In Vivo Comparison of Air Charged Catheters with Water Filled Catheters for Intravesical and Intrarectal Pressures Recording during Urodynamic Testing.

In Vivo Comparison of Air Charged Catheters with Water Filled Catheters for Intravesical and Intrarectal Pressures Recording during Urodynamic Testing. - Comparison AC-WFpressures

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39662

Enrollment

Registered

2013-07-08

Start date

2015-03-16

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lower urinary tract dysfunction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: Difference of intravesical pressure increment maximum during filling cystometry between the two systems.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results