Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04452890 |
| Other study ID # |
BC-06980-ADP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
June 2020 |
| Source |
University Hospital, Ghent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The choice of the best surgical technique for urethral stricture repair depends on the
stricture length. Estimating the length of urethral strictures is therefore of utmost
importance.
Different clinical studies have proven that SUG has a higher sensitivity to evaluate the
length of urethral strictures compared to RUG or VCUG.
The goal of this study is to assess the feasibility of using SUG as single pre-operative
assessment tool in patients with suspicion of anterior urethral strictures. In this way, use
of RUG and/or VCUG could be omitted in the pre-operative work-up of patients with anterior
urethral strictures, thereby avoiding significant radiation load of patients.
Description:
Urethral stricture disease (USD) is a medical condition in which a narrowing of the urethral
lumen occurs due to pathological fibrosis and cicatrix formation of the urethral mucosa and
surrounding spongious tissue (spongiofibrosis). Urethral strictures may occur at any location
from the bladder neck to the external urethral meatus and are categorized based on their
localisation in anterior strictures (including the urethral meatus, penile urethra and bulbar
urethra) and posterior strictures (including the prostatic urethra and membranous urethra).
USD is a disease of all ages but the prevalence increases with increasing age since the
cumulative risk of having had urethral instrumentation equally increases. All processes that
cause urethral trauma may provoke USD. The majority of strictures nowadays is idiopathic or
caused by iatrogenic trauma of the urethra.
The pathological narrowing of the urethral lumen can lead to a wide variety of symptoms which
ask for specific diagnostic investigations, in which imaging of the urethra plays a central
role. Retrograde urethrography (RUG) and voiding cystourethrography (VCUG) are considered to
be the gold standard diagnostic investigation techniques for diagnosis of USD.
In both techniques, contrast is instilled in the urethra through the urethral meatus and
radiographic imaging is used to visualize the urethra. RUG and VCUG offer the possibility to
visualize the urethra completely and to evaluate the number, length and location of urethral
strictures. On the other hand, these techniques have some crucial disadvantages. First and
foremost, the radiation load of the genitopelvic region in often young patients is inevitable
in RUG and VCUG. Secondly, it is impossible to evaluate the degree of spongiofibrosis with
radiographic imaging.
In 1988, McAnnich, et al. were the first to describe sonourethrography (SUG) for the
diagnosis of anterior urethral strictures in males. In this technique, a Foley catheter is
inserted in the urethral meatus and a physiological solution is instilled in the urethra
while a linear 7,5 MHz ultrasound probe is placed sagitally over the course of the urethra.
SUG is not only able to evaluate the length and localization of a US, but it also enables the
investigator to evaluate the grade of spongiofibrosis.
Different strudies have shown that SUG has a higher sensitivity for the measurement of
urethral stricture length compared to classical radiographic imaging such as RUG or VCUG.
Since the choice of the most adequate surgical technique depends on the length of the
urethral stricture, correct estimation of the urethral stricture length is of the utmost
importance.
The goal of this study is to evaluate the feasibility of the use of sonourethrography as
single diagnostic tool in the pre-operative diagnostic work-up of males with suspicion of
anterior urethral strictures. In this way, classic radiographic imaging such as RUG and VCUG
could be omitted in these patients, saving them from a significant radiation load.
Fifty patients with penile strictures and fifty patients with bulbar strictures will be
included in this study. When 50% of patients (25 penile and 25 bulbar strictures) have
completed the study, an interim analysis will be conducted. If this analysis shows that RUG
or VCUG can be omitted in 80% or more of patients, the study will be stopped.
