Overnight Pant Study for Children With Nocturnal Enuresis

NCT05178641 | Completed Results

• 1 other identifier: CSD2021096
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturnal Enuresis

Outcome Measures

Primary Outcomes (1)

• Number, Frequency and Severity of Product Related Adverse Events

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

  From admission to discharge, up to 6 weeks

Secondary Outcomes (1)

• Parent Assessed Product Performance in Terms of Urine Leaking

  From admission to discharge, up to 6 weeks

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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?

You may not qualify if:

• 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?

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

North Cliff Consultants

Cincinnati, Ohio, 45239, United States

Location

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Susanna Brink, Clinical Scientist
• Organization: Procter & Gamble Co.

brink.s@pg.com

+49 6196 89 4474

Study Officials

• Laura Huesing-Wray

  North Cliff Consultants

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 5, 2022
• Study Start: January 13, 2022
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)