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Completed

NCT Number: NCT05178641

Overnight Pant Study for Children With Nocturnal Enuresis

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.

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Key information

Conditions

Nocturnal Enuresis Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Mental Disorders Urination Disorders Urogenital Diseases Urologic Diseases

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Cliff Consultants

Cincinnati, Ohio, 45239, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Ninjamas Pyjama Pants

Device

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.

Participant's Overnight Current Standard of Care

Other

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 outcomes

  1. Number, Frequency and Severity of Product Related Adverse Events

    Time frame: From admission to discharge, up to 6 weeks

    Adverse Device Effect and Adverse Event tracking twice daily via a safety in-use diary.

Secondary outcomes

  1. Parent Assessed Product Performance in Terms of Urine Leaking

    Time frame: From admission to discharge, up to 6 weeks

    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. Only participants who completed both periods and had at least one overnight pant per period with a urine load were included in this analysis. An overnight pant was considered urine loaded when the overall pant weight exceeded 1.1 ounce (oz). The number of leaks for each treatment option was calculated as number of leakage observations answered with "yes".

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2022
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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