Healthy Volunteers, Adolescent
Conditions
Brief summary
A prospective, uncontrolled, open-label healthy volunteer study to assess the performance of the PureWick Male and PureWick Flex Female external catheter devices in adolescents
Detailed description
The objective of this healthy volunteer study is to understand if external catheters are an effective alternative in the adolescent population in both male and female adolescents. The main question it aims to answer is: Do the PureWick Male and PureWick Flex female external catheters effectively capture urine in the adolescent population after both healthcare professional placement and self-placement? Participants will void while wearing the external catheter two times and answer brief questionnaires assessing perceived wetness, IFU comprehension, comfort and ease of use. Total study participation time is 2-3 hours in a single day.
Interventions
DEVICEPureWick System
The PureWick System consists of the PureWick Urine Collection System used with either the PureWick Male External Catheter or the PureWick Flex Female External Catheter, which are intended for non-invasive urine output management.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Adolescent Male or Female aged 12 through 21 years old 2. Able to independently and voluntarily void urine 3. Ability to speak and understand English. 4. Willing to comply with all study procedures in the protocol. 5. Provision of signed and dated informed consent form.
Exclusion criteria
1. Has urinary retention 2. Incontinent to feces 3. Has any irritation, wound, open lesion at the device application site. 4. For females: currently menstruating without use of an internal device, e.g. tampon or menstrual cup, during the execution of the study. 5. For females: currently pregnant at time of consenting (self-reported) 6. Currently enrolled in or has previously been enrolled in or has completed nursing or other clinical training and courses. 7. Has ever been employed as a home health aide or homecare provider. 8. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the PureWick System in Adolescents After HCP Placement and Self-placement | Approximately 2 hours after device placement | Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each void, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants void into the device while laying in a bed with the absorbent pad underneath them. After each void, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) \* 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Comfort | Approximately 2 hours after device placement | Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable or Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable. The last survey question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely Nor Unlikely, 4 - Likely, and 5 = Very Likely. |
| Participant Ease of Use | Approximately 2 hours after device placement | Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy |
| IFU Comprehension | Approximately 2 hours after device placement | Overall IFU comprehension on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, and 5 = Strongly Agree. |
| HCP Ease of Use | From date of first enrollment until the date of last patient completion, approximately 4 weeks | Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy, and 5 = Very Easy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PureWick System PureWick System: The PureWick System consists of the PureWick Urine Collection System used with either the PureWick Male External Catheter or the PureWick Flex Female External Catheter, which are intended for non-invasive urine output management. | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | PureWick System |
|---|---|
| Age, Categorical <=18 years | 43 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 16.8 years STANDARD_DEVIATION 2.86 |
| BMI | 25.37 kg/m2 STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Performance of the PureWick System in Adolescents After HCP Placement and Self-placement
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each void, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants void into the device while laying in a bed with the absorbent pad underneath them. After each void, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) \* 100.
Time frame: Approximately 2 hours after device placement
Population: All evaluable participants defined as those who voided with the device in place.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthcare Professional Placed Device | Performance of the PureWick System in Adolescents After HCP Placement and Self-placement | Overall (Females & Males Combined) | 90.40 Percentage of urine captured | Standard Deviation 19.31 |
| Healthcare Professional Placed Device | Performance of the PureWick System in Adolescents After HCP Placement and Self-placement | PureWick Flex Female | 87.15 Percentage of urine captured | Standard Deviation 17.43 |
| Healthcare Professional Placed Device | Performance of the PureWick System in Adolescents After HCP Placement and Self-placement | PureWick Male | 92.95 Percentage of urine captured | Standard Deviation 20.69 |
| Self-Placed Device | Performance of the PureWick System in Adolescents After HCP Placement and Self-placement | Overall (Females & Males Combined) | 93.09 Percentage of urine captured | Standard Deviation 13.79 |
| Self-Placed Device | Performance of the PureWick System in Adolescents After HCP Placement and Self-placement | PureWick Flex Female | 90.41 Percentage of urine captured | Standard Deviation 7.91 |
| Self-Placed Device | Performance of the PureWick System in Adolescents After HCP Placement and Self-placement | PureWick Male | 95.19 Percentage of urine captured | Standard Deviation 16.95 |
Secondary
HCP Ease of Use
Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy, and 5 = Very Easy.
