PT  - JOURNAL ARTICLE
AU  - Gail Hayward
AU  - Sam Mort
AU  - Ly-mee Yu
AU  - Merryn Voysey
AU  - Margaret Glogowska
AU  - Caroline Croxson
AU  - Yaling Yang
AU  - Julie Allen
AU  - Joanna Cook
AU  - Sarah Tearne
AU  - Nicola Blakey
AU  - Sharon Tonner
AU  - Vanshika Sharma
AU  - Meena Patil
AU  - Sadie Kelly
AU  - Christopher C Butler
TI  - Collection devices to reduce contamination in urine samples provided for diagnosis of uncomplicated urinary tract infection: a single blind randomised controlled trial
AID  - 10.3399/BJGP.2021.0359
DP  - 2021 Oct 28
TA  - British Journal of General Practice
PG  - BJGP.2021.0359
4099  - http://bjgp.org/content/early/2021/10/28/BJGP.2021.0359.short
4100  - http://bjgp.org/content/early/2021/10/28/BJGP.2021.0359.full
AB  - Background: Urine collection devices (UCD) are being marketed and used in clinical settings to reduce urine sample contamination, despite inadequate supporting evidence. Aim: To determine whether UCDs, compared to standardised instructions for urine sample collection, reduce the proportion of contaminated samples. Design, Setting: Single blind randomised controlled trial in UK Primary care. Method: Women aged ≥ 18 years presenting to with symptoms attributable to urinary tract infection (UTI) were randomised (1:1:1) to use either a Peezy UCD, a Whizaway Midstream UCD, or standardised verbal instructions (SVI) for midstream sample collection. The primary outcome was the proportion of urine samples reported as contaminated by microbiology laboratory analysis. Results: 1264 women (Peezy n=424; Whizaway n=421; SVI n=419) were randomised between 5/10/16 and 20/8/18. 90 women were excluded from the primary analysis due to ineligibility or lack of primary outcome data, leaving 1174 (n=381; n=390; n=403) for intention-to-treat analysis. The proportion of contaminated samples was 26.5% with the Peezy, 28.2% Whizaway, and 29% SVI (relative risk (RR) Peezy v SVI 0.91 [95% Confidence Interval (CI) 0.76 to 1.09] (P = 0.32); Whizaway v SI 0.98 [95% CI 0.97 to 1.20] (P = 0.82)). There were 100 (25.3%) device failures with Peezy and 35 (8.8%) with Whizaway UCDs; the proportion of contaminated samples was similar after device failure samples were excluded. Conclusion: Neither Peezy nor Whizaway UCDs reduced sample contamination when used by women presenting to primary care with suspected UTI. Their use cannot be recommended for this purpose in this setting.