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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.

Original publication

DOI

10.3399/BJGP.2021.0359

Type

Journal article

Journal

Br J Gen Pract

Publication Date

28/10/2021

Keywords

Cancer, Clinical (general), Clinical (physical), Diagnosis, Epidemiology, Health promotion and prevention, Prevention, Research methods, Screening