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临床试验/NCT03656601
NCT03656601已完成不适用

Correlation Between Tridimensional Pelvic Floor Ultrasound and Quality of Life Scores Questionnaires in Nulliparous or Parous Women

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年5月5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
120
试验地点
1
主要终点
3D US pelvic floor evaluation of transverse diameter of vagina

研究概览

简要总结

Evaluation of the impact of the delivery in the system of suspension and sustentation of pelvic floor, by 3D ultrasound and quality of life questionnaires.nt

详细描述

The pelvic floor is a complex group of muscle, fascia and connective tissue that recover the basis of the pelvic bones, forming the system of suspension and sustentation of the pelvic organs. Different events that happen during the life of women, like pregnancy, delivery, gain of weight and hormonal alterations from the menopause, may affects the strength of the muscles and of other structures that supports pelvic organs. The importance of the balance of the pelvic organs in maintenance of quality of life have been recognized in literature last years. Different studies established association between sexual disfunction and emotional dissatisfaction, as well as reduction of well-being in that women. The urinary incontinence and anal incontinence are also important factors that compromised quality of life and can provoke harmful effects over the self-esteem of women and diminish relationship. The 3D ultrasound (3D UD) is a non-invasive method, reproductible, and technically easy of evaluate the pelvic floor. Different routes may be used, but the transperineal is the most common. By this route is possible to evaluate the pelvic floor anatomy, as well as its disfunction into deep planes, what we can not afford only with the physical exam.

The objective was to evaluate the impact of the delivery on the pelvic floor, by the 3D ultrasound evaluation and to correlate it with the scores of sexual questionnaire (FSFI), urinary questionnaire (King´s) and anal incontinence questionnaire ( specific questions about loss of gases).

This is a transversal study of a cohort of women in reproductive age recruited from May 2016 to June 2018. The clinical and US evaluation were performed at the same medical visit. Patients signed the consent term and answered the questionnaires (King's health quality of life questionnaire, FSF-I (Female Sexual Function - Index, and a scale of anal incontinence) before the ultrasonographic exams. The USG evaluation was performed using GE Voluson 730 expert systems with RAB 8- 4 Mhz volume transducers with an 85-degree acquisition angle. The exams were performed with patient in supine position with hip flexed and using slightly abduced, after voiding. The US transducer was placed on the perineum in the midsagittal position and volumes were obtained at rest, at maximum Valsalva, and perineal contraction. The volumes datasets were analyzed offline by of the authors. They were blinded and the average values were considered.

The studied parameters was the hiatal area (HA), the antero-posterior diameter (PA), transverse diameter (TD) and the muscle thickness (MT). The measures were obtained by the OmniView VCI mode.

Statistical analysis was performed using student t, ANOVA and Tukey. P value of <0.05 was considered statistically significant.

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
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age between 18 and 50
  • reproductive age

排除标准

  • bad quality of 3D US images
  • post- menopause
  • vulvovaginitis
  • urinary incontinence
  • Human papillomavirus vulvar disease (condyloma acuminata)
  • previous pelvic floor surgery

结局指标

主要结局

3D US pelvic floor evaluation of transverse diameter of vagina

时间窗: One day

Evaluation of transverse diameter of vagina, in cm, by 3D pelvic floor ultrasound

次要结局

  • 3D US pelvic floor evaluation of thickness of pubovisceral muscle(One day)
  • Impact of the delivery in quality of life - regarding sexual life(One day)
  • Impact of the delivery in quality of life - regarding anal incontinente(One day)
  • 3D US pelvic floor evaluation of Hiatal area(One day)
  • Impact of the delivery in quality of life - regarding urinary incontinence(One day)

研究者

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

Ana Maria Homem de Mello Bianchi

PhD of Gynecology Department

Federal University of São Paulo

研究点 (1)

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