PMID- 32914894
OWN - NLM
STAT- MEDLINE
DCOM- 20210308
LR  - 20210308
IS  - 1520-6777 (Electronic)
IS  - 0733-2467 (Linking)
VI  - 39
IP  - 8
DP  - 2020 Nov
TI  - Usability and safety of the new 5 French air-charged catheter for performing 
      urodynamic studies on pediatric patients.
PG  - 2425-2432
LID - 10.1002/nau.24506 [doi]
AB  - AIMS: To assess the performance and safety of the T-DOC(R) 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(R) 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(R) 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.
CI  - (c) 2020 Wiley Periodicals LLC.
FAU - Kern, Nora G
AU  - Kern NG
AUID- ORCID: 0000-0003-4468-0143
AD  - University of Virginia, Charlottesville, Virginia, USA.
FAU - Gray, Mikel
AU  - Gray M
AD  - University of Virginia, Charlottesville, Virginia, USA.
FAU - Corbett, Sean
AU  - Corbett S
AD  - University of Virginia, Charlottesville, Virginia, USA.
FAU - Leroy, Susan
AU  - Leroy S
AUID- ORCID: 0000-0002-6690-0509
AD  - University of Virginia, Charlottesville, Virginia, USA.
FAU - Wildasin, Amy
AU  - Wildasin A
AD  - West Virginia University, Morgantown, West Virginia, USA.
FAU - Al-Omar, Osama
AU  - Al-Omar O
AD  - West Virginia University, Morgantown, West Virginia, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200911
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
SB  - IM
MH  - Child
MH  - Child, Preschool
MH  - Diagnostic Techniques, Urological/*instrumentation
MH  - Female
MH  - Humans
MH  - Infant
MH  - Male
MH  - Pain/*etiology
MH  - Urinary Catheters/*adverse effects
MH  - Urodynamics/*physiology
OTO - NOTNLM
OT  - T-DOC
OT  - air-charged catheter
OT  - pediatrics
OT  - urodynamics
EDAT- 2020/09/12 06:00
MHDA- 2021/03/09 06:00
CRDT- 2020/09/11 08:40
PHST- 2020/06/13 00:00 [received]
PHST- 2020/08/23 00:00 [revised]
PHST- 2020/08/29 00:00 [accepted]
PHST- 2020/09/12 06:00 [pubmed]
PHST- 2021/03/09 06:00 [medline]
PHST- 2020/09/11 08:40 [entrez]
AID - 10.1002/nau.24506 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2020 Nov;39(8):2425-2432. doi: 10.1002/nau.24506. Epub 2020 Sep 
      11.