Non-invasive Urine Output Management
Conditions
Brief summary
A Prospective, Randomized, Crossover, Single-blind, Single Center Healthy Volunteer Study conducted over 1 day, with 2 voids using the PureWick (PW) Male external catheter (MEC) vs. comparator Sage PrimoFit™. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter as compared to the comparator product.
Detailed description
In this prospective, post-market, crossover, single-blind, single center healthy volunteer study, healthy males will be randomized 1:1 to a treatment sequence using two devices (PureWick™ Male External Catheter and Sage PrimoFit™) and followed for 1 day through 2 voids. Approximately 50 participants will be enrolled in this study to obtain 44 evaluable subjects. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter. The purpose of this study is to provide clinical evidence to compare the effectiveness and comfort of PureWick™ Male against a comparator for non-invasive urine output management in patients with varying male anatomy. Specifically, the study will collect data about how the male external catheters perform when participants are positioned on their side using a turning wedge with the head of the bed elevated, mimicking common patient positioning in the hospital setting.
Interventions
DEVICEPureWick 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.
DEVICESage 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.
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are blinded to which device is which and will remain blinded to treatment order until study completion. Investigator, Study Personnel and Sponsor will know which device the participant is treated with at any given time.
Intervention model description
Each subject acts as his own control, and therefore the difference in treatments is derived from a within-subject comparison.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adult Male Patient ≥ 18 years old 2. Male anatomy at time of enrollment 3. Ability to speak and understand English 4. Willing to comply with all study procedures in this protocol 5. Able to independently void urine 6. Provision of signed and dated informed consent form
Exclusion criteria
1. Urinary incontinence which does not allow the subject to spontaneously void 2. Frequent episodes of bowel incontinence 3. Has Urinary Retention 4. Has any irritation, wound, open lesion, at the application site, on the genitalia, perineum, or sacrum 5. Recent surgery of the external urogenital tract, penis, or pubic area 6. Not able to comply with study procedures independently without required assistance 7. 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 MEC Against an Established Comparator | 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 |
|---|---|---|
| Performance of the PureWick MEC in Morbidly Obese Subpopulation | Approximately 2 hours after device placement | Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). |
| 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 Comfort Scale Survey | 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. |
| Ease of Use by Health Care Professional (HCP) | 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, and 5 = Very Easy. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Study 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. | 59 |
| Total | 59 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 40.8 years STANDARD_DEVIATION 12.44 |
| Body Mass Index | 31.6 kg/m^2 STANDARD_DEVIATION 8.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 59 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 59 |
| other Total, other adverse events | 0 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 |
Outcome results
Primary
Performance of the PureWick MEC Against an Established Comparator
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 enrolled and randomized participants were included in the primary endpoint efficacy analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick Male External Catheter | Performance of the PureWick MEC Against an Established Comparator | Void 1 | 97.8 Percentage of urine captured | Standard Deviation 10.03 |
| PureWick Male External Catheter | Performance of the PureWick MEC Against an Established Comparator | Void 2 | 91.1 Percentage of urine captured | Standard Deviation 25.84 |
| Sage PrimoFit | Performance of the PureWick MEC Against an Established Comparator | Void 1 | 90.7 Percentage of urine captured | Standard Deviation 20.68 |
