EPIC: Effect of Povidone Iodine Periurethral Cleansing on Level of Contamination With Clean Catch

• ClinicalTrials.gov Identifier: NCT03933436
• Recruitment Status: Completed
• First Posted: May 1, 2019
• Last Update Posted: May 21, 2020
• Sponsor: Travis Callahan
• Information provided by (Responsible Party): Travis Callahan, Mike O'Callaghan Military Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Urine Contamination	Other: Iodine swabs.; Other: Saline flush.	Not Applicable

Detailed Description:

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. 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. 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 catch urine for screening and a catheter specimen urine collection or suprapubic aspiration for definitive diagnosis. 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.

The investigators chose to use iodine as the 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: EPIC: Effect of Povidone Iodine Periurethral Cleansing on Level of Contamination With Clean Catch: A Randomized Control Trial
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: October 28, 2019
• Actual Study Completion Date: October 28, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Iodine; Iodine swabs.	Other: Iodine swabs.; Children will then have their periurethral region gently cleansed for ten seconds with iodine swabs.
Active Comparator: Normal Saline; Saline flush.	Other: Saline flush.; Children will then have their periurethral region gently cleansed for ten seconds with saline flush.

Outcome Measures

Primary Outcome Measures :

1. Number of participant samples indicating urine contamination [ Time Frame: 24 to 48 hours ]
   Binary yes/no outcome of detection of microbial markers to determine level of contamination

Secondary Outcome Measures :

1. Number of participants who void urine [ Time Frame: 5 minutes ]
   Binary yes/no outcome of voiding urine

Eligibility Criteria

• Ages Eligible for Study: up to 12 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**

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:

• 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.

Contacts and Locations

Locations

United States, Nevada

Mike O'Callaghan Military Medical Center

Las Vegas, Nevada, United States, 89191

Sponsors and Collaborators

Travis Callahan

Investigators

• Study Director: Paul F Crawford, MD; Mike O'Callaghan Military Medical Center, 99MDG, US Air Force

  Study Documents (Full-Text)

Documents provided by Travis Callahan, Mike O'Callaghan Military Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] April 4, 2018

Informed Consent Form  [PDF] January 22, 2019

More Information

Publications:

Shaw KN, Gorelick M, McGowan KL, Yakscoe NM, Schwartz JS. Prevalence of urinary tract infection in febrile young children in the emergency department. Pediatrics. 1998 Aug;102(2):e16.

National Collaborating Centre for Women's and Children's Health (UK). Urinary Tract Infection in Children: Diagnosis, Treatment and Long-term Management. London: RCOG Press; 2007 Aug.

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. 1999 Apr;103(4 Pt 1):843-52. Erratum in: 2000 Jan;105(1 Pt 1):141. Pediatrics 1999 May;103(5 Pt 1):1052, 1999 Jul;104(1 Pt 1):118.

• Responsible Party: Travis Callahan, Principal Investigator, Mike O'Callaghan Military Hospital
• ClinicalTrials.gov Identifier: NCT03933436
• Other Study ID Numbers: FWH20190009H
• First Posted: May 1, 2019
• Last Update Posted: May 21, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No