Overnight Pant Study for Children With Nocturnal Enuresis

Overnight Pant Safety-in-use Diary Clinical Trial 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.

Study Overview

• Status: Completed
• Conditions: Nocturnal Enuresis
• Intervention / Treatment: Device: Ninjamas Pyjama Pants; Other: Participant's Overnight Current Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45239
      • North Cliff Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care; 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; 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.
Experimental: Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Investigators: Principal Investigator: Laura Huesing-Wray, North Cliff Consultants

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Nocturnal Enuresis
• Other Study ID Numbers: CSD2021096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No