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临床试验/NCT05617664
NCT05617664招募中不适用

Is Mirabegron 25 mg Safe and Effective in Treatment of Primary Nocturnal Enuresis as Regard Oral Desmopressin 120 mcg?

Benha University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年11月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
nocturnal enuresis improvement rate

研究概览

简要总结

Investigators will study the efficacy and safety of mirabegron25 in treatment of primary nocturnal enuresis in comparison to oral desmopressin 120 mcg and behavioral therapy

详细描述

No doubt that nocturnal enuresis is one of the commonest types of urinary incontinence which affect children and always run in family . Nocturnal enuresis occurs at the age of 5 years with leakage of urine involuntarily during sleep for two times or more per week in three consecutive months not due to congenital or acquired cause. Nocturnal enuresis can be categorized into primary or secondary depending on occurrence of bed dryness for more than six months or not .

Nocturnal enuresis affects 15% to 20 % of children at five years old mainly due to delay of bladder development and function more in male children with presence of family history in half of cases but 15% of children with enuresis recover spontaneously every year .

limitation of fluid intake, urotherapy and bedwetting alarms are non-pharmacological treatments of nocturnal enuresis while the mostly used drugs for treatment of NE are tricyclic antidepressants(Imipramine®) an arginine vasopressin analog (Desmopressin®) and anticholinergic drugs . Enuresis alarms have pitfalls which disgust a lot of patients as skin irritation, sleep disturbances of other family members and failure to wake the child so that about 30% of patients stop its usage .

Desmopressin is approved as a first-line drug therapy for nocturnal enuresis , but a lot of series declared that monotherapy with desmopressin has little efficacy in treating patients which have bladder storage dysfunction furthermore, high recurrence rate after treatment cessation .

The International Children's Continence Society (ICCS) recommended combination therapy for treatment of primary nocturnal enuresis after failure of first line therapy with desmopressin or enuresis alarms . As regard anticholinergic drugs, oxybutynin was firstly prescribed then tolterodine with less side effects and lately solifenacin . Cognitive impairment as a neurological side effect was authenticated for oxybutynin and other side effects (e.g. headache, dry mouth, behavior change, flushed cheeks, constipation, and blurred vision) were unbearable to many children and impulsed them to stop treatment early .

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
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • primary nocturnal enuresis,
  • negligible daytime wetting,
  • wet at least 4 times over 4 weeks
  • normal clinical examination with no neurological or urological cause for the enuresis

排除标准

  • secondary enuresis, polysymptomatic
  • neurologic bladder, neurological disorders,
  • urinary incontinence disorders
  • previous anti NE drugs.

研究组 & 干预措施

patients with primary nocturnal enuresis will be followed up with behavioral therapy alone.

Placebo Comparator

干预措施: behavioral therapy alone (Behavioral)

patients with primary nocturnal enuresis will take desmopressin 120 mcg oral tablets.

Active Comparator

干预措施: desmopressin 120 mcg oral tablets (Drug)

patients with PNE will take mirabegron 25 mg oral tablets.

Active Comparator

干预措施: Mirabegron 25 MG Oral Tablet, Extended Release (Drug)

结局指标

主要结局

nocturnal enuresis improvement rate

时间窗: four months

decrease number of nights or absent nights the patient get wet

次要结局

  • side effects of drugs used(three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hosam Abu El-nasr

lecturer of urology

Benha University

研究点 (1)

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