Incontinence, Urge
Conditions
Brief 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
Interventions
DEVICETDOC 5Fr
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
Sponsors
Laborie Medical Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 2 months | A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects. |
| 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). | 2 months | A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Urodynamics Arm TDOC 5Fr: 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 | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Urodynamics Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 28 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 4 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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).
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Urodynamics Arm | 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 Participants |
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).
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Urodynamics Arm | 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 |