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

NCT05409014 | Unknown

• 1 other identifier: PFMT exercise
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Pelvic Floor Disorders; Quality of Life

Keywords

Pelvic Floor; Exercise

Outcome Measures

Primary Outcomes (1)

• Urinary incontinence symptoms

  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.

  Pre intervention and 8 week post intervention

Secondary Outcomes (4)

• Quality of life

  Pre intervention and 8 week post intervention

• Maximal voluntary contraction

  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 Arms (1)

PFMT

EXPERIMENTAL

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.

Other: PFMT

Interventions

PFMT 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.

PFMT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Centro de Ciências da Saúde e do Esporte (CEFID)

Florianópolis, Santa Catarina, 88080-350, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Floor Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This was a single-group clinical trial evaluating the effect of pelvic floor muscle training in incontinent women who exercise.

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 7, 2022
• Study Start: May 13, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

BR (1)