Contractility: Cuff Versus Urodynamics Testing In Males With Voiding Lower Urinary Tract Symptoms
Contractility: Cuff Versus Urodynamics Testing In Males With Voiding Lower Urinary Tract Symptoms
A number of men will experience bothersome urinary symptoms, which become more common as they
 age. A number of conditions can cause these symptoms, and general practitioners may refer men
 to their local hospital for further assessment and treatment. Symptoms can include poor flow
 of urine, the need to pass urine more frequently, or the sensation that the bladder is not
 completely emptying. This can be due to an enlargement of the prostate gland. These symptoms
 can also be caused when the bladder muscle is not able to contract (squeeze) as well as it
 previously has to empty the bladder. This is known as underactive bladder (UAB).

 It is important to distinguish between the two conditions as a cause for these symptoms, to
 prevent side effects from unnecessary medications or operations. Currently, men would need to
 undergo a bladder pressure test (urodynamics). This involves inserting a catheter via the
 penis into the bladder, through which the bladder is filled with fluid and pressure is
 measured. A separate second small tube is inserted into the rectum to measure the pressure in
 the abdomen. The pressure changes are observed as the bladder is filled, and then urine is
 passed around the catheter.

 A second technique for measuring bladder pressure is the use of a small inflatable cuff which
 is placed around the penis (penile cuff test). The bladder pressure can then be determined by
 inflating the cuff and interrupting the flow of urine. The bladder can be filled naturally
 before the test, which means a bladder catheter tube is not required. This study is designed
 to find out ways that the penile cuff test can be made more accurate. It will compare the
 cuff results to those obtained from a bladder pressure test, and will take x-ray pictures of
 the urinary tract during the test.
The investigators intend to refine the procedural steps of the cuff test to improve the
 measurement and reduce variability with pves.isv, therefore giving a more reproducible test.
 By improving the penile cuff test, the investigators can then go on to assess how our
 non-invasive measurements correlate with urodynamically derived indices of contractility, and
 use data from this pilot to help construct methodology of future cuff research. The current
 hypotheses are that; 1) accuracy of the cuff interruption pressure (pcuff.int) can be
 improved by modification of penile cuff test factors, 2) the number of valid inflations
 obtained per patient will increase with the modifications, and 3) that this non-invasive
 measure of contractility will correlate with pre-existing invasive indices.

 The research protocol also gives the opportunity to explore correlation between commonly used
 symptom scores, and accuracy in the assessment of ultrasound residual urine volume
 measurement.

 The primary objectives are therefore:

 -  To modify procedural steps of the penile cuff test that may reduce the previously
 observed variability and perform a pilot study to assess a reduction in variance

 -  To identify behaviour of the urethra during penile cuff inflation, by performing x-ray
 screening during the penile cuff test, and assess whether this is another source of
 inaccuracy

 -  To test the basic assumption of the penile cuff test that the bladder neck remains open
 during flow interruption

 Secondary objectives of the study include the following:

 -  To compare non-invasive measurements from the penile cuff test against invasive indices
 of contractility

 -  To compare 2 different symptom scores for men with voiding lower urinary tract symptoms
 (LUTS)

 -  To assess accuracy and inter-observer variability of ultrasound residual measurement
 against a known volume.
Inclusion Criteria:

 -  Male aged 18 years old or over

 -  Referred for video urodynamics within our department

 -  Predominant voiding LUTS as assessed by IPSS at screening. [The total IPSS score is
 out of 35, with up to 15 points for storage symptoms and 20 for voiding symptoms. If
 voiding symptoms as a percentage of total score is higher than storage symptoms they
 will be included in the study].

 -  Capacity to understand study procedures and give informed consent

 -  At least 2 voided volumes on frequency volume chart (FVC) of 250 mL

 Exclusion Criteria:

 -  Female patients

 -  Long term catheterisation

 -  Predominant storage LUTS on IPSS at screening

 -  Fewer than 2 voids on FVC > 250 mL

 -  Known pre-existing neurological cause for symptoms

 -  Active urinary tract infection (UTI)