Clinical trial NCT04846270: Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products
Official title: An Open, Single-arm, Post-market Clinical Investigation to Verify the Ability of TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products in a Home Environment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Essity Hygiene and Health AB
Sponsor class: INDUSTRY
First posted: 2021-04-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.

Detailed description: The TENA SmartCare Change Indicator is intended for use on individuals, dependent end user (DEU), suffering from Urinary Incontinence (UI) who are cared for in a home environment, by one or more caregivers (CGR). The TENA SmartCare Change Indicator is an accessory to TENA absorbing incontinence products. This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to reduce the number of manual checks between daily changes of absorbing incontinence products. Secondarily, the investigation will evaluate number of leakages, skin redness, usability and fecal incidence. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.

Eligibility criteria: Inclusion Criteria:

1. DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.
2. DEU is unable to sufficiently communicate the need for an incontinence product to be changed.
3. DEU is being cared for in a home environment and most of the care is provided by a main CGR.
4. 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.
5. CGR is willing and able to provide informed consent to participate in the clinical investigation.
6. The CGR frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process.
7. If incontinence is managed by pharmaceuticals, the dose regime is stable.
8. DEU and CGR ≥ 18 years of age.

Exclusion Criteria:

1. DEU is cared for in a professional establishment or is institutionalized.
2. DEU has ≥ 4 fecal "incidences" per week.
3. DEU has severe incontinence product related skin problems, as judged by the investigator.
4. DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
5. The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks.
6. Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
7. CGR is incapable or unwilling to use the required smart phone application and/or the diary registration webpage required for the clinical investigation.
8. 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.
9. DEU is pregnant or nursing.
10. CGR or DEU with an alcohol or drug addiction

Primary outcomes:
measure: Number of Manual Checks Per Day at Baseline Week and 3 Weeks
timeFrame: 3 weeks
Secondary outcomes:
measure: Number of Safety Related Events
timeFrame: 3 weeks
measure: Number of Leakages Per Day Into the Clothes and/or Bed Linen at Baseline and 3 Weeks
timeFrame: 3 weeks
measure: Number of Participants With Skin Redness and Irritation
timeFrame: 3 weeks
measure: Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study.
timeFrame: At the end of investigational week (week 3).
measure: Number of Fecal Incidences.
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Medical Concierge Centrum Medyczne
Study officials:
affiliation: Medical Concierge Centrum Medyczne, Polnej Rózy 6/U2, 02-798 Warszawa,
name: Prof. Piotr Radziszewski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: