To validate the use of single urethral sensor catheter in demonstrating urethral pressure variations during filling cystometryIncidence of significant urethral pressure variations during urodynamic filling phase measured with three urethral sensor…
ID
Source
Brief title
Condition
- Urethral disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the reproduction of urethral pressure variations,
demonstrated with three-sensor catheter, with use of a single-sensor catheter
during filling cystometry.
Secondary outcome
none
Background summary
During the filling (urine storage) phase of a urodynamic investigation (=
investigation to measure bladder function or dysfunction, which explains the
pathophysiology of the symptoms), urethral (bladder outlet) pressure variations
can be observed in a proportion of patients. The clinical relevance and or the
role of urethral pressure variations in the pathophysiology are yet not
precisely established.
In the literature, urethral pressure variations have been discussed with the
use of a catheter with single sensor or three-sensor in the urethra. However,
there are very few hospitals using a multiple-sensor catheter. In the gross
majority, a catheter with only one sensor in the urethra is used. If clinical
relevance of urethral pressure variations is to be further examined, the
demonstrating of this condition has to be more widely applicable.
Study objective
To validate the use of single urethral sensor catheter in demonstrating
urethral pressure variations during filling cystometry
Incidence of significant urethral pressure variations during urodynamic filling
phase measured with three urethral sensor catheter versus measurement with
single urethral sensor catheter
Study design
Prospective observational intervention cohort study. Every adult female patient
undergoing urodynamic testing will receive information of this study and will
be asked to participate. When informed consent is obtained, the second
measurement series will be performed with a single-sensor urethral catheter
Study burden and risks
During urodynamic testing usually two series of filling and voiding cystometry
are performed, to be able to reproduce and measure burden symptoms of the
patient. To validate the use of a single-sensor catheter, the three-sensor
catheter has to be removed after the first series and an extra introduction of
the single-sensor urethral catheter has to be performed
Bronovolaan 5
Den haag 2597 AX
NL
Bronovolaan 5
Den haag 2597 AX
NL
Listed location countries
Age
Inclusion criteria
• Female
• > 18 years of age
• Mentally fit to consent
• Indication for urodynamic testing
• Signed informed consent
Exclusion criteria
none
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL50168.058.14 |