CONDUCT - Collection devices to reduce urine contamination

ISRCTN	ISRCTN68511881
DOI	https://doi.org/10.1186/ISRCTN68511881
Protocol serial number	2.0
Sponsor	University of Oxford
Funder	National Institute for Health Research

Submission date: 26/09/2016
Registration date: 29/09/2016
Last edited: 09/06/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Urinary tract infections (UTIs) are common infections that can affect the bladder, kidneys and the tubes that connect the bladder and kidneys together (the urinary tract). Symptoms include needing to urinate more than usual, pain while urinating, a sudden urge to urinate, feeling that the bladder is never fully empty, abdominal pain, cloudy urine and generally not feeling very well. Anyone can get a UTI but they are more common in women than men. 1 in 10 women see their GP each year because they have a UTI. When someone goes to see their GP with UTI symptoms they may be asked to provide a urine sample which can be sent to the laboratory for urine culture, in order to find out if there are any bacteria present. However, up to 30% of urine samples are contaminated by bacteria which normally live on the body. A contaminated sample cannot rule out infection or prove there is an infection. Another sample will need to be sent, and the delay may increase the length of time a patient experiences symptoms and mean they take extra courses of antibiotics; this could result in infections resistant to antibiotics in the future. If every contaminated urine culture was repeated this would cost over £14 million annually in England and Wales. This study will test whether using urine collection devices to produce urine samples can reduce the chances of contamination. There are two urine collection devices available on the NHS; the Whizaway Midstream and the Peezy. Both claim that they reduce contamination, but this has not been properly tested. The devices are funnel shaped containers which use two different methods to collect the urine sample.

Who can participate?
Women (aged over 18) and presenting to their doctor with symptoms that suggest they have a UTI.

What does the study involve?
Participants are randomly allocated to one of three groups Those in group 1 are given standard
Instructions and asked to pass urine into a standard 30ml sterile universal container. Participants in group 2 are given the Peezy Urine collection device to collect their urine sample. Participants in group 3 are asked to provide their urine sample using the Whizaway midstream Urine collection device. All samples collected from each participant is checked for contamination in a laboratory.
Participants are also asked to complete a questionnaire 14 days after they begin the study and will be contacted by telephone 14-21 days and asked for their views.

What are the possible benefits and risks of participating?
This study does not pose significant risks or benefits to participants associated with taking part.

Where is the study run from?
A number of general practices in the UK

When is the study starting and how long is it expected to run for?
April 2016 to November 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Mrs Sarah Tearne
sarah.tearne@phc.ox.ac.uk
2. Dr Gail Hayward

Contact information

Dr Gail Hayward
Public

Nuffield Department of Primary Care Health Sciences
Radclife Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom

