CompletedNot Applicable

Overnight Pant Study for Children With Nocturnal Enuresis

United States32 participantsStarted 2022-01-13

Plain-language 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.

Who can participate

Age range4 Years – 7 Years

SexALL

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Inclusion criteria

✓. 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?

Exclusion criteria

✕. 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?

What they're measuring

Number, Frequency and Severity of Product Related Adverse Events

Timeframe: From admission to discharge, up to 6 weeks

Trial details

NCT IDNCT05178641

SponsorProcter and Gamble

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-28

Results submitted2023-02-23

View on ClinicalTrials.gov More Nocturnal Enuresis trials