N/A
N=49
A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT03209570 ↗Enrolled (actual)
49
Serious AEs
3.9%
Results posted
Jul 2019
Primary outcome: Primary: Wet Events Per 24 Hours — 8.11; 5.75; 7.05; 5.45 events per 24 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Care planning using TENA Identifi sensor wear data (Other); Care planning without using TENA Identifi sensor wear data (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Insight Therapeutics, LLC
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wet Events Per 24 Hours |
8.11; 5.75; 7.05; 5.45 | — |
| SECONDARY Time Wet Per 24 Hours |
10.69; 9.70; 10.24; 8.94 | — |
| SECONDARY Number of Brief Changes Per 24 Hours |
3.25; 2.54; 3.08; 2.52 | — |
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, nursing effort, product use, and wet-time for urinary incontinence.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT03209570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.