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临床试验/NCT02930720
NCT02930720Unknown不适用

The Influence of Various Breathing Protocols and Cough on the Amount of Pelvic Floor Displacement in Women With Stress Urinary Incontinence and Healthy Women: An Ultrasound Study

Assuta Hospital Systems1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
pelvic floor displacement

研究概览

简要总结

Pelvic floor main role is to maintain continence. pelvic floor malfunction could lead to urinary incontinence (UI). The known prevalence of UI among women is 25%-72%, in about 25%-50% it is Stress Urinary Incontinence (SUI), SUI prevalence changes with age and obstetric history. SUI is the complaint of involuntary leakage on activities which involves inter abdominal pressure rase, such as effort or exertion, or sneezing or coughing. pelvic floor movement is coordinated with the diaphragm, it moves caudally while inhaling and cranially while exhaling. it was shown that cranial sagittal displacement of the pelvic floor is correlated to pelvic floor normal and efficient function. in order to maintain continence while internal abdominal pressure rises the pelvic floor as to work in a precise trajectory, timing and force. observing the Urinary bladder by trans abdominal ultra sound (TAUS) was found as a valid and reliable way to estimate pelvic floor sagittal displacement and function.

详细描述

50 women between the age 25-50 with a history of one vaginal delivery will be recruited for the study. 25 women who complain about stress urinary incontinence (research group) and 25 healthy women (control group). all research participants will sign first a participant consent form. all participants will be interviewed about their own delivery, measured for weight and height and follow a trans abdominal ultra sound (TAUS) examination. the research group participants will be asked to fill a quality of life questionaire concerning their SUI complaint.

at the TAUS examination the participant will be asked to perform:

  1. 3 times quiet breathing.
  2. 3 times forced exhalation.
  3. 3 times cough. while doing so an ultra sound image of the urinary bladder will be saved for displacement measurements.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women after one vaginal delivery on term.
  • women aged 25-50
  • members of 'macabi medical services'

排除标准

  • pregnancy
  • nulliparous women
  • women who had C section delivery
  • known neurologic disease
  • previous history of pelvic or back surgery
  • previous history of pelvic fracture
  • known pulmonary disease
  • active urinary tract infection

结局指标

主要结局

pelvic floor displacement

时间窗: 20-30 minutes

in mm

次要结局

  • Incontinence Quality of Life (I-QOL)(5 minutes)

研究者

发起方
Assuta Hospital Systems
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iris sinai

Director

Assuta Hospital Systems

研究点 (1)

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