Nocturnal Enuresis
Conditions
Brief 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.
Interventions
DEVICENinjamas 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.
OTHERParticipant'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.
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes
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?
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number, Frequency and Severity of Product Related Adverse Events | From admission to discharge, up to 6 weeks | Adverse Device Effect and Adverse Event tracking twice daily via a safety in-use diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Assessed Product Performance in Terms of Urine Leaking | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment and enrollment was done by a Clinical Research site, North Cliff Consultants, Inc. in the Cincinnati, Ohio area.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 16 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick I | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick II | 1 Participants | 5 Participants | 6 Participants |
| Fitzpatrick Skin Type Fitzpatrick III | 7 Participants | 7 Participants | 14 Participants |
| Fitzpatrick Skin Type Fitzpatrick IV | 5 Participants | 2 Participants | 7 Participants |
| Fitzpatrick Skin Type Fitzpatrick V | 3 Participants | 1 Participants | 4 Participants |
| Fitzpatrick Skin Type Fitzpatrick VI | 0 Participants | 1 Participants | 1 Participants |
| Height | 44.5 Inches | 45.1 Inches | 44.8 Inches |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 14 Participants | 23 Participants |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
| Weight | 44.9 LBS | 45.0 LBS | 45.0 LBS |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 30 | 0 / 28 |
| other Total, other adverse events | 12 / 16 | 14 / 16 | 21 / 30 | 19 / 28 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 30 | 0 / 28 |
Outcome results
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.
Time frame: From admission to discharge, up to 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Number, Frequency and Severity of Product Related Adverse Events | Serious Adverse Events | 0 Number of product related Adverse Events |
| Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Number, Frequency and Severity of Product Related Adverse Events | Feeling of heat in crotch area | 1 Number of product related Adverse Events |
| Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Number, Frequency and Severity of Product Related Adverse Events | Diaper Dermatitis | 47 Number of product related Adverse Events |
| Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Number, Frequency and Severity of Product Related Adverse Events | Pruritus in diaper area | 5 Number of product related Adverse Events |
| Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | 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 |
| Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Number, Frequency and Severity of Product Related Adverse Events | Feeling of heat in crotch area | 2 Number of product related Adverse Events |
| Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Number, Frequency and Severity of Product Related Adverse Events | Diaper Dermatitis | 63 Number of product related Adverse Events |
| Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Number, Frequency and Severity of Product Related Adverse Events | Pruritus in diaper area | 4 Number of product related Adverse Events |
| Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Number, Frequency and Severity of Product Related Adverse Events | Serious Adverse Events | 0 Number of product related Adverse Events |
| Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Number, Frequency and Severity of Product Related Adverse Events | Product related Adverse Events with causality assessed by PI as doubtful | 63 Number of product related Adverse Events |
| Total | Number, Frequency and Severity of Product Related Adverse Events | Product related Adverse Events with causality assessed by PI as doubtful | 110 Number of product related Adverse Events |
| Total | Number, Frequency and Severity of Product Related Adverse Events | Serious Adverse Events | 0 Number of product related Adverse Events |
| Total | Number, Frequency and Severity of Product Related Adverse Events | Diaper Dermatitis | 110 Number of product related Adverse Events |
| Total | Number, Frequency and Severity of Product Related Adverse Events | Feeling of heat in crotch area | 3 Number of product related Adverse Events |
| Total | Number, Frequency and Severity of Product Related Adverse Events | Pruritus in diaper area | 9 Number of product related Adverse Events |
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | 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 |
| Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Parent Assessed Product Performance in Terms of Urine Leaking | Treatment Effect of Ninjamas Pyjama Pant | 2 Number of pants with reported leaks |
| Ninjamas Pyjama Pant, Then Participant's Overnight Current Standard of Care | Parent Assessed Product Performance in Terms of Urine Leaking | Treatment effect of both periods combined | 10 Number of pants with reported leaks |
| Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Parent Assessed Product Performance in Terms of Urine Leaking | Treatment Effect of Participant's Overnight Current Standard of Care | 3 Number of pants with reported leaks |
| Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Parent Assessed Product Performance in Terms of Urine Leaking | Treatment Effect of Ninjamas Pyjama Pant | 0 Number of pants with reported leaks |
| Participant's Overnight Current Standard of Care, Then Ninjamas Pyjama Pant | Parent Assessed Product Performance in Terms of Urine Leaking | Treatment effect of both periods combined | 3 Number of pants with reported leaks |
| Total | Parent Assessed Product Performance in Terms of Urine Leaking | Treatment Effect of Ninjamas Pyjama Pant | 2 Number of pants with reported leaks |
| Total | Parent Assessed Product Performance in Terms of Urine Leaking | Treatment effect of both periods combined | 13 Number of pants with reported leaks |
| Total | Parent Assessed Product Performance in Terms of Urine Leaking | Treatment Effect of Participant's Overnight Current Standard of Care | 11 Number of pants with reported leaks |