosed. The randomization envelopes should 
be opened in sequential order only when all eligibility criteria are met. 
 
6.5.2 Blinding/Masking 
Complete study blinding is not feasible due to possible HCP familiarity with the 
study devices and visual differences between the product packaging. As such, this 
is a single-blind study in which only participants are blinded to which device is 
which. The Investigator and Sponsor will know which device the participant is 
being treated with at any given time. 
Blinding procedures will be reviewed at the time of site initiation by a Sponsor 
representative. During review of the study and the informed consent process with 
participants, blinding and rationale should be discussed with the participant.  
Any communication to the study personnel placing the device as to the 
randomized treatment sequence should be done in a way as to prevent the 
participant from overhearing. Devices should be referred to throughout the study 
period as ‘Device A’ and ‘Device B’ rather than the marketed product name. 
Participants will remain blinded to treatment order until the study is complete.  
 
7 
STUDY PROCEDURES AND ASSESSMENTS 
 
Study procedures and their timing are summarized in section 1.2. Protocol waivers or 
exemptions are not allowed. Adherence to the study design requirements, including 
those specified in this protocol, 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. 
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7.1 Subject Preparation – Prior to Arrival at Site 
Participants will be instructed to consume fluids prior to their scheduled visit and arrive 
to the site with a full bladder. Participants will be instructed to trim the hair in their pubis/ 
peri-area prior to arrival. 
 
7.2 Screening and Enrollment 
All participants will be screened against the inclusion and exclusion criteria (see section 
5.1 & 5.2). Eligibility criteria requiring a physical exam (e.g., height, weight, skin 
condition) will be confirmed after enrollment prior to device placement. 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 before the collection of 
any study data or performance of any study procedures. A participant who signs an 
informed consent will be considered enrolled in this study.  
A unique identification number will be given to study participants in sequential order.  
The participant number will consist of 7 digits.  The first three digits will designate the 
site number.  The alpha letter represents cohort assignment, and the last three digits will 
designate the participant by number in sequential order (i.e., participant number 301A101 
will be the first participant in cohort A; 301A102 will be the second participant in cohort 
A, etc.). 
 
7.3 Medical History / Baseline Assessments 
Participant demographic information, including age at time of enrollment, race, ethnicity, 
and sex, will be collected at baseline. In addition, the subject’s initials will be collected. 
Height and weight will be captured to calculate BMI.   
 
7.4 Randomization 
Subject will be 1:1 randomized to one of two treatment sequences, stratified by BMI. The 
study site will receive the randomization envelopes for each cohort that are numbered in 
sequential order. Within each randomization envelope, a treatment assignment card with 
randomization ID and treatment sequence assignment will be enclosed. The 
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randomization envelope should be opened in sequential order only when all eligibility 
criteria are met. 
 
7.5 Test Procedure 
1. After enrollment and randomization, the participant will be brought to the testing area 
and instructed to undress and put on a gown.  
a. The bed in the test area will be set with clean sheets, a pre-weighed absorbent 
pad and a pre-weighed urine collection canister.  
2. The Health Care Professional (HCP) will complete a visual assessment of the 
participant’s pubic and genital region to ensure that the participant is trimmed and 
assess the anatomy.  
a. Unless the participant arrives with their pubic hair pre-trimmed, the 
participant’s pubic hair will be clipped by themselves or a trained 
professional. 
b. The HCP will then complete a brief survey to assess for a buried penis and/or 
anatomical compatibility with traditional sheath style condom catheters for 
each participant. “A buried penis refers to a normal-sized phallus 
encompassed by either skin, subcutaneous tissue, and/or fat in the prepubic 
area” causing a reduced visible and/or functional length of the phallus.11 for 
each participant. 
3. The HCP will place either the PureWick™ MEC or the Sage PrimoFit™ device 
(depending on randomized sequence) according to the device IFU and confirm the 
correct placement. 
4. The participant will be placed in a semi-fowler position in the hospital bed and turned 
to one side using a turning wedge. The HCP should reconfirm correct device 
placement after repositioning. 
5. The HCP will ensure the collection cannister and suction tubing are connected to wall 
suction and the suction is set to a minimum of 40mmHg continuous suction. 
6. Once setup is confirmed and the device is placed, the participant will be allowed to 
spontaneously void. The participant will be monitored for up to 2 hours, through one 
void. 
7. After the void, the pre-weighed absorbent pad and urine collection canister (with lid) 
will be weighed and the weights will be documented in the source documents.  
8. The Pure Wick MEC or Sage PrimoFit™ will be removed by the HCP according to 
the IFU and discarded. 
9. After removal, the HCP will note any signs of irritation/injury in the perineal area.  
a. Any unresolved erythema (redness), erythema (swelling), bleeding, injury or 
rash must be recorded as an Adverse Event.  
 
