N/A
Completed N=35
Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products
Source: ClinicalTrials.gov NCT04846270 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Number of Manual Checks Per Day at Baseline Week and 3 Weeks — 3.5; 4.3 Checks per day — p=0.0006
Summary
The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Manual Checks Per Day at Baseline Week and 3 Weeks |
3.5; 4.3 | 0.0006 sig |
| SECONDARY Number of Safety Related Events |
5; 0; 0; 0; 39 | — |
| SECONDARY Number of Leakages Per Day Into the Clothes and/or Bed Linen at Baseline and 3 Weeks |
0.2; 0.33 | 0.0051 sig |
| SECONDARY Number of Participants With Skin Redness and Irritation |
35; 0; 0; 0; 0; 2 | — |
| SECONDARY Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study. |
4.7; 4.8; 4.9; 4.4 | — |
| SECONDARY Number of Fecal Incidences. |
0.059; 0.066 | 0.76 |
Eligibility Criteria
Inclusion Criteria
- DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.
- DEU is unable to sufficiently communicate the need for an incontinence product to be changed.
- DEU is being cared for in a home environment and most of the care is provided by a main CGR.
- DEU is willing and able to provide informed consent and to participate in the clinical investigation or has a legally designated representative willing to provide informed consent on behalf of the DEU. Note, the legally designated representative and main CGR cannot be the same person.
- CGR is willing and able to provide informed consent to participate in the clinical investigation.
- The CGR frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process.
- If incontinence is managed by pharmaceuticals, the dose regime is stable.
- DEU and CGR ≥ 18 years of age.
Exclusion Criteria
- DEU is cared for in a professional establishment or is institutionalized.
- DEU has ≥ 4 fecal "incidences" per week.
- DEU has severe incontinence product related skin problems, as judged by the investigator.
- DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
- The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks.
- Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
- CGR is incapable or unwilling to use the required smart phone application and/or the diary registration webpage required for the clinical investigation.
- Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation.
- DEU is pregnant or nursing.
- CGR or DEU with an alcohol or drug addiction
Data sourced from ClinicalTrials.gov (NCT04846270). 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. Informational only — not medical advice.