EPIC: Effect of Povidone Iodine Periurethral Cleansing on Level of Contamination With Clean Catch: A Randomized Control Trial
Phase: NA
Conditions: Urine Contamination
Sponsor: Travis Callahan

59th Medical Wing Institutional Review Board 
Version: 4 Apr 2018 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 PROTOCOL FOR NON-EXEMPT RESEARCH INVOLVING HUMAN SUBJECTS 
Title: 
EPIC: Effect of Povidone Iodine periurethral Cleansing on level of contamination with clean catch: A randomized 
control trial 
IRB #: 
FWH20190009H 
Principal Investigator 
(PI) 
Rank 
Branch 
AD/DoD Civ/ 
Ctr/Civilian 
Dept/Base 
Phone # 
E-mail 
Travis Callahan,EMPA-C 
Capt 
USAF 
AD 
ED/Nellis 
(702) 653-3619 
travis.a.callahan.mil@mail.mil 
 
The research relevance of this protocol focuses on:  
☒ 
Diagnosis 
☐ 
Treatment 
☐ 
Medical Utilization/Managed Care 
☐ 
Prevention 
☐ 
Medical Readiness 
☒ 
Other:  New method of urine collection in children 
 
Does the research fall under the purview of any other departments or committees? 
No 
1. LOCATION AND SPONSOR 
Collaborating Facilities:  
99MDG/Mike O’Callaghan Military Medical Center 
AF Sites Seeking Regional IRB:  
Jill Clark, (702) 653-3298, jill.m.clark15.ctr@mail.mil 
Study Sponsors: None 
2. RESEARCH PLAN 
Purpose of Study:  
The primary aim of this study is to see if the use of an antiseptic preparation (povidone iodine) versus cold normal saline, will 
decrease rates of urine contamination during the non-invasive Quick Wee (QW) collection of pediatric urine.  
Hypotheses, Research Questions, or Objectives:  
To evaluate two different cleansing solutions in controlling urine contamination. 
Significance 
If the use of antiseptic preparation decreases the level of contamination in this study then it would provide an effective and 
reliable clean catch method that staff could utilize prior to electing for catheterization or suprapubic aspiration.  
Military Relevance: 
Having a noninvasive Quick Wee method with a high 5 minute void success rate; patient wait times in the emergency 
department will decrease, and parents will be happier with avoiding invasive measures. This improves patient safety, and 
provides the clinician with another method for collecting urine. In the Air Force’s move towards a culture of safety, and zero 
harm; further evaluation into this novel technique’s reliability will support our goals provided rates of urine contamination can 
be minimized. The importance of researching noninvasive methods with low levels of contamination is that it may prevent 
further invasive methods from being used. For example if a child’s urine specimen from clean catch is contaminated the next 
step would be to get the sample via catheterization, a method that is traumatic to child, parent and sometimes staff. If 
research shows that urogenital prep with iodine decreases level of contamination in the urine then it provides an acceptable 
method of urine clean catch collection.  
Background and Review of Literature:  
Urinary tract infections (UTI) are common acute illnesses among pediatric patients, accounting for 5-7% of emergency 
department visits in the under two-year-old population [1]. However, obtaining urine samples from the precontinent patient 
can be difficult. There is an ongoing debate regarding which noninvasive method for urine specimen collection is best for this 
population. The main argument against clean catch is the high rate of contamination compared to invasive collection and 
reliability. 
 
There are many methods of noninvasive urine collection. These methods are preferred as they are fairly well tolerated by 
patients, less distressing to parents, cost effective, and require less technical expertise. In the past; these methods have been 
dismissed due to their high rates of contamination, time to void and also effectiveness. The National Institute of Health and 
Clinical Excellence (NICE, UK) recommends a clean-catch urine (CCU) be the first attempt at obtaining a urine specimen from 
children suspected of having UTI [2]. This means placing the urine specimen collection container into the urine mid-stream 
once the child has begun to void to avoid contamination. Conversely, the American Academy of Pediatrics recommends clean 

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catch urine for screening and a catheter specimen urine collection or suprapubic aspiration for definitive diagnosis [3].  Both of 
these invasive techniques produce quick urine samples with low rates of contamination; however they can be painful and 
distressing to both the patient and parent.   
 
The Quick-Wee method for noninvasive urine collection has been evaluated in a one randomized controlled trial and has been 
shown to significantly increase the five minute voiding success rate for CC urine collection; 31%, n= 174. However a past study 
demonstrated contamination rate of 27%, n=174. No study has directly evaluated the use of antiseptic solution in the 
evaluation of the QW rate of contamination in pediatric patients. The purpose of this study is to see whether the use of 
povidone iodine swabs prior to the QW method will decrease the rate of contamination. A decrease of the rate of 
contamination would strengthen the validity of this simple CCU method. Also using the this method for the collection method 
in both the experimental and control groups will further evaluated the five min void success rate. 
 
We chose to use iodine as our prepping agent because it is currently the standard cleaning solution used for adult and 
pediatric patients. It is readily available, inexpensive and has been shown to be less caustic then other prepping agents.  
Bibliography:  
1. Shaw, K. N., Gorelick, M., McGowan, K. L., Yakscoe, N. M., & Schwartz, J. S. (1998). Prevalence of urinary tract infection in 
febrile young children in the emergency department. Pediatrics, 102(2), e16-e16. 
2. Baumer, J. H., & Jones, R. W. A. (2007). Urinary tract infection in children, National Institute for Health and Clinical 
Excellence. Archives of Disease in Childhood-Education and Practice, 92(6), 189-192. 
3. Representatives, L. (1999). Practice parameter: the diagnosis, treatment, and evaluation of the initial urinary tract infection 
in febrile infants and young children. American Academy of Pediatrics. Committee on Quality Improvement. Subcommittee 
on Urinary Tract Infection. Pediatrics, 103(4), 843-52. 
3. RESEARCH DESIGN AND METHODS 
Research Design and Methods: 
Male and Female DoD beneficiaries, aged one month (28 days) to 12 months (365 days), meeting the inclusion/exclusion 
criteria will be offered an opportunity to participate. Each child will already be scheduled for a standard of care urinalysis 
collection procedure through their pediatric PCM. They will be recruited from the clinics located at the 99MDG through direct 
contact with the infant’s parents. All of the below items are research-related unless marked as ‘standard of care’:  
 
The study will be a non-blinded randomized controlled trial with parallel assignment of groups, taking place in the pediatric 
and emergency departments. The subject’s parents will be asked if the patient has had an allergic reaction to iodine in the past 
prior to being placed in experimental group and if they have had a reaction in the past they will be placed in the normal saline 
group instead. Additionally, if the patient develops a reaction to iodine during testing then they will have the region cleansed 
with normal saline, will be evaluated by the medical staff performing the test, then the urine and subject’s data will be 
disposed of and excluded from the study.  The experimental group will have their periurethral region cleansed with povidone 
iodine solution while the control group will be prepped with cold (2oC) normal saline. Both groups will have the urine collection 
performed utilizing the QW method (see attached flow chart). If a sample is not collected within five minutes with the QW 
method it will be documented as a failure and the child will be referred back to their pediatric PCM and removed from the 
study. Urine collection will occur at the hospital.  
 
Utilizing sequentially numbered opaque sealed envelopes (SNOSE), children will be randomly assigned to one of the two 
treatment groups. The envelopes will contain plastic forceps, gauze, and a 3x5 index card listing the group the child has been 
assigned, i.e., iodine or normal saline, as well as child’s ID number; For the experimental group there will be a package of 
iodine swabs and the control will have a normal saline flush. Also contained within the envelope will be the Participant Data 
Sheet to provide an easy way to track the urine collection process for the study.. 
 
