Urinary IncontinenceNCT03209570
A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting
A study testing Care planning using TENA Identifi sensor wear data and Care planning without using TENA Identifi sensor wear data in people with Urinary Incontinence, run by Insight Therapeutics, LLC at 5 sites in United States.
Trial summary
The purpose of this study is to prospectively compare a standard of care manual toileting protocol (e.g., "check and change" strategy) to toileting patterns recorded by the TENA Identifi system in identifying incontinence patterns and events, and, whether such data differentially improve a care planning strategy… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Care planning using TENA Identifi sensor wear data and Care planning without using TENA Identifi sensor wear data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Oct 2017to 11 Aug 2018
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 55 years of age or older with stable clinical status
- Long-stay status (more than 90 days)
- Ambulatory and able to use a toilet either independently or with assistance
- Minimum Data Set (MDS) Level 1 (occasionally), 2 (frequently) or 3 (always) rating of incontinence
- Currently wearing disposable briefs for urinary incontinence
Who cannot join
- Chronically bed-bound (MDS G0110A rating 8)
- MDS self-performance rating of 4 (total dependence) for toilet use
- Fecal incontinence (MDS H0400 rating 0)
- Use of urinary appliance such as catheters or ostomies (MDS H0100 Z)
- Private duty nurse care
- Residents who tear at clothing or disposable undergarments
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- Current urinary tract infection receiving treatment
- Current diarrhea receiving treatment
- Residents who are not likely to benefit from a toileting plan based on assessment of nursing staff
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Chesapeake Health & Rehabilitation Center
Chesapeake, Virginia, 23320
Norfolk Health & Rehabilitation Center
Norfolk, Virginia, 23504
Insight Therapeutics, LLC
Norfolk, Virginia, 23510
Westminster-Canterbury on Chesapeake Bay
Virginia Beach, Virginia, 23451
Beth Sholom Village
Virginia Beach, Virginia, 23464
About this study
The purpose of this study is to prospectively compare a standard of care manual toileting protocol (e.g., "check and change" strategy) to toileting patterns recorded by the TENA Identifi system in identifying incontinence patterns and events, and, whether such data differentially improve a care planning strategy, nursing effort, product use, and wet-time for urinary incontinence.
Read the detailed description
Urinary incontinence in nursing homes influences resident dignity and quality of life. It also drives significant use of healthcare resources, including time and caregiver assistance, and costs of care. Various toileting programs are used to address urinary incontinence, including habit training, bladder training, prompted voiding, and check and change procedures. Clinical trials have found that 33% to 60% of residents either became continent or reduced the frequency of incontinence episodes to less than one per day with the introduction of a prompted voiding program.
There are several drawbacks to current programs. Manually recorded wet checks do not identify when incontinence occurs, only when wetness is detected, reducing the precision of time of incontinence to the window of time between checks. Nursing home staff create individualized care plans for each resident, based on standard check and change procedures, but poor precision in ascertaining timing and quantity of incontinence episodes can contribute to less frequent resident toileting or changing.
- Conditions
- Urinary Incontinence
- Being tested
- Care planning using TENA Identifi sensor wear data, Care planning without using TENA Identifi sensor wear data
- Keywords
- urinary incontinence, nursing home
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care planning using TENA Identifi sensor wear dataOther
All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning.
Care planning without using TENA Identifi sensor wear dataOther
All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning.
| Study group | Role | What they receive |
|---|---|---|
| TENA Identifi with sensor wear data | Experimental | All individuals in this arm will receive care planning using TENA Identifi sensor wear data Receives: Other: Care planning using TENA Identifi sensor wear data |
| TENA Identifi without sensor wear data | Active comparator | All individuals in this arm will receive care planning without using TENA Identifi sensor wear data Receives: Other: Care planning without using TENA Identifi sensor wear data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wet Events Per 24 Hours
Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control
Measured: 6 days
Secondary outcomes (2)
Time Wet Per 24 Hours
Comparison of the amount of time wet per 24 hours as recorded by TENA Identifi, intervention versus control
Measured: 6 days
Number of Brief Changes Per 24 Hours
The number of brief changes per 24 hours, intervention versus control
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start19 Oct 2017
- Primary completion11 Aug 2018
- Study completion11 Aug 2018
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insight Therapeutics, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Essity Hygiene and Health AB
- Responsible party
- Sponsor
- Investigators
- Stefan Gravenstein, MD, MPH, Principal investigator, Brown UniversityH Edward Davidson, PharmD, MPH, Principal investigator, Insight Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209570
- Sponsor's protocol ID
- INSI-201706
- Status last verified
- Jul 2019
- First submitted
- 3 Jul 2017
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ouslander JG, Schnelle JF, Uman G, Fingold S, Nigam JG, Tuico E, Bates-Jensen B. Predictors of successful prompted voiding among incontinent nursing home residents. JAMA. 1995 May 3;273(17):1366-70.
