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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peritron+ | Experimental | SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peritron+ | Device | Peritron+ device to measure intravesical pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, an average of 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Peritron+ | SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter Peritron+: Peritron+ device to measure intravesical pressure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peritron+ | SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter Peritron+: Peritron+ device to measure intravesical pressure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | Through study completion, an average of 4 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peritron+ | SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter Peritron+: Peritron+ device to measure intravesical pressure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Researcher | Laborie | 9056121170 | 1755 | sbitzos@laborie.com |
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| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Participants |
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| 0 |
| 5 |
| 0 |
| 5 |
Sponsor can review results communications prior to public release regarding trial results for a period that is less than 60 days. The sponsor can request changes to the communication.