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临床试验/NCT05858840
NCT05858840已完成不适用

Place of Urinary Artificial Sphincter in Children With Neurogenic Bladder

University of Lorraine1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
1
主要终点
Number of participants with refractory urinary incontinence

研究概览

简要总结

Retrospective monocentric study of the outcomes of patients with neurogenic bladder, who had a urinary artificial sphincter before the age of 18 years old.

Hypothesis: what was the impact of the urinary artificial sphincter on the global management of the patient.

详细描述

The management of patients with neurogenic bladder is complex. Several patients have been operated multiple times. Surgical procedures such as Mitrofanoff's, bladder neck surgery, bladder augmentation and urinary artificial sphincter, are common.

The investigators want to analyse the participants data, that led to indication of an urinary artificial sphincter, and its outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients who were younger than 18 years old when they had an urinary artificial sphincter

排除标准

  • Patients who were 18 years old or older when they had an urinary artificial sphincter

结局指标

主要结局

Number of participants with refractory urinary incontinence

时间窗: Before surgery

Participants with urinary incontinence without response to medical treatment or catheterization

Impact of urinary artificial sphincter on the participants' incontinence

时间窗: Through study completion, an average of 2 years

Three outcomes are possible: the participant is continent, the participant is continent with catheterization or the patient is incontinent.

次要结局

  • Length of stay(From the day of hospitalization to the day of discharge home, up to 20 days)
  • Impact of bladder augmentation on participants' incontinence(Through study completion, an average of 2 years)
  • Impact of bladder neck surgery on participants' incontinence(Through study completion, an average of 2 years)
  • Operating time(Perioperatively)
  • Complications after urinary artificial sphincter(Through study completion, an average of 2 years)
  • Impact of Mitrofanoff procedure on participants' incontinence(Through study completion, an average of 2 years)
  • Last follow-up(Through study completion, an average of 2 years)

研究者

发起方
University of Lorraine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Christelle DESTINVAL

Principal Investigator

University of Lorraine

研究点 (1)

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