跳至主要内容
临床试验/NCT05707793
NCT05707793已完成不适用

Ultrasound Imaging of Core Muscles Activity in Multiparous Women With Vaginal Laxity: A Cross-Sectional Study

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月15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
100
试验地点
1
主要终点
Assessment of transverse abdominis thickness

研究概览

简要总结

This study aims to compare the ultrasound imaging of core muscles activity in multiparous women with vaginal laxity versus normal controls.

详细描述

Vaginal laxity is characterized by the loss of elasticity in the vaginal structure and vaginal looseness, which leads to symptoms including sexual dysfunction, dyspareunia, chronic pelvic pain, and urinary incontinence. It is a symptom of pelvic floor dysfunction. Its mechanisms are not well understood and it is usually worse in women with multiparity.

Since the pelvic floor muscles (PFMs) are one of the core muscles that play a critical role in lumbopelvic stability, their impairment may affect the lumbopelvic area and the activity of other core muscles, like the transverse abdominis, lumbar multifidus, and diaphragm. Therefore, this study aims to compare the ultrasound imaging of core muscles activity in multiparous women with vaginal laxity versus normal controls.

研究设计

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

入排标准

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

入选标准

  • •The participants' age range from 35 to 45 years
  • •their body mass index is 25-30 kg/m2,
  • •The number of normal deliveries ≤ three times,
  • •having a regular menstruation.
  • •They participate in the study after at least two years from their last delivery.

排除标准

  • •Prior history of disc prolapse and sacroiliac joints, symphysis pubic joint as well as lower limb problems, leg length discrepancy, and diastasis recti.
  • •Surgery related to the spine, abdomen or pelvis.
  • •Genital prolapse, urinary tract infection, and intrauterine device.
  • •Diabetes, chest and/or cardiac disease.
  • •Using any drugs for sexual dysfunction.

结局指标

主要结局

Assessment of transverse abdominis thickness

时间窗: 3 months

The measurement of transverse abdominis muscle will be taken from the lower border of internal obliques muscle to the inferior hyperechoic line of peritoneum at rest and during the abdominal drawing in maneuvers (ADIM) for women in both groups, using an ultrasound device.

Assessment of lumbar multifidus thickness

时间窗: 3 months

Lumbar multifidus will be measured, using an ultrasound device, along the line from the L4-5 zygapophyseal joint to the superior border of the lumbar multifidus for women in both groups.

Assessment of pelvic floor muscle force

时间窗: 3 months

It will be assessed, using an ultrasound device, for women in both groups. The position of the bladder base at rest will be marked electronically with an 'X'. The subject will then perform a maximum voluntary pelvic floor muscle contraction and the image will be captured at the moment of maximum displacement. At this time, the subject will relax the pelvic floor muscles. The investigator will then measure the displacement to its current position in the stilled image and will be blinded to the measurement value until after the caliper has been fixed at the end point.

ِAssessment of diaphragmatic force

时间窗: 3 months

Diaphragmatic excursion will be measured, using an ultrasound device, by placing calipers at the bottom and top of the diaphragmatic inspiratory slope. All measurements will be taken at the end of expiration phase for women in both groups.

次要结局

  • Short-Form 36 Health Survey (SF-36)(3 months)
  • Vaginal Laxity Questionnaire(3 months)
  • The Female Sexual Function Index (FSFI)(3 months)
  • Modified Oxford grading scale(3 months)

研究者

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

Doaa A. Osman

Assistant Professor

Cairo University

研究点 (1)

Loading locations...

相似试验