PubMed 7715062Omli R, Skotnes LH, Romild U, Bakke A, Mykletun A, Kuhry E. Pad per day usage, urinary incontinence and urinary tract infections in nursing home residents. Age Ageing. 2010 Sep;39(5):549-54. doi: 10.1093/ageing/afq082. Epub 2010 Jul 14.
PubMed 20631404
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting
- ClinicalTrials.gov ID
- NCT03209570
- Acronym / sponsor ID
- INSI-201706
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, nursing home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Insight Therapeutics, LLCUniversity, hospital or other
- Collaborators
- Essity Hygiene and Health AB
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 11 Aug 2018 (actual)
- Study completion
- 11 Aug 2018 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Posted 26 Jul 2019
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 prospectively compare a standard of care manual toileting protocol (e.g., "check and change" strategy) to toileting patterns recorded by the TENA Identifi system in identifying incontinence patterns and events, and, whether such data differentially improve a care planning strategy, nursing effort, product use, and wet-time for urinary incontinence.
Detailed description
Urinary incontinence in nursing homes influences resident dignity and quality of life. It also drives significant use of healthcare resources, including time and caregiver assistance, and costs of care. Various toileting programs are used to address urinary incontinence, including habit training, bladder training, prompted voiding, and check and change procedures. Clinical trials have found that 33% to 60% of residents either became continent or reduced the frequency of incontinence episodes to less than one per day with the introduction of a prompted voiding program.
There are several drawbacks to current programs. Manually recorded wet checks do not identify when incontinence occurs, only when wetness is detected, reducing the precision of time of incontinence to the window of time between checks. Nursing home staff create individualized care plans for each resident, based on standard check and change procedures, but poor precision in ascertaining timing and quantity of incontinence episodes can contribute to less frequent resident toileting or changing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENA Identifi with sensor wear data | Experimental | Other: Care planning using TENA Identifi sensor wear dataAll individuals in this arm will receive care planning using TENA Identifi sensor wear data |
| TENA Identifi without sensor wear data | Active comparator | Other: Care planning without using TENA Identifi sensor wear dataAll individuals in this arm will receive care planning without using TENA Identifi sensor wear data |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females 55 years of age or older with stable clinical status
- Long-stay status (more than 90 days)
- Ambulatory and able to use a toilet either independently or with assistance
- Minimum Data Set (MDS) Level 1 (occasionally), 2 (frequently) or 3 (always) rating of incontinence
- Currently wearing disposable briefs for urinary incontinence
Key exclusion criteria (9 listed)
- Chronically bed-bound (MDS G0110A rating 8)
- MDS self-performance rating of 4 (total dependence) for toilet use
- Fecal incontinence (MDS H0400 rating 0)
- Use of urinary appliance such as catheters or ostomies (MDS H0100 Z)
- Private duty nurse 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 |
|---|---|---|
| Care planning using TENA Identifi sensor wear dataAll individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning. | Other | TENA Identifi with sensor wear data |
| Care planning without using TENA Identifi sensor wear dataAll individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning. | Other | TENA Identifi without sensor wear data |
Primary outcome
Wet Events Per 24 Hours
Time frame: 6 days
Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control
2 secondary outcomes
Time Wet Per 24 Hours
Time frame: 6 days
Number of Brief Changes Per 24 Hours
Time frame: 6 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7715062Ouslander JG, Schnelle JF, Uman G, Fingold S, Nigam JG, Tuico E, Bates-Jensen B. Predictors of successful prompted voiding among incontinent nursing home residents. JAMA. 1995 May 3;273(17):1366-70.
- Background: PubMed 20631404Omli R, Skotnes LH, Romild U, Bakke A, Mykletun A, Kuhry E. Pad per day usage, urinary incontinence and urinary tract infections in nursing home residents. Age Ageing. 2010 Sep;39(5):549-54. doi: 10.1093/ageing/afq082. Epub 2010 Jul 14.
- 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.
Stefan Gravenstein, MD, MPH principal investigator
Brown University
H Edward Davidson, PharmD, MPH principal investigator
Insight Therapeutics, LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care planning using TENA Identifi sensor wear data and Care planning without using TENA Identifi sensor wear data in people with Urinary Incontinence, run by Insight Therapeutics, LLC at 5 sites 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 9 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 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 26 Jul 2019). 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?
Wet Events Per 24 Hours (time frame: 6 days). 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 NCT03209570, which also lists 2 linked publications.
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 26 Jul 2019.