Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DryNites arm 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
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.
|
| No Intervention: No Pants arm 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. |
Outcome Measures
Primary Outcome Measures
- Wet nights [Last week of the 4-week intervention period]
Average number of wet nights
Secondary Outcome Measures
- Impact of urinary incontinence on emotional wellbeing of child as assessed by PinQ survey [Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])]
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.
- Impact of child nighttime enuresis on parent/carer quality of life as assessed by the WHOQoL-BREF Questionnaire [Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])]
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.
- Child daytime sleepiness as assessed by PDSS Questionnaire [Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])]
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.
- Parent/Carer fatigue as assessed by CIS Questionnaire [Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient aged between 4-8 years at the time of enrollment
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Have a clinical diagnosis of monosymptomatic primary NE
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Have been dry in the day for >/= 6 months prior to enrollment
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Have on average no more than 1 dry night per month during the past 6 months at enrollment
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Have an informed consent signed by the their parent(s)/carer(s)
Exclusion Criteria:
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Children in foster/court care
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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
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Have secondary NE
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Have wetting in the day
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Have faecal soiling
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Have known urinary tract disease
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Have diabetes
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Receive any regular intake of medication
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Have a known developmental/neurological disorder
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Have links to Kimberly-Clark of any kind (including family relations employed by Kimberly-Clark, holding stocks or share in Kimberly-Clark)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aalborg Universitetshospital, Borne og Ungeafdelingen | Aalborg | Connor Downs | United Kingdom | 9000 |
| 2 | Aarhus Universitetshospital, Center for Borneinkontinens | Arhus N | Connor Downs | United Kingdom | 8200 |
| 3 | UZ Gent | Ghent | Connor Downs | United Kingdom | 9000 |
| 4 | Mounts Bay Medical | Connor Downs | United Kingdom | TR27 5DT | |
| 5 | Essex Partnership University NHS Foundation Trust | Essex | United Kingdom | SS4 1RB | |
| 6 | Siddarth Marnekar | Hull | United Kingdom | HU12 8JD |
Sponsors and Collaborators
- Kimberly-Clark Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KCC-DN-001