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10. The HCP will complete a brief survey to assess device ease of use for the participant 
just treated.  
11. Participant will be asked not to void and to drink approximately 16 ounces of liquid.  
12. The second void will be repeated in same manner as the first void using the 2nd device 
assigned per randomization sequence. 
13. When the participant feels the need to void, the HCP will confirm via the bladder 
scanning that the bladder volume is ≥125mL.  
a. If the volume is determined to be inadequate, the participant will be asked to 
drink fluids as tolerated and re-assessed in approximately 30 minutes. If the 
participant does not feel comfortable waiting to void, they will be allowed to 
proceed with void 2. 
14. After device removal, the participant will complete a brief survey to assess device 
comfort. 
15. The HCP will complete a brief survey to assess device ease of use for the participant 
just treated. 
16. Once the second void has completed and all surveys are completed, the participant 
can be discharged from the study site.  
 
8 
PARTICIPANT DISCONTINUATION/WITHDRAWAL  
   
8.1 Discontinuation/Withdrawal 
• A participant may withdraw from the study at any time at his/her own request or may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety, 
behavioral, compliance, or administrative reasons. This is expected to be uncommon. 
• If the participant withdraws consent for disclosure of future information, the sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
• At the time of discontinuing from the study, no further assessments will be performed. 
 
 
8.2 Lost to Follow-Up 
This study only has one visit thus this is not applicable.  
 
9 
ADVERSE EVENTS AND DEVICE DEFICIENCIES 
 
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9.1 Definitions of Events 
 
9.1.1 Adverse Events (AEs) 
An adverse event 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 (ISO 
14155:2020). 
Pre-existing conditions should be considered as part of the participant’s medical 
history and should not be reported as an AE unless there is a substantial increase 
in severity or frequency of the condition, which has not been attributed to natural 
history. Likewise, planned hospital visits and/or hospital stays should not be 
considered as adverse events.  Exacerbation of an existing condition should be 
reported as an AE if the event meets the protocol definition of an AE. 
The clinical course of the event will be followed according to accepted standards 
of medical practice until the event resolves, stabilizes, or in the opinion of the 
Investigator, is no longer considered clinically significant.  The Investigator must 
supply the Sponsor with information concerning the follow up and/or resolution 
of the AE. 
 
9.1.2 Serious Adverse Events (SAEs) 
A serious adverse event is defined by ISO 14155 and/or 21 CFR 803.3 as an 
adverse event that:  
a. led to death;  
b. led to serious deterioration in health that resulted in life-threatening illness 
or injury, resulted in permanent impairment;  
c. required inpatient hospitalization/prolonged hospitalization, or resulted in 
medical/surgical intervention to prevent life-threatening illness/injury or 
permanent impairment; or  
d. led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
 
9.1.3 Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) 
An adverse device effect is defined as any adverse event that is considered to be 
related to the use of an investigational medical device. This definition includes 
any event resulting from insufficiencies or inadequacies in the instructions for 
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use, deployment, implantation, or operation or any malfunction of the 
investigational device (study device) and includes any event that is a result of a 
user error. 
A serious adverse device effect (SADE) is defined as an ADE that has resulted in 
any of the consequences characteristic of an SAE. 
 
9.1.4 Unanticipated (Serious) Adverse Device Effect (UADE/USADE) 
An unanticipated (serious) adverse device effect (UADE/USADE) is any (serious) 
adverse device effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a study device, which by its nature, incidence, 
severity, or outcome has not been identified in the current instructions for use 
and/or current version of the risk analysis report, or any other unanticipated 
serious problem associated with a device that relates to the rights, safety or 
welfare of participants. 
UADEs/USADEs will be reported to FDA as required by 21 CFR Part 812. 
 
9.2 Severity of Adverse Events 
 
Each AE shall be assessed for its severity, or the intensity of an event, experienced by the 
participant according to the criteria below. 
Severity Rating 
Description 
Mild 
Event, signs, or symptoms that do not interfere with the participant’s 
daily activity, are usually considered self-limiting, can be treated 
with non-prescription type medications, and do not require medical 
intervention 
Moderate 
Event may interfere or cause low level inconvenience with the 
participant’s daily activity. Requires medical intervention and/or 
treatment; however, unlikely to require hospitalization or be 
considered potentially life-threatening in nature 
Severe 
Event may cause significant discomfort to the participant and/or 
interferes with the participant’s daily activity. Requires medical 
intervention and/or treatment to preclude a permanent impairment; 
may be life threatening and/or require hospitalization 
 
 
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9.3 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. 
A.  Assess each AE for its relationship to the device or procedure. 
 
• Device Related: This category should be restricted to AEs directly attributable to 
the study device used. 
• Procedure:  A procedure includes any study-related activity performed. 
 
B.  The following categories shall be used for assigning the certainty of the relatedness. 
 
Relatedness 
Description  
Not Related 
Event is independent of study intervention and/or evidence 
exists that the event is related to another etiology. There must 
be an alternative etiology documented by the clinician. 
Unlikely Related 
Event in which the temporal relationship to study intervention 
makes a causal relationship improbable (e.g., the event did not 
occur within a reasonable time of the study device use) and in 
which underlying disease provides plausible explanations (e.g., 
the participant’s clinical condition other concomitant 
treatments). 
Likely Related 
Event in which there is evidence to suggest a causal 
relationship and the influence of other factors is less likely. 
The event occurs within a reasonable time after use of the 
study device and is less likely to be attributed to concurrent 
disease. 
Related 
Event in which there is clear evidence to suggest a causal 
relationship and other possible contributing factors can be 
ruled out. The event occurs in a plausible time relationship to 
use of the study device and cannot be explained by concurrent 
disease. 
 
 
9.4 Reporting of Events 
 
For all adverse events, all sections of the appropriate Case Report Form (CRF) must be 
completed. 
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• All SAEs, SADEs, and/or UADEs/USADEs must be reported to the Sponsor 
within one (1) working day of the site/investigator becoming aware of the event.   
 
• De-identified copies of all requested relevant documentation should be submitted 
to the Sponsor within 72 hours of knowledge, as appropriate.  
It is the responsibility of the Investigator to report adverse events to individual 
Institutional Review Boards (IRBs)/Ethics Committees (ECs) and/or regulatory 
authorities according to the local regulations in each participating country. 
 
9.5 Safety Committees 
Not applicable 
 
9.6 Device Deficiencies 
The Investigator will record a device deficiency if a device used in the study procedure 
failed to meet its performance specifications whether due to mechanical failure, 
malfunction, or defect.  Device deficiencies also include use errors and inadequate 
labeling.  This applies to: devices used to treat the participant, or devices in which the 
package was opened, but the device was not used for treatment, or devices with which 
treatment was attempted, but the device did not remain through the entire study 
procedure/period. 
All mechanical failures, malfunctions, missing components, and defects of the study 
devices will be recorded on the appropriate Case Report Form and will be promptly 
reported to the Sponsor. The device(s) should be returned to the Sponsor as outlined in 
the site’s regulatory binder. 
If the device deficiency was associated with an AE, the reporting provisions for AEs, 
ADEs, SAEs, SADEs and UADEs/USADEs apply. 
Reported deficiencies will be investigated and reported under 21 CFR part 803 Medical 
Device Reporting by the Sponsor if necessary.  The site may be contacted to provide 
additional information to allow the Sponsor to conduct a thorough investigation. 
It is the responsibility of the Investigator to notify the IRB/EC of such device deficiencies 
in accordance with the IRB/EC and/or the Competent Authority’s local regulations. 
 
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10 STATISTICAL METHODS 
 
The statistical analysis plan will be finalized prior to database lock and will include a more 
technical and detailed description of the statistical analyses described in the following 
sections. This section includes a summary of the planned statistical analyses of the most 
important endpoints including primary and key secondary endpoints. 
 
10.1 Overview of Study Design 
This is a prospective, randomized, crossover, single-blind, single-center healthy volunteer 
study conducted over 1 day with 2 voids using the PureWick™ Male external catheter vs. 
the comparator Sage PrimoFit™. This study is designed to assess the performance, 
comfort, and ease of use of the PW Male external catheter.  
A successful hypothesis-test for the primary endpoint (rejection of the Null Hypothesis) 
will provide evidence to support the superiority of PureWick™ Male external catheter 
compared with standard of care, in terms of capture rate.  
 
