Incontinence Clinical Trial
Official title:
In Vivo Comparison of Air Charged Catheters With Water Filled Catheters for Intravesical and Intrarectal Pressures Recording During Urodynamic Study
Various systems to measure intravesical and intrarectal pressure during urodynamic testing;
especially cystometry, exist. Water filled tube -systems are the most commonly used and
should be regarded as the contemporary standard. A water filled system is however sensitive
to tube and or patient movement artefacts and prone to erroneous calibration. Air charged
catheters are less sensitive to patient and especially tubing- movements, and calibrate
easier. However, in vitro tests have demonstrated that air charged catheters respond
somewhat slower and relatively damped, especially to rapid pressure changes as in
(simulated) coughing, in comparison with water filled systems. The clinical relevance of
these observations is unknown.
This is a study to compare the technical reliability and clinical applicability of the two
types of catheter systems for cystometry in a synchronous double catheter testing procedure
in a prospective group or patients scheduled for urodynamic investigation.
Study design: Patient cohort, acute experiment, mono -center synchronous double urodynamic
catheter technique study.
Study population: Adult female patients and male or female patients with spinal cord injury
or meningomyelocele unable to void, scheduled for urodynamic investigation on the basis of
contemporary standards and guidelines, because of signs and or symptoms of lower urinary
tract dysfunction.
Intervention: Synchronous double catheter urodynamic testing; Standard filling cystometry
with both air-charged ánd water filled catheter pairwise inserted, and connected to the
registry equipment.
Main study parameters/endpoints: Difference of intravesical pressure increment maximum
during filling cystometry between the two systems.
Primary hypothesis to test: The average difference as well as the average absolute
difference of maximum water pressure (standard system) and maximum air pressure (comparator)
are both 0 (zero).
There is no per-protocol for follow up of the patients.
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N/A
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