Comparison of Air Charged Catheters With Water Filled Catheters for

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

N/A

Related Conditions & MeSH terms

Incontinence

Clinical Trial Details

NCT number	NCT02030340
Study type	Observational
Source	UMC Utrecht
Contact	Peter FW Rosier, MD PhD
Phone	+31887558081
Email	p.f.w.m.rosier@umcutrecht.nl
Status	Recruiting
Phase	N/A
Start date	December 2013
Completion date	December 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms