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

NCT ID: NCT06265142

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-12-01

Brief Summary

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

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.

Conditions

Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Catheterization

Group A: is the control group, participant will undergo bladder catheterization. (The standard practice)

Group Type: OTHER

Bladder catheterization

Intervention Type: PROCEDURE

Participant will undergo the standard bladder catheterization for urine collection

Clean Catch

Group B: is the experimental group, participant will undergo clean catch urine via bladder massage technique.

Group Type: EXPERIMENTAL

clean catch urine via bladder massage technique

Intervention Type: PROCEDURE

Participant will undergo clean catch urine via bladder massage technique

Interventions

Bladder catheterization

Participant will undergo the standard bladder catheterization for urine collection

Intervention Type: PROCEDURE

clean catch urine via bladder massage technique

Participant will undergo clean catch urine via bladder massage technique

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oman Medical Speciality Board

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sulayyem Saleh Al Harsousi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lubna M Al Lawati, MD

Role: STUDY_DIRECTOR

Oman Medical Speciality Board

Central Contacts

Sulayyem S Al Harsousi, MD

Role: CONTACT

r2123@resident.omsb.org

97383155 ext. +968

Muna M Al Ka'abi, MD

Role: CONTACT

r2126@resident.omsb.org

91797366 ext. +968

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Study Protocol

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Document Type: Informed Consent Form

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Other Identifiers

MoH/CSR/23/26368

Identifier Type: -

Identifier Source: org_study_id