Clinical trial NCT05446792: Comparison Between Pelvic Muscle Training and Pilates Exercises for UI in Postmenopausal Women
Official title: Comparison Between Pelvic Floor Muscle Training and Pilates Exercises on Urinary Incontinence in Postmenopausal Women: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Post-menopause
Pilates
Muscle training of pelvic floor
Lead sponsor: Universidade Estadual do Norte do Parana
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: International Consultation of Urinary questionnaire Incontinence Short Form (ICIQ-UI-SF)
timeFrame: 3 months
measure: Pad-test
timeFrame: 3 months
measure: Voiding diary
timeFrame: 3 months
measure: Manometric assessment of muscle strength and PFM endurance
timeFrame: 3 months
measure: PERFECT test
timeFrame: 3 months
Secondary outcomes:
measure: FSFI Questionnaire (Female Sexual Function Index)
timeFrame: 3 months
measure: Feeling Scale - Pleasure and displeasure during exercise
timeFrame: 3 months
Other outcomes:
Locations:
city: Jacarezinho
country: Brazil
facility: Universidade Estadual do Norte do Paraná
state: Paraná
Study officials:
affiliation: Universidade Estadual do Norte do Paraná
name: Laís C Oliveira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Estadual do Norte do Paraná
name: Raphael G Oliveira, PhD
role: STUDY_CHAIR
References:
citation: de Andrade RL, Bo K, Antonio FI, Driusso P, Mateus-Vasconcelos ECL, Ramos S, Julio MP, Ferreira CHJ. An education program about pelvic floor muscles improved women's knowledge but not pelvic floor muscle function, urinary incontinence or sexual function: a randomised trial. J Physiother. 2018 Apr;64(2):91-96. doi: 10.1016/j.jphys.2018.02.010. Epub 2018 Mar 21.