Aims: To assess the performance and safety of the T-DOC® 5 French air-charged urodynamic catheters in pediatric patients and obtain feedback from providers related to usability performance.
Methods: Patients ages 12 years and younger undergoing urodynamics were prospectively recruited from two institutions. The T-DOC® 5 French air-charged catheters were used. Issues with catheter placement, adverse events (AEs), and pain scores were assessed. A follow-up telephone call was made to assess for post-urodynamic AEs. Providers completed a clinical user questionnaire. Likert scale was used (1 = most negative and 5 = most positive response) and reported in mean (range).
Results: A total of 28 patients completed the study. The mean age was 55 months (5-130) (10 females, 18 males). One problem was noted with the insertion of an abdominal catheter, secondary to stool impaction. Catheters stayed in place on all subjects, except for one related to patient hyperactivity. There were no AEs during the studies. In total four reported post-urodynamics AEs (one hematochezia, three dysuria). Among nine patients, pain level on the bladder and abdominal insertion was 3.6/10 (0-10) and 3.1/10 (0-10). Five providers completed the questionnaire. The overall ease of use was rated 4.3/5 (3-5). The ease of insertion was 4.1/5 (2-5) and set-up/clean-up time was 4.4/5 (3-5). Tracing stability, subtraction accuracy, and artifact sensitivity were all perceived favorably (respectively 4.8/5 [4-5], 4.6/5 [4-5], and 4.4/5 [4-5]).
Conclusions: The T-DOC® 5 French air-charged catheter was considered safe and effective in pediatric patients. No AEs occurred during the studies. Providers, using the catheters, reported favorably on catheter usage.
Keywords: T-DOC; air-charged catheter; pediatrics; urodynamics.
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