Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04017000 |
| Other study ID # |
STH20318 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2, 2019 |
| Est. completion date |
January 31, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Sheffield Teaching Hospitals NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is comparing a novel method of Bladder shape measurements using ultrasound for
diagnosis of lower urinary tract symptoms in comparison to traditional Urodynamic assessment.
All participants will undergo the novel investigation followed by their usual Urodynamics.
Description:
This study hypothesises that bladder shape changes associated with involuntary contractions
of the detrusor muscle, might be detected using trans abdominal ultrasound, which could
itself form the basis of a novel diagnostic test for detecting involuntary contractions
associated with overactive bladder syndrome and urgency incontinence.
The detection of involuntary bladder contractions currently relies on invasive internal
pressure measurement, commonly termed Urodynamics. This is an invasive test involving the
placement of pressure measurement catheters, usually via the urethra into the bladder and via
the anal canal into the rectum. In its normal healthy state, the bladder remains a
contractile throughout filling and is compliant, meaning that there is minimal or zero
increase in pressure as it fills. During Urodynamics, the bladder is filled artificially,
using a pump, with water or contrast medium via a urethral catheter, whilst abdominal
pressure is measured via a rectal catheter introduced anally. Differences between pressure
measurements in the bladder and the abdomen are used to detect involuntary detrusor
contractions; termed 'detrusor over activity when detected during Urodynamics. Patients often
report Urodynamics as being uncomfortable and undignified, and the test carries a risk of
introducing urinary tract infection. Furthermore, there are significant issues relating to
the sensitivity of Urodynamics in the detection of abnormal bladder contractions in the
context of Overactive Bladder.
Variations in bladder shape have been observed in association with detrusor over activity
during video-Urodynamics, when fluoroscopic images are captured during filling with contrast
medium. At one extreme, women with neuropathic overactive bladder have been observed to have
tense, spherical or dome-shaped bladders with trabeculations 'fir tree' or 'Christmas tree'
bladder. In women with normal detrusor muscle function, the bladder outline appears relaxed
and a contractile, following the contours of the pelvis when assessed by cystography.
Although conventional Urodynamics has previously been regarded as the 'Gold Standard' in the
assessment of lower urinary tract disorders, it is also well recognised as having issues of
sensitivity, patient acceptability and cost. The test is commonly employed to diagnose and
better understand the underlying pathophysiology of incontinence and is often deemed
necessary, particularly prior to invasive forms of treatment. The requirement for urodynamic
equipment, including its purchase, maintenance, associated training and size restricts its
use to specialist hospital facilities, rendering it relatively inaccessible as a diagnostic
tool. In addition to this patients have reported finding Urodynamics embarrassing and
uncomfortable and with the inclusion of x-ray screening (video-cystometry) which is part of
the procedure which aims to contemporaneously evaluate lower urinary tract structure and
morphology, involves exposure to ionising radiation and is of unproven benefit. Therefore,
there is a patient & clinical need to objectively assess lower urinary tract function with
less invasive, sensitive, reproducible and more widely available tests.
A pilot study will now be performed to establish the use of bladder shape testing as a new
investigation for the assessment and diagnosis of lower urinary tract disorders. It is
anticipated that this pilot will lead to the development of a new healthcare product that can
be used in the primary care setting as an alternative to urodynamic assessment in the acute
secondary care environment.
