Overnight Pant Study for Children With Nocturnal Enuresis

• 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

• Number, Frequency and Severity of Product Related Adverse Events [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

• Parent Assessed Product Performance in Terms of Urine Leaking [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".

Sex: All, ages: 4 Years to 7 Years, 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?

Participant flow

Outcome results

• Number, Frequency and Severity of Product Related Adverse Events (Primary), Number, Number of product related Adverse Events: Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care 47; Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant 63; Total 110
• Parent Assessed Product Performance in Terms of Urine Leaking (Secondary), Number, Number of pants with reported leaks: Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care 2; Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant 0; Total 2

Adverse events

Time frame: 6 weeks (Jan 13th - Feb 28, 2022)

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2021-12-13)

• Laura Huesing-Wray, Principal investigator, North Cliff Consultants