Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products

NCT04846270 | Completed Results

• 1 other identifier: POWER
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Number of Manual Checks Per Day at Baseline Week and 3 Weeks

  A comparison between the average number of manual checks, in-between the regular changes of the absorbing incontinence product, in the third week of the study (investigational week) and the first week of the study (baseline week).

  3 weeks

Secondary Outcomes (5)

• Number of Safety Related Events

  3 weeks

• Number of Leakages Per Day Into the Clothes and/or Bed Linen at Baseline and 3 Weeks

  3 weeks

• Number of Participants With Skin Redness and Irritation

  3 weeks

• Usability Assessed Via Caregiver-reported Questions With a Qualitative Scale at the End of the Study.

  At the end of investigational week (week 3).

• Number of Fecal Incidences.

  3 weeks

Study Arms (1)

Investigational Device

EXPERIMENTAL

TENA SmartCare Change Indicator

Device: TENA SmartCare Change Indicator

Interventions

TENA SmartCare Change Indicator DEVICE

Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable.

Investigational Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (1)

Medical Concierge Centrum Medyczne

Warsaw, 02-798, Poland

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Fredrik Agholme
• Organization: Essity Hygiene and Health AB

fredrik.agholme@essity.com

+4670323634

Study Officials

• Prof. Piotr Radziszewski, MD, PhD

  Medical Concierge Centrum Medyczne, Polnej Rózy 6/U2, 02-798 Warszawa,

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: April 14, 2021
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: April 8, 2024
• Results First Posted: April 8, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)