Children will then have their periurethral region gently cleansed for ten seconds with one of the previously discussed solutions. 
The procedure requires cold saline (approximately 2°C) soaked gauze to be applied in a circular motion over the bare 
suprapubic region of the child continuously for five minutes. The saline will come in the form of sterile saline flushes kept in a 
cooler of ice in the departments were the study is being conducted. 
 
If the child voids within five minutes the time in seconds will be recorded on the provided worksheet. Also whether or not the 
urine was successfully “caught’ in the specimen cup will be documented. Whether or not the sample was contaminated by lab 
standards will also be recorded on the data sheet once the results are available. 

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At the conclusion of the child’s participation, the parents will be asked to complete a Satisfaction Survey asking their overall 
satisfaction with the collection method utilized. 
a. Interventions and Observations: 
The primary outcome of this study is to evaluate whether there is an improvement in the rate of urine contamination with 
iodine solution over normal saline prior to the QW. The secondary outcome will be the QW’s rate of success in providing a CCU 
in five minutes.  
b. Setting: 
This study will be conducted at the 99MDG at Nellis AFB. Children will be recruited from the emergency department as well as 
the pediatric clinic through parental permission and consent. Research Staff will enroll children through parental authorization, 
based on the child’s age, and if a standard of care urinalysis will be needed during their course of treatment, based on the 
determination of the child’s attending physician. If a urinalysis is not needed as a course of treatment for the infant, the child 
will not be accepted for the study.  
c. 
Date(s): 
11 January 2019 – 31 May 2019 
d. Subjects: 
The sample population for this study are DoD beneficiary children from 28 days of age to 12 months requiring a standard of 
care urinalysis procedure as a course of treatment. They will be patients enrolled at 99MDG for evaluation and treatment. 
Children will be recruited from the pediatric clinic as well as the emergency department through parental permission and 
consent.  
e. Inclusion/Exclusion Criteria:  
Inclusion Criteria 
• DoD children aged one month (28 days) to 12 months (365 days) 
• if the child was born less than 36 weeks gestation, age will be corrected 
• Precontinent (meaning that the child is unable to void on command)  
• Treating clinician has determined that the child requires urine sample collection for course of 
treatment.  
Exclusion Criteria 
• Children that are outside of the age range discussed in the inclusion criteria (less than one month 
(28 days) and older than 12 months (365 days)).  
• If the treating clinician has determined that there is a need for immediate treatment and urine 
sample collection via invasive method, any type of anatomical or neurologic condition that will 
affect the ability to void or sensation of the suprapubic area. Children with past hypersensitivity 
reactions to iodine swabs.  
 
f. 
Source of Research Material:  
Will you be using private information in this study? 
☒Yes 
If Yes 
☒protected health information (PHI) held by a covered entity 
Use of identifiers with private information 
Identifiers to be Used? 
Column A 
Looked at 
by research 
team 
Column B 
Recorded on 
enrollment log, 
subject list, or key 
list 
Column C 
Recorded on data 
collection tool 
(survey, spreadsheet, 
etc.) 
Column D 
Recorded on 
specimen 
containers 
Column E 
Shared w/ 
others not on 
research team 
Column F 
Stored after 
study ended 
Names 
☒ 
☒ 
☐ 
☒ 
☐ 
☐ 
Study codes linked to 
individuals’ identities using 
a key only accessible by the 
researcher 
 
☒ 
☒ 
☐ 
☐ 
☐ 
Dates (except year) 
☒ 
☒ 
☐ 
☒ 
☐ 
☐ 
Phone/Fax Numbers 
☒ 
☐ 
☐ 
☐ 
☐ 
☐ 
DoD ID# & FMP code 
☒ 
☒ 
☐ 
☒ 
☐ 
☐ 
Coding Plan? 
 
