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Behavioural Intervention

Change Indicator for Urinary Incontinence

N/A
Waitlist Available
Led By Adrian Wagg, MD
Research Sponsored by Essity Hygiene and Health AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has urinary incontinence managed with incontinence products with tapes, belted or pull up incontinence product type (products for moderate to heavy incontinence)
Subject is unable to consistently communicate toileting needs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial will show if the TENA SmartCare Change Indicator, a device that helps nurses know when to change an adult diaper, is safe and effective.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You use incontinence products like tapes, belts, or pull-up types for moderate to heavy urinary incontinence.
Select...
You have difficulty telling others when you need to use the bathroom.
Select...
You need help using the toilet and changing pads.
Select...
You are currently using a continence care routine that involves checking and changing a method.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Care Efficiency score
Daily Skin Health score
Secondary outcome measures
Caregiver work conditions
Caregiver work engagement
Level of agitation and responsive behavior.
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DeviceExperimental Treatment1 Intervention
Clusters in this arm will start using the device and use it for 6 weeks.
Group II: ControlActive Control1 Intervention
Clusters in this arm will not receive the device it will continue with usual care with no changes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TENA SmartCare Change Indicator
2023
N/A
~70

Find a Location

Who is running the clinical trial?

Essity Hygiene and Health ABLead Sponsor
12 Previous Clinical Trials
579 Total Patients Enrolled
11 Trials studying Urinary Incontinence
559 Patients Enrolled for Urinary Incontinence
Adrian Wagg, MDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
910 Total Patients Enrolled
1 Trials studying Urinary Incontinence
910 Patients Enrolled for Urinary Incontinence

Media Library

TENA SmartCare Change Indicator (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05247047 — N/A
Urinary Incontinence Research Study Groups: Control, Device
Urinary Incontinence Clinical Trial 2023: TENA SmartCare Change Indicator Highlights & Side Effects. Trial Name: NCT05247047 — N/A
TENA SmartCare Change Indicator (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05247047 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What would be the desired outcome from this experiment?

"This 10-week clinical trial seeks to assess Daily Skin Health scores. Secondary objectives involve evaluating Caregiver Work Engagement using the UWES Questionnaire, measuring the number of Continence Care Toilet Visits from a study diary, and determining the amount of Contience Care Bed Linen Changes over both baseline and intervention periods."

Answered by AI

Is the trial still recruiting participants?

"This medical trial, initially announced on October 1st 2022 and last edited September 23rd of the same year, is no longer recruiting participants. Nevertheless, 145 other clinical trials are currently in need of volunteers."

Answered by AI
~45 spots leftby Mar 2025