Comparison Between Pelvic Muscle Training and Pilates Exercises for UI in Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-02-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Introduction: Urinary incontinence (UI) is a condition that affects around 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PMT) is considered the gold standard for this type of condition. However, other possibilities of exercises have been studied to achieve continence, such as Pilates exercises, which focus on the stabilizing muscles and request a voluntary contraction of the muscles of the pelvic floor (PFM), it is believed that it can recruit fibers from these muscles, improving muscle function and episodes of urinary incontinence. However, the literature is still inconclusive regarding the effects of Pilates exercises on urinary incontinence and PFM function. Objective: To compare the effects of 3 months of muscle training, through TMAP and Pilates exercises on the improvement of UI in postmenopausal women. Methods: 40 postmenopausal women with urinary incontinence will be randomly assigned to two intervention groups: pelvic floor muscle training and Pilates exercises. The evaluations will be carried out before the interventions and after three months of them, and will involve the following instruments: urinary incontinence and aspects related to quality of life, assessed using the International Consultation of Urinary Incontinence questionnaire Short Form (ICIQ-UI-SF); 7-day voiding diary, used to identify possible modifiable factors related to urination and its frequency; Pad-test used to identify and quantify UI; Feeling Scale, to portray the affective valence of the exercises; Female Sexual Function Index, which will assess female sexual function; Manometric assessment of muscle strength and PFM endurance with Epi-no; and Manometric evaluation by bidigital palpation using the PERFECT test. Shapiro Wilk tests will be performed to verify normality, Student's t or Mann Whitney U test according to parametric or non-parametric distribution, ANCOVA for comparison between groups in the post-intervention, considering the 95% confidence interval (p\<0.05) . The data will be processed in the SPSS 25.0 program.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pelvic Floor Muscle Training vs. Pilates Exercises for Urinary Incontinence

NCT07212478

Urinary Incontinence , Stress

RECRUITING NA

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

NCT05409014

Urinary Incontinence Pelvic Floor Disorders Quality of Life

UNKNOWN NA

Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence

NCT03500185

Urinary Incontinence

COMPLETED NA

Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy

NCT02549729

Weak; Pelvic Floor Weak; Muscle Urinary Incontinence

COMPLETED NA

Effects of Training of Pelvic Floor Muscles (MAP) on Stress Urinary Incontinence

NCT03203798

Stress Urinary Incontinence

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The sample will be composed of 40 women in the post-menopausal period, that is, who are at least one year without menstruating, and who are aged between 50 and 70 years. The sample size calculation for this study was performed using the Bioestat 5.3 program (Mamirauá Institute, Amazonas, Brazil), taking into account the values of the ICIQ\_SF instrument (name in English), made available in a previous study (SCHRADER et al., 2017). In this case, the post-intervention mean and standard deviation between the Pilates group (1.0 ± 1.15) and TMAP (3.42 ± 3.4) were used, with test power at 80% and alpha value at 0.05, which generated the need for 17 participants in each group. In order to meet eventual sample losses, 15% of participants will be added in each group, thus totaling 20 women in the Pilates group and 20 in the TMAP group.

The descriptive analysis of the data will be expressed in the form of mean, standard deviation and percentage delta of the difference. The verification of normality will occur by the Shapiro Wilk test. To verify if there are differences between the groups regarding the initial characteristics (age, weight, height and BMI), at the pre-intervention moment, the Student's t test will be used for independent samples or the Mann Whitney U test, in case the data show parametric or nonparametric distribution, respectively. For comparison between groups in the post-intervention ANCOVA will be used, with baseline data being used as covariates. If the data present a non-parametric characteristic, the comparison between the groups will be made using the Mann-Whitney U test, considering the difference between pre and post-intervention. The admitted confidence interval will be 95% (p\<0.05). The data will be processed in the SPSS 25.0 program. Effect sizes (Cohen's d) will be calculated and considered small (0.20), medium (0.50) or large (0.80). For effect size calculations, the program GPower 3.1 (Franz Faul, Universitat Kiel, Germany) will be used.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The interventions will last for twelve weeks, three times a week, for one hour, on non days consecutive.

The Pilates exercises group will perform stretching and strengthening exercises in a single series of 10 repetitions, totaling 10 exercises aimed at the main muscle groups.

