The UroCuff® Test | Healthcare Professionals

The UroCuff Test

The UroCuff Test is a non-invasive pressure-flow study for patients reporting lower urinary tract symptoms (LUTS) such as urgency, frequency, nocturia, and incomplete emptying, or who have noted other changes in voiding patterns. The UroCuff provides the urologist with necessary data for diagnosis of voiding disorders.

Key Benefits of The UroCuff:

  • Clinically proven to accurately measure voiding pressure.
  • Differentiates between bladder outlet obstruction (BOO) and poor bladder contractility.
  • Simple to perform.
  • More comfortable for the patient than an traditional urodynamic study.
  • Optional ultrasound available for high-accuracy bladder volume measurement.

The UroCuff Test is the new standard in non-invasive LUTS diagnostics. Moreover, the UroCuff offers your practice a LUTS patient management platform providing better clinical outcomes and greater efficiency. The UroCuff is simply a better way to manage LUTS patients in the today’s healthcare system.

How It Works

The UroCuff Test simultaneously measures urine flow rate and bladder pressure to assist in determining the underlying cause of the voiding disorder. Bladder pressure is measured non-invasively with a penile cuff (resembling a blood pressure cuff) instead of a catheter. The principle of the test is similar to blood pressure measurement. When the patient is ready to void, a small pneumatic cuff is fitted around the penis, and the patient is asked to void into the flow meter. When voiding has commenced, the cuff is inflated under automatic control until the stream is interrupted. Inflation cycles are repeated until the void is complete. The cuff pressure required to interrupt flow equals bladder pressure at the time of interruption.

Once the test is complete, the UroCuff report summarizes the pressure-flow data on a modified nomogram. Shown to the right are nomograms from two different patients that had identical maximum flow rates of 3.1 ml/s. These patients are therefore both “low flow rate” patients, and they would present with the same flow rates when the traditional uroflow test is prescribed. However, the UroCuff nomogram on the top reveals that the first patient has a low bladder pressure, while the nomogram on the bottom reveals the second patient has high bladder pressure. Click on either of these nomograms to see the complete UroCuff report.

Optionally, one or two surface EMG electrodes may be applied to the patient to monitor skeletal muscle function during the void:

a. Perineal EMG Placement–to monitor sphincter activity.

b. Abdominal EMG Placement–to monitor abdominal straining.

 

For a technical explanation of how the UroCuff Test works
Click here – “Principles of the UroCuff™ Test” (PDF)

Low Pressure Report

High Pressure Report

Equipment

The UroCuff Test has a simple and consistent touch-screen interface that guides the clinician step-by-step through each test. The hardware consists of the following components:

  • UroCuff Instrument Console
  • UroFlow™ scale
  • All-in-one Panel PC
  • Commode
  • Printer
  • All necessary software, cabling, & accessories

Technical Literature

Peer Review Publications

The UroCuff Test is widely written about with positive attestation in peer-reviewed clinical literature. You may use The UroCuff Test Clinical Literature Summary as a single source for most of this literature. Alternatively, you may refer to the individual citations along with abstracts and links to the complete documents provided below.

A Phase IV, prospective, controlled study of the SRS Medical CT3000 UroCuff Test in adult males with lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction (BOO):Interim Analysis. — (RS Matulewicz, MS MD and JC Hairston MD.)

Purpose

Careful surgical candidate selection prior to transurethral resection of the prostate (TURP) can help assure that patients benefit from the procedure. Currently, 15-30% of men do not benefit optimally from this invasive and potentially morbid operation. Success rates following TURP are 15–29% higher if bladder outlet obstruction (BOO) is predetermined by invasive pressure flow studies (PFS) as the cause of the patient’s lower urinary tract symptoms (LUTS). However, PFS may not be performed because of patient discomfort, infection risk, and costs associated with the need for skilled staff and specialized equipment. We report a non-invasive method of assessing BOO.

Methods

Patients undergoing PFS for LUTS presumed to be due to BOO were recruited from a single site to perform a penile cuff test at the time of PFS. Standard PFS were performed followed immediately by a penile cuff test in the same test setting. The results were compared using basic statistical analysis.

