Clinical trial NCT05409014: Pelvic Floor Muscle Training on Urinary Incontinence Symptoms and Quality of Life in Women Who Practice Physical Exercise
Official title: Effect of Pelvic Floor Muscle Training on Urinary Incontinence Symptoms and Quality of Life in Women Who Practice Physical Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Pelvic Floor Disorders
Quality of Life
Keywords: Pelvic Floor
Exercise
Lead sponsor: University of the State of Santa Catarina
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This was a single-group clinical trial evaluating the effect of pelvic floor muscle training in incontinent women who exercise.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Urinary incontinence symptoms
timeFrame: Pre intervention and 8 week post intervention
Secondary outcomes:
measure: Quality of life
timeFrame: Pre intervention and 8 week post intervention
measure: Maximal voluntary contraction
timeFrame: Pre intervention and 8 week post intervention
measure: Vaginal resting pressure
timeFrame: Pre intervention and 8 week post intervention
measure: Pelvic Organ Prolapse - Quantification (POP-Q) System
timeFrame: Pre intervention and 8 week post intervention
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Centro de Ciências da Saúde e do Esporte (CEFID)
state: Santa Catarina
Study officials:
References: