A Pivotal Study to Assess the Performance and Safety of a new 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Patients
Christopher Ballantyne, M.D.1, Osama Al-Omar, M.D.2, Mikel Gray, PhD, CUNP1, Sean Corbett, M.D.1, Susan Leroy, CPNP1, Amy Wildasin, CPNP2, Nora Kern, M.D.1.
1University of Virginia, Charlottesville, VA, USA, 2University of West Virginia, Morgantown, WV, USA.
Air-charged urodynamic catheters are newer technology that are thought to provide less artifact due to the air column continuity and elimination of air-bubble interference experienced in water-filled catheters. A T-DOCŪ 7Fr air-charged catheter has been in use, but a 5Fr version has not been commercially available in the US. We sought to assess the performance and safety of the T-DOCŪ 5Fr air-charged urodynamic bladder/abdominal catheters in pediatric patients and obtain feedback from providers related to user feasibility.
Patients ages 12 years and younger were prospectively recruited from 2 institutions who were undergoing urodynamics. Exclusion criteria were patients with bladder infections, urethral strictures, and suprapubic catheters.
T-DOCŪ 5Fr catheters were connected, tested for competency and inserted, and standard urodynamics was performed. Issues with catheter placement, unexplained artifact, and adverse events (AEs) were assessed. Providers completed a Clinical User Questionnaire to subjectively assess catheters. Likert scale was used (1=difficult, 3=equal to, 5=much easier compared to existing catheters). Data are reported in mean (range). A follow-up telephone call was made 5-7 days after study to assess for any AEs.
28 patients were enrolled and completed the study. Mean age was 55 months (5-130) with 10 females and 18 males. 50% were spina bifida patients, while the remaining diagnoses included tethered cord, dysfunctional voiding, caudal regression, and posterior urethral valve. One problem was noted with insertion of abdominal catheter, secondary to stool impaction. Catheters stayed in place on all subjects, except for 1 related to patient hyperactivity. There were no unexplained artifacts; no AEs occurred during the studies. On follow-up call, 4 reported AEs, 1 with hematochezia and 3 with dysuria, all resolving within 72 hours.
Table 1 demonstrates results from the 5 providers who completed the questionnaire. The overall ease of use for the T-DOCŪ 5Fr catheters was rated a mean of 4.1 (3-5). Ease of insertion was 3.9 (2-5) and set-up/clean-up time was 4.4 (3-5). Tracing stability, subtraction accuracy, and artifact sensitivity were all perceived as favorable (respectively 4.8 (4-5), 4.6 (4-5), and 4.4 (4-5)).
The T-DOCŪ 5Fr air-charged catheter is safe for use in pediatric patients. The catheter was perceived to be easier to use compared to existing catheters with higher tracing stability and less artifact. Further studies are needed to compare the urodynamic results of the air-charged catheter compared to the traditional water-filled urodynamic catheter in pediatric patients.
Table 1. Provider questionnaire
|Overall ease of use||4.1 (3-5)|
|Ease of insertion||3.9 (2-5)|
|Ease of securing catheter to patient||3.7 (2-5)|
|Ease of test set-up and zeroing||4.1 (3-5)|
|Impact on workflow||4.2 (3-5)|
|Set-up and clean-up time||4.4 (3-5)|
|Tracing stability||4.8 (4-5)|
|Subtraction accuracy||4.6 (4-5)|
|Artifact sensitivity||4.4 (4-5)|
|Patient voiding around the catheter||4.0 (3-5)|
|Readability of the Instructions For Use||4.0 (3-5)|
|Usability performance||4.6 (3-5)|
Ratings were categorized compared to existing catheter as follows: 1.) Difficult, 2.) Little more difficult, 3.) Equally, 4.) Little easier, and 5.) Much easier.
This Study was funded by Laborie
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