Results

A total of 19 men were evaluated by both PFS and UroCuff evaluation. Using PFS as the gold standard, the positive predictive value of the UroCuff penile cuff test to diagnose BOO was found to be 92%. The sensitivity of the Urocuff test for detecting BOO was 75%. When compared to PFS, patients preferred the UroCuff 100% of the time.

Materials

The CT3000 UroCuff test was compared to traditional catheter based urodynamic studies in adult males with lower urinary tract symptoms.

Conclusion

The CT3000 UroCuff test is accurate in predicting BOO when compared to conventional invasive pressure flow studies in men with LUTS. It is well tolerated and preferred over invasive pressure flow studies.

http://onlinelibrary.wiley.com/doi/10.1002/nau.22366/abstract

Review of invasive urodynamics and progress towards non-invasive measurements in the assessment of bladder outlet obstruction. — (C. J. Griffiths, R. S. Pickard. Indian Journal of Urology January-March 2009.)

Purpose

This article defines the need for objective measurements to help diagnose the cause of lower urinary tract symptoms (LUTS). It describes the conventional techniques available, mainly invasive, and then summarizes the emerging range of non-invasive measurement techniques.

Methods

This is a narrative review derived from the clinical and scientific knowledge of the authors together with consideration of selected literature.

Results

Consideration of measured bladder pressure urinary flow rate during voiding in an invasive pressure flow study is considered the gold standard for categorization of bladder outlet obstruction (BOO). The diagnosis is currently made by plotting the detrusor pressure at maximum flow (PdetQmax) and maximum flow rate (Qmax) on the nomogram approved by the International Continence Society. This plot will categorize the void as obstructed, equivocal or unobstructed. The invasive and relatively complex nature of this investigation has led to a number of inventive techniques to categorize BOO either by measuring bladder pressure non-invasively or by providing a proxy measure such as bladder weight.

Materials

The CT3000 UroCuff test was compared to traditional catheter based urodynamic studies in adult males with lower urinary tract symptoms.

Conclusion

Non-invasive methods of diagnosing BOO show great promise and a few have reached the stage of being commercially available. Further studies are however needed to validate the measurement technique and assess their worth in the assessment of men with LUTS.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684312/

The penile cuff test: A clinically useful non-invasive urodynamic investigation to diagnose men with lower urinary tract symptoms. — (Christopher Harding, Wendy Robson, Michael Drinnan, Stuart McIntosh, Mustafa Sajeel, Clive Giffiths, Robert Pickard. Indian Journal of Urology January-March 2009)

Purpose

his article defines the need for objective measurements to help diagnose the cause of lower urinary tract symptoms (LUTS). It describes the conventional techniques available, mainly invasive, and then summarizes the emerging range of non-invasive measurement techniques.

Methods

This is a narrative review derived from the clinical and scientific knowledge of the authors together with consideration of selected literature.

Results

Consideration of measured bladder pressure urinary flow rate during voiding in an invasive pressure flow study is considered the gold standard for categorization of bladder outlet obstruction (BOO). The diagnosis is currently made by plotting the detrusor pressure at maximum flow (PdetQmax) and maximum flow rate (Qmax) on the nomogram approved by the International Continence Society. This plot will categorize the void as obstructed, equivocal or unobstructed. The invasive and relatively complex nature of this investigation has led to a number of inventive techniques to categorize BOO either by measuring bladder pressure non-invasively or by providing a proxy measure such as bladder weight.

Conclusion

Non-invasive methods of diagnosing BOO show great promise and a few have reached the stage of being commercially available. Further studies are however needed to validate the measurement technique and assess their worth in the assessment of men with LUTS.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684312/

Interobserver Agreement for Noninvasive Bladder Pressure Flow Recording With Penile Cuff. — (Frank McArdle, Becky Clarkson, Wendy Robson, Clive Griffiths, Michael Drinnan and Robert Pickard. The Journal of Urology Vol. 182, 2397-2403, November 2009..)

Purpose

To summarize the development of a novel non-invasive test to categorize voiding dysfunction in men complaining of lower urinary tract symptoms (LUTS) – the penile cuff test.

Methods

TThe test involves the controlled inflation of a penile cuff during micturition to interrupt voiding and hence estimate isovolumetric bladder pressure (Pves.isv). The validity, reliability, and clinical usefulness of the test were determined in a number of studies in men with LUTS.

Results

The penile cuff test can be successfully performed in over 90% of men with LUTS. The reading of cuff pressure at flow interruption (Pcuff.int) gives a valid and reliable estimate of invasively-measured Pves.isv and when combined with the reading for maximum flow rate obtained during the test (Qmax) produces an accurate categorization of bladder outlet obstruction (BOO). Use of this categorization prior to treatment allows improved prediction of outcome from prostatectomy.

Materials

The CT3000 UroCuff test was compared to traditional catheter based urodynamic studies in adult males with lower urinary tract symptoms.

Conclusion

The penile cuff test fulfills the criteria as a useful clinical measurement technique applicable to the diagnosis and treatment planning of men with LUTS.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684319/

Multisite Evaluation of Noninvasive Bladder Pressure Flow Recording Using the Penile Cuff Device: Assessment of Test-Retest Agreement. — Becky Clarkson, Wendy Robson, Clive Griffiths, Frank McArdle, Michael Drinnan and Robert Pickard. The Journal of Urology Vol. 180, 2515-2521, December 2008.

Purpose

We assessed variability in interpreting noninvasive measurements of bladder pressure and urine flow between experienced and novice users of the penile cuff.

Materials & Methods

Urodynamicists at 6 sites were asked to use the penile cuff test as part of clinical assessment in 30 men presenting with lower urinary tract symptoms. After a short training period they measured maximum flow rate and cuff interruption pressure from penile cuff test recordings to enable categorization of bladder outlet obstruction using a nomogram. Similar measurements were then made on the same traces by 2 expert observers from the originating center. Interobserver differences were assessed.

Results

Complete agreement on obstruction categorization was seen in 77% of subjects, which increased to 86% when plots positioned on category boundary lines were allocated to the favored category. The 95% confidence limits of interobserver variability in maximum flow rate and cuff interruption pressure measurements were ± 1.7 ml per second and ± 13 cm H2O, respectively, although a small number of studies yielded discrepancies between observers that were larger than expected. They arose from complex recordings but were equally likely between experts as between expert and novice. Investigation of the causes suggested in some cases how such discrepancies may be avoided in the future.

Materials

The CT3000 UroCuff test was compared to traditional catheter based urodynamic studies in adult males with lower urinary tract symptoms.

Conclusion

The excellent level of agreement in measurement and categorization after a short training period suggests that introducing the penile cuff test as part of assessment in men with lower urinary tract symptoms would be straightforward.

http://www.sciencedirect.com/science/article/pii/S0022534709017698

Categorization of Obstruction Using Noninvasive Pressure Flow Measurements: Sensitivity to Change Following Prostatectomy. — Mustafa Sajell, Christopher Harding, Wendy Robson, Michael Drinnan, Clive Griffiths and Robert Pickard. The Journal of Urology Vol. 178, 996-1001, September 2007.

Purpose

We performed a pragmatic study of the penile cuff test, a noninvasive method of categorizing bladder outlet obstruction, at a number of United Kingdom urology centers remote from the originating site. We report the agreement of the test and the subsequent retest using the cuff test in the short term.

Methods

Men requiring urodynamic investigation for lower urinary tract symptoms were recruited from 6 sites to perform a penile cuff test twice at an interval of approximately 4 weeks. Tests were analyzed by a single interpreter to assess differences in the flow rate, cuff interruption pressure and diagnostic categorization in an individual between the 2 tests due to measurement and physiological error.

Results

A total of 136 men (69%) performed 2 suitable cuff tests at a median of 20 days (IQR 8–31). The mean ± SD difference between the 2 tests in the maximum flow rate was 0.2 ± 3.7 ml per second and in cuff interruption pressure was 4.0 ± 26 cm H2O. Of the men 33% changed diagnostic category on the Newcastle nomogram, while 47% maintained a consistent diagnosis of obstruction or no obstruction.

