Overnight Pant Study for Children With Nocturnal Enuresis

Nocturnal Enuresis Clinical Trial

Official title:

Overnight Pant Safety-in-use Diary Clinical Trial for Children With Nocturnal Enuresis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05178641
• Other study ID #: CSD2021096
• Status: Completed
• Phase: N/A
• Start date: January 13, 2022
• Est. completion date: February 28, 2022

Study information

• Verified date: June 2022
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

Participants are eligible for enrollment if the parent/legal guardian responds positively ("Yes") to the following questions:

1. Have you read, understood and signed the Informed Consent document?

2. Is your child generally healthy?

3. Is your child 4-7 years of age?

4. Does your child weigh approximately 37-63 pounds and fit into the test pant?

5. Thinking of the past 3 months, does your child wet the bed at night at least once per week?

6. Is your child currently using overnight pants or diapers?

7. Is your child willing to use their usual and/or supplied overnight pant products every night for the duration of the study?

8. Are you and your child willing to refrain from using wet wipes in the pant area for the duration of the clinical trial?

9. Are you willing to refrain from enrolling your child in other clinical or consumer studies for the duration of this clinical trial?

10. 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?

11. Are you and your child willing and able to comply with all study instructions?

12. 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:

1. Does your child have any acute or chronic skin conditions (excluding skin rash) in or around the pant area?

2. Does your child currently have (or have a history of) any significant illness or chronic medical condition?

3. Is your child currently using any medications?

4. Does your child currently wear absorbent products during the day?

5. 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?

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Device:
• Ninjamas Pyjama Pants
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.

Other:
• Participant's Overnight Current Standard of Care
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.

Locations

Country	Name	City	State
United States	North Cliff Consultants	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number, Frequency and Severity of Product Related Adverse Events	Daily parent reported Adverse Events captured in diary.	From admission to discharge, up to 6 weeks
Secondary	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.	From admission to discharge, up to 6 weeks