Introduction & Objective : This clinical investigation assessed the safety and effectiveness of the new T-DOC® 5 French (Fr) vesicle and abdominal catheters for measuring urodynamic pressure in pediatric patients. Secondly, to obtain feedback related to user feasibility. Currently, a T-DOC® 7 Fr catheter is used. The 5 Fr catheter is a smaller version of the 7 Fr catheter. The 5 Fr version is intended for both adult and pediatric patients, however, there are no published data related to use in the pediatric population.
Study site obtained ethics board approval. Parents completed informed consent and assent as applicable. Study conducted from January 2018 - May 2018.
Inclusion criteria are pediatric patients 12 and younger indicated for Video Urodynamics (VUDS) for medically necessary reason per physician discretion. Exclusion criteria are patients with bladder infections, urethral strictures, or suprapubic catheter.
To assess first objective, T-Doc® 5 Fr vesical and abdominal catheters were connected to VUDS transducers. Product competency was tested. Vesicle and then abdominal catheter was placed. Catheter insertion depth, problems during insertion, and catheters staying in place were assessed. Unexplained artefacts and patient factors that affect tracing were recorded. Any adverse events during study were documented. An Investigator Assessment evaluation of the safety and effectiveness of the vesical and abdominal catheter was recorded. Patients received a follow up telephone call 5 – 7 days after study to assess for any adverse events.
Four female and 8 male patients were in the study. Average insertion depth of vesical and abdominal catheter was 11.3 cm and 14.5 cm. One problem noted with insertion of abdominal catheter was related to patient stool retention. Catheters stayed in place on all studies. There were no unexplained artefacts or non-physiologic causes on study tracing. No adverse events occurred during the VUDS studies. On follow up call, 4 of 11 patients reported an adverse event after VUDS. All resolved within 24 hours. One patient was unable to reach and did not return phone call.
Conclusions : The T-Doc® 5 Fr air charged catheter is safe and effective for use with pediatric patients age 12 and younger in need of VUDS testing.