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临床试验/NCT03566121
NCT03566121已完成不适用

Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra

CMC Ambroise Paré4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年7月10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
50
试验地点
4
主要终点
Measurement of ultrasonic urethral length

研究概览

简要总结

This study aims to evaluate the correlation of the ultrasonic functional length of the urethra and the incontinence urinary disorder (IUD). The goal is to predict the severity of the IU by measuring new static and dynamic ultrasound parameters of the urethra.

详细描述

The urinary incontinence is a disorder which affects 25 to 45% of women. Nowadays, the role of urethral tissue in IUD is not explored although well viewed in perineal ultrasound. Our actual knowledge demonstrates that urodynamic ultrasound is reliable to establish the bladder neck mobility. And the posterior urethral wall mobility was often associated to the stress urinary incontinence. Two elements appeared to indicate the elasticity of the urethral environment: functional length urethral variation and urethral closure angle variation during Valsalva manoeuvres compared to rest. This study aims to evaluate the correlation of the ultrasonic functional length of the urethra and the incontinence urinary disorder for the purpose to predict the severity of this syndrome.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients aged over 18 years addressed to pelvic ultrasound

排除标准

  • Post-partum (under 6 month of childbirth)
  • Operated for a genitourinary prolapse or/and urinary incontinence
  • Utero vaginal symptomatic prolapse
  • Overactive bladder ± UI by
  • Severe deep pelvic endometriosis
  • Respiratory failure (Unable to perform the Valsalva manoeuvres)
  • History of pelvic cancer
  • Unable to understand the information communicated

结局指标

主要结局

Measurement of ultrasonic urethral length

时间窗: From 3 to 11 days after gynecological consultation

LT total length LF functional length LE funnel urethral length Measurement of the angle between proximal and distal urethra

次要结局

未报告次要终点

研究者

发起方
CMC Ambroise Paré
申办方类型
Other
责任方
Sponsor

研究点 (4)

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