Trial Outcomes & Findings for Male External Catheters' Comparison of Comfort and Efficacy (NCT NCT05955560)
NCT ID: NCT05955560
Last Updated: 2024-08-27
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
59 participants
Approximately 2 hours after device placement
2024-08-27
Participant Flow
Potential subjects were identified by a third party recruitment vendor. Targeted enrollment included 50 male, healthy volunteer participants in proximity to the clinical site. Participants were excluded if incontinent to urine or feces, or had any pre-existing wound, open lesion or irritation in the device application area.
Participant milestones
| Measure |
PureWick Male, Then Sage PrimoFit
Participants used PureWick MEC for void 1. After consuming fluids to ensure adequate bladder volume, participants completed void 2 using Sage PrimoFit.
|
Sage PrimoFit, Then PureWick Male
Participants used Sage PrimoFit for void 1. After consuming fluids to ensure adequate bladder volume, participants completed void 2 using PureWick MEC.
|
|---|---|---|
|
Void 1
STARTED
|
30
|
29
|
|
Void 1
COMPLETED
|
30
|
29
|
|
Void 1
NOT COMPLETED
|
0
|
0
|
|
Void 2
STARTED
|
30
|
29
|
|
Void 2
COMPLETED
|
30
|
29
|
|
Void 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Male External Catheters' Comparison of Comfort and Efficacy
Baseline characteristics by cohort
| Measure |
All Study Participants
n=59 Participants
This single-blind, controlled, crossover study randomized participants 1:1 to a treatment sequence using two non-invasive urine collection devices (PureWick Male External Catheter or Sage PrimoFit). Participants were followed for 1 day through 2 voids. After void 1 was completed with PureWick MEC or Sage PrimoFit, participants consumed fluids and completed void 2 using the alternative device.
|
|---|---|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 12.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
|
Body Mass Index
|
31.6 kg/m^2
STANDARD_DEVIATION 8.58 • n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 hours after device placementPopulation: All enrolled and randomized participants were included in the primary endpoint efficacy analysis
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 |
PureWick Male External Catheter
n=59 Participants
PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.
|
Sage PrimoFit
n=59 Participants
Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.
|
|---|---|---|
|
Performance of the PureWick MEC Against an Established Comparator
Void 1
|
97.8 Percentage of urine captured
Standard Deviation 10.03
|
90.7 Percentage of urine captured
Standard Deviation 20.68
|
|
Performance of the PureWick MEC Against an Established Comparator
Void 2
|
91.1 Percentage of urine captured
Standard Deviation 25.84
|
85.2 Percentage of urine captured
Standard Deviation 21.67
|
SECONDARY outcome
Timeframe: Approximately 2 hours after device placementPopulation: As there were only 2 participants that were assessed as unable to use traditional sheath style condom catheters, the secondary analysis was performed on the ITT subpopulation of morbidly obese participants.
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).
Outcome measures
| Measure |
PureWick Male External Catheter
n=15 Participants
PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.
|
Sage PrimoFit
n=15 Participants
Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.
|
|---|---|---|
|
Performance of the PureWick MEC in Morbidly Obese Subpopulation
Void 1
|
99.7 Percentage of urine captured
Standard Deviation 0.88
|
83.5 Percentage of urine captured
Standard Deviation 32.24
|
|
Performance of the PureWick MEC in Morbidly Obese Subpopulation
Void 2
|
80.8 Percentage of urine captured
Standard Deviation 36.94
|
79.3 Percentage of urine captured
Standard Deviation 23.32
|
SECONDARY outcome
Timeframe: Approximately 2 hours after device placementPopulation: All enrolled and randomized participants were included in the secondary endpoint analysis (ITT Population)
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 |
PureWick Male External Catheter
n=59 Participants
PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.
|
Sage PrimoFit
n=59 Participants
Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.
|
|---|---|---|
|
Participant Comfort
Device Placement Comfort
|
3.85 score on a scale
Standard Deviation 1.4
|
3.69 score on a scale
Standard Deviation 1.34
|
|
Participant Comfort
Device Voiding Comfort
|
3.71 score on a scale
Standard Deviation 1.35
|
3.41 score on a scale
Standard Deviation 1.23
|
|
Participant Comfort
Device Removal Comfort
|
3.57 score on a scale
Standard Deviation 1.11
|
3.62 score on a scale
Standard Deviation 1.3
|
|
Participant Comfort
Likelihood to recommend device to a loved one
|
3.98 score on a scale
Standard Deviation 1.33
|
3.51 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Approximately 2 hours after device placementPopulation: ITT removing subjects who used source worksheet with typographic errors on Likert scale scoring choices
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 |
PureWick Male External Catheter
n=38 Participants
PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.
|
Sage PrimoFit
n=38 Participants
Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.
|
|---|---|---|
|
Participant Comfort Scale Survey
Device Placement Comfort
|
4.29 score on a scale
Standard Deviation 1.06
|
3.92 score on a scale
Standard Deviation 1.24
|
|
Participant Comfort Scale Survey
Device Voiding Comfort
|
4.0 score on a scale
Standard Deviation 1.25
|
3.58 score on a scale
Standard Deviation 1.27
|
|
Participant Comfort Scale Survey
Device Removal Comfort
|
3.84 score on a scale
Standard Deviation 1.0
|
3.92 score on a scale
Standard Deviation 1.17
|
|
Participant Comfort Scale Survey
Likelihood to recommend device to a loved one
|
3.97 score on a scale
Standard Deviation 1.44
|
3.58 score on a scale
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: Approximately 2 hours after device placementPopulation: All enrolled and randomized participants were included in the secondary endpoint analysis (ITT Population)
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 |
PureWick Male External Catheter
n=59 Participants
PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.
|
Sage PrimoFit
n=59 Participants
Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.
|
|---|---|---|
|
Ease of Use by Health Care Professional (HCP)
Ease of device placement
|
4.59 score on a scale
Standard Deviation 0.65
|
4.58 score on a scale
Standard Deviation 0.7
|
|
Ease of Use by Health Care Professional (HCP)
Ease of device removal
|
4.71 score on a scale
Standard Deviation 0.56
|
4.81 score on a scale
Standard Deviation 0.47
|
Adverse Events
PureWick Male External Catheter
Sage PrimoFit
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Affairs
Becton, Dickinson & Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place