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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Other | PureWick™ Male External Catheter is used first, followed by cross-over to Sage PrimoFit. |
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| Treatment Sequence 2 | Other | The Sage PrimoFit™ is used first, followed by cross-over to PureWick MEC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PureWick Male External Catheter | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 2 hours after device placement |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Approximately 2 hours after device placement |
| Participant Comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria-Victoria Sena, RN | Tampa General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USF Health Center for Advanced Medical Learning and Simulation (CAMLS) | Tampa | Florida | 336020 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Void 1 |
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| Void 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of overall study population |
| 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 | 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. | All enrolled and randomized participants were included in the primary endpoint efficacy analysis | Posted | Mean | Standard Deviation | Percentage of urine captured | Approximately 2 hours after device placement |
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24 hours
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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 | PureWick Male External Catheter | 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. |
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The secondary endpoint intended to assess capture rate in men with a buried penis/anatomy not compatible with a traditional sheath-style catheter; however, there were too few men meeting this criteria to make this assessment. Instead, the ITT subpopulation of morbidly obese participants was assessed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Becton, Dickinson & Company | 551-225-1164 | kirsten.hammitt@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2023 | Jun 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2023 | Jun 14, 2024 | SAP_001.pdf |
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Each subject acts as his own control, and therefore the difference in treatments is derived from a within-subject comparison.
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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.
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| Sage PrimoFit | Device | 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. |
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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.
| Approximately 2 hours after device placement |
| 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. | Approximately 2 hours after device placement |
| 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. | Approximately 2 hours after device placement |
| NOT COMPLETED |
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| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| PureWick Male External Catheter |
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. |
| OG001 | Sage PrimoFit | 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. |
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| 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). | 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. | Posted | Mean | Standard Deviation | Percentage of urine captured | Approximately 2 hours after device placement |
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| 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. | All enrolled and randomized participants were included in the secondary endpoint analysis (ITT Population) | Posted | Mean | Standard Deviation | score on a scale | Approximately 2 hours after device placement |
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| 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. | ITT removing subjects who used source worksheet with typographic errors on Likert scale scoring choices | Posted | Mean | Standard Deviation | score on a scale | Approximately 2 hours after device placement |
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| 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. | All enrolled and randomized participants were included in the secondary endpoint analysis (ITT Population) | Posted | Mean | Standard Deviation | score on a scale | Approximately 2 hours after device placement |
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| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Sage PrimoFit | 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. | 0 | 59 | 0 | 59 | 0 | 59 |
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| Void 2 |
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| Device Removal Comfort |
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| Likelihood to recommend device to a loved one |
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| Device Removal Comfort |
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| Likelihood to recommend device to a loved one |
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