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临床试验/NCT03812094
NCT03812094已完成不适用

The Efficacy of Basic Bladder Advice and Alarm Therapy in Nocturnal Enuresis - a Randomized Controlled Trial

Dalarna County Council, Sweden2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Reduction of wet nights per two weeks as compared to baseline enuresis frequency.

研究概览

简要总结

Enuresis is the scientific term for bedwetting. Modern research has established three pathogenic mechanisms as crucial:

  1. Excessive urine production at night (nocturnal polyuria).
  2. Detrusor over activity. The bladder may contract regardless of whether it is full or not.
  3. Difficulties to arouse from sleep and will not wake up when the bladder is full or contracts.

Children with daytime incontinence usually suffer from detrusor over activity and many of them are constipated. The reason for this connection is probably partly anatomical; constipated children have to use the rectum as a storage space, and the chronically distended rectum will compress the bladder from behind.

The link between constipation and enuresis (as opposed to daytime incontinence) is less clear although it is logically plausible. Our experience is that some enuretic children become dry at night just by treatment of constipation, but this is yet not supported by sufficient evidence The standard primary treatment of enuresis - as reflected by global consensus guidelines - rests upon three pillars. The recommended first step is 1) bladder advice. The next step, if the child is still wet at night, is either 2) the antidiuretic drug desmopressin or 3) the sleep-modifying enuresis alarm.

The underlying idea behind basic bladder advice is that the child is taught to more actively take command over the bladder by voiding according to a regular daytime schedule, using correct voiding posture and spread fluid intake evenly across the day. The rationale behind the recommendation of this strategy is that is the established cornerstone of the treatment of daytime incontinence and that detrusor over activity is a pathogenic factor common to both conditions. By influencing bladder, function during the day it is assumed that nocturnal bladder function will also normalize. The problem is a glaring lack of evidence.

Our primary aims with this study is to better understand which roles basic bladder advice, constipation therapy and/or the enuresis alarm play in the first-line therapy of enuresis.

详细描述

Treatment strategies in nocturnal enuresis

BACKGROUND. Enuresis is the scientific term for bedwetting. Approximately one in ten children in early school age suffers from this condition. Modern research has established three pathogenic mechanisms as crucial:

  1. Excessive urine production at night (nocturnal polyuria). The bladder is filled to capacity before the night is over.
  2. Nocturnal detrusor overactivity. In these cases, the bladder may contract regardless of whether it is full or not.
  3. Almost all children with enuresis are difficult to arouse from sleep and will not wake up when the bladder is full or contracts.

Regardless of which of the above factors is relevant in the individual child, the condition is often inherited.

All enuretic children do not wet their beds every night, but even children who experience wet nights sporadically may be very much bothered by their condition - they may, for instance, not dare to participate in school camps or sleepovers. Many of the children also suffer from concomitant daytime incontinence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 6-11 Years
  • Enuresis (monosymtomatic enuresis)

排除标准

  • Day incontinence (nonmonosymtomatic enuresis)
  • Neurological disease
  • Urological malformation
  • Kidney disease
  • Previous alarm treatment for enuresis
  • Don´t want to stop medication whit Vasopressin (if currant)

结局指标

主要结局

Reduction of wet nights per two weeks as compared to baseline enuresis frequency.

时间窗: 14 days mesurement before study compered to 14 days in treatment week 7 and 8

Respons to treatment is at least 3 nights per two weeks

次要结局

未报告次要终点

研究者

发起方
Dalarna County Council, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbro Hedin Skogman

MD, associate professor

Dalarna County Council, Sweden

研究点 (2)

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