10.2 Sample Size Considerations 
Using a two-sided paired t-test at significance level of 0.05, a sample size of 44 provides 90% 
power to detect a mean paired difference in capture rate that is half of the standard deviation of the 
paired difference. For example, if the standard deviation of paired difference in capture rate is 10%, 
a sample size of 44 provide 90% power to detect a mean paired difference of 5%. 
 
10.3 Analysis Population 
The following populations are defined: 
Population 
Description 
Enrolled  
All participants who sign the ICF. 
Intent-to-Treat (ITT) 
Enrolled and randomized participants. 
Per-Protocol 
ITT subjects who are without major protocol deviation. 
ITT Subpopulation 
ITT subjects who are deemed unable to use traditional sheath 
style condom catheters. 
 
ITT population will be used for the primary endpoint analysis. ITT subpopulation will be 
used for the secondary endpoint with hypothesis test. Per-protocol analyses may be 
performed as a sensitivity analysis. 
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10.4 General Considerations 
 
10.4.1 Handling of Missing Data 
Endpoint data may be missing due to reasons including withdrawal of consent, 
investigator’s decision, or loss to follow-up. It is important to minimize missing 
data and always record the reason for missing.  Analyses are primarily based on 
evaluable data. If there is any indication that missing is related to study endpoints, 
sensitivity analyses may be carried out to assess the impact of missing data. 
  
10.4.2 Covariates 
Confounding introduced by subject characteristics is mitigated by having each 
subject as their own control. Potential effects of treatment period and sequence 
will be evaluated using descriptive statistics and regression models. 
 
10.4.3 Multiplicity Control 
Study-wise Type I error is controlled using the Fixed Sequence method. The 
primary endpoint and a secondary endpoint are tested sequentially. The secondary 
hypothesis will be carried out, only if the primary hypothesis test is successful. 
Otherwise, the test for the secondary endpoint is considered exploratory.  
 
10.5 Primary Endpoint(s) 
 
Capture rate is defined by: 
 
Captured urine weight / (captured urine weight + leaked urine weight) 
 
The primary endpoint will be evaluated against the following hypotheses: 
 
H0: Capture rate of PureWick™ Male (system) = Capture rate of established 
comparator (Stryker/ Sage PrimoFit™) 
H1: Capture rate of PureWick™ Male (system) ≠ Capture rate of established 
comparator (Stryker/ Sage PrimoFit™) 
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A two-sided paired t-test will be used to test the hypotheses and p-value will be derived. A 
p-value < 0.05, combined with a capture rate in favor of PureWick™, indicates that 
PureWick™ is superior to PrimoFit™ in terms of urine capture. 
An exploratory analysis will be performed using regression, where subject may be 
included as the random effect, and period, sequence, treatment may be included as fixed 
effects.  
 
10.6 Secondary Endpoint(s) 
Secondary Endpoint with Hypothesis Test 
 
If primary endpoint passes the hypothesis test, the same hypothesis test will be performed 
in the subgroup population of ITT participants who are unable to use traditional sheath 
style condom catheters. Using the fix-sequence method, the overall type I error is 
controlled since the test of this secondary endpoint is conditional on the success of the test 
of the primary endpoint.  
 
Secondary Endpoints without Hypothesis Test 
• 
Overall Comfort score on a 5-point Likert scale (brief questionnaire). 
• 
Ease of use by HCP in placing the MEC (brief questionnaire). 
 
10.7 Other Analyses 
No other analyses are needed for this study. 
 
11 DATA COLLECTION AND RECORD MAINTENANCE 
 
11.1 Case Report Forms 
The Investigator is responsible for ensuring the completeness and accuracy of all study 
documentation. 
All required clinical data will be collected/documented in sponsor-provided web-based 
electronic Case Report Forms (eCRFs).  The Investigator may delegate eCRF completion 
to study personnel. However, the Sponsor must be apprised in writing of the name of 
such persons and the scope of their authority. The Investigator or designee is obligated to 
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review each eCRF page and sign EDC, using an electronic signature. An individual 
record will be kept for each participant that provided informed consent. 
Electronic CRFs must be completed as per the BD provided training instructions. 
Electronic CRF entries will be compared to source documents by the study monitor or 
designated personnel. Unless specified otherwise, all information on the eCRFs must be 
traceable to original source documents. Modification of the eCRFs will only be made if 
deemed necessary by the Sponsor and/or the appropriate regulatory body. 
Site numbers and participant numbers will be used to track participant information 
throughout the study.  Participant personal information will be de-identified. Site 
numbers and participant numbers will be used to track participant information throughout 
the study. 
 
