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临床试验/NCT04288648
NCT04288648已完成不适用

Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence

University of Haifa1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
direction of urinary bladder displacement during contraction

研究概览

简要总结

Examination of pelvic floor contraction in different positions among women with and without stress urinary incontinence (SUI) will be conducted via diagnostic ultrasound. This will enable clinicians and researchers to establish an appropriate protocol for pelvic floor muscle examination and treatment.

详细描述

The main goal of this study is to compare the ability of the pelvic floor muscles to contract in different positions among women suffering from SUI to healthy women. Secondary objectives: is to compare subjective reports of the difficulty to contract the pelvic floor muscles between the two groups, and to examine the connection between the severity of urinary leakage and the ability to contract pelvic floor muscles.

The study will include 50 female participants in the ages of 18-45. Research group will include 25 participants suffering from SUI in accordance with the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and 25 healthy participants (grade 0 on the ICIQ-SF questionnaire).

The examination will be performed with an abdominal ultrasound device in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction. The extent and direction of bladder base movement would indicate the quality of pelvic floor performance. Next, the length of contraction time will be measured. The participant would hold the maximal contraction as long as possible in order to examine muscular endurance. Rest will be given between tests. After finishing the tests in all four postures, the participants will be questioned about the degree of difficulty contracting the pelvic floor.

Significance of the study: The importance of the research is about granting the clinicians and researchers additional tools in order to help establishing a protocol for pelvic floor muscle activity examination and treatment.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Other types of urinary leakage
  • receiving pelvic floor treatments in the past or present
  • active urinary or vaginal infections
  • neurological diseases
  • urologic, gynecologic or abdominal surgery
  • pelvic organ prolapse
  • pregnancy
  • chronic cough
  • constipation
  • unbalanced diabetes and the use of medication that affects urination

结局指标

主要结局

direction of urinary bladder displacement during contraction

时间窗: baseline

upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound

次要结局

  • urinary bladder displacement in millimeters(baseline)
  • pelvic floor muscles endurance of contraction in seconds(baseline)
  • questioned about the degree of difficulty contracting the pelvic floor.(baseline)

研究者

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

Gali Dar

principal investigator

University of Haifa

研究点 (1)

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