Nocturnal EnuresisNCT05178641
Overnight Pant Study for Children With Nocturnal Enuresis
A study testing Ninjamas Pyjama Pants in people with Nocturnal Enuresis, run by Procter and Gamble at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- Ninjamas Pyjama Pants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2022to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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?
Show all 13Show fewer
- 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?
Who cannot join
- 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?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Nocturnal Enuresis
- Being tested
- Ninjamas Pyjama Pants, Participant's Overnight Current Standard of Care
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ninjamas Pyjama PantsDevice
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Ninjamas Pyjama Pants; Other: Participant's Overnight Current Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, Frequency and Severity of Product Related Adverse Events
Adverse Device Effect and Adverse Event tracking twice daily via a safety in-use diary.
Measured: From admission to discharge, up to 6 weeks
Secondary outcomes (1)
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. 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".
Measured: From admission to discharge, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start13 Jan 2022
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Huesing-Wray, Principal investigator, North Cliff Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178641
- Sponsor's protocol ID
- CSD2021096
- Status last verified
- Jun 2024
- First submitted
- 15 Dec 2021
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Pant Safety-in-use Diary Clinical Trial for Children With Nocturnal Enuresis
- ClinicalTrials.gov ID
- NCT05178641
- Acronym / sponsor ID
- CSD2021096
- Conditions
- Nocturnal Enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Experimental | Device: Ninjamas Pyjama Pants, Other: Participant's Overnight Current Standard of CareFor the first 3 weeks participants use Ninjamas Pyjama Pants, then for the next 3 weeks they switch to the Overnight Current Standard of Care. |
| Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Experimental | Device: Ninjamas Pyjama Pants, Other: Participant's Overnight Current Standard of CareFor the first 3 weeks participants use their Overnight Current Standard of Care, then for the next 3 weeks they switch to Ninjamas Pyjama Pants. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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?
Key exclusion criteria (6 listed)
- 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?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ninjamas Pyjama PantsDisposable, 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. | Device | 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 CareAny 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. | Other | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care, Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant |
Primary outcome
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.
1 secondary outcome
Parent Assessed Product Performance in Terms of Urine Leaking
Time frame: From admission to discharge, up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Nocturnal Enuresis
Recruiting
Effectiveness of Individualized Pelvic Floor Muscle Rehabilitation in Addition to Standard Urotherapy and Alarm Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis
Primary Monosymptomatic Nocturnal Enuresis
Active, not recruitingPhase 3
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
Stress Urinary Incontinence
Not yet recruiting
Potential Adjuvant Therapies for Children With Primary Nocturnal Enuresis
Nocturnal Enuresis in Children, Primary Nocturnal Enuresis
Active, not recruitingPhase 3
Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children
Treatment of Non-monosymptomatic Nocturnal Enuresis
Recruiting
Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
Urinary Incontinence, Urinary Incontinence,Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Huesing-Wray principal investigator
North Cliff Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ninjamas Pyjama Pants in people with Nocturnal Enuresis, run by Procter and Gamble at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number, Frequency and Severity of Product Related Adverse Events (time frame: From admission to discharge, up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.