Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence

NCT04071301 | Completed Results

• 1 other identifier: FUEL_CIP_Ver.B_19-Jul-2019
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Urine Volume Quantification and Impedance Measurements

  Descriptive statistics were used to summarize any individual differences between the predicted urine volume from the Change Indicator and the true urine volume (by measuring absorbent product weight). A measure of mean difference for the predicted volume minus true volume is assessed. A combination of these values were used to assess the mathematical algorithms for the TENA SmartCare Change Indicator.

  11 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 a Change Indicator and absorbent products for the duration of the investigation. Nine types of absorbent products will be used to collect real-life measurement data in order to assess the mathematical algorithms involved in the TENA SmartCare Change Indicator. Each participating subject will be allocated to the type(s) that are considered most suitable. Gateways will be placed in the resident's rooms as well as in common areas, this to enable full measurement registration.

Investigational Device

Eligibility Criteria

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

You may qualify if:

• The subject is willing and able to provide informed consent and to participate in the clinical investigation.
• The subject is ≥18 years of age.
• The subject is diagnosed with urinary incontinence.
• The subject is being cared for at Tre Stiftelser.

You may not qualify if:

• The subject has ≥ 4 fecal "incidences" per week.
• The subject has severe absorbent product related skin problems, as judged by the investigator.
• The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
• The subject has ≥ 2 intermittent urinary catheters per day.
• The subject has a pacemaker or an implantable cardioverter-defibrillator.
• The subject removes the incontinence product.
• The subject demonstrates responsive behavior towards sensors.
• The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
• The subject is not cared for at Tre Stiftelser.
• The subject is pregnant or lactating.

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (1)

Tre Stiftelser

Gothenburg, Sweden

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

Limitations and Caveats

Only the Change indicator and Gateway were used, i.e. the smart phone app was not part of the investigation why the clinical benefit relating to app notifications was not investigated. There was a drop off in eligible data points compared to the total number of data points. The reason to this was device deficiencies on some sensors leading to erroneous raw data. The deficiencies were anticipated as the sensors being pre-production devices. 2/3 of the data points were used for evaluation.

Results Point of Contact

• Title: Fredrik Agholme, Clinical Trials Manager, Clinical Affairs
• Organization: Essity Hygiene and Health

Fredrik.AGHOLME@essity.com

+46 73 0323634

Study Officials

• Ulla Molander, MD, PhD

  Avd. för Invärtes medicin och klinisk nutrition, Högsbo sjukhus, Göteborg

  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: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: September 5, 2019
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: June 2, 2021
• Results First Posted: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)