| Sage PrimoFit | Performance of the PureWick MEC Against an Established Comparator | Void 2 | 85.2 Percentage of urine captured | Standard Deviation 21.67 |
p-value: 0.04t-test, 2 sided
Secondary
Ease of Use by Health Care Professional (HCP)
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: Approximately 2 hours after device placement
Population: All enrolled and randomized participants were included in the secondary endpoint analysis (ITT Population)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick Male External Catheter | Ease of Use by Health Care Professional (HCP) | Ease of device placement | 4.59 score on a scale | Standard Deviation 0.65 |
| PureWick Male External Catheter | Ease of Use by Health Care Professional (HCP) | Ease of device removal | 4.71 score on a scale | Standard Deviation 0.56 |
| Sage PrimoFit | Ease of Use by Health Care Professional (HCP) | Ease of device placement | 4.58 score on a scale | Standard Deviation 0.7 |
| Sage PrimoFit | Ease of Use by Health Care Professional (HCP) | Ease of device removal | 4.81 score on a scale | Standard Deviation 0.47 |
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 and randomized participants were included in the secondary endpoint analysis (ITT Population)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick Male External Catheter | Participant Comfort | Device Placement Comfort | 3.85 score on a scale | Standard Deviation 1.4 |
| PureWick Male External Catheter | Participant Comfort | Device Voiding Comfort | 3.71 score on a scale | Standard Deviation 1.35 |
| PureWick Male External Catheter | Participant Comfort | Device Removal Comfort | 3.57 score on a scale | Standard Deviation 1.11 |
| PureWick Male External Catheter | Participant Comfort | Likelihood to recommend device to a loved one | 3.98 score on a scale | Standard Deviation 1.33 |
| Sage PrimoFit | Participant Comfort | Likelihood to recommend device to a loved one | 3.51 score on a scale | Standard Deviation 1.5 |
| Sage PrimoFit | Participant Comfort | Device Placement Comfort | 3.69 score on a scale | Standard Deviation 1.34 |
| Sage PrimoFit | Participant Comfort | Device Removal Comfort | 3.62 score on a scale | Standard Deviation 1.3 |
| Sage PrimoFit | Participant Comfort | Device Voiding Comfort | 3.41 score on a scale | Standard Deviation 1.23 |
Secondary
Participant Comfort Scale Survey
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: ITT removing subjects who used source worksheet with typographic errors on Likert scale scoring choices
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick Male External Catheter | Participant Comfort Scale Survey | Device Placement Comfort | 4.29 score on a scale | Standard Deviation 1.06 |
| PureWick Male External Catheter | Participant Comfort Scale Survey | Device Voiding Comfort | 4.0 score on a scale | Standard Deviation 1.25 |
| PureWick Male External Catheter | Participant Comfort Scale Survey | Device Removal Comfort | 3.84 score on a scale | Standard Deviation 1 |
| PureWick Male External Catheter | Participant Comfort Scale Survey | Likelihood to recommend device to a loved one | 3.97 score on a scale | Standard Deviation 1.44 |
| Sage PrimoFit | Participant Comfort Scale Survey | Likelihood to recommend device to a loved one | 3.58 score on a scale | Standard Deviation 1.54 |
| Sage PrimoFit | Participant Comfort Scale Survey | Device Placement Comfort | 3.92 score on a scale | Standard Deviation 1.24 |
| Sage PrimoFit | Participant Comfort Scale Survey | Device Removal Comfort | 3.92 score on a scale | Standard Deviation 1.17 |
| Sage PrimoFit | Participant Comfort Scale Survey | Device Voiding Comfort | 3.58 score on a scale | Standard Deviation 1.27 |
Secondary
Performance of the PureWick MEC in Morbidly Obese Subpopulation
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).
Time frame: Approximately 2 hours after device placement
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick Male External Catheter | Performance of the PureWick MEC in Morbidly Obese Subpopulation | Void 1 | 99.7 Percentage of urine captured | Standard Deviation 0.88 |
| PureWick Male External Catheter | Performance of the PureWick MEC in Morbidly Obese Subpopulation | Void 2 | 80.8 Percentage of urine captured | Standard Deviation 36.94 |
| Sage PrimoFit | Performance of the PureWick MEC in Morbidly Obese Subpopulation | Void 1 | 83.5 Percentage of urine captured | Standard Deviation 32.24 |
| Sage PrimoFit | Performance of the PureWick MEC in Morbidly Obese Subpopulation | Void 2 | 79.3 Percentage of urine captured | Standard Deviation 23.32 |