11.2 Source Documentation 
Original or certified copies of all relevant clinical findings, observations, and other 
activities throughout the clinical investigation must be recorded and maintained in the 
study file of each enrolled participant.  Where there is no prior written or electronic 
record of data, such as for subjective data (e.g., pain scales, questionnaires), these data 
may be recorded directly on the eCRF(s) and thee CRF is then considered to be the 
source.   
 
11.3 Data Management 
Data management is the responsibility of the Sponsor.  Data from completed eCRFs will 
be managed in a secured, controlled database. A Data Management Plan (DMP) will be 
developed that outlines the procedures used for data review, database cleaning and 
issuing/resolving data queries. Procedures for validations and data storage will also be 
contained within the DMP.  Observation data will be collected prospectively at the time 
of each urine output monitoring event. As such, any missing data or inconsistent data 
cannot be retrieved from an alternate source. Particular care must be taken to ensure that 
all data are recorded in a clear and complete manner. 
 
11.4 Record Retention 
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 
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approval application or a notice of completion of a product development protocol (21 
CFR Part 812.140). The data for some of these records may be available in computerized 
form but the final responsibility for maintaining study records remains with the 
Investigator. 
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. 
 
12 QUALITY CONTROL AND ASSURANCE 
 
12.1 Control of Study Products 
Investigational study products will be released only for use by Investigators who have 
obtained written IRB/EC approval (as required) for participation in this study, who have 
completed all required study documentation, and who have been qualified by the 
Sponsor.  Investigators must maintain control over all study products, and ensure they are 
used in accordance with this protocol.  Failure to do so may result in the Sponsor 
suspending or terminating the study at the Investigator’s site.  
  
The Investigator will ensure that study products are only dispensed to participants (or 
used for specimens) properly enrolled in the study. The Investigator must maintain 
records of receipt, disposition, return and/or destruction of all study products. All 
investigational study products released to the site must be accounted for at the unit level 
prior to study close out, regardless of disposition.  The Sponsor-Monitor will regularly 
review all records regarding study product accountability. 
The Sponsor will maintain records that document the shipment, receipt, disposition, 
return and/or destruction of study products. 
 
12.2 Monitoring 
The Sponsor will designate trained and qualified personnel to monitor the progress of this 
clinical study in accordance with established standard operating procedures and the 
study-specific Monitoring Plan. 
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Prior to study start, a study initiation visit (SIV) will be conducted to review with the 
Investigator(s) and staff the provisions and proper conduct of this study. This visit will 
include a detailed review of this protocol, verification that all necessary documents are on 
file at the investigational site and confirmation of IRB/EC approvals. 
During the study, routine monitoring visits (RMVs) will be conducted to assure the site 
continues to adhere to the protocol, the investigator agreement, and regulations regarding 
conduct of clinical studies.  The Sponsor-Monitor will confirm that the ICF to be used is 
the version approved by the IRB/EC, confirm the applicable national privacy laws have 
been followed, verify that all necessary documents are on file at the investigational site 
and confirm that there are provisions to continue and maintain all documents and records 
throughout the study as required by applicable regulations. These monitoring visits will 
assess continued protocol compliance, adequate participant enrollment, accurate data 
reporting, monitoring of participant safety through identification and/or review of any 
device-related AEs, UADEs, or SAEs, device accountability, continued maintenance, and 
calibration of study-specific equipment (if applicable), and continued IRB/EC acceptance 
of the study. 
At the completion of the study, the Sponsor-Monitor will conduct a final close-out visit 
or COV. The purpose of this visit may include but is not limited to collecting all 
outstanding study data documents, confirming that the Investigator’s files are accurate 
and complete, reviewing the record retention requirements with the Investigator, 
providing for the return of unused devices to the Sponsor, reviewing records which 
account for device shipments and ensuring that all applicable requirements for closure of 
the study are met.  
 
