Non-invasive Urine Output ManagementMECCENCT05955560

Male External Catheters' Comparison of Comfort and Efficacy

A study testing PureWick Male External Catheter and Sage PrimoFit in people with Non-invasive Urine Output Management, run by C. R. Bard at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Non-invasive Urine Output Management
What is being tested?: PureWick Male External Catheter and Sage PrimoFit
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteUnited States
Study dates: 12 Jun 2023to 16 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult Male Patient ≥ 18 years old
Male anatomy at time of enrollment
Ability to speak and understand English
Willing to comply with all study procedures in this protocol
Able to independently void urine
Provision of signed and dated informed consent form

Who cannot join

Urinary incontinence which does not allow the subject to spontaneously void
Frequent episodes of bowel incontinence
Has Urinary Retention
Has any irritation, wound, open lesion, at the application site, on the genitalia, perineum, or sacrum
Recent surgery of the external urogenital tract, penis, or pubic area
Not able to comply with study procedures independently without required assistance
Any other condition that, in the opinion of the investigator, would preclude them from participating in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

USF Health Center for Advanced Medical Learning and Simulation (CAMLS)
Tampa, Florida, 336020

Other trials in United States

About this study

Official title: Evaluating the Efficacy and Comfort of the PureWick Male External Catheter Against a Comparator in Healthy Volunteers

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.

Read the 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.

Conditions: Non-invasive Urine Output Management
Being tested: PureWick Male External Catheter, Sage PrimoFit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PureWick Male External CatheterDevice
Also called PureWick MEC
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 PrimoFitDevice
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.

Study groups in NCT05955560
Study group	Role	What they receive
Treatment Sequence 1	Other	PureWick™ Male External Catheter is used first, followed by cross-over to Sage PrimoFit. Receives: Device: PureWick Male External Catheter; Device: Sage PrimoFit
Treatment Sequence 2	Other	The Sage PrimoFit™ is used first, followed by cross-over to PureWick MEC. Receives: Device: PureWick Male External Catheter; Device: Sage PrimoFit

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Approximately 2 hours after device placement

Secondary outcomes (4)

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).
Measured: Approximately 2 hours after device placement
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.
Measured: 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.
Measured: 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.
Measured: Approximately 2 hours after device placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 202316 Jun 2023

First posted21 Jul 2023
Study start12 Jun 2023
Primary completion16 Jun 2023
Study completion16 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-invasive Urine Output ManagementStudies of the same condition, open and under way.
More trials run by C. R. BardThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Each subject acts as his own control, and therefore the difference in treatments is derived from a within-subject comparison.
Masking: Single blind
Who is masked: Participant
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05955560
Sponsor's protocol ID: UCC-23AC022
Acronym: MECCE
Status last verified: Jun 2024
First submitted: 5 Jul 2023
Last updated: 27 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Efficacy and Comfort of the PureWick Male External Catheter Against a Comparator in Healthy Volunteers
ClinicalTrials.gov ID: NCT05955560
Acronym / sponsor ID: MECCE / UCC-23AC022
Conditions: Non-invasive Urine Output Management
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: 12 Jun 2023 (actual)
Primary completion: 16 Jun 2023 (actual)
Study completion: 16 Jun 2023 (actual)
First posted: 21 Jul 2023 (actual)
Results: Posted 27 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: Each subject acts as his own control, and therefore the difference in treatments is derived from a within-subject comparison.

Arm	Type	Receives
Treatment Sequence 1	Other	Device: PureWick Male External Catheter, Device: Sage PrimoFitPureWick™ Male External Catheter is used first, followed by cross-over to Sage PrimoFit.
Treatment Sequence 2	Other	Device: PureWick Male External Catheter, Device: Sage PrimoFitThe Sage PrimoFit™ is used first, followed by cross-over to PureWick MEC.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adult Male Patient ≥ 18 years old
Male anatomy at time of enrollment
Ability to speak and understand English
Willing to comply with all study procedures in this protocol
Able to independently void urine

Key exclusion criteria (7 listed)

Urinary incontinence which does not allow the subject to spontaneously void
Frequent episodes of bowel incontinence
Has Urinary Retention
Has any irritation, wound, open lesion, at the application site, on the genitalia, perineum, or sacrum
Recent surgery of the external urogenital tract, penis, or pubic area

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PureWick Male External CatheterAlso: PureWick MECThe 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.	Device	Treatment Sequence 1, Treatment Sequence 2
Sage PrimoFitThe 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.	Device	Treatment Sequence 1, Treatment Sequence 2

Primary outcome

Performance of the PureWick MEC Against an Established Comparator
Time frame: 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.

4 secondary outcomes

Performance of the PureWick MEC in Morbidly Obese Subpopulation
Time frame: Approximately 2 hours after device placement
Participant Comfort
Time frame: Approximately 2 hours after device placement
Participant Comfort Scale Survey
Time frame: Approximately 2 hours after device placement
Ease of Use by Health Care Professional (HCP)
Time frame: Approximately 2 hours after device placement

Results and safety

Results posted to the registry on 27 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PureWick Male, Then Sage PrimoFit	30	30
Sage PrimoFit, Then PureWick Male	29	29

Primary outcome: Performance of the PureWick MEC Against an Established Comparator

Time frame: Approximately 2 hours after device placement. Mean (Standard Deviation). Unit: Percentage of urine captured

Measure	PureWick Male External Catheter n = 59	Sage PrimoFit n = 59
Void 1	97.8 (10.03)	90.7 (20.68)
Void 2	91.1 (25.84)	85.2 (21.67)

PureWick Male External Catheter vs Sage PrimoFit: p = 0.04, t-test, 2 sided

Population analysed: All enrolled and randomized participants were included in the primary endpoint efficacy analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PureWick Male External Catheter	0 of 59 (0%)	0 of 59 (0%)	0 of 59
Sage PrimoFit	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria-Victoria Sena, RN principal investigator

Tampa General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PureWick Male External Catheter and Sage PrimoFit in people with Non-invasive Urine Output Management, run by C. R. Bard at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of the PureWick MEC Against an Established Comparator (time frame: Approximately 2 hours after device placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05955560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.