Incontinence, Urge
Conditions
Brief summary
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Interventions
DEVICETDOC NXT
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Sponsors
Laborie Medical Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and Female (Adult age 21+) * Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician.
Exclusion criteria
* Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria) * Patients who are pregnant * Patients with recent (less than 2 weeks) pelvic floor surgery * Patients who require the use of a suprapubic catheter * Patients with significant cognitive deficiency that prevent the patient from giving informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults. | 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 20 patient questionnaires is required to answer YES the device is safe for a positive outcome and a maximum of 40. |
| The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults. | 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 20 patient questionnaires is required to answer YES the device is effective for a positive outcome and a maximum of 40. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Urodynamics Arm TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Urodynamics Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 11 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults.
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 20 patient questionnaires is required to answer YES the device is effective for a positive outcome and a maximum of 40.
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Urodynamics Arm | The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults. | 20 Participants |
Primary
The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults.
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 20 patient questionnaires is required to answer YES the device is safe for a positive outcome and a maximum of 40.
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Urodynamics Arm | The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults. | 20 Participants |