Trial Outcomes & Findings for PureWick™ Adolescent Study (NCT NCT06631313)
NCT ID: NCT06631313
Last Updated: 2025-10-17
Results Overview
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.
COMPLETED
NA
43 participants
Approximately 2 hours after device placement
2025-10-17
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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43
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Overall Study
Female Participants
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20
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Overall Study
Male Participants
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23
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Overall Study
Healthcare Professional Placed Device
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42
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Overall Study
Self-Placed Device
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42
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Overall Study
COMPLETED
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41
|
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PureWick™ Adolescent Study
Baseline characteristics by cohort
| Measure |
PureWick System
n=43 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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43 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=99 Participants
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
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Age, Continuous
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16.8 years
STANDARD_DEVIATION 2.86 • n=99 Participants
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Sex: Female, Male
Female
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20 Participants
n=99 Participants
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Sex: Female, Male
Male
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23 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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18 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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24 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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20 Participants
n=99 Participants
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Race (NIH/OMB)
White
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21 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
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1 Participants
n=99 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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43 participants
n=99 Participants
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BMI
|
25.37 kg/m2
STANDARD_DEVIATION 5.6 • n=99 Participants
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PRIMARY outcome
Timeframe: Approximately 2 hours after device placementPopulation: All evaluable participants defined as those who voided with the device in place.
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.
Outcome measures
| Measure |
Healthcare Professional Placed Device
n=41 Participants
Evaluation of the PureWick System after being placed on the participant by a healthcare professional (HCP).
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Self-Placed Device
n=41 Participants
Evaluation of the PureWick System after being self-placed by the participant.
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|---|---|---|
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Performance of the PureWick System in Adolescents After HCP Placement and Self-placement
Overall (Females & Males Combined)
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90.40 Percentage of urine captured
Standard Deviation 19.31
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93.09 Percentage of urine captured
Standard Deviation 13.79
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Performance of the PureWick System in Adolescents After HCP Placement and Self-placement
PureWick Flex Female
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87.15 Percentage of urine captured
Standard Deviation 17.43
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90.41 Percentage of urine captured
Standard Deviation 7.91
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Performance of the PureWick System in Adolescents After HCP Placement and Self-placement
PureWick Male
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92.95 Percentage of urine captured
Standard Deviation 20.69
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95.19 Percentage of urine captured
Standard Deviation 16.95
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SECONDARY outcome
Timeframe: Approximately 2 hours after device placementPopulation: All enrolled participants that completed a comfort questionnaire
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.
Outcome measures
| Measure |
Healthcare Professional Placed Device
n=18 Participants
Evaluation of the PureWick System after being placed on the participant by a healthcare professional (HCP).
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Self-Placed Device
n=23 Participants
Evaluation of the PureWick System after being self-placed by the participant.
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|---|---|---|
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Participant Comfort
Device Removal Comfort
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4.7 score on a scale
Standard Deviation 0.46
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4.0 score on a scale
Standard Deviation 1.02
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Participant Comfort
Device Placement Comfort
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4.4 score on a scale
Standard Deviation 0.61
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4.3 score on a scale
Standard Deviation 0.82
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Participant Comfort
Device Voiding Comfort
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4.2 score on a scale
Standard Deviation 0.81
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4.3 score on a scale
Standard Deviation 0.76
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Participant Comfort
Likelihood to Recommend Device to a Loved One
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4.3 score on a scale
Standard Deviation 0.69
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4.1 score on a scale
Standard Deviation 1.06
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SECONDARY outcome
Timeframe: Approximately 2 hours after device placementPopulation: All enrolled participants that completed an ease-of-use questionnaire after device self-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
Outcome measures
| Measure |
Healthcare Professional Placed Device
n=19 Participants
Evaluation of the PureWick System after being placed on the participant by a healthcare professional (HCP).
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Self-Placed Device
n=23 Participants
Evaluation of the PureWick System after being self-placed by the participant.
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|---|---|---|
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Participant Ease of Use
Ease of Use during Device Placement
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4.4 score on a scale
Standard Deviation 0.78
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4.3 score on a scale
Standard Deviation 0.69
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Participant Ease of Use
Ease of Use during Device Removal
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5.0 score on a scale
Standard Deviation 0.00
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4.7 score on a scale
Standard Deviation 0.65
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SECONDARY outcome
Timeframe: Approximately 2 hours after device placementPopulation: All enrolled participants that completed an IFU Comprehension questionnaire
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.
Outcome measures
| Measure |
Healthcare Professional Placed Device
n=18 Participants
Evaluation of the PureWick System after being placed on the participant by a healthcare professional (HCP).
|
Self-Placed Device
n=23 Participants
Evaluation of the PureWick System after being self-placed by the participant.
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|---|---|---|
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IFU Comprehension
I was able to understand and follow the written instructions
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4.8 score on a scale
Standard Deviation 0.43
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4.7 score on a scale
Standard Deviation 0.56
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IFU Comprehension
I was able to place the PureWick device on myself
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4.7 score on a scale
Standard Deviation 0.46
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4.6 score on a scale
Standard Deviation 0.66
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IFU Comprehension
I was able to understand the pictures in the instructions
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4.8 score on a scale
Standard Deviation 0.38
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4.7 score on a scale
Standard Deviation 0.45
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SECONDARY outcome
Timeframe: From date of first enrollment until the date of last patient completion, approximately 4 weeksPopulation: All HCPs who completed an ease-of-use questionnaire after placing at least one device on study participants.
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.
Outcome measures
| Measure |
Healthcare Professional Placed Device
n=3 Participants
Evaluation of the PureWick System after being placed on the participant by a healthcare professional (HCP).
|
Self-Placed Device
n=5 Participants
Evaluation of the PureWick System after being self-placed by the participant.
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|---|---|---|
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HCP Ease of Use
Ease of Use during Device Removal
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5.0 score on a scale
Standard Deviation 0.00
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5.0 score on a scale
Standard Deviation 0.00
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HCP Ease of Use
Ease of Use during Device Placement
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5.0 score on a scale
Standard Deviation 0.00
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5.0 score on a scale
Standard Deviation 0.00
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Adverse Events
PureWick System
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Affairs
Becton, Dickinson and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place