N/A
N=105
Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
Nocturnal Enuresis
Bottom Line
View on ClinicalTrials.gov: NCT04620356 ↗Enrolled (actual)
105
Serious AEs
1.0%
Results posted
Dec 2024
Primary outcome: Primary: Wet Nights — 2.4; 4.6 wet nights per week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DryNites Pyjama Pants (Device)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Kimberly-Clark Corporation
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wet Nights |
2.4; 4.6 | — |
| SECONDARY Impact of Urinary Incontinence on Emotional Wellbeing of Child as Assessed by Paediatric Incontinence Questionnaire (PinQ) |
12.9; 15.2 | — |
| SECONDARY Impact of Child Nighttime Enuresis on Parent/Carer Quality of Life as Assessed by the WHOQoL-BREF Questionnaire |
21.3; 21.5 | — |
| SECONDARY Child Daytime Sleepiness as Assessed by PDSS Questionnaire |
7.7; 8.5 | — |
| SECONDARY Parent/Carer Fatigue as Assessed by Checklist Individual Strength (CIS Questionnaire) |
43.7; 46.1 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04620356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.