Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence

Study Overview
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Brief Summary
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This study evaluates the action of the pelvic floor muscle training with and without EMG Biofeddback in the treatment of stress urinary incontinence in menopausal, peri and post menopausal women and their quality of life before and after the interventions.

Detailed Description
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The Pelvic floor muscle training has been the first line of choice in the treatment of Stress Urinary Incontinence. The goal of this technique is increasing the strength and function of the pelvic floor which aims to support the pelvic viscera, as well as part of their duties, such as locks sphincter muscles. Risk factors such as advanced age, obesity, multiple pregnancy, can cause a woman to present urinary incontinence (SUI), where the main cause is the dysfunction of the pelvic floor muscles and the lack of awareness of these muscles as well as biomechanical problems. Some studies describe the use of EMG biofeedback to assess and improve the function of the pelvic floor muscles, however, the studies are not yet conclusive about the action of adding this equipment in the treatment of SUI. In this regard, the EMG Biofeedback has the ability to physiologically evaluate these disorders and perform a faster treatment for these patients, improving their quality of life. The EMG has the ability to monitor and measure the progression of activation of the pelvic floor muscles, giving feedback to the patient and therapist about the actual condition of muscle function.

Official Title
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Evaluating the Effectiveness of Pelvic Floor Muscle Training With and Without EMG Biofeedback and Quality of Life in Peri and Postmenopausal Women With Stress Urinary Incontinence.

Conditions
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Menopause, Urinary Incontinence, Stress

Intervention / Treatment
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* Other: Pelvic floor muscle training
* Other: Eletromyography Biofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Will be included in this study: all women, spontaneous free will, have knowledge of research and sign the Instrument of Consent -TCLE. Menopausal women, pre and post-menopause, urinary incontinence with the effort Exclusion Criteria: Will be excluded from the study: patients with neurological, cardiovascular, rheumatologic diseases, diabetes mellitus, chronic lung disease, rheumatoid arthritis, Enhlers-danlos, Sexually Transmitted Diseases (STDs), do not submit annual gynecological exams.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic Floor Muscle Training(PFMT)<br>The conducted training by two groups, consisting of phasic contractions (3 sets of 10 repetitions of maximal contraction for two seconds to double or triple rest), endurance (two sets of six repetitions of sustained contractions of 6-10 seconds with the same rest time) and training effort, requesting the anticipated contraction of the abdominal pelvic floor coughing effort. We used the same protocol in the supine position, sitting and standing, as evolution of the patient. Both were treated 2 times per week, 20 minutes, totaling 8 sessions. | Other: Pelvic floor muscle training<br>* assessment and intervention group with a training of the pelvic floor muscles, another group with training of the pelvic floor muscles and electromyographic biofeedback and a control group will be held. All groups respond to a questionnaire of quality of life. At the end, all groups will be reassessed and compare the effectiveness of interventions between groups.<br>|
| Active Comparator: EMG Biofeedback treatment<br>In this group, the same protocol of the TMAP will be held, however, emg biofeedback is used during training for 20 minutes, 2 times a week, 8 sessions. | Other: Pelvic floor muscle training<br>* assessment and intervention group with a training of the pelvic floor muscles, another group with training of the pelvic floor muscles and electromyographic biofeedback and a control group will be held. All groups respond to a questionnaire of quality of life. At the end, all groups will be reassessed and compare the effectiveness of interventions between groups.<br>Other: Eletromyography Biofeedback<br> <br> |
| No Intervention: no treatment<br>In this group, will be held only the initial assessment, you will not receive treatment for a month and will be reevaluated after being serviced this period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pelvic floor muscle strength with Oxford Scale | The evaluation consists in bidigital intravaginal test which evaluates the pelvic floor muscle strength using the following 0-5 scale, where 0 = no contraction and 5 = maximal contraction with support against gravity The graduates range from 0 - 5 = 0 has no muscle contraction, 1 = outline of muscle contraction, 2 = contracts without support against gravity, 3 = contracts and holds little against gravity, 4 = contracts and holds up to 6 seconds against gravity and 5 = contracts and holds more than 6 seconds against gravity ntravaginal bidigital test that evaluates scale of pelvic floor muscle strength. The graduates range from 0 - 5 = 0 has no muscle contraction, 1 = outline of muscle contraction, 2 = contracts without support against gravity, 3 = contracts and holds little against gravity, 4 = contracts and holds up to 6 seconds against gravity and 5 = contracts and holds more than 6 seconds against gravity | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The myoelectric activity evaluation of the pelvic floor | The myoelectric activity evaluation of the pelvic floor [Time Frame: 1month] [Safety Issue: No] assessment of myoelectric record by EMG biofeedback through an intra-cavity disposable electrode which evaluates the initial and final rest in 60 seconds, the average of three maximal voluntary contractions, time of sustained contraction, number of peaks of contraction in 10 seconds and the test effort requesting cough | 1month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Stress Urinary Incontinence, EMG Biofeedback, Pelvic Floor Muscle Training, Quality of life, Physical Therapie