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临床试验/NCT02866292
NCT02866292已完成不适用

Is There Relationship Between the Pelvic Floor Muscles Strength and Sexual Function in Primigravid and Non-pregnant Nulliparous?

Federal University of Uberlandia1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
154
试验地点
1
主要终点
muscle strength with Oxford scale

研究概览

简要总结

This study has two aims: a) to evaluate the pelvic floor muscles strength in primigravid and non-pregnant nulliparous women and to correlate with their sexual function and b) to compare PFM strength and sexual function between women in the second and third pregnancy trimesters.

详细描述

This is an observational cross-sectional study. The sample consisted of 161 women divided into two groups: the first of pregnant women, formed by 81 primigravidae participants in the Prenatal Program of the public health system in Uberlandia city (Brazil). The second consists of 80 non-pregnant nulliparous. All participants signed an informed consent and the study was approved by the Ethics Committee of the Federal University of Uberlandia (nº 145.623/2012).

To estimate the average strength of vaginal palpation and vaginal squeeze pressure in primigravid, the investigators used the following equation to scale the sample: Zα/2 refers to the probability (α/2) standard one-tailed normal distribution; σ2 is the variance associated with vaginal palpation and vaginal squeeze pressure; ε is the sampling error. Based on a similar study, which evaluated similar population, it was assumed: α=0.05, σ=1.34 and ε=0.32 for vaginal palpation; and it was assumed: α=0.05, σ=12.60 and ε=3.00 for vaginal squeeze pressure. Therefore, the sample size would be 67 and 68 women, respectively.

The PFM assessment

PFM evaluation was performed by vaginal palpation and vaginal squeeze pressure. These methods are widely used in research involving the female pelvic floor and many studies have shown its reproducibility and validity.

The same examiner conducted all evaluations and before the start of the study, the reproducibility was tested. Ten women were evaluated twice, with an interval of one week to determine the intraclass correlation coefficient (ICC) of all variables.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Be non-pregnant nulliparous or primigravid women with pregnant only one fetus alive and without abnormalities that could increase uterine volume
  • Present ability to contract the pelvic floor muscles
  • Report at least one sexual relationship in the four weeks prior to data collection

排除标准

  • Were previous urogynecological surgery history
  • Non-pregnant nulliparous who did not have sexual intercourse with vaginal penetration
  • Presence of cognitive impairment or neurological condition that could affect muscle activation
  • Present urinary tract infection at the time of data collection.

结局指标

主要结局

muscle strength with Oxford scale

时间窗: through study completion, an average of 1 year

score of Female Sexual Function Index questionnaire

时间窗: through study completion, an average of 1 year

次要结局

未报告次要终点

研究者

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

Marília Duarte dos Santos

Principal Investigator

Federal University of Uberlandia

研究点 (1)

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