Clinical trial NCT02030340: Comparison of Air Charged Catheters With Water Filled Catheters for Urodynamic Study
Official title: In Vivo Comparison of Air Charged Catheters With Water Filled Catheters for Intravesical and Intrarectal Pressures Recording During Urodynamic Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Incontinence
Keywords: urodynamic investigation
lower urinary tract dysfunction
catheter
air-charged
water filled
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: UMCUtrecht, department of Urology
name: T-Doc-LLC
First posted: 2014-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled (on the basis of contemporary clinical standards and protocols) for standard urodynamic investigation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

(All necessary:)

* Female gt18 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 above 20 millilitre per second without postvoid residual)
* No signs of bladder /pelvic pain syndrome

OR:

(All necessary)

* Male or female gt18years
* Complete spinal cord injury, level above T12, or meningomyelocele unable to void and significantly reduced or no pelvic floor, urethral 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) indwelling catheter.

Exclusion Criteria:

* Unwilling or unfit to sign informed consent.
* American Society of Anesthesiologists -score gt2; karnovsky lt80percent.
* Male with normal lower urinary tract sensation.
* Women with signs of voiding dysfunction.
* Patients included in scientific studies (for other reasons).

Primary outcomes:
measure: The difference between the water filled catheter recorded and simultaneously air charged catheter recorded maximum pressure (amplitude)during the bladder filling phase of urodynamic test.
timeFrame: acute comparison during one test with two types of catheter
Secondary outcomes:
measure: responses to relevant pressure events: end fill pressure, maximum contraction pressure, maximum pressure at overactive detrusor contraction and maximum cough pressure.
timeFrame: acute comparison during one test with two types of catheter
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: University Medical Center Utrecht, the Netherlands
name: Peter FW Rosier, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosier PF, Gajewski JB, Sand PK, Szabo L, Capewell A, Hosker GL; International Consultation on Incontinence 2008 Committee on Dynamic Testing. Executive summary: The International Consultation on Incontinence 2008--Committee on: "Dynamic Testing"; for urinary incontinence and for fecal incontinence. Part 1: Innovations in urodynamic techniques and urodynamic testing for signs and symptoms of urinary incontinence in female patients. Neurourol Urodyn. 2010;29(1):140-5. doi: 10.1002/nau.20764.