Describe the method that will be used 
Each participant will be assigned a patient identifier starting with either A or B to 

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to create and assign unique study codes 
to data. 
show which group they were a member of and number 01-60 following the letter. 
Describe the method that will be used 
to create and assign unique study codes 
to specimens. 
Urine specimens will be associated with the child’s DoD ID# and FMP code for the 
initial results from the hospital laboratory and then the microscopy results will be 
put into the work book and the original results will be shredded. On the work book 
the results will assigned to the child’s study code. 
What is the format of the key? 
☒Electronic 
Who will have access to the key? 
Research Coordinators and Investigators 
Where will the key be stored and how 
will it be protected? 
 
Location(s): All research data will be kept separately from the Master Key of coded, 
identifiable PHI/PII in an electronic database, which will be encrypted, double 
password protected and the access will be restricted.  At the conclusion of the 
study, the research data will be de-identified prior to review and analysis. 
Confidentiality measures: The research data will be coded to mask the identity of 
the child.  The code will be retained until the conclusion of the research study. Once 
a Final Report has been approved by the IRB, all the paper records will be stored 
and destroyed in accordance with the Long Term Storage Plan. The anonymized 
research data will not be utilized for further research activity beyond the protocol 
stipulations without additional IRB approval.  At the end of all data mergers, or no 
later than at the closure of the study, all identifiable patient information will be 
destroyed based on AFI 33-332, “The Air Force Privacy and Civil Liberties Program” 
and the National Institute of Standards and Technology Special Publication (NIST SP 
800-88) for the approved methods to destroy PII. 
Source of Research Material per Participant (Procedures) 
# Routine Care 
# Research Driven 
# Total Procedures 
Urine specimen  
1 
0 
1 
Participant Data Sheet completed by research staff 
0 
1 
1 
Satisfaction survey (Parent) 
0 
1 
1 
“All specimens kept at 99MDG will be handled and disposed of in accordance with federal regulations.” 
g. Instrumentation: N/A 
4. HUMAN SUBJECT PROTECTION 
Recruitment and Consent Processes:  
All potentially eligible childrens’ parents will be approached to have their child participate. Primary Care Manager (PCM) 
referrals, with the patients’ parents oral or written authorization, and posted advertisements will be utilized for recruiting 
children to the study. Some children may be patients of the PI or AI, however, they will have another study staff recruit the 
children through their parents to prevent any misconception of coercion or undue influence. When a potential child is 
identified by the treating PCM, their parent(s) will either be provided a contact number to the Research Staff, the Research 
Staff will be given the potential subjects contact information by the PCM with the parent’s oral or written authorization, or the 
Research Staff will speak with the child’s parent(s) directly, if contacted by the parent.  
 
Consent Processes: 
Parental Informed Consent (ICD) and HIPAA Authorization (HIPAA) will be sought in advance from each prospective child’s 
parent(s) and appropriately documented in accordance with 32 CFR 219.117. Potential childrens’ parents will be notified about 
the study either through posted advertisements, verbally through their child’s primary care manager, or upon check in at the 
clinic and will be given the opportunity to consent for the child by one of the referred study coordinators. The study 
coordinator will provide a written copy of the Parental Informed Consent Document and HIPAA Authorization. The potential 
child’s parents may decline to consent for the child without prejudice. At the parent’s discretion, they may take the ICD and 
HIPAA home to discuss further prior to making a decision. If the parent consents to having their child enrolled in the study, a 
copy of the ICD will be given to them. Each parent will be asked to allow us to include their child’s de-identified research data 
into the “Mike O’Callaghan Military Medical Center General Research Data Repository (FWH20180064H)” for future research. 
 
Recruiting Service Members 
Will you be recruiting service members in a group setting?  
☐Yes 
☒No 
 
Participation Compensation:   

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Children and parents will not be paid for participation in this study. 
 
Assent Process:   
Parent consent will be acquired via the written consent forms prior to the initiation of any research activities. 
 
Benefits:  
There may be decreased levels of urine contamination in either the saline or the iodine prep group’s urine sample. If so, this 
will give a child’s treatment team more reliable test results and decrease the need for more invasive urine testing. Additionally 
the normal saline preparation may be effective at decreasing the level of contamination as the iodine, this is the benefit of 
using normal saline for a preparation and comparing it to the iodine.  
 
