Pelvic Floor Muscle Training vs. Pilates Exercises for Urinary Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PFMT, Pilates exercises.
- Who it may be relevant to
- Registry conditions: Urinary Incontinence , Stress. Basic parameters: 50 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Between Pelvic Floor Muscle Training and Pilates Exercises for Postmenopausal Women With Urinary Incontinence
Overview
Urinary incontinence (UI) affects approximately 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PFMT) is considered the gold standard for this condition. However, other exercise options have been studied, such as Pilates exercises, which focus on stabilizing muscles and require voluntary contraction of the pelvic floor muscles. The literature remains inconclusive regarding the effects of Pilates exercises on urinary incontinence and pelvic floor muscle function. Objective: To compare the effects of 3 months of muscle training, through PFMT and Pilates exercises, on improving UI in postmenopausal women. Methods: Twenty-four postmenopausal women with urinary incontinence will be randomized into two intervention groups: pelvic floor muscle training and mat Pilates exercises. Assessments will be conducted before and after three months of intervention and will include the following instruments: urinary incontinence and quality of life, assessed using the International Consultation of Urinary Incontinence Short Form (ICIQ-UI-SF) questionnaire; a 7-day voiding diary to identify potential modifiable factors related to urination and its frequency; a Pad test to identify and quantify UI; the Female Sexual Function Index to assess female sexual function; and pelvic floor muscle strength and endurance by bidigital palpation using the PERFECT test. Shapiro-Wilk tests will be used to assess normality, Student's t-test or Mann-Whitney U test according to parametric or nonparametric distribution, and ANCOVA will be used to compare groups post-intervention, considering a 95% confidence interval (p\<0.05). Data will be processed using SPSS 25.0.
Detailed description
The sample will consist of 24 postmenopausal women, that is, who have not menstruated for at least one year and are between 50 and 70 years of age. The sample size was determined by a sample calculation performed in the Bioestat 5.3 program (Mamirauá Institute, Amazonas, Brazil), taking into account the values of the ICIQ\_SF (International Consultation on Incontinence Questionnaire - Short Form) instrument, made available in a previous study (SCHRADER et al., 2017). In this case, the post-intervention mean and standard deviation between the Pilates (8.71 ± 2.98) and PFMT (5.14 ± 2.73) groups were used, with the test power at 80% and an alpha value of 0.05, which generated the need for 10 participants in each group. To account for potential sample losses, 15% of participants were added to each of the two groups, totaling 12 women in each group.
Descriptive data analysis will be expressed as mean, standard deviation, and delta percentage difference. Normality will be verified using the Shapiro-Wilk test. To assess for differences between groups regarding baseline characteristics (age, weight, height, and BMI) at the pre-intervention stage, the Student's t-test for independent samples or the Mann-Whitney U test will be used if the data present a parametric or nonparametric distribution, respectively. For comparison between groups post-intervention, ANCOVA will be used, with baseline data used as covariates. If the data present nonparametric characteristics, the comparison between groups will be made using the Mann-Whitney U test, considering the difference between pre- and post-intervention. The accepted confidence interval will be 95% (p\<0.05). Data will be processed using SPSS 25.0. 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 GPower 3.1 program (Franz Faul, Universitat Kiel, Germany) will be used.
Interventions
- Other PFMT
O PFMT consistirá em 10 contrações voluntárias máximas que devem ser mantidas por pelo menos 6 segundos. Os participantes serão incentivados a sustentar a contração máxima por um tempo maior a cada semana. O intervalo entre as contrações será de segundos. Os participantes realizarão 4 séries de 10 contrações e, ao final de cada série de 10 contrações, serão realizadas cinco contrações rápidas. Cada série será realizada em uma posição: deitado em decúbito lateral; sentado; de quatro apoios e em p - Other Pilates exercises
The Pilates group will perform 10 solo exercises, containing stretching and strengthening for the main muscle groups, with a single series of 10 repetitions.
Primary outcome measures
- Voiding diary [Time frame: 12 weeks]
- International Consultation of Urinary questionnaire Incontinence Short Form (ICIQ-UI-SF) [Time frame: 12 weeks]
- PERFECT test [Time frame: 12 weeks]
- FSFI Questionnaire (Female Sexual Function Index) [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Laís Campos de Oliveira — Jacarezinho
Identifiers
NCT: NCT07212478 · 5.264.703