N/A
Completed N=28
T-DOC® 5 Fr Pediatric Clinical Investigation
Incontinence, Urge
Source: ClinicalTrials.gov NCT03429270 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: 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
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
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 | — |
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. Informational only — not medical advice.