12.3 Audits and Inspections 
If the study is selected for audit by the Sponsor or if there is an inspection by the 
appropriate Health Authorities, the Investigator and his team will make themselves 
available during the visit.  The Investigator must agree to the inspection of all study 
related records and give the auditor/inspector direct access to source documents for 
verification of data on CRFs.  The participant’s anonymity must be ensured, and data 
checked during the audit must remain confidential. 
As soon as the Investigator is aware of an upcoming inspection/audit by the Health 
Authorities, he/she will promptly inform the Sponsor.  As agreed with the Investigator, 
Sponsor personnel may be present at the site during the inspection. 
 
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12.4 Protocol Deviations 
A protocol deviation is defined as an event where the Investigator or site personnel did 
not conduct the study according to the protocol. 
Except when necessary to protect the life or physical well-being of a participant, protocol 
deviations are not permitted.  The Sponsor and the investigational site’s IRB/EC must be 
notified immediately if an emergency situation arises in which the safety of a participant 
may require immediate intervention different than that defined in the protocol.  This must 
be followed by written confirmation that describes the emergency action and outcomes, 
within five (5) working days from the date of the emergency action in accordance with 
the governing IRB/EC’s requirement. 
It is the Investigator’s responsibility to ensure that there are no deviations from the 
Protocol. Except in an emergency, when a protocol deviation is planned or anticipated, 
the Sponsor should be contacted for approval.  Any and all deviations must be recorded 
on the appropriate CRF regardless of whether medically justifiable or sponsor approved.  
Upon evaluation by the Sponsor, actions may be required to prevent additional 
deviations, such as retraining of the site, implementation of additional site procedures, 
and more frequent monitoring.  If these steps fail, more serious measures, up to and 
including termination of enrollment at the site. 
 
 
13 ADMINISTRATIVE REQUIREMENTS 
 
13.1 Investigator and Site Selection 
 
The Investigator must be of good standing as an Investigator and knowledgeable in 
relevant areas of clinical research to ensure adherence to the requirements of this 
protocol, including the protection of human participants.  Other site personnel must have 
appropriate research experience and infrastructure to ensure adherence to this protocol 
and enrollment of sufficient numbers of evaluable participants. The curriculum vitae 
(CV) of the Investigator(s), Sub-Investigator(s) and Study Coordinator(s) will be 
maintained in the Sponsor’s files as documentation of qualification by training and 
experience. 
The Principal Investigator will sign the Investigator Agreement pages of this protocol, 
agreeing to comply with all applicable regulations and the requirements of this study  
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13.2 Training 
 
In addition to each Investigator and appropriate site personnel being trained on this 
protocol and study procedures during the Site Initiation Visit, product training will be 
provided by the Sponsor or designee and is required for each Investigator. Additional 
study staff (e.g., Sub-Investigator(s)) will also require device training provided from the 
Sponsor or proctoring by the PI. All training will be documented and filed at the 
investigational site and with the Sponsor. 
 
13.3 Required Documents 
 
An Investigator may not screen or enroll participants until authorized to do so by the 
Sponsor. At a minimum, the following documentation should be received by the Sponsor 
prior to the commencement of study activities: 
• Fully executed Non-disclosure Agreement (NDA) between PI/site and Sponsor; 
• CVs, signed and dated within 2 years of study start for the PI and Sub-
Investigator(s); 
• CVs for Study Coordinator(s); 
• Signed CSA by PI/site (or designee); 
• Signed Investigator Agreement Page by PI and Sub-Investigator(s); 
• Signed Financial Disclosure Statement by PI and Sub-Investigator(s); 
• Completed and Signed Training Log by PI and Sub-Investigator(s); 
• Study Personnel Identification list; 
• Written approval from the IRB/EC of both the protocol and ICF, and any other 
applicable protocol specific material; and 
• IRB/EC Membership List, Assurance of Compliance Form, or equivalent. 
 
13.4 Publication Policy 
 
The sponsor believes that results of applicable clinical studies should be published in 
peer-reviewed literature in a timely, accurate, complete and balanced manner, regardless 
of study outcomes, whenever possible.  As such, at the conclusion of this study, an article 
may be prepared for publication in a reputable scientific journal.  Formal presentation(s) 
or publication(s) of data collected from this study will be considered as a joint publication 
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by the investigator(s) and the appropriate personnel of the Sponsor. Authorship will be 
based on generally accepted criteria of the ICMJE (International Committee of Medical 
Journal Editors) and determined by mutual agreement. 
The publication of the principal results from any single-center experience within the 
study is not allowed until the preparation and publication of the multicenter results. 
Exceptions to this rule require the prior approval of the Sponsor. The analysis of other 
pre-specified and non-pre-specified endpoints will be performed by the Sponsor or its 
designee. Such analyses, as well as other proposed investigations or manuscripts will 
require the approval of the Sponsor. 
 
