Clinical trial NCT04620356: Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
Official title: Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nocturnal Enuresis
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-09
Enrollment: 105
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Children with severe monosymptomatic NE between 4 and 8 years of age were recruited from study centers in Denmark, Belgium, and the UK. All participants had used absorbents pandt of any manufacturer for at least the previous 6 months. Participants fulfilling the inclusion criteria entered a 4-week run-in period during which they slept wearing the intervention absorbent pant. To be eligible for randomization, participants needed to have 7/7 wet nights in the last week of the run-in period. Eligible participants were then randomly assigned (2:1) to either discontinuation or continuation of absorbent pants for the 4-week core intervention period. The children sleeping without absorbent pants were permitted to sleep with an absorbent bed mat instead. No behavioral changes such as fluid restriction or lifting the child to the toilet when the parents went to bed were allowed in either group. After completing the core intervention period, participants were invited to take part in a 4-week extension period, during which they would remain on their randomly assigned treatment. Number of wet nights were assesed during the study using an electronic diary. Quality- of- life (QoL) and sleep parameters were assessed using the following validated questionnaires: Paediatric Incontinence Questionnaire (PinQ), World Health Organization Quality of Life Brief Version Paediatric Daytime Sleepiness Scale (PDSS), and Checklist Individual Strength. Questionnaires were completed jointly by children and parents.

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)

Primary outcomes:
measure: Wet Nights
timeFrame: Last week of the 4-week intervention period
Secondary outcomes:
measure: Impact of Urinary Incontinence on Emotional Wellbeing of Child as Assessed by Paediatric Incontinence Questionnaire (PinQ)
timeFrame: Assessment will be done at each study clinic visit (Day 56 +/- 7)
measure: Impact of Child Nighttime Enuresis on Parent/Carer Quality of Life as Assessed by the WHOQoL-BREF Questionnaire
timeFrame: Assessment will be done at each study clinic visit (Day 56 +/- 7)
measure: Child Daytime Sleepiness as Assessed by PDSS Questionnaire
timeFrame: Assessment will be done at each study clinic visit (Day 56 +/- 7)
measure: Parent/Carer Fatigue as Assessed by Checklist Individual Strength (CIS Questionnaire)
timeFrame: Assessment will be done at each study clinic visit (Day 56 +/- 7 )
Other outcomes:
Locations:
city: Connor
country: United Kingdom
facility: Mounts Bay Medical
state: Haley
city: Hull
country: United Kingdom
facility: Siddarth Marnekar
Study officials:
affiliation: Department of Pediatrics, Aarhus University Hospital, Aarhus, Denmark
name: Søren Riting
role: PRINCIPAL_INVESTIGATOR
References: