Urine collection devices to reduce contamination in urine samples for diagnosis of uncomplicated UTI: a single-blind randomised controlled trial in primary care

Abstract

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.

Corrections

“…Notwithstanding, usage of these instructions is variable across practices and across countries. In addition, a midstream urine sample is not always easy to collect, mainly among older patients, let alone when patients are instructed to use external devices as recently analysed by Hayward et al 1 It is no wonder that a high number of patients failed to accomplish the proper use of these devices. The results were expected and the use of two devices did not reduce the number of contaminated samples when compared with the classical procedure of recommending a midstream urine collection.…”

Application of a new urine collection device in the collection of 24-hour urine specimens from patients--Improving the efficiency of clinical urine specimen collection

“…The urine specimen collection bag developed by Ji Huiqin et al [18] is suitable for the retention of urine specimens that require the addition of preservatives. Some scholars have also developed an intelligent visualized 24-h urine specimen collection container, which can solve the problems of inaccurate urine volume recording and uneven mixing of urine by manual operation, but it is only applicable to patients who can get out of bed for toileting and cannot solve the problem of 24-h urine specimen collection for bedridden patients and urine leakage due to patients going out for examination [19].…”

Experiences of urine collection devices during suspected urinary tract infections: a qualitative study in primary care

“… 7 The authors of the current study recently conducted a three-arm randomised controlled trial (RCT) comparing outcomes from the use of two UCDs (Whiz Midstream and Peezy) to outcomes from standardised practice (which consisted of verbal instructions for collecting a midstream urine [MSU] sample in a sample container — without a UCD — as follows: ‘Please pass the first portion of your urine into the toilet and collect the next portion in this sample pot’), reported elsewhere. 10 …”

“…A qualitative study was embedded in the current authors’ RCT 10 and, using semi- structured interviews, the perceptions and experiences of using the UCDs were explored in a subsample of the women with suspected UTIs who had enrolled in the RCT. The aim was to gather information on the usability and acceptability of the two devices to the women, compared with their usual practice in collecting urine, and this is the focus of the current article.…”