RT Journal Article
SR Electronic
T1 Collection devices to reduce contamination in urine samples provided for diagnosis of uncomplicated urinary tract infection: a single blind randomised controlled trial
JF British Journal of General Practice
JO Br J Gen Pract
FD British Journal of General Practice
SP BJGP.2021.0359
DO 10.3399/BJGP.2021.0359
A1 Gail Hayward
A1 Sam Mort
A1 Ly-mee Yu
A1 Merryn Voysey
A1 Margaret Glogowska
A1 Caroline Croxson
A1 Yaling Yang
A1 Julie Allen
A1 Joanna Cook
A1 Sarah Tearne
A1 Nicola Blakey
A1 Sharon Tonner
A1 Vanshika Sharma
A1 Meena Patil
A1 Sadie Kelly
A1 Christopher C Butler
YR 2021
UL http://bjgp.org/content/early/2021/10/28/BJGP.2021.0359.abstract
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.