Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

Six studies are summarised in this briefing. The 6 studies included 1,350 adults. Table 1 summarises the clinical evidence as well as its strengths and limitations.

Overall assessment of the evidence

There is limited published evidence on Peezy Midstream. The evidence available is helpful to see the potential of the technology, particularly the potential reduction in urine samples sent for culture as a result of a reduction in false-positive dipstick tests. However, a well-conducted randomised control trial would be helpful to gain more certainty in terms of contamination rates and potential savings.

Table 1 Summary of selected studies

Southworth et al. (2019)

Study size, design and location

Cross-sectional pilot cohort study (n=62).

USA.

Intervention and comparator(s)

Peezy Midstream (n=21).

Peezy Midstream with cleansing wipe (n=21).

Standard method of urine collection (n=20).

Key outcomes

The authors used EQUC to compare microbial abundance and diversity of paired periurethral swabs and urine samples for each woman. Bacterial profiles of urine samples collected by Peezy Midstream differed substantially by multiple diversity indices and had substantially reduced colony-forming units compared with the paired periurethral swab. However voided urine using the standard clean-catch method had higher abundance and richness than paired periurethral swabs.

Strengths and limitations

Small study. Provides insight into the potential for Peezy to reduce cross contamination and shows that the standard clean-catch method may be contaminated by periurethral bacteria not present in urine.

Collier et al. (2014)

Study size, design and location

Observational study. Female renal transplant recipients compared with matched historical controls.

UK.

Intervention and comparator(s)

Peezy Midstream (n=420).

Standard method of urine collection (n=424).

Key outcomes

Peezy Midstream statistically significantly increased the rates of epithelial cells (p=0.008). There was also a non-significant (p=0.1) increase in mixed growths in the urine samples (when compared with the historical controls).

Strengths and limitations

Statistically significant baseline differences between the 2 groups (eGFR, p=0.002 and underlying renal diagnosis, p<0.001), which could have affected the results. Historical matched controls used, which alongside potential baseline differences between the 2 groups could lead to decreased power or type I error rates. The study is also at risk of selection bias.

This study used a previous version of the device which has since been modified.

National Institute for Health Research (2017) Usability Study

Study size, design and location

Usability study, 17 adults recruited on an opportunistic basis, with consideration of providing equal male/female balance.

UK.

Intervention and comparator(s)

Peezy Midstream.

No comparator.

Key outcomes

Overall, Peezy Midstream had positive feedback from both males and females. The results showed the ease-of-use of the device compared with current methods of MSU collection. Most people felt the device was more hygienic than current standards, however a small number highlighted that Peezy Midstream caused a mess and it was suggested that a glove or extra wipes could be included in the package. The most substantial negative aspect of the technology both in scores and comments, was the packaging and the integrated instructions. People highlighted that the bag would tear open unpredictably, causing the instructions to become unreadable or for contents to spill on the floor.

Strengths and limitations

Small study using an opportunistic sample. Provides insight into ease of use.

Chow and Hussain (2013)

Study size, design and location

106 (76 males, 30 females) consecutive patients who attended a urology clinic were given the new Peezy Midstream device for standard collection of an MSU sample. Patient questionnaire and examination of the exterior surface of the specimen bottle was recorded. Microscopy and microbiological culture reports were obtained subsequently.

UK.

Intervention and comparator(s)

Peezy Midstream.

Standard MSU collection.

Key outcomes

55% of all patients (male 28%, female 80%) reported problems mainly in spillage with existing method of MSU collection. 90% of patients found the device instructions clear, 21% experienced problems with Peezy Midstream. Spillage happened in 6% of patients. Although the device was new to 99% of the patients, 89% of them would prefer to use Peezy Midstream in the future instead of the previous methods. MSU bacteriology suggested possible contamination in only 7 specimens (6.5%) compared with 22.9% of reported incidence in the local laboratory.

Strengths and limitations

Study published as a poster presentation, so it is difficult to assess the quality of the study. Study done in the NHS so the results are generalisable.

Jie et al. (2018)

Study size, design and location

A retrospective review of MSU samples taken using standard collection. Inclusion criteria: pregnancies booked before 12 weeks gestation and continued their care, ending in delivery at study hospital. 100 most recent deliveries from 8 September 2019. Variables examined: MSU samples sent in total, positive MSU samples, antibiotics administered to protocol, contamination rate.

A service evaluation study on Peezy (n=40) for MSU collection.

UK.

Intervention and comparator(s)

Peezy Midstream.

Standard MSU collection.

Key outcomes

5% positive culture rate for standard MSU collection with a 95.5% false-positive rate and treated unnecessarily, resulting in a possible £25,847 per year spent on contaminated dipstick samples.

Peezy Midstream showed a reduction in laboratory contamination to 2.5% and 70% of patients found Peezy Midstream user friendly.

Strengths and limitations

Study published as a poster presentation, so difficult to assess the quality of the study. Study done in the NHS so the results are generalisable.

Lewis (2019)

Study size, design and location

Observational study n=281.

UK.

Intervention and comparator(s)

Peezy Midstream (n=158).

Standard MSU collection (n=123).

Key outcomes

The results showed that the introduction of Peezy increased the rate of negative culture from 115/158 (73%) to 106/123 (86%), decreased the rate of E. coli from 10/158 (6%) to 4/123 (3%), decreased the rate of faecal streps (enterococci) from 6/158 (4%) to 1/123 (1%), decreased the rate of mixed cultures from 20/158 (13%) to 8/123 (7%).

Strengths and limitations

Study published as a blog, so difficult to assess the quality of the study. Study done in the NHS so the results are generalisable.

Abbreviations: eGFR, estimated glomerular filtration rate; EQUC, expanded

quantitative urine culture; MSU, midstream urine.

Recent and ongoing studies