Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)

Study Overview
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Brief Summary
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Children vary in the age at which they achieve night-time dryness; in almost all cases children will stop bed-wetting without any need for treatment. Use of absorbent pants for the management of nocturnal enuresis is controversial regarding the impact on the speed at which children become dry throughout the night. The aim of this study is to determine the effect of using DryNites absorbent pants in children with monosymptomatic nocturnal enuresis on the speed they become dry throughout the night compared with removing absorbent pants.

Official Title
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Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)

Conditions
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Nocturnal Enuresis

Intervention / Treatment
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* Device: DryNites Pyjama Pants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged between 4-8 years at the time of enrollment Have a clinical diagnosis of monosymptomatic primary NE Have been dry in the day for >/= 6 months prior to enrollment Have on average no more than 1 dry night per month during the past 6 months at enrollment Have an informed consent signed by the their parent(s)/carer(s) Exclusion Criteria: Children in foster/court care Have implemented any previous intervention to address NE (use of prescribed alarm schedule, desmopressin, imipramine, anticholinergics) or withdrawal of pants/nappies for > 7 days in the previous 6 months Have secondary NE Have wetting in the day Have faecal soiling Have known urinary tract disease Have diabetes Receive any regular intake of medication Have a known developmental/neurological disorder Have links to Kimberly-Clark of any kind (including family relations employed by Kimberly-Clark, holding stocks or share in Kimberly-Clark)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DryNites arm<br>Participants in this arm use DryNites every night for 4 weeks (run-in period), an additional 4 weeks (intervention core trial period), and an optional additional 4 weeks (extension period). All participants in this arm also receive absorbent bad mats to use every night. | Device: DryNites Pyjama Pants<br>* DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.<br>|
| No Intervention: No Pants arm<br>Participants in this arm use DryNites every night for 4 weeks only during the initial run-in period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention core trial period or the optional additional 4 weeks extension period. All participants in this arm also receive absorbent bad mats to use every night. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet nights | Average number of wet nights | Last week of the 4-week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of urinary incontinence on emotional wellbeing of child as assessed by PinQ survey | The Paediatric Incontinence Questionnaire (PinQ) measures the emotional impact of urinary incontinence in children with bladder dysfunction. It is comprised of 20 urinary incontinence quality of life questions and rated on a 5-point scale with 0 = No and 4 = All the time. The questionnaire will be completed by the child themselves (with attendance of an adult) in the older participant group and by the parent/carer on behalf of the child in the younger participant group. Higher scores indicate greater emotional impact of urinary incontinence on the child's quality of life. | Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional]) | 
| Impact of child nighttime enuresis on parent/carer quality of life as assessed by the WHOQoL-BREF Questionnaire | The World Health Organization Quality of Life Brief Version (WHOQoL-BREF) questionnaire measures an individual's perceptions of well-being in the context of their culture and value systems and their personal goals, standards and concerns. It is comprised of 26 items grouped into four domains (physical health, psychological, social relationships, and environment) along with 2 separate items asking the respondent about overall perception of quality of life and the individual's overall perception of their health. Each question is rated on a 5-point scale with 1 corresponding to the most negative response and 5 corresponding to the most positive response. Higher scores indicate a higher quality of life. | Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional]) | 
| Child daytime sleepiness as assessed by PDSS Questionnaire | The Paeditric Daytime Sleepiness Scale (PDSS) questionnaire measures daytime sleepiness in children. It is comprised of 8 items assessing daytime sleepiness and rated on a 5-point scale with 0 = Never and 4 = Always/Very Often. The questionnaire will be completed by the child themselves (with attendance of an adult) in the older participant group and by the parent/carer on behalf of the child in the younger participant group. Higher scores indicate greater daytime sleepiness. | Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional]) | 
| Parent/Carer fatigue as assessed by CIS Questionnaire | The Checklist Individual Strength (CIS) questionnaire measures fatigue-related problems. It is compromised of 20 statements on fatigue-related problems respondents might have experienced in the past two weeks, and respondents indicate on a 7-point scale to what extent the particular statement applies to him or her. The CIS measures four dimensions of fatigue (fatigue severity, concentration problems, reduced motivation, and activity). A CIS total score is calculated by adding the 4 dimensions, and higher scores indicate greater fatigue. | Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional]) |