Time frame: From date of first enrollment until the date of last patient completion, approximately 4 weeks
Population: All HCPs who completed an ease-of-use questionnaire after placing at least one device on study participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthcare Professional Placed Device | HCP Ease of Use | Ease of Use during Device Placement | 5.0 score on a scale | Standard Deviation 0 |
| Healthcare Professional Placed Device | HCP Ease of Use | Ease of Use during Device Removal | 5.0 score on a scale | Standard Deviation 0 |
| Self-Placed Device | HCP Ease of Use | Ease of Use during Device Placement | 5.0 score on a scale | Standard Deviation 0 |
| Self-Placed Device | HCP Ease of Use | Ease of Use during Device Removal | 5.0 score on a scale | Standard Deviation 0 |
Secondary
IFU Comprehension
Overall IFU comprehension on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, and 5 = Strongly Agree.
Time frame: Approximately 2 hours after device placement
Population: All enrolled participants that completed an IFU Comprehension questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthcare Professional Placed Device | IFU Comprehension | I was able to understand and follow the written instructions | 4.8 score on a scale | Standard Deviation 0.43 |
| Healthcare Professional Placed Device | IFU Comprehension | I was able to understand the pictures in the instructions | 4.8 score on a scale | Standard Deviation 0.38 |
| Healthcare Professional Placed Device | IFU Comprehension | I was able to place the PureWick device on myself | 4.7 score on a scale | Standard Deviation 0.46 |
| Self-Placed Device | IFU Comprehension | I was able to understand and follow the written instructions | 4.7 score on a scale | Standard Deviation 0.56 |
| Self-Placed Device | IFU Comprehension | I was able to understand the pictures in the instructions | 4.7 score on a scale | Standard Deviation 0.45 |
| Self-Placed Device | IFU Comprehension | I was able to place the PureWick device on myself | 4.6 score on a scale | Standard Deviation 0.66 |
Secondary
Participant Comfort
Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable or Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable. The last survey question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely Nor Unlikely, 4 - Likely, and 5 = Very Likely.
Time frame: Approximately 2 hours after device placement
Population: All enrolled participants that completed a comfort questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthcare Professional Placed Device | Participant Comfort | Device Placement Comfort | 4.4 score on a scale | Standard Deviation 0.61 |
| Healthcare Professional Placed Device | Participant Comfort | Device Voiding Comfort | 4.2 score on a scale | Standard Deviation 0.81 |
| Healthcare Professional Placed Device | Participant Comfort | Device Removal Comfort | 4.7 score on a scale | Standard Deviation 0.46 |
| Healthcare Professional Placed Device | Participant Comfort | Likelihood to Recommend Device to a Loved One | 4.3 score on a scale | Standard Deviation 0.69 |
| Self-Placed Device | Participant Comfort | Likelihood to Recommend Device to a Loved One | 4.1 score on a scale | Standard Deviation 1.06 |
| Self-Placed Device | Participant Comfort | Device Placement Comfort | 4.3 score on a scale | Standard Deviation 0.82 |
| Self-Placed Device | Participant Comfort | Device Removal Comfort | 4.0 score on a scale | Standard Deviation 1.02 |
| Self-Placed Device | Participant Comfort | Device Voiding Comfort | 4.3 score on a scale | Standard Deviation 0.76 |
Secondary
Participant Ease of Use
Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy
Time frame: Approximately 2 hours after device placement
Population: All enrolled participants that completed an ease-of-use questionnaire after device self-placement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthcare Professional Placed Device | Participant Ease of Use | Ease of Use during Device Placement | 4.4 score on a scale | Standard Deviation 0.78 |
| Healthcare Professional Placed Device | Participant Ease of Use | Ease of Use during Device Removal | 5.0 score on a scale | Standard Deviation 0 |
| Self-Placed Device | Participant Ease of Use | Ease of Use during Device Removal | 4.7 score on a scale | Standard Deviation 0.65 |
| Self-Placed Device | Participant Ease of Use | Ease of Use during Device Placement | 4.3 score on a scale | Standard Deviation 0.69 |