The Pelvic floor muscle training group will consist of 10 maximal voluntary contractions that must be maintained for at least 6 seconds (participants will be encouraged to sustain the maximal contraction for a longer time each week). The interval time between contractions will be the same seconds as the contraction. Participants will perform 4 sets of 10 contractions, and at the end of each set of 10 contractions, five fast contractions will be performed. Each series will be performed in one position: 1st lying in lateral decubitus, 2nd sitting, 3rd on all fours and 4th standing.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The randomization of the sample will be confidential. A professional in the field who is unaware of the study and the participants will perform the draw through random numbers that will distribute the participants into two groups: Pelvic Floor Muscle Training Group (TMAP) (n= 20) and Pilates Exercise Group (PE) (n= 20). This same professional will deliver the answers in opaque envelopes, which will be sealed and contain the answer. Participants will be duly informed that they can be allocated to either of the two groups at the time of recruitment and selection and, in addition, the participants and the responsible researchers will know in which group each woman will participate at the time of delivery of the envelopes.

The evaluations will be carried out before and after three months of interventions, by the same professionals, experienced in these evaluations, who will be blind to the participants.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pelvic floor muscle training (PFMT)

For the intervention of the PFMT group, which is non-invasive, a physical therapist experienced in this type of training will carry out the sessions, which will be individualized, in a specific room for care ocused on pelvic physiotherapy, with a stretcher, air conditioning and a lock on the door, for the patient to feel safe.

Group Type ACTIVE_COMPARATOR

PFMT

Intervention Type OTHER

The PFMT will consist of 10 maximum voluntary contractions that must be maintained for at least 6 seconds. Participants will be encouraged to sustain the maximum contraction for a longer time each week. The interval time between contractions will be the same seconds as the contraction. Participants will perform 4 sets of 10 contractions, and at the end of each set of 10 contractions, five fast contractions will be performed. Each series will be performed in one position: lying in lateral decubitus; seated; on all fours and standing.

Pilates exercises (PE)

For the intervention of the PE group, in the first week the protocol will be used to familiarize the participants with the exercises, where the correct execution of the movements will be demonstrated and each principle of the method will be explained: concentration, centralization, precision, breathing, control and fluidity; and for familiarization with the correct voluntary contraction of the PFM. Participants in the PE group will be instructed and reminded to voluntarily contract the PFM during each repetition of the Pilates strengthening exercises. During the stretching exercises, the participant will be instructed not to perform the contraction. The springs will be changed according to the evolution of the participants, by replacing them with a spring of greater resistance. Basic equipment such as: Cadillac Trapezio, Combo Chair, Universal Reformer, Ladder Barrel and Wall Unit will be used.

Group Type EXPERIMENTAL

PE

Intervention Type OTHER

The PE group will be instructed and reminded to voluntarily contract the PFMs during each repetition of the Pilates strengthening exercises. During the stretching exercises, the participant will be instructed not to perform the contraction.

The stretching and strengthening exercises will be performed in a single series of 10 repetitions, totaling 10 exercises aimed at the main muscle groups.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PFMT

The PFMT will consist of 10 maximum voluntary contractions that must be maintained for at least 6 seconds. Participants will be encouraged to sustain the maximum contraction for a longer time each week. The interval time between contractions will be the same seconds as the contraction. Participants will perform 4 sets of 10 contractions, and at the end of each set of 10 contractions, five fast contractions will be performed. Each series will be performed in one position: lying in lateral decubitus; seated; on all fours and standing.

Intervention Type OTHER

PE

The PE group will be instructed and reminded to voluntarily contract the PFMs during each repetition of the Pilates strengthening exercises. During the stretching exercises, the participant will be instructed not to perform the contraction.

The stretching and strengthening exercises will be performed in a single series of 10 repetitions, totaling 10 exercises aimed at the main muscle groups.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being naturally post-menopause (at least one year without menstruating);
* Demonstrate independence to carry out activities of daily living;
* Have a report of urinary loss when performing physical exertion.

Exclusion Criteria

* Women who have had hysterectomy or oophorectomy surgery;
* Women who underwent cancer treatment with hormone therapy;
* Present cognitive deficits or neurological diseases;
* Practice any type of physical activity regularly in the last six months;
* Present inability to hire PFM (Oxford Scale \< 1);
* Report pain or discomfort in the vulva or vagina;
* Present dyspareunia, vaginismus or pelvic organ prolapse greater than grade II in the Baden-Walker classification;
* Present symptoms of urinary infection at the time of evaluation;
* Have participated in previous pelvic floor reeducation programs.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes