Introduction to the Technology

Lower Urinary Tract Symptoms

The bladder is described as an "unreliable witness" because it is often difficult to differentiate between similar conditions of the lower turinary tract on the basis of symptoms alone. Urine flow measurements and ultrasound determine residual urine, which are first line investigations used in the assessment of men with Lower Urinary Tract Symptoms (LUTS). Although they can raise or lower the suspicion of bladder outlet obstruction, neither can make a definitive diagnosis.

LUTS are a common complaint of the ageing male and it is estimated that the main cause, Benign Prostatic Hyperplasia (enlarged prostate) is prevalent in one third of males aged between 50 and 60. In 2009, a ProState of the nation report published that in the UK, a third of the 9.4 million men aged over 50 experience symptoms suggestive of BPH and it reported that the total UK secondary care cost associated with the complications presented with this area of health is £111,568,793.

Men experience LUTS when passing urine and these are often presumed to be caused by Bladder Outlet Obstruction. Symptoms may include straining, hesitancy, weak or intermittent urinary stream, dribbling and incomplete emptying. A subset of patients with the symptoms will have poor bladder contraction as a cause rather than bladder outlet obstruction. It is important to distinguish between them to ensure that appropriate management is delivered.

The Technology in Use

The National Institute for Health and Clinical Excellence (NICE) hguidance on the Management of Lower Urinary Tract Symptoms in Men (2010) suggests that the consequences of poorly managed LUTS can lead to serious complications of the urogenital tract (conduits leading from the pelvis of the kidneys to the urinary meatus). Without effective diagnostic pathways, unnecessary treatment (including surgery) is currently being offered to certain patients suffering from LUTS, and as a result a huge burden is being placed on the NHS.

The non-invasive cuff test is a technique that employs a method similar to that used for non-invasive blood pressure measurement. A cuff is placed around the shaft of the patient's penis who is then asked to pass urine in the normal way. Whilst urinating, the cuff automatically inflates to temporarily obstruct the urine stream and then deflates to allow flow to resume. The pressure that is generated by the contraction of the bladder against the closed cuff provides a measure of bladder contraction. When the cuff pressure required to interrupt the urine stream is combined with the maximum flow rate generated, it can be used to distinguish between a low flow rate caused by bladder outlet obstruction and an under active bladder.

The test is only considered valid if 150ml of urine is collected and there is a return of urine flow once the constriction of the cuff has been removed. This is further described within the instructions for use document, which also contains example data.

Click here to access the NICE Quick Reference Guide for the Management of Lower Urinary Tract Symptoms in Men.

What problems does it solve?

Invasive pressure-flow studies are considered to be the Gold Standard tool for diagnosing Bladder Outlet Obstruction (BOO), however, the routine use in the investigation of Lower Urinary Tract Symptoms (LUTS) is limited by the invasive nature of performing this test alongside the requirement for specialist facilities and staff and associated morbidities of carrying out the procedure. This approach is also expensive (as the current expenditure on treating suspicious Benign Prostatic Hyperplasia (which BOO falls under) is ProState of the nation, time-consuming and requires skilled analysis and interpretation of results.

The non invasive cuff test being described in this How to Why to Guide can help to reduce the need for conventional urodynamic testing and can provide patients with a faster route to treatment. This can lead to overall improvements in quality of life and can reduce the morbidities associated with an unnecessary surgical procedure. The non invasive cuff test offers a simple alternative for the diagnosis of BOO which does not require specialist input and analysis which is otherwise necessary for conventional invasive investigations.

Invasive pressure flow studies are associated with significantly more morbidity including inflammation within the urinary tract, formulation of bacterimia, and adverse effects on kidney function. In elderly patients, urinary tract infections are a significant cause of morbidity and death, with the expected death rate as high as 3% in those who develop pyelonephritis. The high mortality rate is largely due to delayed presentation and the development of bacteria. The non invasive cuff test therefore enhances the overall diagnostic pathway and ensures that Trusts meet policy guidance which are associated with improving the overall patient experience whilst reducing unnecessary resource burden on the NHS.

Clinical and Patients Benefits

Non-invasive bladder analysis can enhance the overall patient experience by reducing the need for pressure-flow studies (PFS) and avoiding the embarrassment and complications associated with invasive testing. The test is easy to perform and an appropriate Procurement Section ensures that it can easily be utilised within the clinical environment. Patients, clinical staff and business managers may benefit from implementation of this technology as follows:

Reduced infection risk, as patients may no longer need to be referred for invasive tests.
The time taken to perform the non invasive cuff test is much shorter than full urodynamics (5 - 10 minutes as compared to roughly 60 minutes).
Potential shorter diagnostic pathway.
The result of this implementation project show that patients consider the non invasive cuff test to cause less discomfort and embarrassment than invasive urology tests.

The non invasive cuff test can play a significant role in diagnosing patients and streamlining the pathway for patients with Lower Urinary Tract Symptoms (LUTS). Whilst reducing the morbidity associated with diagnosis determined through invasive urodynamics. A 2009 ProState of the nation report estimated that the total UK secondary care cost associated with the complications presented with this area of health is £111,568,793.

Click here to go to the Benefits 'v' Barriers section which gives an essential overview of the benefits that can be achieved.

Providers of the Technology

Whilst it is not NTAC's role to recommend specific manufacturers, the non invasive cuff test is currently manufactured by a single supplier Mediplus Ltd.

The Procurement Section of this How to Why to Guide explains all of the details surrounding the options available to Trusts when purchasing this technology and any associated consumables.