IncontinenceNCT03023072
Evaluation of an Incontinence Product
An observational study of Incontinence, run by Hill-Rom at 1 site in United States.
Trial summary
The purpose of this study is to determine if the sponsor's Incontinence Product reduces patient exposure time to a wet and/or soiled incontinence pad. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incontinence
- What is being tested?
- Incontinence Detection System
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 30 Jan 2018
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute Care Unit
Who may be able to join
- English speaking/reading adults, age ≥ 18 years
- Incontinent (fecal, urine, or dual incontinence)
- Patients with dual incontinence who require use of a fecal management system (but no urinary catheter)
- Absence of skin irritation, breakdown, and pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the Study Investigator
- Willing and able to provide written informed consent or legal authorized representative is willing and able to provide written informed consent
Who cannot join
- Presence of skin irritation and/or breakdown including but not limited to IAD or pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the study Investigator
- Require use of an absorbent undergarment (e.g. Depends) or catheter as the primary incontinence management strategy
- Is considered to be near death or requires hospice care
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkview Regional Medical Center
Fort Wayne, Indiana
About this study
The purpose of this study is to determine if the sponsor's Incontinence Product reduces patient exposure time to a wet and/or soiled incontinence pad.
- Conditions
- Incontinence
- Being tested
- Incontinence Detection System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incontinence Detection SystemOther
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Subjects will use the incontinence pad with incontinence detection notifications turned on Receives: Other: Incontinence Detection System | |
| Phase 2 | Subjects will use the incontinence pad with incontinence notification turned off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient exposure time following an incontinence event
Measured: Through study completion, an average of 6 months
Secondary outcomes (5)
Patient satisfaction surveys
Measured: Through study completion, an average of 6 months
Staff satisfaction surveys
Measured: Through study completion, an average of 6 months
Family/patient support member surveys
Measured: Through study completion, an average of 6 months
Incidence of incontinence associated skin irritation and breakdown issues
Measured: Through study completion, an average of 6 months
Incidence of pressure injuries
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Why it stopped: Site no longer met criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9 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
- NCT03023072
- Sponsor's protocol ID
- CR-CWS2016-001
- Status last verified
- Feb 2018
- First submitted
- 12 Jan 2017
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Incontinence Product
- ClinicalTrials.gov ID
- NCT03023072
- Acronym / sponsor ID
- CR-CWS2016-001
- Conditions
- Incontinence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Site no longer met criteria
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 18 Jan 2017 (estimated)
- 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 purpose of this study is to determine if the sponsor's Incontinence Product reduces patient exposure time to a wet and/or soiled incontinence pad.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | Other: Incontinence Detection SystemSubjects will use the incontinence pad with incontinence detection notifications turned on |
| Phase 2 | – | –Subjects will use the incontinence pad with incontinence notification turned off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Care Unit
Key inclusion criteria (5 listed)
- English speaking/reading adults, age ≥ 18 years
- Incontinent (fecal, urine, or dual incontinence)
- Patients with dual incontinence who require use of a fecal management system (but no urinary catheter)
- Absence of skin irritation, breakdown, and pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the Study Investigator
- Willing and able to provide written informed consent or legal authorized representative is willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- Presence of skin irritation and/or breakdown including but not limited to IAD or pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the study Investigator
- Require use of an absorbent undergarment (e.g. Depends) or catheter as the primary incontinence management strategy
- Is considered to be near death or requires hospice 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 Detection System | Other | Phase 1 |
Primary outcome
Patient exposure time following an incontinence event
Time frame: Through study completion, an average of 6 months
5 secondary outcomes
Patient satisfaction surveys
Time frame: Through study completion, an average of 6 months
Staff satisfaction surveys
Time frame: Through study completion, an average of 6 months
Family/patient support member surveys
Time frame: Through study completion, an average of 6 months
Incidence of incontinence associated skin irritation and breakdown issues
Time frame: Through study completion, an average of 6 months
Incidence of pressure injuries
Time frame: Through study completion, an average of 6 months
Results and safety
The study was stopped early (reason given: Site no longer met criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- 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?
An observational study of 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Feb 2018. 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 was stopped early (reason given: Site no longer met criteria). Results are not available in the source record.
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?
Patient exposure time following an incontinence event (time frame: Through study completion, an average of 6 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 8 Feb 2018.