Collection devices to reduce contamination in urine samples provided for diagnosis of uncomplicated urinary tract infection: a single blind randomised controlled trial

Gail Hayward; Sam Mort; Ly-mee Yu; Merryn Voysey; Margaret Glogowska; Caroline Croxson; Yaling Yang; Julie Allen; Joanna Cook; Sarah Tearne; Nicola Blakey; Sharon Tonner; Vanshika Sharma; Meena Patil; Sadie Kelly; Christopher C Butler

doi:10.3399/BJGP.2021.0359

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Astonishing results
Gail N. Hayward and Christopher C. Butler

Published on: 28 February 2022
Astonishing results
Vincent Forte

Published on: 20 February 2022
Mid-stream vs. first-void urine samples
Carl Llor

Published on: 07 February 2022

Published on: (28 February 2022)
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Astonishing results
Gail N. Hayward, Associate Professor of Primary Care, University of Oxford
Other Contributors:
Christopher C. Butler, Professor of Primary Care, University of Oxford
We thank Dr Forte for his comments on our findings. Our randomised, controlled clinical trial reported on the use of two urine collection devices in women presenting to primary care with symptoms attributable to urinary tract infection (UTI). Frequency is a cardinal symptom of acute urinary tract infection. Requiring these women to have a full bladder before using such devices is not feasible, nor is it easy to objectively confirm.

Our participants were only eligible for inclusion if they felt able to produce a urine sample at the time of randomisation. As such the use of urine collection devices in our pragmatic study is likely to be similar to how the devices might be used by women with UTI symptoms who consult in routine general practice. We made no claim that our findings apply to use in the populations that Dr Forte refers to, such as asymptomatic pregnant women and in preoperative assessment.

Competing Interests: None declared.
Published on: (20 February 2022)
Page navigation anchor for Astonishing results
Astonishing results
Vincent Forte, GP, Forensic Physician and Medical Author, retired., Forte Medical Ltd
Peezy was developed in response to patient feedback to address the hygiene and dignity issues complained of by patients. Evidence of reduced contamination of urine samples was found later. Our UK and US customers have found reduced contamination, and savings in reduced retesting, overall expenditure and antibiotic prescribing due to improved accuracy of diagnosis. Device failure is almost unknown. A recent anecdotal report from a US distributor states: "Some lab employees and the supervisor stated they had previously taken Peezy home for personal use. The lab supervisor felt Peezy was “indestructible”, and she was unable to get it to fail.”

Had we experienced the massive 25% device failure rate quoted, we would never have launched the product. We provide training for staff issuing Peezy. In turn first-time users are correctly instructed in its use. Other than device supply, we were excluded from any involvement in the study, so this was not possible.

We wrote to the principal author asking to clarify if Peezy patients were asked to ensure a full bladder before sampling but this specific question was not answered. We cannot verify that Peezy was used correctly. The authors admit that the Peezy failure rate may have affected the analysis. “About a quarter of Peezy UCDs failed, and this may have impacted the intention-to-treat analysis “. As an SME we are unable to fund large clinical trials and rely on smaller inde...
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Peezy was developed in response to patient feedback to address the hygiene and dignity issues complained of by patients. Evidence of reduced contamination of urine samples was found later. Our UK and US customers have found reduced contamination, and savings in reduced retesting, overall expenditure and antibiotic prescribing due to improved accuracy of diagnosis. Device failure is almost unknown. A recent anecdotal report from a US distributor states: "Some lab employees and the supervisor stated they had previously taken Peezy home for personal use. The lab supervisor felt Peezy was “indestructible”, and she was unable to get it to fail.”

Had we experienced the massive 25% device failure rate quoted, we would never have launched the product. We provide training for staff issuing Peezy. In turn first-time users are correctly instructed in its use. Other than device supply, we were excluded from any involvement in the study, so this was not possible.

We wrote to the principal author asking to clarify if Peezy patients were asked to ensure a full bladder before sampling but this specific question was not answered. We cannot verify that Peezy was used correctly. The authors admit that the Peezy failure rate may have affected the analysis. “About a quarter of Peezy UCDs failed, and this may have impacted the intention-to-treat analysis “. As an SME we are unable to fund large clinical trials and rely on smaller independent studies. However, a reduction in contamination rates has been widely reported.^1-6

Llor comments⁷“We certainly do not know how patients collect the urine samples despite being instructed to perform midstream urine sample collection.“ Peezy standardises urine sampling. NICE says of Peezy⁸: “The device is the only urine collection method that meets Public Health England's UK Standards for Microbiology Investigations: Investigation of urine. “

The astonishing failure rate is unprecedented, and points to inadequate instruction. The absence of sample contamination reduction contradicts the evidence given to us. We do not accept the results of this study, which is at odds with the clear satisfaction of our customers and their end users.

