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
| ISRCTN | ISRCTN84676764 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84676764 |
| IRAS number | 339327 |
| Secondary identifying numbers | CPMS 60565, Grant Code: NIHR156005, Protocol number: B24/28 |
- Submission date
- 10/03/2025
- Registration date
- 01/04/2025
- Last edited
- 06/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Internationally, the approach to urine collection varies. For example, in Europe and North America, national guidelines typically favour invasive urine collection methods, given their advantage of much lower rates of bacterial contamination. A UK-based study is required to determine which invasive or non-invasive urine sampling infants, children, and young people should be offered. 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 RCT would be possible and, if so, to inform its design.
The researchers aim to conduct a study of feasibility to assess which participants and interventions should be included in a subsequent randomised controlled trial, explore potential barriers to recruitment and determine the feasibility of randomisation to invasive versus non-invasive urine testing.
This study will be conducted in three parts or work packages.
Work Package 1: a randomised controlled feasibility trial
Work Package 2: a mixed-methods feasibility study
Work Package 3: consensus meeting
Who can participate?
Work Package 1:
Children who are under 16 years old who have a suspected urinary tract infection and cannot provide a midstream urine sample
Work Packages 2 & 3:
1. Parents/guardians of children (0 to under 16 years) and children (aged 7 to under 16 years) who are approached to participate in Work Package 1 including those who decline randomisation, or who have required urine testing in hospital setting for suspected UTI in the last 3 years.
2. Healthcare practitioners (doctors, nurses, research staff and Allied Health professionals) involved in recruitment to the FROG feasibility trial (Work Package 1) or who are not involved in recruitment to the FROG feasibility trial (WP1).
What does the study involve?
Work Package 1 assesses the feasibility of randomising children to receive invasive (catheter or needle) and non-invasive (clean catch urine in a pot) urine sampling.
Invasive urine sampling involves a catheter inserted into the urethra to collect the urine or a needle placed in the bladder to collect the urine. Non-invasive urine sampling involves catching the urine in a pot while doing a wee.
Children and parents/guardians can consent to share their clinical data, answer brief questions about the sampling method they received, whether randomised or not, and complete a questionnaire 3- 6 months after the urine sample was collected.
Work Package 2 is a mixed methods study including a questionnaire, interviews and focus groups to explore parent/guardian, children’s and healthcare professional’s views and acceptability of the proposed study and sampling methods.
Work Package 3 is a stakeholder consensus meeting to discuss and describe the feasibility of a final definitive study design.
What are the possible benefits and risks of participating?
Children/parents/guardians will receive an Amazon voucher for taking part in an interview as part of Work Package 2.
There is a risk of discomfort or pain and small risk of damage to the bladder or urethra (where urine comes out of your body) during invasive urine sampling methods as part of Work Package 1.
Where is the study run from?
The Northern Ireland Clinical Trials Unit
When is the study starting and how long is it expected to run for?
September 2024 to February 2026
Who is funding the study?
National Institute for Health and Care Research (UK)
Who is the main contact?
Dr Paula Taylor Miller, FROG@nictu.hscni.net
Contact information
Scientific
7 Lennoxvale
Belfast H&SC Trust
Belfast
BT9 5BY
United Kingdom
 ORCID ID |
0000-0001-6842-2566 |
|---|---|
| Phone | +44 (0)28 9615 1447 |
| paula.taylormiller@nictu.hscni.net |
Scientific
Queens University Belfast
Wellcome-Wolfson Institute for Experimental Medicine
Queen’s University Belfast
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom
| ORCID ID |
0000-0001-9452-7716 |
|---|---|
| t.waterfield@qub.ac.uk |
Scientific
Room 320
University of Liverpool
Department of Public Health, Policy and Systems
Institute of Population Health and Society
Whelan Building
Liverpool
L69 3GL
United Kingdom
| ORCID ID |
0000-0002-5726-5304 |
|---|---|
| K.Woolfall@liverpool.ac.uk |
Study information
| Study design | Pragmatic multicentre randomized controlled feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | 46972_PIS_V1.0_27Jan25.pdf |
| Scientific title | 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 |
| Study acronym | FROG |
| Study objectives | It is feasible and acceptable to conduct a randomised controlled trial comparing invasive and non-invasive urine sampling techniques in children who are under 16 years old with a suspected urinary tract infection |
| Ethics approval(s) | Approved 13/02/2025, North East - Newcastle & North Tyneside 1 Research Ethics Committee (2nd Floor, 2 Redman Place, Stratford, London, E20 1JQ; +44 (0)20 71048061; newcastlenorthtyneside1.rec@hra.nhs.uk), ref: 24/NE/0222 |
| Health condition(s) or problem(s) studied | Urinary tract infection |
