Condition category
Urological and Genital Diseases
Date applied
25/03/2020
Date assigned
31/03/2020
Last edited
27/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Urine is a waste product produced by the kidneys, so testing it can show if the kidneys are not working well. For instance, if there is protein in the urine sample, the kidneys may not be filtering it out well. If there is sugar in the urine sample, this might be an indicator that sugar levels in the blood are too high. If your child has a urine infection, the bacteria may be present in the urine sample. Testing a urine sample is usually the first stage in carrying out a general assessment, before blood tests are needed.
The process of obtaining a clean catch urine sample from pre-continent infants without the use of invasive strategies can be difficult and time consuming for clinicians. However, the invasive methods are not well received by parents and require staff with the ability to perform such methods on young babies.
The use of bladder stimulation techniques to obtain samples in a timelier manner have recently been studied. One such method, the Quick Wee method has been shown in one randomized control trial in a tertiary paediatric emergency department to lead to quicker sample collection. The quick wee method involves rubbing cold saline onto the abdomen of infants to attempt to prompt urination and collect a sample that is not contaminated.

Who can participate?
Infants between 1 month and 12 months old.

What does the study involve?
After parental consent is obtained babies are randomised to either the intervention arm (quick wee method during clean catch collection) or control arm (usual care clean catch urine collection). This involves preparing the baby for urine sampling by clean catch method and performing either the control or intervention for the five minute study time.

What are the possible benefits and risks of participating?
The benefits of participation are the potential for a quicker sample collection in the control arm, as well as adding to the evidence base for this method. Infants in the control arm have usual care performed so there are no added risks in this group. The potential risk to the intervention group is the possibility of discomfort to the infant due to the cold saline stimulation.

Where is the study run from?
Mayo University Hospital (Ireland)

When is the study starting and how long is it expected to run for?
February 2019 to July 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Aoife Branagan, Branagaa@tcd.ie

Trial website

Contact information

Type

Public

Primary contact

Dr Aoife Branagan

ORCID ID

https://orcid.org/0000-0001-5220-5372

Contact details

Care of Prof M. O’Neill
Paediatric Department
Mayo University Hospital
Castlebar
Mayo
-
Ireland
+353 (0)872218141
Branagaa@tcd.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil Known

Protocol/serial number

Nil known

Study information

Scientific title

Does the Quick Wee method induce faster urination for the collection of clean catch urine samples in pre-continent infants when compared with standard clean catch urine collection?

Acronym

Study hypothesis

The use of cold fluid applied to the supra-pubic area in infants will induce urination. This can be used to induce urination for collection of sterile samples for testing in the diagnosis of urinary tract infection.

Ethics approval

Approved 23/11/2018, Research Ethics committee, Mayo University Hospital (Castlebar, Co. Mayo, Ireland; +353 (0)94 9042000; no email provided), ref: TOM/DP

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Urinary tract infection

Intervention

Randomisation was done by random permuted blocks of 8 using shuffling of sealed opaque envelopes.

The intervention arm of this study was the Quick Wee method - rubbing of cold saline to the supra-pubic area.

The control arm was standard method of collection for clean catch urine samples.

All infants were prepared for collection of a clean catch urine sample and all necessary equipment was prepared to carry out the quick wee method. The envelope containing the group assignment was opened at the bedside immediately prior to the opening of the nappy.

In the intervention group, infants underwent cleaning of the perineum for ten seconds with room temperature sterile water and then had cold saline rubbed to the supra-pubic area up to five minutes study time.

In the usual care arm, after initial cleaning the clinician waited up to five minutes to see if the infant would spontaneously void.

The duration of the treatment in both groups was 5 minutes – either with cold saline stimulation or no stimulation with a clinician waiting to catch a sample if the baby voided.

There was no follow-up of infants after the study period described above, however, the results of any samples obtained which were sent for culture were followed.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Void or no void measured during the 5 minute study period

Secondary outcome measures

1. Time to void (seconds) measured using stopwatch during the 5 minute study period
2. Contamination measured using screening dipstick at the time of data collection, and number of white cells on microscopy and any growth on culture
3. Parental and clinician satisfaction measured using a 5-point Likert scale (Very satisfied, Satisfied, Neutral, Unsatisfied, Very unsatisfied) at the end of the 5 minute study period

Overall trial start date

01/10/2018

Overall trial end date

30/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Infants between 1 month and 12 months of age

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

130

Total final enrolment

130

Participant exclusion criteria

1. Anatomical or neurological abnormality affecting voiding
2. Clinician decision that participation would delay necessary care

Recruitment start date

01/02/2019

Recruitment end date

20/07/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

Mayo University Hospital
Castlebar
Mayo
-
Ireland

Sponsor information

Organisation

Mayo General Hospital

Sponsor details

Prof M. O’Neill
Paediatric Department
Mayo University Hospital
Castlebar
Mayo
-
Ireland
+353 (0)94-9042000
michael.oneill1@hse.ie

Sponsor type

Hospital/treatment centre

Website

http://www.mayokaset.com/en/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Data stored as excel spreadsheet, data is now available. Requests for data will be looked at on case by case basis. Analysis was by intention to treat. Written consent was obtained from parents. Data is anonymised, patients are identified by study number only.

Intention to publish date

01/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/03/2020: Trial’s existence confirmed by Mayo University Hospital