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临床试验/NCT06285006
NCT06285006招募中不适用

Predictors of Success and Relapse After Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
The number of episodes per week after desmopressin treatment

研究概览

简要总结

Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.

NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • School age group (from 7 to 14 years)
  • Primary monosymptomatic nocturnal enuresis

排除标准

  • Patients with one or more of the following will be excluded from the study.
  • Diurnal enuresis
  • Urinary tract infection within the preceding 3 months
  • Diabetes mellitus
  • History of renal disease, hypertension or genitourinary abnormality, neurological disease, or psychological disease.
  • Post-micturition residual urine >1/3 expected bladder capacity.
  • Each patient will be subjected to the following.

研究组 & 干预措施

Desmopressin

Experimental

Desmopressin is a synthetic analogue of ADH released by the posterior pituitary gland that reduces urine production by increasing water reabsorption by the collecting tubules.

干预措施: Desmopressin (Drug)

结局指标

主要结局

The number of episodes per week after desmopressin treatment

时间窗: After the end of the treatment for one month.

Patients will be evaluate by no. of episodes per week after desmopressin treatment.

次要结局

未报告次要终点

研究者

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

Hosny Mohamed Ahmed Elmasry

Professor

Al-Azhar University

研究点 (1)

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