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临床试验/NCT05168358
NCT05168358Unknown不适用

Effect of Overnight Bladder Drainage on Posterior Urethral Valve Sequelae: A Randomized Controlled Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2021年12月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
55
试验地点
1
主要终点
Improvement or Resolution of Hydronephrosis

研究概览

简要总结

We hypothesize that overnight catheter drainage (OCD) of the urinary bladder might improve bladder dynamics and subsequently lead to improvement or resolution of hydronephrosis (HN) and renal function in boys who underwent PUV ablation.

Patients who have persistent HN and bladder dysfunction at least one year after PUV ablation will be randomly allocated into two groups: the first group (control group): 55 patients, their parents will be taught the timed voiding regimen every 2 hours, while the second group (OCD group): 55 patients, their parents will be taught the timed voiding regimen every 2 hours, in addition to placing an overnight catheter to drain the urinary bladder during night.

We will study the effect of OCD of the urinary bladder on the improvement or resolution of HN and urinary bladder function within a year of starting this regimen.

详细描述

Posterior urethral valve (PUV) is the most common cause of bladder outlet obstruction (BOO) in boys. PUV induces damage to the smooth muscles of the bladder and ureter with subsequent damage to the renal parenchyma. All these sequelae begin antenatally and persist even after successful valve ablation.

The standard management of these sequelae includes timed voiding, double voiding, clean intermittent catheterization (CIC) to facilitate bladder emptying and anticholinergic drugs to improve poor bladder compliance. However, in some polyuric cases even voiding or catheterization as frequently as every 2 hours is not effective to maintain safe bladder volumes especially at night.

Overnight catheter drainage (OCD) of the urinary bladder has been increasingly suggested to be beneficial in protecting the upper tracts of patients with high urine output, defective and poorly compliant bladders, thus resulting in improvement of the renal function, hydronephrosis (HN) and the urodynamic changes as well.

Therefore, we hypothesize that OCD of the urinary bladder might improve bladder dynamics and subsequently lead to improvement or resolution of HN and renal function in boys who underwent PUV ablation.

Patients who have persistent HN and bladder dysfunction at least one year after PUV ablation will be randomly allocated into two groups: the first group (control group): 55 patients, their parents will be taught the timed voiding regimen every 2 hours, while the second group (OCD group): 55 patients, their parents will be taught the timed voiding regimen every 2 hours, in addition to placing an overnight catheter to drain the urinary bladder during night.

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
1 Year 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients who have;
  • Persistent hydronephrosis and
  • Unfavorable bladder dynamics on urodynamic study performed at least one year after posterior urethral valve ablation will be included in the study. The unfavorable bladder dynamics will be defined as poor compliance or detrusor overactivity.

排除标准

  • Patients who;
  • Underwent urinary diversion (e.g. vesicostomy or ureterostomy),
  • Have other conditions that could affect lower urinary tract function,
  • Have infravesical obstruction or
  • Those who will refuse to participate in the study will be excluded.

结局指标

主要结局

Improvement or Resolution of Hydronephrosis

时间窗: One Year

Impact of overnight bladder drainage on improvement or resolution of hydronephrosis assessed by renal and bladder ultrasonography. Improvement of hydronephrosis will be defined as downgrading of hydronephrosis according to Society of Fetal Urology grading system.

次要结局

  • Improvement of Bladder and Renal Function and Resolution of Urinary Tract Infection(One Year)

研究者

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

Ahmed Elkashef

Ahmed Elkashef

Mansoura University

研究点 (1)

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