Conclusion

Diagnostic category repeatability was similar to that of conventional urodynamics, although there was greater variability in pressure measurements. This supports widespread routine use of the penile cuff test.

http://www.sciencedirect.com/science/article/pii/S0022534708022052

Categorization of Obstruction Using Noninvasive Pressure Flow Measurements: Sensitivity to Change Following Prostatectomy. — Mustafa Sajell, Christopher Harding, Wendy Robson, Michael Drinnan, Clive Griffiths and Robert Pickard. The Journal of Urology Vol. 178, 996-1001, September 2007.

Purpose

We determined whether categorizing men with lower urinary tract symptoms using a noninvasive pressure flow nomogram is sensitive to change following the removal of obstruction.

Materials and Methods

A prospective cohort of men undergoing transurethral prostate resection was recruited, of whom 143 (69%) underwent noninvasive pressure flow study using the penile cuff technique before and 4 months following surgery. Cuff pressure required to interrupt voiding, estimated isovolumetric bladder pressure and maximum flow rate were recorded during a single void. Values were plotted on a nomogram categorizing cases as obstructed (upper left quadrant), not obstructed (lower right quadrant) or diagnosis uncertain (upper right and lower left quadrants). Changes in maximum flow rate, cuff pressure required to interrupt voiding and nomogram position following transurethral prostate resection were then analyzed.

Results

Transurethral prostate resection resulted in an improved flow rate for all diagnostic groups, which was highest for obstructed cases with a mean ± SD increase of 11 ± 6 ml second (p <0.01). Men categorized with obstruction and those placed in the upper right quadrant showed significant decreases in cuff pressure required to interrupt voiding following transurethral prostate resection with a mean decrease of – 45 ± 35 and – 48 ± 32 cm H2O, respectively (p <0.01). The number of cases classified as not obstructed increased from 28 (19%) preoperatively to 114 (80%) after transurethral prostate resection.

Conclusion

Sensitivity to change following the removal of obstruction further validated the usefulness of noninvasive measurement of bladder pressure by the penile cuff test and the categorization of obstruction by the noninvasive nomogram. Decreased isovolumetric bladder pressure following transurethral prostate resection may reflect a return to normal detrusor contraction strength.

http://www.sciencedirect.com/science/article/pii/S0022534707012566

Predicting the Outcome of Prostatectomy Using Noninvasive Bladder Pressure and Urine Flow Measurements. — Christopher Harding, Wendy Robson, Michael Drinnan, Mustafa Sajeel, Peter Ramsden, Clive Griffiths, Robert Pickard. European Urology 52 (2007) 186–192.

Purpose

To determine whether categorisation of bladder outlet obstruction (BOO) using measurements of bladder pressure and urine flow obtained by a novel noninvasive medical device (the penile cuff test) improves prediction of outcome from endoscopic prostatectomy (TURP).

Methods

A consecutive cohort of 208 men undergoing TURP following standard assessment in our institution was recruited, and 179 (86%) completed the protocol. Each subject underwent a penile cuff test prior to surgery; outcome was assessed by change in IPSS at 4 mo. The proportion of men with good outcome (>50% reduction in IPSS) was compared according to categorisation by noninvasive bladder pressure and urine flow measurements.

Results

Consideration of measured bladder pressure urinary flow rate during voiding in an invasive pressure flow study is considered the gold standard for categorization of bladder outlet obstruction (BOO). The diagnosis is currently made by plotting the detrusor pressure at maximum flow (PdetQmax) and maximum flow rate (Qmax) on the nomogram approved by the International Continence Society. This plot will categorize the void as obstructed, equivocal or unobstructed. The invasive and relatively complex nature of this investigation has led to a number of inventive techniques to categorize BOO either by measuring bladder pressure non-invasively or by providing a proxy measure such as bladder weight.

Conclusion

Urodynamic categorisation using measurements obtained by the noninvasive penile cuff test improves prediction of outcome for men with LUTS undergoing TURP. This finding together with the ease and acceptability of the test suggest its suitability for office-based clinical use to assist men and their physicians in the selection for surgical treatment for relief of LUTS.

http://www.sciencedirect.com/science/article/pii/S0302283806013856

Evidence Review: Mediplus CT3000 Cuff Machine for Diagnosis of Bladder Outlet Obstruction.

