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Evidence Base

Evidence Base

This section has been designed to provide Trusts wishing to progress with implementation of the technology with the evidence base required to agree business cases and ensure that the technology being adopted is safe and complies with relevant clinical governance frameworks locally and nationally.

In this section you will find a short background to national standards, relevant trial reports & supporting evidence, other useful validated technique, information about any ongoing trials, testimonials from the Trusts involved in the implementation project and other useful websites.

NTAC Project Data

Methods of quantitative and qualitative measurement and evaluation of the clinical utility of implementing the intra-operative test were developed by project teams from the NTAC implementation project implementation sites . These were used in the determination of the impact of the technology on patient outcomes, hospital resource requirements and the clinical utility of adopting the technology.

The evaluation measures and values were subjected to independent analysis undertaken by the NHS Technology Adoption Centre and York Health Ecomonic Consortium.

  • Click here to access summary data presentation in a pdf file.
  • Click here to access the full project data report.

Background to National Standards

According to NICE, initial assessment of male patients presenting with Lower Urinary Tract Symptoms (LUTS) should comprise of a careful history and a number of focused investigations, including a digital rectal examination and a number of simple baseline investigations including:

  • Urinalysis (testing of chemicals that may be present in the patient's urine).
  • Completion of a frequency volume chart (bladder diary).
  • A blood test to investigate possible cancer indicators.

Urine flow analysis is the simplest form of testing bladder function and is often combined with the non invasive measurement of urine residuals using ultrasound. These measures are used in the initial assessment of men complaining of LUTS, but urine flow analysis and assessment of urine residual volumes fail to distinguish low flow rates due to BOO from those with poor bladder contraction.

Invasive pressure flow studies are the most reliable means of assessing lower urinary tract function and pressure flow studies are considered to be the Gold Standard tool for diagnosing BOO. Unfortunately, their routine use in the investigation of LUTS is limited by the invasive nature, cost and morbidity of the procedure. This has led to the development of a variety of non invasive tests to assess bladder function. The non invasive cuff test is a novel and validated technique that can be used to determine the presence or absence of BOO.

List of relevant peer reviewed publications

Griffiths CJ, Harding C, Blake C, McIntosh S, Drinnan MJ, Robson WA, Abrams P, Ramsden PD and Pickard RS ( 2005).

A nanogram to classify men with lower urinary tract symptoms using urine flow and noninvasive measurement of bladder pressure .J Urol; 174(4 Pt 1): 1323-6

Griffiths CJ, Rix D, MacDonald AM, Drinnan MJ, Pickard RS and Ramsden PD (2002).

Noninvasive measurement of bladder pressure by controlled inflation of a penile cuff . J Urol; 167(3): 1344-7

Harding C, Robson W, Drinnan M, McIntosh S, Sajeel M, Giffiths C and Pickard R (2009)

The penile cuff test: A clinically useful non-invasive urodynamic investigation to diagnose men with lower urinary tract symptoms .Indian J Urol; 25(1): 116-21

Harding C, Robson W, Drinnan M, Sajeel M, Ramsden P, Griffiths C and Pickard R (2007).

Predicting the outcome of prostatectomy using noninvasive bladder pressure and urine flow measurements. Eur Urol; 52(1): 186-92

Sajeel M, Harding C, Robson W, Drinnan M, Griffiths C and Pickard R (2007)

Categorization of obstruction using noninvasive pressure flow measurements: sensitivity to change following prostatectomy. J Urol; 178(3 Pt 1): 996-1000

Pickard, R.S., et al. 2006.

The role of non-invasive bladder pressure by penile cuff device for assessment of men with lower urinary tract symptoms . Urodinamica; 16:298-309

Additional peer reviewed material can be found in the down-loadable resources section on the left hand section of this page.

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Neither the NHS Technology Adoption Centre (NTAC) nor its contributors are responsible for the contents of any off-site pages referenced. The user specifically acknowledges that neither NTAC nor its contributors is liable for the defamatory, offensive, or illegal conduct of other users, links, or third parties and that the risk of injury from the foregoing rests entirely with the user.

Links from the NTAC How to Why to Guides site on the World Wide Web to other sites do not constitute any endorsement. These links are provided as an information service only. It is the responsibility to the web surfer to evaluate the content and usefulness of information obtained from other sites.

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