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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
CUPID Trial 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.Check my eligibility
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.See study design
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.
CUPID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Successful Toileting Episodes
Secondary outcome measures
Cost of care partner time
Number of Care Partners satisfied with treatment
Number of PLWD satisfied with treatment
+7 moreCUPID 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
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Who is running the clinical trial?
Essity Hygiene and Health ABIndustry Sponsor
13 Previous Clinical Trials
696 Total Patients Enrolled
11 Trials studying Urinary Incontinence
652 Patients Enrolled for Urinary Incontinence
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,119 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are eligible to join this experiment?
"Affirmative. Clinicaltrials.gov hosts evidence that suggests this clinical trial is currently recruiting and originated on August 1st 2021. Last updated on April 5th 2022, the study seeks 15 research participants from one medical facility."
Answered by AI
Is enrollment into this experiment currently available for participants?
"According to the details hosted on clinicaltrials.gov, recruitment for this medical trial is still ongoing; it was originally published on August 1st 2021 and revised most recently on April 5th 2022."
Answered by AI
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