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

Universidade Estadual do Norte do Parana

Status: Completed

Conditions: Urinary Incontinence

Treatments: Other: PE; Other: PFMT

Study type: Interventional

Funder types: Other

Identifiers

NCT05446792

TMAP X Pilates in the UI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Pelvic floor muscle training (PFMT)

Active Comparator group

Description:

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.

Treatment:

Other: PFMT

Pilates exercises (PE)

Experimental group

Description:

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.

Treatment:

Other: PE