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临床试验/NCT07668232
NCT07668232已完成不适用

Efficacy and Safety of Mirabegron Versus Oxybutynin After Posterior Urethral Valve Ablation: A Comparative Prospective Randomized Study

South Valley University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Safety of Mirabegron usage after posterior urethral valve ablation by measuring arterial blood pressure

研究概览

简要总结

Posterior urethral valve is the main cause of bladder outlet obstruction in male infants and the most common cause of obstructive uropathy leading to chronic renal failure and end-stage renal disease in children.The incidence of posterior urethral valve is approximately 1:7,000-8,000 live births.

详细描述

Posterior urethral valve is the main cause of bladder outlet obstruction in male infants and the most common cause of obstructive uropathy leading to chronic renal failure and end-stage renal disease in children.The incidence of posterior urethral valve is approximately 1:7,000-8,000 live births.

Anatomically, it is a membrane starting at the verumontanum and attached distally in the posterior urethra in the male child, resulting in valve like obstruction to the urine outflow leading to harmful effects on the urinary bladder and the upper urinary tracts.

Initial management of children with posterior urethral valves is immediate bladder drainage followed by endoscopic posterior urethral valve ablation. However, despite the early relief of bladder outlet obstruction, remaining pathological changes in the urinary bladder can lead to significant bladder dysfunction which leads to impaired upper tract drainage; valve bladder syndrome.

Oxybutynin is primarily indicated for the treatment of overactive bladder syndrome. It is still the most widely prescribed drug for overactive bladder in the world. It has been demonstrated to be safe for administration in the paediatric neurogenic bladder population.

Mirabegron, a beta-3 adrenergic agonist has been used for the treatment of overactive bladder symptoms as an alternative to anticholinergics with minimal side effects. Few studies stated safety of mirabegron in pediatric population with overactive bladder.

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
3 Years 至 12 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • - All children older than 3 years old who have undergone posterior urethral valve ablation

排除标准

  • Children younger than 3 years old.
  • Children with residual valve.
  • Children who had undergone urinary diversion (vesicostomy or ureterostomy).
  • Children with other conditions that can potentially affect upper or lower urinary tract function (spina bifida, anorectal malformation,prune belly syndrome).

研究组 & 干预措施

Group A (Mirabegron Tablets):

Active Comparator

About 26 children suffering from Valve Bladder Syndrome after posterior urethral valve ablation and will be maintained on Mirabegron tablets (0.5-1 mg/kg/daily) orally.

干预措施: Mirabegron (Drug)

Group B (Oxybutynin Tablets):

Active Comparator

About 26 children suffering from Valve Bladder Syndrome after posterior urethral valve ablation and will be maintained on Oxybutynin Syrup (0.2 mg/kg 3 times per day) orally.

干预措施: Mirabegron (Drug)

结局指标

主要结局

Safety of Mirabegron usage after posterior urethral valve ablation by measuring arterial blood pressure

时间窗: 6 Months

Assessment of the safety of Mirabegron drug in children after posterior urethral valve ablation by measuring arterial blood pressure by Mercury Sphygmomanometer (mmHg )

Safety of Mirabegron usage after posterior urethral valve ablation by measuring heart rate

时间窗: 6 Months

Assessment of the safety of Mirabegron drug in children after posterior urethral valve ablation by measuring heart rate by pulse oximeter (beat per minute).

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

Mohamed Ahmed Hassan

Assisstant Lecture at Urology Department

South Valley University

研究点 (1)

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