Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence

Study Overview
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Brief Summary
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The present study is a clinical intervention applied to patients with urinary incontinence, with the intention of verifying the effects of the Pilates method associated or not with photobiomodulation with static magnetic field. The sample will consist of women with stress urinary incontinence from Bento Gonçalves attended at the school clinic of Faculdade Cenecista de Bento Gonçalves.

Official Title
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Pilates Method and/or Photobiomodulation Therapy Combined to Static Magnetic Field in Women With Stress Urinary Incontinence: What is Better?

Conditions
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Laser Therapy, Urinary Incontinence,Stress, Pilates Method

Intervention / Treatment
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* Other: Pilates
* Other: Photobiomodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 30 and 60 years old; Present a clinical diagnosis of SUI; The patient must be available at pre-scheduled times for a period of 12 weeks, with full participation; The participant must agree with the methodology proposed by the project and, if so, must sign the TCLE as legal proof of their participation. Exclusion Criteria: Patients with urge urinary incontinence; Constant flow urinary incontinence and stress urinary incontinence during the gestational period (because these are possible transitory cases due to pregnancy); Women who have difficulty in understanding; Patients who have more than one absence per month during the interventions.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilates PBMT<br>This group will receive training in the Pilates method associated with the effective application of photobiomodulation. | Other: Pilates<br>* The solo Pilates method will be applied twice a week for 12 weeks using the following exercises: 20 Breaths, Double leg stretch, Single leg stretch, Leg circles, Hip lift on ball, Abdominal tightening on ball, Alternating two supports, Side bend, Side kick - side kick, Side kicks, Shell and Swan and Neck pull stretches; in the tenth session, we evolved some exercises: The saw, Swan dive, Book close series, Hip lift on the ball and Front pulls; in the eighteenth session we changed again some exercises for: Leg pull back, Rolling like a Ball, Swimming, Roll over and Leg pull front.<br>* Other names: Pilates Methods;Other: Photobiomodulation<br>* Applications of FBM or placebo (MR4 ACTIVet PRO Laser Shower Portable, MRM, USA) will last for 115s and will deliver 60 J at each point. The mode of application, with the patient supine on a stretcher, with the grouping probe held stationary in contact with the skin, at a 90-degree angle, in the pubic mound and in the perineum region.<br>|
| Experimental: Pilates<br>This group will receive training in the Pilates method associated with the not effective (placebo) application of photobiomodulation. | Other: Pilates<br>* The solo Pilates method will be applied twice a week for 12 weeks using the following exercises: 20 Breaths, Double leg stretch, Single leg stretch, Leg circles, Hip lift on ball, Abdominal tightening on ball, Alternating two supports, Side bend, Side kick - side kick, Side kicks, Shell and Swan and Neck pull stretches; in the tenth session, we evolved some exercises: The saw, Swan dive, Book close series, Hip lift on the ball and Front pulls; in the eighteenth session we changed again some exercises for: Leg pull back, Rolling like a Ball, Swimming, Roll over and Leg pull front.<br>* Other names: Pilates Methods;|
| Placebo Comparator: PBMT<br>This group will receive effective application of photobiomodulation and will not perform the pilates method training | Other: Photobiomodulation<br>* Applications of FBM or placebo (MR4 ACTIVet PRO Laser Shower Portable, MRM, USA) will last for 115s and will deliver 60 J at each point. The mode of application, with the patient supine on a stretcher, with the grouping probe held stationary in contact with the skin, at a 90-degree angle, in the pubic mound and in the perineum region.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreased urinary loss | PAD test | 01, 09, 17 and 24 day of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| single-digital vaginal touch | Muscle strength will be assessed through the unidigital vaginal touch, applied by a blind evaluator, so called because she does not monitor the performance of the interventions, as well as their respective evolutions during treatment, this assessment is subjective and will be classified by the scale of Modified Oxford (scale with a score between 0-5; 0- absence of muscle response, 1- Outline of non-sustained contraction; 2- presence of small intensity contraction, but which is sustained; 3- moderate contraction, felt as an increase in intravaginal pressure, which compresses the examiner's fingers with a small cranial elevation of the vaginal wall; 4- satisfactory contraction, which squeezes the examiner's fingers with elevation of the vaginal wall towards the pubic symphysis; 5- strong contraction, firm compression of the fingers of the examiner with positive movement towards the pubic symphysis). | 01 and 24 day of intervention. | 
| International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) | The ICIQ-SF is a questionnaire used to assess urinary incontinence, consisting of six questions that assess the frequency, severity of urinary loss and the impact of urinary incontinence on daily life, in addition to a sequence of eight self-diagnostic items, related to causes or incontinence situations that are not scored. The sum of the scores for questions three, four and five ranges from 0 to 21, and the higher the total score, the greater the severity of urinary incontinence. The impact of daily life is defined according to the score of question five; (0) not at all, (1-3) mild, (4-6) moderate, (7-9) severe, and (10) very severe. | 01 and 24 day of intervention. |