Comparison Between Pelvic Muscle Training and Pilates Exercises for UI in Postmenopausal Women
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): PFMT; PE
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post-menopause; Pilates; Muscle training of pelvic floor