An interventional study of Ninjamas Pyjama Pants and Participant's Overnight Current Standard of Care in Nocturnal Enuresis, sponsored by Procter and Gamble. Completed at 1 site in United States. Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Procter and Gamble · Not applicable, Interventional, and Other
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.
104 studies on the registry are indexed under Nocturnal Enuresis; 22 are open to participants now.
This study's enrollment of 32 is below the median of 68 across 76 interventional studies indexed under Nocturnal Enuresis.
Browse Nocturnal Enuresis studies →Procter and Gamble is the lead sponsor of 83 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible for enrollment if the parent/legal guardian responds positively ("Yes") to the following questions:
Exclusion Criteria:
Participants are ineligible for enrollment if the parent/legal guardian responds positively ("Yes") to any of the following questions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Other: Participant's Overnight Current Standard of Care
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 · Other: Participant's Overnight Current Standard of Care
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.
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.
Number, Frequency and Severity of Product Related Adverse Events
Adverse Device Effect and Adverse Event tracking twice daily via a safety in-use diary.
Time frame: From admission to discharge, up to 6 weeks
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".
Time frame: From admission to discharge, up to 6 weeks
Recruitment and enrollment was done by a Clinical Research site, North Cliff Consultants, Inc. in the Cincinnati, Ohio area.
| Milestone | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant |
|---|---|---|
| Started | 16 | 16 |
| Completed | 12 | 14 |
| Not completed | 4 | 2 |
| Withdrew: Protocol violation | 4 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant |
|---|---|---|
| Started | 12 | 14 |
| Completed | 12 | 14 |
| Not completed | 0 | 0 |
Adverse Device Effect and Adverse Event tracking twice daily via a safety in-use diary.
| Number of product related Adverse Events | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| Diaper Dermatitis | 47 | 63 | 110 |
| Pruritus in diaper area | 5 | 4 | 9 |
| Feeling of heat in crotch area | 1 | 2 | 3 |
| Serious Adverse Events | 0 | 0 | 0 |
| Product related Adverse Events with causality assessed by PI as doubtful | 47 | 63 | 110 |
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".
| Number of pants with reported leaks | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| Treatment Effect of Ninjamas Pyjama Pant | 2 | 0 | 2 |
| Treatment Effect of Participant's Overnight Current Standard of Care | 8 | 3 | 11 |
| Treatment effect of both periods combined | 10 | 3 | 13 |
Collected over 6 weeks (Jan 13th - Feb 28, 2022). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | 0/16 (0%) | 0/16 (0%) | 12/16 (75%) |
| Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | 0/16 (0%) | 0/16 (0%) | 14/16 (87.5%) |
| Ninjamas Pyjama Pant | 0/30 (0%) | 0/30 (0%) | 21/30 (70%) |
| Participant's Overnight Current Standard of Care | 0/28 (0%) | 0/28 (0%) | 19/28 (67.9%) |
| Event | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Ninjamas Pyjama Pant | Participant's Overnight Current Standard of Care |
|---|---|---|---|---|
| Dermatitis diaperSkin and subcutaneous tissue disorders | 11/16 | 11/16 | 17/30 | 16/28 |
| PruritusSkin and subcutaneous tissue disorders | 5/16 | 4/16 | 6/30 | 6/28 |
| VomitingGastrointestinal disorders | 1/16 | 3/16 | 1/30 | 3/28 |
| DiarrhoeaGastrointestinal disorders | 2/16 | 2/16 | 2/30 | 2/28 |
| Feeling hotSkin and subcutaneous tissue disorders | 1/16 | 2/16 | 1/30 | 2/28 |
| Ear InfectionEar and labyrinth disorders | 1/16 | 0/16 | 0/30 | 1/28 |
| Covid-19Respiratory, thoracic and mediastinal disorders | 0/16 | 1/16 | 0/30 | 1/28 |
| Tooth AbscessInfections and infestations | 0/16 | 1/16 | 1/30 | 0/28 |
| Nasal CongestionRespiratory, thoracic and mediastinal disorders | 1/16 | 0/16 | 0/30 | 1/28 |
| PyrexiaGeneral disorders | 1/16 | 1/16 | 1/30 | 1/28 |
| Age, Categorical(Participants) | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| <=18 years | 16 | 16 | 32 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 9 | 8 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 14 | 16 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 9 | 14 | 23 |
| More than one race | 3 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| United States | 16 | 16 | 32 |
| Height(Inches) | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| Mean | 44.5 (42 to 48) | 45.1 (40 to 51) | 44.8 (40 to 51) |
| Weight(LBS) | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| Mean | 44.9 (37.4 to 56) | 45.0 (34 to 61.6) | 45.0 (34 to 61.6) |
| Fitzpatrick Skin Type(Participants) | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| Fitzpatrick I | 0 | 0 | 0 |
| Fitzpatrick II | 1 | 5 | 6 |
| Fitzpatrick III | 7 | 7 | 14 |
| Fitzpatrick IV | 5 | 2 | 7 |
| Fitzpatrick V | 3 | 1 | 4 |
| Fitzpatrick VI | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2022 to primary completion in Feb 2022, 1 month.
Results were first posted in Oct 2024, 2 years 7 months after primary completion.
Of 40 interventional studies with no phase under Nocturnal Enuresis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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