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Executive Summary

If you are a patient and would like some more information about this technology and what it may mean for you, please click here

 

Lower urinary tract symptoms (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. According to the National Institute for Health and Clinical Evidence (NICE), LUTS are a major burden for the ageing male population (NICE claim that 3.2 million men in the UK present with clinical BPH). Age is an important risk factor for LUTS and the prevalence increases as men get older.

Implementation Project: Final Data Report demonstrated that there are significant challenges with successfully implementing a non invasive test for the management of LUTS. This test has the potential to streamline the diagnostic process by identifying which symptoms are prevalent as a result of a Bladder Outlet Obstruction (BOO) - which is a common urological problem that cannot be diagnosed from symptoms alone. Despite the availability of effective prescription therapies, many men with storage and/or voiding LUTS may not be receiving appropriate treatment in UK general practice.

This How to Why to Guide aims to provide practical guidance to enable the successful implementation of a diagnostic cuff test and to help you to realise the benefits this test can bring. While it is not a replacement for conventional urodynamic testing, which remains the Gold Standard, this test provides useful clinical information on male bladder contraction pressure which can inform the most appropriate pathway of care for patients.

In this site you will find:

  • Click here to help you understand more about the intra-operative test and the technology that sits behind it.
  • Support to put together a business case.
  • The roadmap to service implementation and the necessary supporting Policy Section that implementation aligns to.

The guide also includes useful information which will assist NHS organisations in developing this service, which include:

  • An Introduction to the Non invasive bladder analysis test.
  • The Benefits of adopting this technology.
  • Supporting Clinical Evidence.
  • Overcoming perceived barriers to adoption and realising the benefits.
  • Lessons learnt by NTACs Clinical Implementation Sites.
  • How to effectively procure this technology and its associated consumables.
  • Key policy areas that will be impacted on as a result of implementation.

The Technology Explained:

Benign Prostatic Hyperplasia (BPH) is the term used to describe the benign - i.e. noncancerous - enlargement of the prostate gland, a walnut-shaped gland located beneath the bladder. According to NICE, in BPH, Benign Prostatic Enlargement (BPE) causes narrowing of the urethra where it passes through the prostate, leading in turn to Bladder Outlet Obstruction (BOO) and Lower Urinary Tract Symptoms (LUTS). The Gold Standard diagnostic test for investigating BOO's, is known as a Pressure-Flow Study (PFS). However, this invasive test is expensive (and contributes to the enormous expenditure on treating suspicious BPH's, which is £55,357,650), time-consuming and requires skilled analysis and interpretation of results.

The non invasive cuff test however provides a rapid means of investigating men with LUTS. The technology measures both the urinary flow rate of a patient and the pressure their bladder generates to produce this flow. A specialised cuff, placed around the shaft of the penis, is temporarily inflated to obstruct flow and the cuff pressure required to interrupt voiding, which then provides a measure of bladder pressure. The combination of maximum flow rate and cuff pressure can then be used to determine whether BOO is present or not. The non invasive cuff test is intended to compliment standard pressure flow studies and the Management of Lower Urinary Tract Symptoms in Men (2010) available to patients.

This technology can therefore play a significant role in ensuring that diagnostic services throughout the NHS are more productive whilst removing the burden (and associated morbidities) that a diagnosis would otherwise be determined through a surgical procedure) brings to the health service. For example, 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.

Key Benefits of the Technology

  • Reducing inappropriate treatment by introducing the use of the diagnostic cuff test, the overall pathway of care is enhanced and savings are obtained due to these efficiencies.
  • Reducing the risk of urinary tract infections, social isolation, embarrassment, discomfort and morbidity associated with invasive techniques and depression by accurate diagnosis and appropriate management of LUTS. There are also fewer complications compared to invasive urodynamic studies.
  • Increasing clinical and cost effectiveness by making informed decisions on the appropriate follow up pathway, providers can ensure that they are using their resources more effectively and are closing the inequality gap in the provision of these services.
  • Improving clinical outcomes and improving emotional and physical wellbeing through accurate diagnosis and effective treatments in line with NICE guidance
  • Increasing patient choice by offering a diagnostic test that can be performed in the outpatient setting as opposed to more conventional means of testing (which would otherwise take place through surgery).
  • Simple training requirement. The diagnostic cuff test is easily applied and removed. Minimum staff training time is required for use of the technology.

Click here to be taken to the Benefits vs. Barriers section of this How to Why to Guide. This will compare some of the perceived adoption barriers within the organisation and how they may hinder uptake of this technology.

Impact on Key Policy Areas

The National Institute for Health and Clinical Excellence (NICE) 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 (. 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. For example, 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.

It would also seem likely that expenditure in this area will continue to escalate due to our ageing population, adding an increasing burden on NHS resources. The effective management of patients (as recommended in the NICE guidance) with voiding symptoms through a time efficient diagnostic (cuff) test can therefore inform whether surgery or further investigations for bladder outlet obstruction is required. This will contribute to lowering the burden (and associated costs) that these symptoms are currently placing on the NHS. Reducing the need for invasive urodynamics and the morbidity associated with invasive techniques (including catheter insertion) could be avoided through the use of the non invasive cuff test.

The Policy Section of this How to Why to Guide discusses policy in more detail and hosts an array of documentation and supporting resources for Trusts surrounding these areas that you may find helpful.

Summary of Clinical Evidence

An evidence review of the non invasive cuff test was undertaken by the Centre for Evidence-based Purchasing (CEP) in 2007 which concluded that the technique has "significant potential", showing that this test may reduce the number of ineffective surgical procedures whilst also reducing the number of invasive studies, which both carry associated costs and risks. The report also showed that the non invasive cuff test can be used in conjunction with conventional urodynamics to improve diagnostic accuracy and overall outcome where patients are otherwise referred for surgery. A 2007 article in the European Journal of Urology also stated that the outcome associated with the non invasive cuff test rivals that offered by invasive urodynamic studies.

Since the CEP report, NICE have published guidance on the Management of Lower Urinary Tract Symptoms in Men (2010) which stipulates effective and appropriate pathways of care for patients suffering from Lower Urinary Tract Symptoms.

Click here to be taken to the evidence base section of this How to Why to Guide, which will explain the evidence base behind the test in more detail.

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