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Completed

NCT Number: NCT04846270

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Concierge Centrum Medyczne

Warsaw, 02-798, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. Number of Safety Related Events

    Time frame: 3 weeks

    Reported number of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD) as reported in the investigation.

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

    Time frame: 3 weeks

    A comparison between the average number of urine leakages (out of the absorbing incontinence product), onto the clothes and/or bed linen, in the third week of the study (investigational week) and the first week of the study (baseline week).

  3. Number of Participants With Skin Redness and Irritation

    Time frame: 3 weeks

    A comparison between investigational (week 3) week and baseline week (week 1). The Ghent Global IAD Categorisation Tool (GlOBIAD) was used. It has a 4 point scale from minimum 1A to maximum 2B (with 1A being better outcome). In the measure. IAD is incontinence associated dermatitis.

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

    Time frame: At the end of investigational week (week 3).

    Average score is presented. The scale is 5-point, from minimum 1 to maximum 5 (with 5 being the better outcome).

  5. Number of Fecal Incidences.

    Time frame: 3 weeks

    Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements.

Sponsors and collaborators

Lead sponsor

Essity Hygiene and Health AB

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2021
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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