Objective: To compare the in vivo pressure responses of air-charged catheters with water filled catheter systems pressure responses during standard cystometry.
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Difference of intravesical pressure increment
maximum during filling cystometry between the two systems.
Secondary outcome
Difference (cmH2O) between air charged and water filled systems in intravesical
pressure cough maximum (peak) amplitude during filling cystometry (for patients
able to cough).
Difference (cmH2O) between air charged and water filled systems in intravesical
pressure standard strain to 50cmH2O (on water filled system) increment maximum
during filling cystometry (for patients able to strain).
Difference (cmH2O) between air charged and water filled systems in intrarectal
pressure standard strain to 50cmH2O in intravesical pressure on water filled
system increment maximum during filling cystometry (for patients able to
strain).
Difference (cmH2O) between air charged and water filled systems in intravesical
pressure overactive contraction increment duration (return to baseline) during
filling cystometry.
Difference between both systems in the number of small amplitude (* 5cmH2O)
intravesical pressure events during filling.
Qualitative difference in pattern of spontaneous rectal activity
Qualitative difference in pattern of -one per investigation- provoked tube
kicking artefact in both systems
Background summary
PROTOCOL TITLE: In Vivo Comparison of Air Charged Catheters with Water Filled
Catheters for Intravesical and Intrarectal Pressures Recording during
Urodynamic Testing
Rationale: 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. To compare the
technical reliability and clinical applicability of the two types of catheter
systems for cystometry an in vivo double catheter testing procedure, in a
prospective group or patients scheduled for urodynamic investigation is the
necessary step, following on to the in vitro tests.
Study objective
Objective: To compare the in vivo pressure responses of air-charged catheters
with water filled catheter systems pressure responses during standard
cystometry.
Study design
Study design: Prospective patient cohort monocenter double urodynamic technique
study.
Study burden and risks
Both catheter systems that are compared in this study are marketed and safe for
intended routine use. Only patients that are scheduled for urodynamic
investigation on the basis of standard clinical practice protocols and
guidelines are recruited for this study.
For this scientific study we will introduce a standard 6F (=2 mm diameter)
single lumen transurethral intravesical catheter synchronously with an extra 7F
(2,3 mm diameter) air charged transurethral intravesical catheter and also a
standard 10F (3,3 mm diameter) transanally inserted intrarectal rectal tube
synchronously with an extra intrarectal (7F) air charged catheter. These extra
catheters cause only minimal (if any) extra burden because the catheters are
introduced together (side by side). Furthermore lubricating (lidocaine)
anaesthetic gel is instilled in the urethra before insertion of the catheters
as a routine. Any extra sensation or harm is not expected, not in the female
urethra that has usually a diameter of 30F (10 mm) and also not in the
neurologically affected (male of female) patients with spinal cord injury or
meningomyelocele that have no lower urinary tract sensation at all. This lack
of relevant extra burden due to catheterisation transurethrally, is even more
pertinent for the intrarectal catheters.
It is unlikely that the catheterisation as employed in this study produces an
extra risk for haematuria or urinary tract infection.
It is not expected that the double system cystometry influences the clinical
result in any manner therefore the inclusion of (normal) volunteers is
unnecessary.
Results obtained in the selected patients are scientifically relevant and
generalizable to all patient categories usually scheduled for urodynamic
testing and will have consequences for the clinical practice care of future
patients.
Edgemoor Road 181
Wilmington DE 19802
US
Edgemoor Road 181
Wilmington DE 19802
US
Listed location countries
Age
Inclusion criteria
2 sets of criteria follow: for 'all female' and for all persons with neurogenid dysfunction.;Female >18 years
Scheduled for urodynamic investigation on the basis of contemporary standards and guidelines, because of signs and symptoms of lower urinary tract dysfunction.
*May perform (not excluded) intermittent (self) catheterisation.
No signs of voiding dysfunction (routine outpatient max flow >20mL/s without significant (>100mL)postvoid residual)
No signs of bladder /pelvic pain syndrome;OR:
Male or female >18years
Complete spinal cord injury, level above T12, or meningomyelocele unable to void and significantly reduced or no pelvic floor, urethral and or bladder sensation.
* May have (not excluded) *sacral sparing*; some residual anal sensation
Scheduled for urodynamic investigation on the basis of contemporary standards and guidelines, because of signs and symptoms of lower urinary tract dysfunction or because of routine (protocol, guidelines) follow -up.
* (Usually: performing intermittent (self) catheterisation); not excluded.
* May have (not excluded) chronic indwelling catheter.
Exclusion criteria
One (or more) of the following necessitates exclusion of the patient:;Male with normal lower urinary tract sensation.;Unwilling or unfit to sign informed consent.
ASA >2; Karnovski <80%.;Women with voiding dysfunction
Patients included in other scientific studies (for other reasons).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Clinical Trials Gov: Pending |
| CCMO | NL42098.041.13 |