Abstract
BackgroundUrine collection devices (UCDs) are being marketed and used in clinical settings to reduce urine sample contamination, despite inadequate supporting evidence.AimTo determine whether UCDs, compared with standardised instructions for urine sample collection, reduce the proportion of contaminated samples.Design and settingSingle-blind randomised controlled trial in general practices in England and Wales.MethodWomen aged ≥18 years presenting with symptoms attributable to urinary tract infection (UTI) were randomised (1:1:1) to use either a Peezy UCD or a Whiz Midstream UCD, or were given standardised verbal instructions (SVI) for midstream sample collection. The primary outcome was the proportion of urine samples reported as contaminated by microbiology laboratory analysis.ResultsA total of 1264 women (Peezy UCD: n = 424; Whiz Midstream UCD: n = 421; SVI: n = 419) were randomised between October 2016 and August 2018. Ninety women were excluded from the primary analysis as a result of ineligibility or lack of primary outcome data, leaving 1174 (Peezy UCD: n = 381; Whiz Midstream UCD: n = 390; SVI: n = 403) for intention-to-treat analysis. The proportion of contaminated samples was 26.5% with the Peezy UCD, 28.2% with the Whiz Midstream UCD, and 29.0% with SVI (relative risk: Peezy UCD versus SVI = 0.91, 95% CI = 0.76 to 1.09, P = 0.32; Whiz Midstream UCD versus SVI = 0.98, 95% CI = 0.97 to 1.20, P = 0.82). There were 100 (25.3%) device failures with the Peezy UCD and 35 (8.8%) with the Whiz Midstream UCD; the proportion of contaminated samples was similar after device failure samples were excluded.ConclusionNeither the Peezy UCD nor the Whiz Midstream UCD reduced urine sample contamination when used by women presenting to primary care with suspected UTI. Their use cannot be recommended for this purpose in this setting.
Highlights
Urinary tract infection (UTI) is one of the commonest bacterial infections managed in general practice and is the reason for 1-3% of all GP consultations[1]
Neither Peezy nor Whizaway Urine collection devices (UCD) reduced sample contamination when used by women presenting to primary care with suspected urinary tract infection (UTI)
How this fits in: This trial is the first to evaluate the effectiveness of urine collection devices in the population of most relevance: women with symptoms of UTI presenting to primary care
Summary
Urinary tract infection (UTI) is one of the commonest bacterial infections managed in general practice and is the reason for 1-3% of all GP consultations[1]. A test which can take up to 3 days to provide a result, is commonly requested by primary care clinicians to confirm a suspected diagnosis of UTI and to understand antibiotic sensitivities. GPs will not receive a clinically useful result from the urine culture in up to 30% of cases because these samples are contaminated by bacteria from the host’s faeces, skin and vaginal secretions[2]. Such samples are often reported as contaminated or as ‘mixed growth’, and this result neither rules in nor rules out bacterial infection. Aim: To determine whether UCDs, compared to standardised instructions for urine sample collection, reduce the proportion of contaminated samples
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