Overnight Pant Study for Children With Nocturnal Enuresis

NCT ID: NCT05178641

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-13
• Study Completion Date: 2022-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ninjamas Pyjama Pants

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Ninjamas Pyjama Pants

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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?

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Huesing-Wray

Role: PRINCIPAL_INVESTIGATOR

North Cliff Consultants

Locations

North Cliff Consultants

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CSD2021096

Identifier Type: -

Identifier Source: org_study_id