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临床试验/NCT05409014
NCT05409014Unknown不适用

Effect of Pelvic Floor Muscle Training on Urinary Incontinence Symptoms and Quality of Life in Women Who Practice Physical Exercise

University of the State of Santa Catarina2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年5月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
7
试验地点
2
主要终点
Urinary incontinence symptoms

研究概览

简要总结

Introduction: The practice of physical exercises can lead to the development of urinary incontinence (UI) symptoms, in addition to negatively impacting the function of the pelvic floor muscles (PFM) and the quality of life (QoL) of women. Aim: To evaluate the effect of pelvic floor muscle training (PFMT) on UI symptoms and QoL in women who practice physical exercise. Methods: The clinical trial was carried out in two stages, one online and the other in person. The online stage was carried out through a website, with the application of forms and validated questionnaires on urine leakage (International Consultation on Incontinence Questionnaire - Short Form) and quality of life (King's Health Questionnaire). In the face-to-face interview, all women practicing physical exercise and with symptoms of UI were invited to perform PFM assessment and Pelvic Organ Prolapse - Quantification (POP-Q) System, then the PFMT protocol. Women aged 18 years or older, in the reproductive phase and who practiced regular physical exercise for at least 6 months and at least 3 times a week were included. Results: Women are expected to improve UI symptoms and quality of life after PFMT.

详细描述

This is a non-randomized controlled clinical trial. The present research was approved by the Ethics Committee in Research with Human Beings of the Universidade do Estado de Santa Catarina (UDESC) with number 4.670.454. Data collection took place between November 2021 and June 2022 in two stages, one online and the other in person. The online stage was carried out through a website developed by the research team (https://projetocrossfititudesc.wixsite.com/saudedamulher), on this website the participants agreed to the Free and Informed Consent Term; completed forms on sociodemographic data, presence of UI and urinary habits and their participation in physical exercise; and completed validated questionnaires on urine leakage (International Consultation on Incontinence Questionnaire - Short Form) and quality of life (King's Health Questionnaire).

In the face-to-face stage, all women who practiced physical exercise and had symptoms of UI were invited to undergo an evaluation of the PFM and, then, the PFMT protocol at the Biomechanics Laboratory of the Center for Health Sciences and Sport (CEFID/UDESC). This protocol lasted eight weeks and consisted of five phases. At the end of the eight weeks, the same forms, questionnaires and PFM evaluation procedures were applied by the same evaluator.

All participants were recruited through the dissemination of a folder on social media (Instagram, Whatsapp and through the UDESC website) and visits to the exercise practice places (gyms and Crossfit box).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Women over 18 years of age;
  • Practitioners of any physical exercise for at least six months and with a frequency of at least three times a week.

排除标准

  • Women with climacteric or menopausal symptoms;
  • Who report symptoms of urinary tract infection in the last week (self-reported pain and burning sensation when urinating);
  • Who underwent physiotherapeutic, surgical or drug treatment in the last 6 months for UI;
  • Diagnosis or signs and symptoms of ongoing neurological, cardiac, gastrointestinal or genitourinary diseases;
  • Being in the gestational period.

结局指标

主要结局

Urinary incontinence symptoms

时间窗: Pre intervention and 8 week post intervention

Will be assessed using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF). It is a simple, brief (four-item) and self-administered questionnaire that asks the frequency of urine leakage (0 = "Never" to 5 = "All the time"), the volume of urine lost (0 = "None" to 6 = "A large amount") and the impact of UI on quality of life (0 = "Does not interfere" to 10 = "It interferes a lot"). For women undergoing non-surgical treatments for UI, 4-point reductions in the overall ICIQ-UI SF score are perceived as clinically significant (LIM et al., 2019). The fourth item has eight alternatives with situations in which the individual may have urine leakage and aims to identify the type of UI.

次要结局

  • Maximal voluntary contraction(Pre intervention and 8 week post intervention)
  • Quality of life(Pre intervention and 8 week post intervention)
  • Vaginal resting pressure(Pre intervention and 8 week post intervention)
  • Pelvic Organ Prolapse - Quantification (POP-Q) System(Pre intervention and 8 week post intervention)

研究者

发起方
University of the State of Santa Catarina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gilmar Moraes Santos, PT

Clinical Professor

University of the State of Santa Catarina

研究点 (2)

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