The technology

Peezy Midstream (Forte Medical) is a medical device for midstream urine (MSU) collection for children and adults. There are other types of methods for getting a urine sample, such as bag, pad, catheter, prostate massage or secretions, clean catch, suprapubic aspirate, cystoscopy, ureteric, ileal conduit, urostomy and nephrostomy urine. Peezy Midstream is used when collecting a sample which needs collecting during urination. The device kit includes a genital wipe, the Peezy Midstream funnel collection device and either a 30 ml or 10 ml tube which stores the urine sample and is then sent to the microbiology lab (and can accommodate a bar code label). During urine collection, the first void urine is automatically expelled into the toilet, MSU urine is captured in the collection tube, and excess urine is diverted into the toilet once the tube is full. When collection is finished, the sample collection tube is detached from the Peezy Midstream funnel and sealed with a lid.

An MSU sample is primarily collected to check for infection. A sample of urine from the middle of a person's bladder does not normally carry contaminants that may mean the specimen is unreliable. If bacteria are found in the sample, it means that the urine is infected. Urine samples can be tested in clinic using a dipstick test or in a laboratory if a more complex urine analysis is needed.

Innovations

Peezy Midstream captures only MSU, without needing the patient to interrupt urine flow. The device is the only urine collection method that meets Public Health England's UK Standards for Microbiology Investigations: Investigation of urine. The potential benefits of Peezy Midstream are that it is hygienic and easy to use to collect MSU. This could increase the accuracy of MSU testing, reducing the need for repeat tests and rates of false-positive dipstick samples.

Current care pathway

Currently, people with a suspected urinary tract infection (UTI) need to provide a urine sample. MSU samples are recommended for routine urine collection. MSU samples are commonly captured using a clean-catch technique, where avoidance of contamination of the urine sample (for example from skin contact) is needed. Patients are usually given a standard container only and must empty the first part of the urine then while continuing flow, collect about 10 ml (in a CE-marked leak proof container) to provide an MSU specimen. The current method also results in soiled hands and containers, creating additional infection control risks. The sample may be associated with contamination by bacteria from the hands or genitals, which may grow on culture and be mistakenly identified as bacteria in the urine.

Pregnant women are routinely screened for gestational diabetes, pre-eclampsia and asymptomatic bacteriuria which can be done using MSU culture early in pregnancy. MSU samples are mainly done in primary care.

The following publications have been identified as relevant to this care pathway:

Population, setting and intended user

Peezy Midstream would be used for MSU collection. Urine samples are often taken to diagnose UTIs. UTIs are among the most common types of infections, with an estimated 145,132 people admitted as an emergency in 2010/11, at an estimated cost of £316 million per year (about £2,177 per patient; Bardsley et al. 2013). This trend is increasing, in 2013/14 there were 184,000 unplanned admissions associated with UTI at a cost of £434 million (about £2,358 per patient) to the NHS (Unplanned Admissions Consensus Committee, accessed 30 January 2019).

In children, UTIs are common bacterial infections that cause illness and can be difficult to diagnose because the presenting symptoms are often non-specific. Failure to diagnose and treat a UTI quickly and successfully may result in renal scarring and eventually loss of function. About 10% to 20% of women will experience a symptomatic UTI at some point during their life time. The incidence of UTI is highest in young women. In adult men, most infections are complicated and related to abnormalities of the urinary tract. However, there is a low incidence of spontaneous UTIs in otherwise healthy young men.

In the elderly population, the incidence of UTIs increase with age for men and women and are 1 of the most common infections associated with this age group. About 10% of men and 20% of women over the age of 80 have asymptomatic bacteriuria. Underlying health issues can make diagnosis difficult and make this group susceptible to resistant strains.

Urine samples are also taken for routine antenatal screening (gestational diabetes, pre-eclampsia and asymptomatic bacteriuria), diabetic screening (routine screening for ketones and metabolites) and diagnostic screening for sexually transmitted diseases. During pregnancy, there is a 4% incidence of asymptomatic bacteriuria (persistent colonisation of the urinary tract without urinary symptoms). If left untreated or if treatment is delayed, there is an increased risk of preterm birth and pyelonephritis affecting maternal and fetal outcome. About 20% to 40% of pregnant women with untreated bacteriuria will develop pyelonephritis (UK Standards for microbiology investigations: general information, accessed 19 February 2019).

Costs

Technology costs

Peezy Midstream costs £0.87 per kit. There are possible savings through a reduction in urine samples being sent for culture because of a reduction in false-positive dipstick results.

Costs of standard care

A standard plain white universal container without an additional collection product costs between £0.05 and £0.09. Red boric acid containers cost about £0.06 each. Microbiological culture and microscopy of an MSU sample costs between £6.97 and £7.62.

Resource consequences

Peezy Midstream is currently used in 2 NHS trusts. There are no anticipated practical difficulties or changes in facilities and infrastructure associated with adopting this technology.