N/A
N=28
T-DOC® 5 Fr Pediatric Clinical Investigation
Incontinence, Urge
Bottom Line
View on ClinicalTrials.gov: NCT03429270 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Safe in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger). — 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TDOC 5Fr (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Laborie Medical Technologies Inc.
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Safe in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger). |
28 | — |
| PRIMARY The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Effective in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger). |
28 | — |
Summary
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
Eligibility Criteria
Inclusion Criteria
- Male and Female (Children and infants, 12 years of age and younger)
- Subjects who are scheduled and normally indicated for urodynamics testing, for any medically necessary reason as per the physician.
Exclusion Criteria
- Subjects who suffer from bladder infections (not including subjects with asymptomatic bacteruria)
- Subjects with urethral strictures
- Subjects who require the use of a suprapubic catheter
Data sourced from ClinicalTrials.gov (NCT03429270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.