Urinary IncontinenceNCT03628833
Incontinence Management System ICU Field Evaluation
A study testing Incontinence Management System in people with Urinary Incontinence and Fecal Incontinence, run by Hill-Rom at 1 site in United States.
Trial summary
The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence, Fecal Incontinence
- What is being tested?
- Incontinence Management System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 3 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with urinary, fecal, or dual incontinence who are ≥ 18 years old
- The patient, or the patient's legal authorized representative (LAR), is willing and able to provide written informed consent
Who cannot join
- Patients that are considered to be near death or require palliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hill-Rom Incontinence Management System ICU Field Evaluation
The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.
- Conditions
- Urinary Incontinence, Fecal Incontinence
- Being tested
- Incontinence Management System
- Medical subject headings
- Urinary Incontinence, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incontinence Management SystemDevice
Incontinence detection device
| Study group | Role | What they receive |
|---|---|---|
| Incontinence Management system | Experimental | Not described Receives: Device: Incontinence Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staff satisfaction surveys on product performance
Following product use, staff can complete an optional, Likert scale survey
Measured: Through study completion, an average of 4 months
Secondary outcomes (1)
Patient exposure time following an incontinence event
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start10 Jul 2018
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628833
- Sponsor's protocol ID
- CR-CWS2018-002
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hill-Rom Incontinence Management System ICU Field Evaluation
- ClinicalTrials.gov ID
- NCT03628833
- Acronym / sponsor ID
- CR-CWS2018-002
- Conditions
- Urinary Incontinence, Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incontinence Management system | Experimental | Device: Incontinence Management System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with urinary, fecal, or dual incontinence who are ≥ 18 years old
- The patient, or the patient's legal authorized representative (LAR), is willing and able to provide written informed consent
Key exclusion criteria (1 listed)
- Patients that are considered to be near death or require palliative care
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 |
|---|---|---|
| Incontinence Management SystemIncontinence detection device | Device | Incontinence Management system |
Primary outcome
Staff satisfaction surveys on product performance
Time frame: Through study completion, an average of 4 months
Following product use, staff can complete an optional, Likert scale survey
1 secondary outcome
Patient exposure time following an incontinence event
Time frame: Through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- 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 Incontinence Management System in people with Urinary Incontinence and Fecal Incontinence, run by Hill-Rom 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 2 inclusion and 1 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 11 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Staff satisfaction surveys on product performance (time frame: Through study completion, an average of 4 months). 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 11 Jan 2019.