Risks:  
Procedure is safe and the only possible negative outcome could be skin irritation from the iodine prep group. There are risks 
that urine sample may show that there was growth of bacteria on culture in which event the parents will be contacted by the 
PI or AI and made aware of these results and will be advised to follow up with their pediatrician. There is a possibility that the 
child has an allergic reaction to the iodine swab. If this occurs, the child will be referred to their pediatric PCM. The urine 
sample collected during the QW procedure will still be used for the study. There may be a risk of inadvertent breach of 
confidentiality. 
 
Costs: None 
 
Safeguards for Protecting Information: 
Parental Informed Consent and HIPAA authorization will be sought in advance of any screening and study-related procedures 
for each prospective child participant and appropriately documented in accordance with 32 CFR 219.117. Parents of potential 
children will be notified about the study either through posted advertisements or through their healthcare provider and 
parents will be given the opportunity to be consented by one of the referred study coordinators. The study coordinator will 
provide a written copy of the Informed Consent Document (ICD) to the parent. The parent may decline to consent for their 
child without prejudice. At the parent’s discretion, they may take the ICD home to discuss further with family members or 
another physician, prior to making a decision. If they decide they are interested in their child participating in the study, they 
can contact the research department. If the parent consents, a copy of the signed ICD and HIPAA Authorization Document will 
be given to the parent. Parents who cannot provide Informed Consent on behalf of their child, then the child will not be 
allowed to participate in the study. No Legally Authorized Representatives (LAR) will be utilized. Each parent will be asked to 
place their child’s de-identified research data into the “Mike O’Callaghan Military Medical Center General Research Data 
Repository” (FWH20180064H) for future research. If the parent does not give their authorization, then the child’s de-identified 
research data will be destroyed no later than 3 years following the closure of the study. 
Data and Specimen Storage Plan 
How will coded or identifiable data/specimens be stored? 
☒ 
Paper data, including 
completed consent forms 
The research consents and HIPAA Authorization Documents will be stored in a locked 
cabinet in a locked room with restricted access. 
☒ 
Electronic data 
Medical records will not be annotated to reflect the child’s participation in a 
research study since the child will not receive an invasive research intervention or 
procedure. All coded, de-identified research data will be electronically stored 
separately from the Master Key of identifiable patient demographics and PHI/PII. 
☒ 
Specimens 
Urine samples will be disposed of by the lab after analysis is complete. Results will be 
acquired through CHCS using the child’s DoD ID# and name. DoD ID# will be used 
initially for urinalysis results tracking and then Study code IDs will be used for de-
identified research data 
☒ 
Long-term storage (following 
completion of the study and 
inactivation of IRB approval) 
The research data will be coded and any links to identifiable data will be destroyed 
(an approved shredding bin) as soon as possible or no later than at the closure of the 
study, with the exception of those parents that consented to place their child’s de-
identified research data into the “Mike O’Callaghan Military Medical Center General 
Research Data Repository” (FWH20180064H) for future research. The anonymized 

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research data will not be utilized for further research activity beyond the protocol 
stipulations without additional IRB approval.  All de-identified research data will be 
maintained for 3 years following study closure. 
 
Safeguards for Protecting Subjects Relative to Reasonably Expected Risks:  
The principal investigator will be responsible for the protocol safety monitoring.  The PI will make study documents (e.g., 
consent forms, data pulls) and pertinent hospital or clinical records readily available for inspection by the 59 MDW IRB and 
over sight staff for confirmation of the study data. If at any time the parent reports a side effect being experienced by their 
child, they will be referred to one of the Investigators for care or to the child’s pediatric PCM. 
 