| Intervention | 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 children to receive either invasive (trans-urethral bladder catheterisation or suprapubic aspiration) or non-invasive (clean catch) urine sampling methods. Work Package 2 is a mixed methods study involving questionnaires, interviews and focus groups with parents, children, young people and health practitioners to explore views on the proposed study. Work Package 3 is a consensus meeting with key stakeholders to explore the design of a future RCT comparing the effectiveness of invasive versus non-invasive urine sampling in children with suspected UTI. Work Package 1: The target population for Work Package 1 are infants, children, and young people (under 16 years of age) requiring an investigation for a suspected UTI who are not toilet trained or cannot provide a caught urine sample in a pot. During Work Package 1, children and young people under 16 years old will be assessed for eligibility to take part in the randomised feasibility trial. Participants who are eligible to take part will be approached by a member of the research team, who will answer any questions and provide the parent/guardian and child/young person with participant information on the study. If a participant would like to take part, they will be presented with the consent form, and a member of the research team will then discuss the consent/assent form with the child and parent/guardian. Work Package 2: Parent/guardians, children and young people who take part in Work Package 1, including those who decline consent to be randomised, will have an option of taking part in an interview and completing a self-report questionnaire to explore decision-making and acceptability. Based on previous feasibility studies, the researchers anticipate approximately 50 questionnaires will be completed by parents/guardians. To ensure sample diversity, including parents and children from varied geographic populations and ethnicities, we will use social media and contact charities to recruit 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 three years. Approximately 25-35 interviews will be conducted to explore trial feasibility including views on different sampling methods, approach to recruitment and patient-centred outcomes. Healthcare professionals who were members of the research teams administering sampling procedures in Work Package 1 and wider UK Healthcare practitioners recruited via social media will be invited to take part in a focus group to discuss their views on trial feasibility and design. A total of five focus groups of a maximum of eight healthcare professionals will be conducted. Work Package 3: The researchers will conduct a face-to-face consensus meeting for Work Package 3 bringing together stakeholders from PERUKI, GAPRUKI, PPI, general practice, nursing, ED, inpatient and outpatient settings. The aim is to bring together key stakeholders to review all the data and seek consensus on the design of a future comparative study. A matrix of 40 key stakeholders involved in WP1 and WP2, investigator and advisory group contacts and literature searches will be constructed. The methodology used will be similar to that used in previous NIHR HTA-funded studies (e.g. FERN, GASTRIC). Any areas of disagreement and study feasibility will be discussed and agreed upon about a potential study and clinical settings. Once the potential trial design is established, the researchers will then seek consensus on the overall trial acceptability and feasibility. A mixed methods study design has been chosen to enable both quantitative and qualitative exploration of the feasibility of the research design, intervention methods, recruitment and consent methods, with qualitative data providing a rich set of data to further explain acceptability data captured in work package 1 in more granular detail further enhancing a family centred approach to RCT design. This study has been informed by PPI input throughout the application phases, as well as the development of participant-facing materials and study processes. Timeline: The total study duration will be 18 months. |
| Intervention type | Other |
| Primary outcome measure | Work Package 1 Randomised Controlled Feasibility Trial: Consent to randomisation is measured using the recruitment data at Timepoint 1 (Baseline) |
| Secondary outcome measures | 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) |
| Overall study start date | 01/09/2024 |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Work Package 1: Sample Size: 100 children; Work Package 2: Sample Size: Questionnaires: 50 parents/guardians; Interviews: 15-20 parents and 10-15 children; Focus groups: 25 - 40 healthcare practitioners; Work Package 3: Sample Size: 40 stakeholders (parents/guardians, healthcare practitioners) |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/05/2025 |
| Date of final enrolment | 30/11/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- United Kingdom
Study participating centres
Belfast
BT12 6BA
United Kingdom
Leicester
LE1 5WW
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Birmingham
B4 6NH
United Kingdom
Bristol
BS2 8HW
United Kingdom
London
NW1 2BU
United Kingdom
Sponsor information
University/education
University Road
Belfast
BT7 1NN
England
United Kingdom
| Phone | +44 (0)28 90973296 |
|---|---|
| k.taylor@qub.ac.uk | |
| Website | https://www.qub.ac.uk |
"ROR" |
https://ror.org/00hswnk62 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal https://x.com/TheFrogStudy @TheFrogStudy https://bsky.app/profile/frogstudy.bsky.social @frogstudy.bsky.social https://www.facebook.com/share/1A9LZneoah/?mibextid=wwXIfr |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request following the publication of the primary and secondary outcomes. Formal requests for data should be made in writing to Dr Tom Waterfield (Chief Investigator) via the Northern Ireland Clinical Trials Unit (NICTU) (FROG@nictu.hscni.net) and will be reviewed on a case-by-case basis in collaboration with the Sponsor. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 27/01/2025 | 27/03/2025 | No | Yes |
Additional files
Editorial Notes
06/06/2025: The recruitment end date was changed from 31/10/2025 to 30/11/2025.
10/03/2025: Study's existence confirmed by the NIHR.
