Back to resultsOvernight Pant Study for Children With Nocturnal Enuresis
Primary Purpose
Nocturnal Enuresis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ninjamas Pyjama Pants
Participant's Overnight Current Standard of Care
Sponsored by
About this trial
This is an interventional other trial for Nocturnal Enuresis
Eligibility Criteria
Inclusion Criteria:
Participants are eligible for enrollment if the parent/legal guardian responds positively ("Yes") to the following questions:
- Have you read, understood and signed the Informed Consent document?
- Is your child generally healthy?
- Is your child 4-7 years of age?
- Does your child weigh approximately 37-63 pounds and fit into the test pant?
- Thinking of the past 3 months, does your child wet the bed at night at least once per week?
- Is your child currently using overnight pants or diapers?
- Is your child willing to use their usual and/or supplied overnight pant products every night for the duration of the study?
- Are you and your child willing to refrain from using wet wipes in the pant area for the duration of the clinical trial?
- Are you willing to refrain from enrolling your child in other clinical or consumer studies for the duration of this clinical trial?
- Are you and your child willing to refrain from using lotions, creams, ointments, oils, moisturizing bubble baths, powders, sunscreen and/or skin preparations in the child's pant area and on thighs for the duration of this clinical trial, unless required for medical reasons?
- Are you and your child willing and able to comply with all study instructions?
- Are you able to fill in the required questionnaires in English?
Exclusion Criteria:
Participants are ineligible for enrollment if the parent/legal guardian responds positively ("Yes") to any of the following questions:
- Does your child have any acute or chronic skin conditions (excluding skin rash) in or around the pant area?
- Does your child currently have (or have a history of) any significant illness or chronic medical condition?
- Is your child currently using any medications?
- Does your child currently wear absorbent products during the day?
- Does your child suffer from any other lower urinary tract symptoms (e.g., increased frequency, daytime incontinence, urgency, genital, or lower urinary tract pain) or a history of bladder dysfunction?
Sites / Locations
- North Cliff Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care
Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant
Arm Description
For the first 3 weeks participants use Ninjamas Pyjama Pants, then for the next 3 weeks they switch to the Overnight Current Standard of Care.
For the first 3 weeks participants use their Overnight Current Standard of Care, then for the next 3 weeks they switch to Ninjamas Pyjama Pants.
Outcomes
Primary Outcome Measures
Number, Frequency and Severity of Product Related Adverse Events
Daily parent reported Adverse Events captured in diary.
Secondary Outcome Measures
Parent assessed product performance in terms of urine leaking
Daily urine leakage diary (yes/no) reported every morning by parent via visual inspection of presence of wet stain on bed sheet and location of wet stain on clothes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05178641
Brief Title
Overnight Pant Study for Children With Nocturnal Enuresis
Official Title
Overnight Pant Safety-in-use Diary Clinical Trial for Children With Nocturnal Enuresis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the in-use tolerance of an absorbent disposable underwear pant developed for children with nocturnal enuresis by assessing adverse events. In addition product performance will be assessed by the parent at home via a daily diary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care
Arm Type
Experimental
Arm Description
For the first 3 weeks participants use Ninjamas Pyjama Pants, then for the next 3 weeks they switch to the Overnight Current Standard of Care.
Arm Title
Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant
Arm Type
Experimental
Arm Description
For the first 3 weeks participants use their Overnight Current Standard of Care, then for the next 3 weeks they switch to Ninjamas Pyjama Pants.
Intervention Type
Device
Intervention Name(s)
Ninjamas Pyjama Pants
Intervention Description
Disposable, absorbent underwear-like pyjama pant specifically designed to manage nocturnal enuresis in children by absorbing involuntary urine loss overnight and keeping the child's bed and clothing dry.
Intervention Type
Other
Intervention Name(s)
Participant's Overnight Current Standard of Care
Intervention Description
Any disposable or reusable absorbent diaper or pant product available on the US market that is used to absorb involuntary urine loss for children who are wetting the bed at night.
Primary Outcome Measure Information:
Title
Number, Frequency and Severity of Product Related Adverse Events
Description
Daily parent reported Adverse Events captured in diary.
Time Frame
From admission to discharge, up to 6 weeks
Secondary Outcome Measure Information:
Title
Parent assessed product performance in terms of urine leaking
Description
Daily urine leakage diary (yes/no) reported every morning by parent via visual inspection of presence of wet stain on bed sheet and location of wet stain on clothes.
Time Frame
From admission to discharge, up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants are eligible for enrollment if the parent/legal guardian responds positively ("Yes") to the following questions:
Have you read, understood and signed the Informed Consent document?
Is your child generally healthy?
Is your child 4-7 years of age?
Does your child weigh approximately 37-63 pounds and fit into the test pant?
Thinking of the past 3 months, does your child wet the bed at night at least once per week?
Is your child currently using overnight pants or diapers?
Is your child willing to use their usual and/or supplied overnight pant products every night for the duration of the study?
Are you and your child willing to refrain from using wet wipes in the pant area for the duration of the clinical trial?
Are you willing to refrain from enrolling your child in other clinical or consumer studies for the duration of this clinical trial?
Are you and your child willing to refrain from using lotions, creams, ointments, oils, moisturizing bubble baths, powders, sunscreen and/or skin preparations in the child's pant area and on thighs for the duration of this clinical trial, unless required for medical reasons?
Are you and your child willing and able to comply with all study instructions?
Are you able to fill in the required questionnaires in English?
Exclusion Criteria:
Participants are ineligible for enrollment if the parent/legal guardian responds positively ("Yes") to any of the following questions:
Does your child have any acute or chronic skin conditions (excluding skin rash) in or around the pant area?
Does your child currently have (or have a history of) any significant illness or chronic medical condition?
Is your child currently using any medications?
Does your child currently wear absorbent products during the day?
Does your child suffer from any other lower urinary tract symptoms (e.g., increased frequency, daytime incontinence, urgency, genital, or lower urinary tract pain) or a history of bladder dysfunction?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Huesing-Wray
Organizational Affiliation
North Cliff Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Cliff Consultants
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Overnight Pant Study for Children With Nocturnal Enuresis
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