Overnight Pant Study for Children With Nocturnal Enuresis

Procter & Gamble (P&G)

Status: Completed

Conditions: Nocturnal Enuresis

Treatments: Device: Ninjamas Pyjama Pants; Other: Participant's Overnight Current Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05178641

CSD2021096

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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?

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care

Experimental group

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.

Treatment:

Other: Participant's Overnight Current Standard of Care

Device: Ninjamas Pyjama Pants

Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant

Experimental group

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.

Treatment:

Other: Participant's Overnight Current Standard of Care

Device: Ninjamas Pyjama Pants