References

1. Lewis T. Observational study: Use of the Peezy device to try to improve quality of urine culture. GIRFT Microbiology Lead. 2019. https://girftpathology.blogspot.com/2019/03/use-of-peezy-device-to-try-to-improve.html.

2. Bone S. Midwifery BACK-TO-BASICS: auditing urinalysis in practice. 2019. www.all4maternity.com/midwifery-back-to-basics-auditing-urinalysis-in-practice.

3. Southworth E, Hochstedler B, Price TK at al. A Cross-sectional Pilot Cohort Study Comparing Standard Urine Collection to the Peezy Midstream Device for Research Studies Involving Women. Female Pelvic Med Reconstr Surg 2019;25(2): e28-e33. doi:10.1097/SPV.0000000000000693

4. Barts NHS Hospital London: A comparative historic Quality Improvement Audit of specimens collected in Urology Clinic. Unpublished data. 2017. Available on request

5. Jie, M; Adamczyk, M; Morton, K. Midstream urine in obstetrics: improving. diagnostic accuracy. Royal Surrey County Hospital, Guildford, UK. 2018. Poster presentation (No 0212): https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.15493

6. GP Liaison Services. Case study 4. UTI pathway improvement. https://www.gp-liaison.com/case-studies.

7. Llor C. Mid-stream vs. first-void urine sample. eLetter. Br J Gen Prac 2022. https://bjgp.org/content/early/2022/01/24/BJGP.2021.0359/tab-e-letters

8. NICE. Peezy midstream for urine collection. MedTech Innovation Briefing. 2018. www.nice.org.uk/advice/mib183/chapter/Summary.
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Competing Interests: Inventor of the Peezy and a Founder Director of Forte Medical Ltd.
Published on: (7 February 2022)
Page navigation anchor for Mid-stream vs. first-void urine samples
Mid-stream vs. first-void urine samples
Carl Llor, GP, senior researcher and associate professor, University of Southern Denmark, Public Health, General Practice. Denmark
In general practice simple practices should be endorsed to avoid overcomplicating patient management. We have always been told to recommend the use of mid-stream samples when collecting a specimen of urine for culture, with or without previous cleansing and with or without soap or disinfectants. 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 elderly 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 to the classical procedure of recommending a midstream urine collection. The need to collect a midstream urine clean-catch sample has also been controversial.². Only Eley et al. found a significantly lower number of contaminations among emergency department female patients when they were provided illustrated instructions about how to collect a proper midstream urine sample compared to those who only received verbal instructions.³ Other studies, however, failed to show a benefit from cleansing prior to sample collection.

We certainly do not know how patients collect the urine samples despite being instructed...
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In general practice simple practices should be endorsed to avoid overcomplicating patient management. We have always been told to recommend the use of mid-stream samples when collecting a specimen of urine for culture, with or without previous cleansing and with or without soap or disinfectants. 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 elderly 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 to the classical procedure of recommending a midstream urine collection. The need to collect a midstream urine clean-catch sample has also been controversial.². Only Eley et al. found a significantly lower number of contaminations among emergency department female patients when they were provided illustrated instructions about how to collect a proper midstream urine sample compared to those who only received verbal instructions.³ Other studies, however, failed to show a benefit from cleansing prior to sample collection.

We certainly do not know how patients collect the urine samples despite being instructed to perform midstream urine sample collection. No studies have compared first-void or random sampling with mid-stream urine specimens with urine culture, which is the gold standard. This is the most important question. With the use of paired samples, Hølmkjær et al. compared both sampling techniques and found a slightly lower number of contaminations with the use of a midstream urine collection, but urine culture was not used as the gold standard for the two sampling groups, except in those who collected midstream urine specimens.⁴ To our knowledge, no study has compared the highly recommended midstream urine collection with a first-void urine sample or letting patients with symptoms of urinary tract infection collect the sample as they please. This type of study has yet to be done.

References

1. Hayward G, Mort S, Yu LM et al. Urine collection devices to reduce contamination in urine samples for diagnosis of uncomplicated UTI: a single-blind randomised controlled trial in primary care. Br J Gen Pract. 2021; doi:10.3399/BJGP.2021.0359.
2. Holm A, Aabenhus R. Urine sampling techniques in symptomatic primary-care patients: a diagnostic accuracy review. BMC Fam Pract 2016; 17:72.
3. Eley R, Judge C, Knight L, Dimeski G, Sinnott M. Illustrations reduce contamination of midstream urine samples in the emergency department. J Clin Pathology; London. 2016;69(10):921-5.
4. Hølmkjær P, Lars B, Marjukka M, Volkert S, Anne H. Sampling of urine for diagnosing urinary tract infection in general practice - First-void or mid-stream urine? Scand J Prim Health Care 2019; 37:113-119.

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Competing Interests: None declared.