NCT04620356

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Kimberly-Clark Corporation · Industry
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nocturnal Enuresis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-21
• Primary completion: 2023-01-28
• Completion: 2023-06-28
• First posted: 2020-11-09
• Last updated: 2024-12-06
• Results posted: 2024-12-06

Locations

2 sites across 1 country: United Kingdom