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临床试验/NCT03550898
NCT03550898已完成不适用

Can Dynamic Ultrasonography Replace Urodynamics in the Follow-up of Patients With Myelomeningocele: A Prospective Concurrent Study

Hospital de Clinicas de Porto Alegre0 个研究点目标入组 81 人开始时间: 2014年6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
81
主要终点
To evaluate the accuracy of dynamic ultrasonography to identify bladder overactivity in neurogenic bladder.

研究概览

简要总结

Patients with neurogenic bladder need periodic evaluation with urodynamic study, a invasive and uncomfortable procedure.

Aim: To evaluate the accuracy of dynamic ultrasonography as a feasible and noninvasive alternative diagnostic method to identify detrusor overactivity in patients with neurogenic bladder

详细描述

The urodynamic study and dynamic ultrasonography were performed concurrently, to identify detrusor overactivity, in patients with myelomeningocele and clinical indication for urodynamics, by investigators without verbal or visual contact.

The overactivity was diagnosed through active conformational change of the bladder during filling phase.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic

盲法说明

Dynamic ultrasonography was performed during the filling phase of the urodynamic study. The radiologist and the urodynamicist had no verbal or visual contact during the examinations, with use of a siding.

入排标准

性别
All
接受健康志愿者

入选标准

  • All outpatients of the Pediatric Urology Department of the investigator's institution with diagnosis of myelomeningocele and clinical indication for urodynamic study

排除标准

  • Previous bladder augmentation surgery
  • Current urinary tract infection
  • Fail to provide consent for participation

研究组 & 干预措施

Dynamic ultrasonography

Other

Dynamic ultrasonography was performed in all patients who underwent urodynamics, simultaneously.

干预措施: Dynamic Ultrasonography (Diagnostic Test)

结局指标

主要结局

To evaluate the accuracy of dynamic ultrasonography to identify bladder overactivity in neurogenic bladder.

时间窗: 20 minutes

Dynamic Ultrasonography evaluated the dynamic conformational change of the bladder to identify the presence of detrusor overactivity, based on a subjective graduation of contractions, compared to the urodynamic data.

次要结局

  • To evaluate the accuracy of dynamic ultrasonography to identify maximum cystometric capacity.(20 minutes)
  • To assess the ability of dynamic ultrasonography to estimate the pressure of detrusor contractions.(20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

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