Trial Outcomes & Findings for Overnight Pant Study for Children With Nocturnal Enuresis (NCT NCT05178641)

NCT ID: NCT05178641

Last Updated: 2024-10-01

Results Overview

Adverse Device Effect and Adverse Event tracking twice daily via a safety in-use diary.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: From admission to discharge, up to 6 weeks
• Results posted on: 2024-10-01

Participant Flow

Recruitment and enrollment was done by a Clinical Research site, North Cliff Consultants, Inc. in the Cincinnati, Ohio area.

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.

Participant milestones

Measure	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.	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.
First 3 Weeks of Study (Week 1-3) STARTED	16	16
First 3 Weeks of Study (Week 1-3) COMPLETED	12	14
First 3 Weeks of Study (Week 1-3) NOT COMPLETED	4	2
Last 3 Weeks of Study (Week 3-6) STARTED	12	14
Last 3 Weeks of Study (Week 3-6) COMPLETED	12	14
Last 3 Weeks of Study (Week 3-6) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	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.	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.
First 3 Weeks of Study (Week 1-3) Protocol Violation	4	1
First 3 Weeks of Study (Week 1-3) Withdrawal by Subject	0	1

Baseline Characteristics

Overnight Pant Study for Children With Nocturnal Enuresis

Baseline characteristics by cohort

Measure	Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care n=16 Participants 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.	Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant n=16 Participants 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.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
Height	44.5 Inches n=5 Participants	45.1 Inches n=7 Participants	44.8 Inches n=5 Participants
Weight	44.9 LBS n=5 Participants	45.0 LBS n=7 Participants	45.0 LBS n=5 Participants
Fitzpatrick Skin Type Fitzpatrick I	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick II	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick III	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick IV	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick V	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick VI	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From admission to discharge, up to 6 weeks

Adverse Device Effect and Adverse Event tracking twice daily via a safety in-use diary.

Outcome measures

Measure	Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care n=16 Participants 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.	Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant n=16 Participants 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.	Total n=32 Participants All participants who participated in the study
Number, Frequency and Severity of Product Related Adverse Events Diaper Dermatitis	47 Number of product related Adverse Events	63 Number of product related Adverse Events	110 Number of product related Adverse Events
Number, Frequency and Severity of Product Related Adverse Events Pruritus in diaper area	5 Number of product related Adverse Events	4 Number of product related Adverse Events	9 Number of product related Adverse Events
Number, Frequency and Severity of Product Related Adverse Events Feeling of heat in crotch area	1 Number of product related Adverse Events	2 Number of product related Adverse Events	3 Number of product related Adverse Events
Number, Frequency and Severity of Product Related Adverse Events Serious Adverse Events	0 Number of product related Adverse Events	0 Number of product related Adverse Events	0 Number of product related Adverse Events
Number, Frequency and Severity of Product Related Adverse Events Product related Adverse Events with causality assessed by PI as doubtful	47 Number of product related Adverse Events	63 Number of product related Adverse Events	110 Number of product related Adverse Events

SECONDARY outcome

Timeframe: From admission to discharge, up to 6 weeks

Population: 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).

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".

Outcome measures

Measure	Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care n=369 Number of pants with a urine load 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.	Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant n=395 Number of pants with a urine load 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.	Total n=764 Number of pants with a urine load All participants who participated in the study
Parent Assessed Product Performance in Terms of Urine Leaking Treatment Effect of Participant's Overnight Current Standard of Care	8 Number of pants with reported leaks	3 Number of pants with reported leaks	11 Number of pants with reported leaks
Parent Assessed Product Performance in Terms of Urine Leaking Treatment Effect of Ninjamas Pyjama Pant	2 Number of pants with reported leaks	0 Number of pants with reported leaks	2 Number of pants with reported leaks
Parent Assessed Product Performance in Terms of Urine Leaking Treatment effect of both periods combined	10 Number of pants with reported leaks	3 Number of pants with reported leaks	13 Number of pants with reported leaks

Adverse Events

Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Ninjamas Pyjama Pant

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Participant's Overnight Current Standard of Care

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care n=16 participants at risk 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.	Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant n=16 participants at risk 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.	Ninjamas Pyjama Pant n=30 participants at risk 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.	Participant's Overnight Current Standard of Care n=28 participants at risk 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.
Skin and subcutaneous tissue disorders Dermatitis diaper	68.8% 11/16 • 6 weeks (Jan 13th - Feb 28, 2022)	68.8% 11/16 • 6 weeks (Jan 13th - Feb 28, 2022)	56.7% 17/30 • 6 weeks (Jan 13th - Feb 28, 2022)	57.1% 16/28 • 6 weeks (Jan 13th - Feb 28, 2022)
Skin and subcutaneous tissue disorders Pruritus	31.2% 5/16 • 6 weeks (Jan 13th - Feb 28, 2022)	25.0% 4/16 • 6 weeks (Jan 13th - Feb 28, 2022)	20.0% 6/30 • 6 weeks (Jan 13th - Feb 28, 2022)	21.4% 6/28 • 6 weeks (Jan 13th - Feb 28, 2022)
Gastrointestinal disorders Vomiting	6.2% 1/16 • 6 weeks (Jan 13th - Feb 28, 2022)	18.8% 3/16 • 6 weeks (Jan 13th - Feb 28, 2022)	3.3% 1/30 • 6 weeks (Jan 13th - Feb 28, 2022)	10.7% 3/28 • 6 weeks (Jan 13th - Feb 28, 2022)
Gastrointestinal disorders Diarrhoea	12.5% 2/16 • 6 weeks (Jan 13th - Feb 28, 2022)	12.5% 2/16 • 6 weeks (Jan 13th - Feb 28, 2022)	6.7% 2/30 • 6 weeks (Jan 13th - Feb 28, 2022)	7.1% 2/28 • 6 weeks (Jan 13th - Feb 28, 2022)
Ear and labyrinth disorders Ear Infection	6.2% 1/16 • 6 weeks (Jan 13th - Feb 28, 2022)	0.00% 0/16 • 6 weeks (Jan 13th - Feb 28, 2022)	0.00% 0/30 • 6 weeks (Jan 13th - Feb 28, 2022)	3.6% 1/28 • 6 weeks (Jan 13th - Feb 28, 2022)
Respiratory, thoracic and mediastinal disorders Covid-19	0.00% 0/16 • 6 weeks (Jan 13th - Feb 28, 2022)	6.2% 1/16 • 6 weeks (Jan 13th - Feb 28, 2022)	0.00% 0/30 • 6 weeks (Jan 13th - Feb 28, 2022)	3.6% 1/28 • 6 weeks (Jan 13th - Feb 28, 2022)
Infections and infestations Tooth Abscess	0.00% 0/16 • 6 weeks (Jan 13th - Feb 28, 2022)	6.2% 1/16 • 6 weeks (Jan 13th - Feb 28, 2022)	3.3% 1/30 • 6 weeks (Jan 13th - Feb 28, 2022)	0.00% 0/28 • 6 weeks (Jan 13th - Feb 28, 2022)
Respiratory, thoracic and mediastinal disorders Nasal Congestion	6.2% 1/16 • 6 weeks (Jan 13th - Feb 28, 2022)	0.00% 0/16 • 6 weeks (Jan 13th - Feb 28, 2022)	0.00% 0/30 • 6 weeks (Jan 13th - Feb 28, 2022)	3.6% 1/28 • 6 weeks (Jan 13th - Feb 28, 2022)
Skin and subcutaneous tissue disorders Feeling hot	6.2% 1/16 • 6 weeks (Jan 13th - Feb 28, 2022)	12.5% 2/16 • 6 weeks (Jan 13th - Feb 28, 2022)	3.3% 1/30 • 6 weeks (Jan 13th - Feb 28, 2022)	7.1% 2/28 • 6 weeks (Jan 13th - Feb 28, 2022)
General disorders Pyrexia	6.2% 1/16 • 6 weeks (Jan 13th - Feb 28, 2022)	6.2% 1/16 • 6 weeks (Jan 13th - Feb 28, 2022)	3.3% 1/30 • 6 weeks (Jan 13th - Feb 28, 2022)	3.6% 1/28 • 6 weeks (Jan 13th - Feb 28, 2022)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/16 • 6 weeks (Jan 13th - Feb 28, 2022)	6.2% 1/16 • 6 weeks (Jan 13th - Feb 28, 2022)	3.3% 1/30 • 6 weeks (Jan 13th - Feb 28, 2022)	0.00% 0/28 • 6 weeks (Jan 13th - Feb 28, 2022)

Additional Information

Dr. Susanna Brink, Clinical Scientist

Procter & Gamble Co.

Phone: +49 6196 89 4474

Email: brink.s@pg.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60