Feasibility of conducting a randomised controlled trial (RCT) comparing invasive (catheter or needle) and non-invasive (clean catch/urine caught in a pot) urine sampling techniques in children under 16 years old with a suspected urinary tract infection

Determining the feasibility of randomising children and young people to invasive and non-invasive urine sampling techniques (FROG): a pragmatic multi-centred randomised controlled feasibility trial and a mixed methods feasibility perspectives study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84676764

Enrollment

100

Registered

2025-04-01

Start date

2025-06-08

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary tract infection Urological and Genital Diseases

Interventions

This is a mixed-methods study consisting of three work packages: Work Package 1 is a pragmatic multicentre randomised controlled feasibility trial to assess whether it is acceptable to randomise child

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Work Package 1: Randomised Controlled Feasibility Trial 1. Child under 16 years of age at presentation 2. Requiring urine testing for suspected UTI 3. Cannot provide a mid-stream urine sample (are not toilet trained) Work Package 2: Mixed Methods Feasibility Study Parents and Children: 1. Parents/guardians of children (0 to under 16 years) and children (aged 7 to under 16 years) who are approached to participate in WP1 including those who decline randomisation OR 2. Parents/guardians of children (0 to under 16 years) and children (aged 7 to under 16 years) who have required urine testing in hospital setting for suspected UTI in the last 3 years Healthcare Practitioners: 1. Healthcare practitioners (doctors, nurses, research staff and Allied Health professionals) involved in recruitment to the FROG feasibility trial (WP1) OR 2. UK healthcare practitioners (doctors, nurses, research staff and Allied Health Professionals) not involved in recruitment, screening or conduct of the FROG feasibility trial (WP1) Work Package 3: Consensus Meeting 1. Parents/guardians of children (0 to under 16 years) and children if feasible (aged 7 to under 16 years) who are approached to participate in WP1 including those who decline randomisation. OR 2. Parents/guardians of children (0 to under 16 years) and children if feasible (aged 7 to under 16 years) who have required urine testing in hospital setting for suspected UTI in the last three years. OR 3. Healthcare practitioners (doctors, nurses, research staff and Allied Health Professionals) involved in recruitment to the FROG feasibility trial (WP1) OR 4. UK healthcare practitioners (doctors, nurses, research staff and Allied Health Professionals) not involved in recruitment, screening or conduct of the FROG feasibility trial (WP1)

Exclusion criteria

Exclusion criteria: Work Package 1: Randomised Controlled Feasibility Trial 1. A clinical need to collect an immediate invasive urine sample without delay 2. Participants where both methods of invasive urine sampling are deemed inappropriate by the treating clinician or are unavailable 3. Children sedated or admitted to intensive care units at the time of screening 4. Language issues (not overcome with the use of translators and available translated information sheets) 5. Parent or legal representative unavailable to provide informed consent 6. Consent declined Work Package 2: Mixed Methods Feasibility Study Parents and Children: 1. Language issues (not overcome with the use of translators and available translated information sheets) 2. Declined consent Work Package 3: Consensus Meeting: 1. Language issues (not overcome with the use of translators and available translated information sheets) 2. Declined consent

Design outcomes

Primary

Measure	Time frame
Work Package 1 Randomised Controlled Feasibility Trial: Consent to randomisation is measured using the recruitment data at Timepoint 1 (Baseline)	—

Secondary

Measure	Time frame
Randomised Controlled Feasibility Trial: 1. Age, gender, ethnicity and basic demographic data are measured using participants' clinical data records at Timepoint 0 (Screening) 2. Patients who are judged unsuitable for the study are measured using eligibility data at Timepoint 0 (Screening) 3. Participants who consent to randomisation to CCU, TUBC or SPA are measured using consent (WP1) and urine sampling methods data at Timepoint 0 (Screening) and Timepoint 2 (Baseline, 1 hour) 4. Participants who consent to randomisation to CCU or TUBC are measured using consent (WP1) and urine sampling methods data at Timepoint 0 (Screening) and Timepoint 2 (Baseline, 1 hour) 5. Participants who consent to randomisation to CCU or SPA only are measured using consent (WP1) and urine sampling methods data at Timepoint 0 (Screening) and Timepoint 2 (Baseline, 1 hour) 6. Participants in each randomised group who received the allocated intervention are measured using adherence to the intervention at Timepoint 3 (2-4 hours following urine sample collection) 7. Contamination by urine collection method is measured using urinalysis results at either Timepoint 3 (2-4 hours) or Timepoint 4 (within 24 hours of urine sample collection) 8. Safety is measured using adverse events/serious adverse events data at Timepoint 1 (Baseline, 1 hour), Timepoint 2 (2-4 hours), Timepoint 3 (24 hours) 9. Time to collect the urine sample is measured using health resource data at Timepoint 2 (2-4 hours) 10. Pain and distress associated with the urine sample method are measured using the pain and distress scales (FLACC, Wong Baker, SUDS) at Timepoint 2 (2-4 hours) 11. Diagnosis of UTI is measured by urine culture results at Timepoint 3 (within 24 hours of urine sample collection), Timepoint 4 (24 – 72 hours after sample collection)	—

Measure

Time frame

Randomised Controlled Feasibility Trial: 1. Age, gender, ethnicity and basic demographic data are measured using participants' clinical data records at Timepoint 0 (Screening) 2. Patients who are judged unsuitable for the study are measured using eligibility data at Timepoint 0 (Screening) 3. Participants who consent to randomisation to CCU, TUBC or SPA are measured using consent (WP1) and urine sampling methods data at Timepoint 0 (Screening) and Timepoint 2 (Baseline, 1 hour) 4. Participants who consent to randomisation to CCU or TUBC are measured using consent (WP1) and urine sampling methods data at Timepoint 0 (Screening) and Timepoint 2 (Baseline, 1 hour) 5. Participants who consent to randomisation to CCU or SPA only are measured using consent (WP1) and urine sampling methods data at Timepoint 0 (Screening) and Timepoint 2 (Baseline, 1 hour) 6. Participants in each randomised group who received the allocated intervention are measured using adherence to the intervention at Timepoint 3 (2-4 hours following urine sample collection) 7. Contamination by urine collection method is measured using urinalysis results at either Timepoint 3 (2-4 hours) or Timepoint 4 (within 24 hours of urine sample collection) 8. Safety is measured using adverse events/serious adverse events data at Timepoint 1 (Baseline, 1 hour), Timepoint 2 (2-4 hours), Timepoint 3 (24 hours) 9. Time to collect the urine sample is measured using health resource data at Timepoint 2 (2-4 hours) 10. Pain and distress associated with the urine sample method are measured using the pain and distress scales (FLACC, Wong Baker, SUDS) at Timepoint 2 (2-4 hours) 11. Diagnosis of UTI is measured by urine culture results at Timepoint 3 (within 24 hours of urine sample collection), Timepoint 4 (24 – 72 hours after sample collection)

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Countries

England, Northern Ireland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026