Urinary IncontinenceNCT04619992
Consumer Evaluation of Intermittent Catheter Product Modifications
A study testing Currently marketed Hydrophillic Intermittent Catheter and Test Hydrophilic Intermittent Catheter in people with Urinary Incontinence, run by Hollister Incorporated at 1 site in United States.
Trial summary
This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Currently marketed Hydrophillic Intermittent Catheter and Test Hydrophilic Intermittent Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2020to 17 Aug 2021
- 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
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria for Arm 1
Subject who:
- is male and at least 18 years of age
- has been performing unassisted, self-catheterizations, with a Hollister standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month
- Exclusion Criteria for Arm 1
Subject who:
- is currently undergoing chemotherapy, radiation or steroid therapy
- has a symptomatic urinary tract infection (UTI)
- is currently using a coude intermittent catheter product to perform catheterization
- performs non-urethral catheterization
- Inclusion Criteria for Arm 2
Subject who:
- is male and at least 18 years of age
- has been performing unassisted, self-catheterizations, with a non-standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month
- Exclusion Criteria for Arm 2
Subject who:
- is currently undergoing chemotherapy, radiation or steroid therapy
- has a symptomatic urinary tract infection (UTI)
- is currently using a coude intermittent catheter product to perform catheterization
- performs non-urethral catheterization
- is unable to use a Hollister standard with tip hydrophilic intermittent catheter
Trial locations and contacts
1 site in 1 country.
United States1 site
Hollister Incorporated
Libertyville, Illinois, 60048
About this study
This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.
- Conditions
- Urinary Incontinence
- Being tested
- Currently marketed Hydrophillic Intermittent Catheter, Test Hydrophilic Intermittent Catheter
- Keywords
- Intermittent Catheterization
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Currently marketed Hydrophillic Intermittent CatheterDevice
Currently marketed Hollister standard with tip hydrophilic intermittent catheter
Test Hydrophilic Intermittent CatheterDevice
Hollister standard with tip hydrophilic intermittent catheter with design enhancements
| Study group | Role | What they receive |
|---|---|---|
| Current users of Hollister standard with tip hydrophilic intermittent catheters | Other | Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. Receives: Device: Test Hydrophilic Intermittent Catheter |
| New users of Hollister standard with tip hydrophilic intermittent catheters | Other | Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. Receives: Device: Currently marketed Hydrophillic Intermittent Catheter; Device: Test Hydrophilic Intermittent Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Test Hydrophilic Intermittent Catheter
Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter.
Measured: 10 days
Preference of Test Hydrophilic Intermittent Catheter
Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start14 Oct 2020
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
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 Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hollister Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619992
- Sponsor's protocol ID
- 6009-CONT
- Status last verified
- Aug 2022
- First submitted
- 27 Oct 2020
- Last updated
- 3 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer Evaluation of Intermittent Catheter Product Modifications
- ClinicalTrials.gov ID
- NCT04619992
- Acronym / sponsor ID
- 6009-CONT
- Conditions
- Urinary Incontinence
- Keywords
- Intermittent Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hollister IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Posted 3 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current users of Hollister standard with tip hydrophilic intermittent catheters | Other | Device: Test Hydrophilic Intermittent CatheterSubjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. |
| New users of Hollister standard with tip hydrophilic intermittent catheters | Other | Device: Currently marketed Hydrophillic Intermittent Catheter, Device: Test Hydrophilic Intermittent CatheterSubjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Currently marketed Hydrophillic Intermittent CatheterCurrently marketed Hollister standard with tip hydrophilic intermittent catheter | Device | New users of Hollister standard with tip hydrophilic intermittent catheters |
| Test Hydrophilic Intermittent CatheterHollister standard with tip hydrophilic intermittent catheter with design enhancements | Device | Current users of Hollister standard with tip hydrophilic intermittent catheters, New users of Hollister standard with tip hydrophilic intermittent catheters |
Primary outcome
Acceptability of Test Hydrophilic Intermittent Catheter
Time frame: 10 days
Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter.
Preference of Test Hydrophilic Intermittent Catheter
Time frame: 10 days
Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Currently marketed Hydrophillic Intermittent Catheter and Test Hydrophilic Intermittent Catheter in people with Urinary Incontinence, run by Hollister Incorporated 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?
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 3 Aug 2022. 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 3 Aug 2022). 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?
Acceptability of Test Hydrophilic Intermittent Catheter (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2022.