13.5 Study Registration 
In compliance with Title VIII of Public Law 110-85, known as FDA Amendments Act of 
2007 (FDAAA), the Sponsor will register this study studies and disclose study results in a 
publicly accessible database (i.e., ClinicalTrials.gov). This study will be registered no 
later than 21 days after commencing enrollment. Study results will be posted to the 
website within 12 months of the last participant visit. 
 
13.6 Termination of Study 
The Sponsor reserves the right to suspend enrollment or terminate the study at any time 
for any reason.  The Sponsor may suspend enrollment or terminate the study at a specific 
investigational site for reasons including, but not limited to, inadequate data collection, 
low participant enrollment rate, achievement of the total enrollment, conditions imposed 
by the reviewing IRB/EC and/or non-compliance with this protocol or other clinical 
research requirements. Written notice will be submitted to the Investigator in advance of 
such termination. 
In the event of study suspension or termination, the Sponsor will send a report outlining 
the circumstances to the IRB/EC, and all Investigators and Regulatory Authorities as 
required by regulation.  
 
14 ETHICAL AND REGULATORY CONSIDERATIONS 
 
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14.1 IRB/EC Approval 
Investigators or designees must submit the study protocol, Informed Consent Form (if 
applicable), and all other locally required documentation to an appropriate IRB/EC and 
obtain study-specific written approval (favorable opinion) before being allowed to 
participate in the study. Before commencement of the study, the Investigator or designee 
must provide the Sponsor with written documentation of such approval.  The IRB/EC 
must give written renewal of the original approval at least annually to continue the study. 
A copy of the written renewal must be provided to the Sponsor. 
The IRB/EC will be notified of any amendments to the protocol, as well as possible 
associated information and consent form changes, where applicable, and written approval 
(favorable opinion) will be obtained prior to implementation, as applicable. 
The Investigator or designee is responsible for fulfilling any conditions of approval 
imposed by the IRB/EC, such as regular safety reporting, study timing, etc. The 
Investigator or designee will provide the Sponsor with copies of such reports. 
 
14.2 Informed Consent and Confidentiality 
Prior to any study procedure, the Investigator (or designee) must explain to each 
participant in layman’s terms, the nature of the study, its purpose, expected duration, and 
the risks and benefits of study participation. Also, participant will be informed of uses 
and disclosures of their medical information for research purposes, and their rights to 
access information about them. All applicable national privacy laws (e.g., HIPAA 
requirements in the U.S.) will be followed in this study. The participants must be 
informed of their right to withdraw from the study at any time and for any reason without 
sanction, penalty, or loss of benefits to which they are otherwise entitled, and that 
withdrawal from the study will not jeopardize their future medical care. Participants will 
be informed of their right to new information and/or findings relating to the clinical 
study, and the process by which this information is made available. After this 
explanation, given sufficient time to decide whether to participate, before any study 
procedure is conducted, and before entering the study, the participant must voluntarily 
provide consent in accordance with 21 CFR Parts 50 and 56 and ISO 14155:2020(E). The 
participant will receive a copy of his/her signed ICF. 
 
14.2.1 Confidentiality 
Participant confidentiality must be strictly held in trust by the Investigator, study 
staff, and the Sponsor.  Participant confidentiality and anonymity will be 
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maintained by removal of identifiers from any data, documentation, or clinical 
samples submitted to the Sponsor. 
Any data collected meeting the definition of protected/confidential health 
information or personal identifying information will be collected and maintained 
using the designated authorizations and following privacy procedures as specified 
in the applicable health authority regulations. 
The Sponsor-Monitor, authorized representatives of the sponsor, and/or applicable 
Health Authorities may inspect all documents and records required to be 
maintained by the Investigator.  The Investigator/Site will permit access to such 
records.  
 
14.3 Regulatory Status 
The PureWick™ Male External Catheter is a Class I, 510(k) exempt device currently 
marketed in the United States and will be evaluated for its approved indication. The 
comparator device, Sage PrimoFit™, is also a commercially available device which is 
Class I, 510(K) exempt. Institutional Review Board (IRB) submission of this study plan 
along with IRB study approval or waiver is required.  
 
