Urology
Conditions
Brief summary
In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry method. In the home setting a human factor/usability study will be conducted to measure the subject's ability to perform a successful SMIP assessment at full and empty bladder with the Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a clean intermittent catheter (CIC).
Interventions
DEVICEPeritron+
Peritron+ device to measure intravesical pressure
Sponsors
Laborie Medical Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Children (2 to 18 years old) * Subjects who perform CIC regularly * Must be able to understand English instructions (written or oral)
Exclusion criteria
* Subjects suffering from symptomatic bladder infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary. | Through study completion, an average of 4 days | Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peritron+ SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter
Peritron+: Peritron+ device to measure intravesical pressure | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Peritron+ |
|---|---|
| Age, Categorical <=18 years | 5 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Gender Female | 2 Participants |
| Gender Male | 3 Participants |
| Region of Enrollment United States | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.
Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group
Time frame: Through study completion, an average of 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peritron+ | Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary. | 65 participants |