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临床试验/NCT02275728
NCT02275728Unknown不适用

Evaluating the Effectiveness of Pelvic Floor Muscle Training With and Without EMG Biofeedback and Quality of Life in Peri and Postmenopausal Women With Stress Urinary Incontinence.

Federal University of Rio Grande do Sul0 个研究点目标入组 45 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
主要终点
Evaluation of pelvic floor muscle strength with "Oxford Scale"

研究概览

简要总结

This study evaluates the action of the pelvic floor muscle training with and without EMG Biofeddback in the treatment of stress urinary incontinence in menopausal, peri and post menopausal women and their quality of life before and after the interventions.

详细描述

The Pelvic floor muscle training has been the first line of choice in the treatment of Stress Urinary Incontinence. The goal of this technique is increasing the strength and function of the pelvic floor which aims to support the pelvic viscera, as well as part of their duties, such as locks sphincter muscles.

Risk factors such as advanced age, obesity, multiple pregnancy, can cause a woman to present urinary incontinence (SUI), where the main cause is the dysfunction of the pelvic floor muscles and the lack of awareness of these muscles as well as biomechanical problems.

Some studies describe the use of EMG biofeedback to assess and improve the function of the pelvic floor muscles, however, the studies are not yet conclusive about the action of adding this equipment in the treatment of SUI.

In this regard, the EMG Biofeedback has the ability to physiologically evaluate these disorders and perform a faster treatment for these patients, improving their quality of life. The EMG has the ability to monitor and measure the progression of activation of the pelvic floor muscles, giving feedback to the patient and therapist about the actual condition of muscle function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Will be included in this study:
  • all women,
  • spontaneous free will,
  • have knowledge of research and sign the Instrument of Consent -TCLE.
  • Menopausal women,
  • pre and post-menopause,
  • urinary incontinence with the effort

排除标准

  • Will be excluded from the study:
  • patients with neurological, cardiovascular, rheumatologic diseases,
  • diabetes mellitus,
  • chronic lung disease,
  • rheumatoid arthritis,
  • Enhlers-danlos,
  • Sexually Transmitted Diseases (STDs),
  • do not submit annual gynecological exams.

结局指标

主要结局

Evaluation of pelvic floor muscle strength with "Oxford Scale"

时间窗: 1 month

The evaluation consists in bidigital intravaginal test which evaluates the pelvic floor muscle strength using the following 0-5 scale, where 0 = no contraction and 5 = maximal contraction with support against gravity The graduates range from 0 - 5 = 0 has no muscle contraction, 1 = outline of muscle contraction, 2 = contracts without support against gravity, 3 = contracts and holds little against gravity, 4 = contracts and holds up to 6 seconds against gravity and 5 = contracts and holds more than 6 seconds against gravity ntravaginal bidigital test that evaluates scale of pelvic floor muscle strength. The graduates range from 0 - 5 = 0 has no muscle contraction, 1 = outline of muscle contraction, 2 = contracts without support against gravity, 3 = contracts and holds little against gravity, 4 = contracts and holds up to 6 seconds against gravity and 5 = contracts and holds more than 6 seconds against gravity

次要结局

  • The myoelectric activity evaluation of the pelvic floor(1month)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adriane Bertotto

Maria Celeste Osório Wender

Federal University of Rio Grande do Sul

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