Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves.
研究概览
简要总结
To determine whether there is a role for Tamsulosin, A Selective Alpha-1 Adrenergic Blocker, as therapy in children with Posterior Urethral Valve post valve ablation , and whether there are side effects involved.
详细描述
We aim to evaluate the safety and efficacy of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves regarding:
- Effect on upper urinary tract (Hydronephrosis improvement, Vesicoureteric Reflux resolution and renal function)
- Effect on bladder outlet resistance
- Effect on intravesical detrusor pressure
- Febrile Urinary Tract Infection recurrence
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
- — 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Children with a diagnosis of PUV.
排除标准
- •Patients with other conditions that can potentially affect lower or upper urinary tract functions (e.g. spinal dysraphism, anorectal malformation and prune belly syndrome)
- •Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy.
- •Patients who had primary treatment of PUV ablation at other hospitals.
- •Contraindications to α blocker treatment.
- •Patients who refuse to participate in the study
研究组 & 干预措施
Oxybutynin and Trimethoprim/sulphamethoxazole
Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily
干预措施: Oxybutynin (Drug)
Oxybutynin and Trimethoprim/sulphamethoxazole
Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily
干预措施: Trimethoprim/sulfamethoxazole (TMP/SMZ) (Drug)
Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole
Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily
干预措施: Tamsulosin (Drug)
Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole
Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily
干预措施: Oxybutynin (Drug)
Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole
Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily
干预措施: Trimethoprim/sulfamethoxazole (TMP/SMZ) (Drug)
结局指标
主要结局
The effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves.
时间窗: 1 year
The effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves. This will be assessed by: - Change in Hydronephrosis grading (resolution of low grade (I or II) Hydronephrosis or downgrading of high grade (III or IV) Hydronephrosis to grade II or less)
The safety of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves.
时间窗: 1 year
Number of children with treatment related adverse effects. Potential side effects will be discussed after initiating therapy, including postural hypotension, dizziness, headache and rhinitis.
次要结局
- The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves.(1 year)
- Febrile Urinary Tract Infections recurrence(1 year)