Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Wet Nights
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Wet Nights
时间窗: Last week of the 4-week intervention period
Average number of wet nights
次要结局
- Impact of Urinary Incontinence on Emotional Wellbeing of Child as Assessed by Paediatric Incontinence Questionnaire (PinQ)(Assessment will be done at each study clinic visit (Day 56 +/- 7))
- 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 56 +/- 7))
- Child Daytime Sleepiness as Assessed by PDSS Questionnaire(Assessment will be done at each study clinic visit (Day 56 +/- 7))
- Parent/Carer Fatigue as Assessed by Checklist Individual Strength (CIS Questionnaire)(Assessment will be done at each study clinic visit (Day 56 +/- 7 ))