Determining the feasibility of randomising children and young people to invasive and non-invasive urine sampling techniques.

Background:

When healthcare practitioners are unsure if an infant, child, or young person has a UTI they perform a urine test. The results of this test determine if they receive antibiotic treatment and follow up. Where possible toilet trained children and young people provide a mid-stream urine sample.

When this is not possible urine can be collected using invasive and non-invasive methods. The advantage of the non-invasive methods for urine collection are that they are painless and can be conducted in primary care settings. Unfortunately, non-invasive urine collection methods such as clean catch urine (CCU) are complicated by high rates of bacterial contamination and the samples are time consuming to collect.

Invasive urine collection methods have the advantage of much lower rates of bacterial contamination but are typically more painful to perform. Research Question:

A UK based study is required to determine if infants, children, and young people with suspected UTI should be offered invasive or non-invasive urine sampling methods. However, it is not clear if potential participants could be recruited to a Randomised Controlled Trial (RCT) comparing the various urine collection methods and a feasibility study is required to determine if a definitive study would be possible and, if so, to inform its design.

Aims and objectives:

Acceptability of the definitive study to healthcare professionals and to parents/guardians (assessed by exploring willingness to recruit and acceptability of the interventions, recruiting and consenting procedures). Selection of suitable patient-centered primary and secondary outcomes and evidence of adequate number of eligible children to deliver the proposed definitive RCT.

Methods:

A mixed methods study involving three work packages. WP1 is a small randomised controlled study (n=100) to assess the feasibility of randomising children to invasive and non-invasive urine sampling. WP2 is a qualitative study to explore views on the proposed study and WP3 is a consensus meeting to describe the final definitive study design.

Target population: WP1: Children (under 16-years of age) requiring an investigation for suspected UTI who are not yet toilet trained.

WP2/3: Parents, children, young people, and healthcare practitioners with experience of invasive and non-invasive urine sampling in children under 16-years of age with suspected UTI. Health technologies assessed:

Invasive urine sampling is defined as either trans-urethral bladder catheterisation (TUBC) or suprapubic aspiration (SPA). Sample size:

WP1: 100 participants, WP2. 50 questionnaires, 25-35 interviews, ~5 focus groups, WP3: A range of stakeholders including parents, children and clinicians. Analysis:

WP1: Descriptive statistics with means and medians with the associated standard deviations/interquartile ranges for continuous data; and frequencies and proportions for categorical data.

WP2: Reflexive thematic approach to analysis, drawing on the adapted Theoretical Framework of acceptability for paediatric studies. WP3: Synthesise data from the three work packages to make a recommendation regarding progression to a definitive RCT. Timeline:

Study duration 18 months. Months 1-4: Set up activities. Months 5-14: WP1 and WP2, recruitment, data collection, qualitative interviews and analysis. Month 15: WP3, stakeholder meeting. Months 16 – 18: Write up, reporting and dissemination. Anticipated Impact: Following WP3 a definitive trial design will be agreed upon (if deemed feasible).