CONDUCT - Collection devices to reduce urine contamination

• Register: ISRCTN
• Last refreshed on: 20 June 2023
• Main ID: ISRCTN68511881
• Date of registration: 29/09/2016
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: CONDUCT - Collection devices to reduce urine contamination
• 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
• Date of first enrolment: 01/10/2016
• Target sample size: 1260
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN68511881
• Study type: Interventional
• Study design: Single blind individually randomised controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Gail Hayward

Key inclusion & exclusion criteria

Inclusion criteria: Women =18 years of age presenting to UK General Practice with symptoms consistent with urinary tract infection.
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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Urinary tract infections
Urological and Genital Diseases
Urinary tract infection

Intervention(s)

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.

Primary Outcome(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

Secondary Outcome(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

Secondary ID(s)

2.0

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

East of England - Cambridge East Research Ethics Committee, 08/06/2016, ref: 16/EE/0200

Results

• Results available: Yes
• Date Completed: 31/12/2018