Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children

February 14, 2024 updated by: Sulayyem Saleh Al Harsousi, Oman Medical Speciality Board

Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children: Randomized Control Trial

Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral bladder catheterization, and noninvasive techniques, such as sterile bag and clean catch. However, catheterization can be a painful and invasive procedure, particularly in young infants who are less cooperative, and sometimes tends to be rejected by parents.

Given the availability of alternative methods with comparable contamination rates, we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization, as well as secondary outcomes such as pain scores, parental satisfaction, and time required to collect urine for each technique.

Methods: To achieve this, we will conduct a randomized control trial in precontinent pediatric patients. A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting. A well-designed and labeled data collection sheets will be used for data collection, and the data will be entered using EPI-data software. Statistical analysis will be performed using IBM SPSS statistics.

Aim: The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.

Patient Population: young infants from 0 to 6 months of age

Intervention: There will be two groups:

  1. Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).
  2. Group B (Control group): Urine samples will be collected using the standard bladder catheterization method.

Clinical Measurement: All collected urine samples will be labeled and sent to the laboratory. All results will be retrieved from the medical records. Direct measurement will be for the duration of the procedures in both experiment and control group (stopwatch will be used). Pain score (Neonatal Infant Pain Scale) and parental satisfaction survey will be filled at the time of the procedure.

Outcome: Contamination rate and feasibility of both urine sampling techniques

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Urinary tract infection (UTI) is a common source of infection in children. It accounts for 5 to 14 percent of visits by children every year. The overall prevalence is around 7% among different age subgroups of children. Several factors affect the prevalence of UTI including age, gender, and circumcision status.

The diagnosis of UTI requires obtaining a urine specimen from the patient. Generally, there are four methods used in collecting urine samples which can be categorized as invasive (such as suprapubic aspiration and urethral bladder catheterization) and noninvasive (such as Sterile bag and clean catch).

The selection of the urine collection technique is mainly determined by whether the patient is toilet-trained or not. In non-toilet-trained patients, urethral bladder catheterization or suprapubic aspiration can be used. The latter is having the least contamination rate in urine culture. Clean-catch urine is commonly used for toilet-trained patients. If the clinical assessment of febrile infants necessitates immediate antimicrobial therapy, urine culture should be obtained either by urethral bladder catheterization or suprapubic aspiration.

Previous observational studies showed approximately a 1 percent contamination rate using the suprapubic aspiration technique. In a prospective study done on premature infants it was found that the suprapubic aspiration technique resulted in increased pain and a higher probability of procedural failure compared to urethral bladder catheterization. According to American academy of pediatrics (AAP), for non-toilet trained children, it's advisable to gather a urine sample through methods like ureteral catheterization or suprapubic bladder aspiration, especially when a sample obtained using a perineal bag shows positive results on a dipstick test. The latest guideline from AAP recommends urine culture to be obtained via either SPA or bladder catheterization in pediatric patients aged between 8 to 60 days old, due to false positive results that can occur in the other urine collection techniques.

Urethral bladder catheterization carries a 6 to 12 percent of contamination rate. In regard clean catch urine method 16 to 63 percent of the contamination rate.

As outlined in the guideline in National Institute for Health and Care Excellence (NICE) guideline, to use clean catch urine wherever possible in pediatric patients below 16 years old. And to reserve bladder catheterization and suprapubic aspiration when noninvasive methods are not possible or practical.

previous literature demonstrated a safe and noninvasive technique to collect midstream clean-catch urine in infants. It was based on bladder stimulation and paravertebral lumbar massage. This technique yielded accurate and low contamination rates for infants below 90 days old. Moreover, the success rate was 86.3 percent, while the contamination rate was 5 percent. The safety and efficacy of the same stimulation technique in a neonatal intensive care unit setting were described in the literature. The median time to collect urine was 64 seconds. The success rate is 90 percent. However, some literature showed a lower success rate reaching 61 percent, possibly due to patients with a low oral intake that were not excluded from the study.

In the effort to reduce bladder catheterization in children, different techniques were introduced in the previous literature to improve the clean catch urine success rate as well as the contamination rate. Bladder and lumbar paravertebral massage maneuvers are a safe, time-saving technique that needs to be studied further.

In our setting, the recommendations from international guidelines are being followed. For non-toilet trained children suspected to have UTI, initial urine specimen for urine dipstick is collected by sterile bag or bladder catheterization. If the result of the urine dipstick came positive, then urine culture is obtained via bladder catheterization, if the initial specimen collected by the sterile bag. In addition, we lack the statistics of urine culture contamination in our laboratories.

The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hemodynamically stable infants.
  • Require urine collection as part of their work-up in the emergency department.
  • Age 0 to 6 months.

Exclusion Criteria:

  • Parental refusal.
  • Unstable hemodynamically young infants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Catheterization
Group A: is the control group, participant will undergo bladder catheterization. (The standard practice)
Procedure: Bladder catheterization
Participant will undergo the standard bladder catheterization for urine collection
Experimental: Clean Catch
Group B: is the experimental group, participant will undergo clean catch urine via bladder massage technique.
Procedure: clean catch urine via bladder massage technique
Participant will undergo clean catch urine via bladder massage technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine culture contamination rate
Time Frame: After urine culture report (usually 2-3 days after urine collection)
Urine culture contamination rate will be evaluated in both techniques used in the study which includes dividing the total number of contaminated urine culture sets by the total number of urine culture.
After urine culture report (usually 2-3 days after urine collection)
Parental satisfaction questionnaire
Time Frame: After the procedure immediately
Parental satisfaction with the procedure techniques (in both arms) will be evaluated by a questionnaire.
After the procedure immediately

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of the procedure
Time Frame: during each procedure
duration of the procedure in both arms (in seconds)
during each procedure
Pain score
Time Frame: after the procedure immediately
Pain score will be assessed by using Neonatal Infant Pain Scale (NIPS), values can range from 0 to 7. NIPS score interpretation 0-1: no pain; 2: mild pain; 3-4: moderate pain; 5-7: severe pain
after the procedure immediately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oman Medical Speciality Board

Investigators

  • Study Director: Lubna M Al Lawati, MD, Oman Medical Speciality Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MoH/CSR/23/26368

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Still undecided, as it is a pilot study. in the next main study, the IPD will be available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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