Purpose

To determine whether categorisation of bladder outlet obstruction (BOO) using measurements of bladder pressure and urine flow obtained by a novel noninvasive medical device (the penile cuff test) improves prediction of outcome from endoscopic prostatectomy (TURP).

Methods

A consecutive cohort of 208 men undergoing TURP following standard assessment in our institution was recruited, and 179 (86%) completed the protocol. Each subject underwent a penile cuff test prior to surgery; outcome was assessed by change in IPSS at 4 mo. The proportion of men with good outcome (>50% reduction in IPSS) was compared according to categorisation by noninvasive bladder pressure and urine flow measurements.

Results

Consideration of measured bladder pressure urinary flow rate during voiding in an invasive pressure flow study is considered the gold standard for categorization of bladder outlet obstruction (BOO). The diagnosis is currently made by plotting the detrusor pressure at maximum flow (PdetQmax) and maximum flow rate (Qmax) on the nomogram approved by the International Continence Society. This plot will categorize the void as obstructed, equivocal or unobstructed. The invasive and relatively complex nature of this investigation has led to a number of inventive techniques to categorize BOO either by measuring bladder pressure non-invasively or by providing a proxy measure such as bladder weight.

Conclusion

Urodynamic categorisation using measurements obtained by the noninvasive penile cuff test improves prediction of outcome for men with LUTS undergoing TURP. This finding together with the ease and acceptability of the test suggest its suitability for office-based clinical use to assist men and their physicians in the selection for surgical treatment for relief of LUTS.

http://www.sciencedirect.com/science/article/pii/S0302283806013856

The role of non-invasive bladder pressure measurement by the penile cuff device for assessment of men with lower urinary tract symptoms. — R.S. Pickard, C. Harding, W.A. Robson, S.L. McIntosh, M. Sajeel, P. Ramsden, M.J. Drinnan, C.J. Griffiths. Urodinamica 16: 298-309, 2006.

THE PRODUCT: CT3000 cuff machine manufactured by Mediplus Ltd, UK.

Field of Use

Bladder outlet obstruction (BOO) giving rise to lower urinary tract symptoms (LUTS) is a common problem for older men in the UK and effective diagnosis and treatment of BOO is extremely important.

Diagnosis based on symptoms and simple urinary flow rate measurement identifies only 70% of patients correctly (1). More accurate diagnosis is possible through an invasive urodynamics procedure, but some consider the expense and risks associated with the procedure outweigh its diagnostic accuracy, and consequently it is not routinely performed. The CT3000 is the most developed of several non invasive diagnostic techniques that offer better diagnostic accuracy than is achieved by flow rate measurement and symptomatic assessment. This review outlines the clinical usefulness of the Mediplus CT3000 cuff machine as an adjunct to current diagnostic methods, and also summarises evidence relating to some alternative non invasive methods.

Evidence Reviewed

Cep’s Verdict- Significant Potential:
The Mediplus CT3000 system offers greater accuracy in diagnosis of BOO than diagnosis based on flow rate measurement alone. Recent results (3) suggest its prediction of outcome from surgery rivals that offered by invasive urodynamic studies, though this has not been conclusively proven by this limited evidence. The invasive approach also provides additional information, and therefore remains the gold standard for the diagnosis of BOO in men. The existing evidence supports the manufacturer’s claim that the CT3000 system has a useful role as an adjunct to current methods. Diagnoses based on CT3000 and urine flow measurement can be compared. Where there is agreement, surgery is indicated, and where there is disagreement or uncertainty, follow up invasive urodynamics are indicated. This approach may well reduce the number of ineffective surgical prostatectomies while also reducing the number of invasive studies, both of which carry associated costs and risks. Independent validating studies on the Mediplus CT3000 cuff system are recommended, and a multi-centre trial is reported to be underway (3). A detailed economic evaluation is also recommended, considering both the costs and consequences of the diagnostic accuracy of the CT3000 system.

http://srsmedical.com/products/downloads/UroCuff – Physician/CT3000 Evidence Review.pdf