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Briefs vs Pull-Ups for Urinary Incontinence in Dementia (CUPID Trial)
N/A
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two types of underwear for people with urinary incontinence who also have dementia.
Who is the study for?
This trial is for older individuals with mild to moderate dementia who can use the toilet on their own or with a reminder, move around (with aids if needed), and are currently using products for moderate urinary incontinence. They must have a caregiver willing to help with the study. People who need daily help applying these products, don't fit the product sizes, can't signal when they need to go, have severe bowel incontinence, live in nursing homes or might enter one soon cannot join.
What is being tested?
The CUPID trial is comparing two types of incontinence products: styled briefs with tapes versus pull ups. The goal is to see which one better helps manage urinary incontinence for people living with dementia. Participants will be randomly assigned to use either styled briefs with tapes or pull ups and their effectiveness will be evaluated.
What are the potential side effects?
While this trial does not involve medications that typically cause side effects, participants may experience discomfort or skin issues depending on how well each type of containment product works for them and fits their body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Successful Toileting Episodes
Secondary study objectives
Cost of care partner time
Number of Care Partners satisfied with treatment
Number of PLWD satisfied with treatment
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Styled briefs with tapesExperimental Treatment1 Intervention
Styled briefs with tapes
Group II: Pull upsExperimental Treatment1 Intervention
Pull-up continence products
Find a Location
Who is running the clinical trial?
Essity Hygiene and Health ABIndustry Sponsor
15 Previous Clinical Trials
880 Total Patients Enrolled
11 Trials studying Urinary Incontinence
652 Patients Enrolled for Urinary Incontinence
University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,394 Total Patients Enrolled
6 Trials studying Urinary Incontinence
853 Patients Enrolled for Urinary Incontinence
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You use any type of product to manage moderate incontinence.You have a moderate level of urine leakage as measured by the Incontinence Severity (Sandvik) index.Your waist size or body shape makes it difficult to administer the investigational product.People with diabetes who are unable to say when they need to use the bathroom.People with significant problems controlling their bowel movements.You can move around on your own, with or without help from walking aids.
Research Study Groups:
This trial has the following groups:- Group 1: Pull ups
- Group 2: Styled briefs with tapes
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.