ORCID ID	0000-0003-0852-627X
Phone	+44 (0)1865 289357
Email	gail.hayward@phc.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Single blind individually randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The effectiveness and acceptability of two urine collection devices that aim to reduce contaminated urine samples in women presenting with symptoms of urinary tract infection: a three arm trial in UK primary care
Study acronym	CONDUCT
Study objectives	To investigate whether use of urine collection devices (UCD), compared to urine collection with standardised instructions, can reduce the proportion of contaminated urine specimens.
Ethics approval(s)	East of England - Cambridge East Research Ethics Committee, 08/06/2016, ref: 16/EE/0200
Health condition(s) or problem(s) studied	Urinary tract infections
Intervention	Adult women aged 18 years and over presenting to UK general practice with symptoms attributable to urinary tract infection (UTI), including at least one of dysuria, haematuria or frequency of urination, will be randomised to one of three arms determining how they will provide a urine sample. The arms are: 1. Standard urine collection method: participants will be given a standardised instruction and will be asked to pass urine into a standard 30ml sterile universal container 2. Peezy Urine collection device: a funnel shaped device which channels the early portion of the stream into a sponge and collects the midstream portion in a standard 30ml universal container, with instructions for its use from the manufacturer 3. Whizaway midstream Urine collection device: a funnel shaped device which uses a valve system to discharge the first portion of the stream into the toilet and the midstream into a standard 30ml universal container, with instructions for its use from the manufacturer Participants will complete a questionnaire 14 days after recruitment and will be contacted by telephone 14-21 days after recruitment.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Peezy Urine collection device, Whizaway midstream Urine collection device
Primary outcome measure(s)	The proportion of contaminated urine specimens; measured as the proportion of samples in each arm reported as a mixed growth following NHS microbiology laboratory urine culture performed according to national standard operating procedures and reported within 7 days of sampling
Key secondary outcome measure(s)	To investigate the impact of urine collection devices on: 1. Detection of urine infection using laboratory techniques, measured using the proportion of samples reported as a pure or predominant growth of a known urinary pathogen following urine culture performed according to national standard reporting procedures, and the presence and number of white cells on urine microscopy within 7 days of sampling. 2. The diagnostic accuracy of dipstick urinalysis performed at the time of sample provision for urine infection by reporting sensitivity and specificity of dipstick urinalysis for a pure growth of a known urinary pathogen on urine culture 3. Presence of cells in urine which are suggestive of contamination measured by the presence and number of epithelial cells on urine microscopy reported within 7 days of sampling Also to investigate: 4. The acceptability of three urine sampling methods to patients using qualitative interviews, which will be ongoing during the trial until saturation of themes is reached 5. The acceptability of three urine sampling methods to primary care professionals from qualitative thematic analysis of focus groups. Focus groups will be performed with primary care professionals at the end of the trial, once results are available for discussion 6. The cost effectiveness and impact on NHS resources measured by: 6.1.Cost per contaminated urine specimen avoided and Cost per QALY gained 6.2. Number of participants requiring one or more further urine culture tests within 14 days 7. Health care utilization and complications in patients using each device compared to standardised usual care measured by the number of participants requiring repeat consultation with the GP or hospital admission for symptoms or complications of UTI within 14 days 8. Morbidity of UTI in patients using a device compared to standardised usual care measured by duration of symptoms in days from index consultation across 14 days form the index consultation Exploratory additional analyses using combined trial data set: 9. The impact of device use on the types of bacteria identified within ‘mixed growth’ samples measured as relative amounts of different bacterial species identified by DNA sequencing. This exploratory additional analysis will be performed throughout the period of sample collection and at the end of the trial 10. Whether the patterns of microbial presence in those specimens reported as mixed growth can be reclassified as ‘likely infection and ‘likely contamination’, using patterns of microbial presence identified by DNA sequencing and the correlation of these with patient characteristics (medical history, patient reported features of the UTI and historic and future urine culture results) in order to evaluate a potential reclassification into ‘likely infection and ‘likely contamination’. This exploratory additional analysis will be performed analysis throughout the period of sample collection and at the end of the trial 11. Whether previous antibiotic use is associated with future urinary tract infection with bacteria which are resistant to antibiotics by evaluating the correlation between resistance profile of urinary pathogens and previous antibiotic usage evaluated by review of the medical records. This exploratory additional analysis will be performed at the end of the trial
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	1260
Total final enrolment	1264
Key inclusion criteria	Women ≥18 years of age presenting to UK General Practice with symptoms consistent with urinary tract infection.
Key exclusion criteria	The participant may not enter the study if ANY of the following apply: 1. Patients who are currently taking antibiotics or have taken antibiotics in the last 7 days 2. Patients with indwelling catheters or using intermittent self-catheterisation 3. Patients unable to give informed consent 4. Previously recruited to the trial
Date of first enrolment	01/10/2016
Date of final enrolment	20/08/2018

Locations

Countries of recruitment

United Kingdom

Study participating centre

A number of UK general practices.

-
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		24/02/2022	09/06/2023	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

09/06/2023: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been changed from 1260 to 1264.
19/08/2021: A contact was removed.
26/03/2021: The intention to publish date was changed from 10/12/2019 to 31/12/2021.
10/12/2019: The following changes have been made:
1. The total final enrolment number has been added.
2. The intention to publish date has been changed from 30/11/2019 to 10/12/2019.
20/11/2018: An ORCID ID has been added for the scientific contact.
15/11/2018: The following changes have been made:
1. The recruitment end date has been changed from 01/10/2017 to 20/08/2018.
2. The total target enrolment has been changed from 1191 to 1260.
3. The intention to publish date has been changed from 01/11/2018 to 30/11/2019.
4. The overall trial end date has been changed from 01/11/2017 to 31/12/2018.
5. Sharon Tonner has been added as a public contact and Sarah Tearne removed.