NCT02030340

Comparison of Air Charged Catheters With Water Filled Catheters for Urodynamic Study

In Vivo Comparison of Air Charged Catheters With Water Filled Catheters for Intravesical and Intrarectal Pressures Recording During Urodynamic Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Incontinence

Interventions

Type	Name	Description
PROCEDURE	lower urinary tract dysfunction	Urodynamic investigation with a double (two systems: air-charged and water filled) catheter system

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2014-01-08
• Last updated: 2014-01-08

Locations

1 site across 1 country: Netherlands