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Clinical Trials/NCT05409014
NCT05409014
Unknown
Not Applicable

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 Catarina1 site in 1 country7 target enrollmentMay 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
University of the State of Santa Catarina
Enrollment
7
Locations
1
Primary Endpoint
Urinary incontinence symptoms
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
May 13, 2021
End Date
September 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
University of the State of Santa Catarina
Responsible Party
Principal Investigator
Principal Investigator

Gilmar Moraes Santos, PT

Clinical Professor

University of the State of Santa Catarina

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Urinary incontinence symptoms

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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