14.4 Statement of Compliance 
This clinical investigation will be conducted in compliance with the protocol and 
following regulatory requirements: 
• 21 CFR 50, 54, 56 and 812; 
• 21 CFR 812.28(a)(1) (Good Clinical Practice); 
• ISO14155:2020 (Good Clinical Practice); 
• Ethical principles of the Declaration of Helsinki, in its current revision; and 
• Applicable sections of the national laws and regulations. 
 
The clinical investigation will not commence at a clinical site until approval (favorable 
opinion) from the respective IRB/EC has been received. All additional requirements 
imposed by the IRB/EC(s) will be followed. Involvement of the national competent 
authorities (e.g., by notification, seeking authorization) will be accomplished as required 
by national laws and regulations. 
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15 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. 
Incontinenceassociated 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. CATHETER, U. C. M. E. (2008) Good Practice in Healthcare: Male External Catheters, 
Condom Catheter Urinary Sheath. EAUN MEC Guidelines 
8. Staniorski, C. J., & Rusilko, P. J. (2021). The concealed morbidity of buried penis: a 
narrative review of our progress in understanding adult-acquired buried penis as a 
surgical condition. Translational Andrology and Urology, 10(6), 2536. 
9. Mirastschijski, U. (2018). Classification and treatment of the adult buried penis. Annals 
of Plastic Surgery, 80(6), 653-659. 
10. Fuller, T. W., Theisen, K. M., Shah, A., & Rusilko, P. J. (2018). Surgical management of 
adult acquired buried penis. Current Urology Reports, 19, 1-8. 
11. 11. Ho, T. S., & Gelman, J. (2018). Evaluation and management of adult acquired buried 
penis. Translational Andrology and Urology, 7(4), 618. 
 
 
 
 
 
 
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16 APPENDICES 
16.1 Appendix 1: PureWick™ Male External Catheter Instructions for Use (IFU) 
 
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16.2 Appendix 2: Sage PrimoFit™ Instructions for Use (IFU) 
 
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16.3 Appendix 3: Participant Comfort Scale Survey 
To be completed by each participant once per device (total of 2 per participant). 
Participant Number:  
Void # (Void 1 or Void 2) 
Now that you have experienced the use of the device as well as voiding with the device in place, 
please answer the following questions considering the use of the current male external catheter. 
1.  On a scale of 1 to 5 where 1 is very uncomfortable and 5 is very comfortable, how comfortable 
was the placement of the male external catheter? 
1 
Very 
uncomfortable 
2 
Uncomfortable 
3 
Neither 
comfortable nor 
uncomfortable 
4 
Comfortable 
5 
Very 
Comfortable 
 
2.  On a scale of 1 to 5 where 1 is very uncomfortable and 5 is very comfortable, how comfortable 
was the device while you were voiding? 
1 
Very 
uncomfortable 
2 
Uncomfortable 
3 
Neither 
comfortable nor 
uncomfortable 
4 
Comfortable 
5 
Very 
Comfortable 
3.  On a scale of 1 to 5 where 1 is very uncomfortable and 5 is very comfortable, how comfortable 
was the removal of the male external catheter? 
1 
Very 
uncomfortable 
2 
Uncomfortable 
3 
Neither 
comfortable nor 
uncomfortable 
4 
Comfortable 
5 
Very 
Comfortable 
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 male external catheter to one of your loved ones? 
1 
Very Unlikely 
2 
Unlikely 
3 
Neither Likely nor 
Unlikely 
4 
Likely 
5 
Very Likely 
 
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16.4 Appendix 4: Professional Ease of Use Questionnaire 
To be completed by HCP after each participant void. 
HCP: 
Void #: 
Now that you have experienced the application and removal of the device for this participant, 
please answer the following questions using your professional opinion in regard to device ease 
of use for this specific participant. 
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? 
1 
Very difficult 
2 
Somewhat 
difficult 
3 
Average 
difficulty 
4 
Somewhat easy 
5 
Very easy 
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? 
1 
Very difficult 
2 
Somewhat 
difficult 
3 
Average 
difficulty 
4 
Somewhat easy 
5 
Very easy 
UCC-23AC022-- Protocol | VV-TMF-270487
Downloaded on 14 Jun 2024
System Version Number 1.0