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

NCT ID: NCT05409014

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2022-09-30

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).

Conditions

Urinary Incontinence; Pelvic Floor Disorders; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PFMT

The exercises of this protocol were performed at home, but with face-to-face meetings in the first phase of the protocol (awareness) and every 15 days, where the physical therapist taught the new exercises to be performed in the next phase. All protocol meetings were performed by a trained physical therapist/researcher. In situations where it was not possible to hold the meetings in person, due to the Covid-19 pandemic, they were held online through video calls with the responsible researcher. The PFMT protocol lasts for eight weeks and was divided into five phases: awareness, stabilization, strength, potency and potency complement. Each phase is 2 weeks long.

Group Type: EXPERIMENTAL

PFMT

Intervention Type: OTHER

The phase 1 of the protocol was awareness-raising, the athlete receives guidance from a physical therapist and learns the location of the PFM and the ability to contract them in isolation. The phase 2 is stabilization, consisting of 15 stabilization exercises, which are performed through pelvic floor contractions for 10 seconds and with the same relaxation time, repeating each group 10 times. The phase 3 is strength, the same exercises as the second phase are performed using 2 kg weights at the end of each leg and/or arm. There are eight groups of exercises and with changes in the time of slow contraction and relaxation. The phase 4 is power, in power exercises the training loads are increased and the sequence of movements is also increased. The phase 5 is to complement the power, this phase was the continuation of the previous one in the sense of potentiation of the results where ballistic movements, speed and impact fundamentally predominate.

Interventions

PFMT

The phase 1 of the protocol was awareness-raising, the athlete receives guidance from a physical therapist and learns the location of the PFM and the ability to contract them in isolation. The phase 2 is stabilization, consisting of 15 stabilization exercises, which are performed through pelvic floor contractions for 10 seconds and with the same relaxation time, repeating each group 10 times. The phase 3 is strength, the same exercises as the second phase are performed using 2 kg weights at the end of each leg and/or arm. There are eight groups of exercises and with changes in the time of slow contraction and relaxation. The phase 4 is power, in power exercises the training loads are increased and the sequence of movements is also increased. The phase 5 is to complement the power, this phase was the continuation of the previous one in the sense of potentiation of the results where ballistic movements, speed and impact fundamentally predominate.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of the State of Santa Catarina

OTHER

Sponsor Role: lead

Responsible Party

Gilmar Moraes Santos, PT

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Ciências da Saúde e do Esporte (CEFID)

Florianópolis, Santa Catarina, Brazil

Countries

Brazil

Other Identifiers

PFMT exercise

Identifier Type: -

Identifier Source: org_study_id