Overnight Pant Study for Children With Nocturnal Enuresis

June 24, 2024 updated by: Procter and Gamble

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 months to 3 years (Child)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From admission to discharge, up to 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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".
From admission to discharge, up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Procter and Gamble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura Huesing-Wray, North Cliff Consultants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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