Categories of subjects 
☒Children (17 yrs or less), includes viable neonates (28 days of age to 12 months) 
 
Clinical Care:  
All children will receive standard of care regardless of inclusion into this study. If at any time a child experiences any injury or 
adverse effects, appropriate clinical care will be given or the child will be referred to appropriate provider. If a urine sample 
should be abnormal the PI or AI will follow up with the child’s parents and ensure they either follow up with their primary care 
provider or report to the emergency department, if symptomatic.  
 
Injury Compensation: N/A 
 
Data Safety Monitoring 
☒N/A – none of the situations listed above apply 
5. ALTERNATIVES 
Alternatives:  
The alternatives for QW urine collection are urine specimen collection by using the bag specimen collection method or the 
invasive straight catheterization or suprapubic aspiration. The alternative to using an iodine cleansing solution is to use a 
normal saline solution. The parents also have the authority to deny their child’s participation in the study. 
6. DATA ANALYSIS 
Data Analysis:  
Primary analysis will be performed by intent-to-treat including all randomized children, where primary outcome data are 
available, consistent with the CONSORT guidelines for intention to treat analysis. The primary outcome measure is a binary 
yes/no outcome of detection of microbial markers to determine level of contamination. The absolute difference between the 
two groups will be reported so that the percentage of contamination samples, together with the 95% CI for the differences of 
percentages, and calculate p values using a chi squared test. A p value of <0.05 will be considered significant. For the secondary 
outcome there will also be a measure of binary yes/no outcome of voiding urine within 5 minutes. The rate of successful 
voiding within 5 min will be described for each group with percentages and 95% CI. The p value will be estimated using chi 
squared test for categorical variables and t-test or Wilcoxon’s rank sum tests for continuous variables.  
 
Additionally we will also be evaluating patient’s gender, and age in months for comparative data analysis to help strengthen 
the study’s statistical design outcomes. 
 
Outcome Measures:  
Level of urine contamination (binary yes or no), if there was a sample collected in 5 minutes (binary yes or no), and time to 
void with a 300 second cap are the two outcome measures being evaluated in this study.  
 
Sample Size Estimation/Power Analysis: 
This is a pilot study and will have a relativity low sample of 60 subjects.  
 
Statistical Analysis:  
Data analysis will be conducted by Baylor University statistics department (Dr. Jack Tubbs) 
 
Number of Subjects: 
# Planned to Enroll 
# Enrolled 
# Planned to Complete Study 
TOTAL 

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Number of Subjects at 99 MDG 
60 
0 
60 
60 
7. STUDY DURATION 
Duration of Study:  
Approximate duration of the study: four months 
8. LOCAL AND EXTERNAL SUPPORT SERVICES 
Local and External Support Services: None 
Describe the plan for training/informing 
clinical personnel about the study. 
Who will you train? ☒Other: Nursing staff who will perform the QW and urine 
collection and will be instructed when to use an iodine swab or saline flush to 
cleanse the periurethral area. When will you provide the training? ☒Prior to the 
first subject being enrolled. How will you provide the training? ☒In person 
9. INTRAMURAL (GME) AND EXTRAMURAL FUNDING SUPPORT 
Intramural (GME) and Extramural Funding Support: None 
10. DRUGS, BIOLOGICS, DIETARY SUPPLEMENTS, AND MEDICAL DEVICES 
Is this research an “applicable clinical trial” which must be registered on ClinicalTrials.gov? ☒No 
 
Use of a placebo in place of standard therapy: 
Is a placebo being used in place of standard therapy? 
☒No 
☐Yes 
11. MEDICAL RESEARCH AREA 
☒Emergency medicine 
 ☒Pediatrics 
12. ATTACHMENTS 
1. Form A, Signature Sheet 
2. Form A-2, Study Personnel Listing 
3. Form D, Informed Consent Document 
4. E-1 Parental HIPAA Authorization Form 
5. H23 Template, Research Involving Children Form 
6. Recruitment Flyer 
7. Participant Data Sheet 
8. Lab Letter of Support 
9. Flow Chart QW 
10. Application Checklist