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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number, Frequency and Severity of Product Related Adverse Events | Adverse Device Effect and Adverse Event tracking twice daily via a safety in-use diary. | From admission to discharge, up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Huesing-Wray | North Cliff Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Cliff Consultants | Cincinnati | Ohio | 45239 | United States |
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Participants were given 4 days practice time to get used to the study procedures (Jan 13th - Jan 16th), before the first period started on Jan 17th.
Recruitment and enrollment was done by a Clinical Research site, North Cliff Consultants, Inc. in the Cincinnati, Ohio area.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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. |
| FG001 | 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 3 Weeks of Study (Week 1-3) |
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| Last 3 Weeks of Study (Week 3-6) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number, Frequency and Severity of Product Related Adverse Events | Adverse Device Effect and Adverse Event tracking twice daily via a safety in-use diary. | Posted | Number | Number of product related Adverse Events | From admission to discharge, up to 6 weeks |
|
6 weeks (Jan 13th - Feb 28, 2022)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susanna Brink, Clinical Scientist | Procter & Gamble Co. | +49 6196 89 4474 | brink.s@pg.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2021 | Feb 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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. |
|
| From admission to discharge, up to 6 weeks |
| NOT COMPLETED |
|
| BG001 | 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. 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Full Range | Inches |
|
| Weight | Mean | Full Range | LBS |
|
| Fitzpatrick Skin Type | The Fitzpatrick skin type is a numerical classification schema for human skin color ranging from I (fair skin) to IV (dark skin). | Count of Participants | Participants |
|
| OG001 | 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. 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. 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. |
| OG002 | Total | All participants who participated in the study |
|
|
| Secondary | 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". | 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 loaded when the overall pant weight exceeded 1.1 ounce (oz). | Posted | Number | Number of pants with reported leaks | From admission to discharge, up to 6 weeks | Number of pants with a urine load | Number of pants with a urine load |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 12 |
| 16 |
| EG001 | 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. 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. 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. | 0 | 16 | 0 | 16 | 14 | 16 |
| EG002 | Ninjamas Pyjama Pant | For either the first 3 weeks of the study or the last 3 weeks of the study participants used Ninjamas Pyjama Pants, depending on randomization. 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. | 0 | 30 | 0 | 30 | 21 | 30 |
| EG003 | Participant's Overnight Current Standard of Care | For either the first 3 weeks of the study or the last 3 weeks of the study participants used their Overnight Current Standard of Care. 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. | 0 | 28 | 0 | 28 | 19 | 28 |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment | Localized itching in diaper area |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Ear Infection | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
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| Covid-19 | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Tooth Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Feeling hot | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment | Sensation of heat in crotch area |
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| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment | Fever |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment | Allergy with cold symptoms |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
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| Treatment Effect of Participant's Overnight Current Standard of Care |
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| Treatment effect of both periods combined |
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