A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting

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.

Inclusion Criteria:

1. Males or females 55 years of age or older with stable clinical status

2. Long-stay status (more than 90 days)

3. Ambulatory and able to use a toilet either independently or with assistance

4. Minimum Data Set (MDS) Level 1 (occasionally), 2 (frequently) or 3 (always) rating of
incontinence

5. Currently wearing disposable briefs for urinary incontinence

Exclusion Criteria:

1. Chronically bed-bound (MDS G0110A rating 8)

2. MDS self-performance rating of 4 (total dependence) for toilet use

3. Fecal incontinence (MDS H0400 rating 0)

4. Use of urinary appliance such as catheters or ostomies (MDS H0100 Z)

5. Private duty nurse care

6. Residents who tear at clothing or disposable undergarments

7. Current urinary tract infection receiving treatment

8. Current diarrhea receiving treatment

9. Residents who are not likely to benefit from a toileting plan based on assessment of
nursing staff