Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence

Study Overview
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Brief Summary
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The Investigators decided to examine whether the Paula method is more effective than Pelvic Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. In addition to the pad test and two urinary incontinence questionnaires, we will use other assessment tools such as; quality of life and sexual function which have been found to correlate significantly with pad test results. These results may indicate that menopausal women with Stress Urinary Incontinence may be more successful controlling incontinence if they will practice the Paula method as compared to PFMT.

Official Title
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The Effectiveness of Circular Muscle Exercise (the Paula Method) as Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence (SUI) in Menopausal Women: A Randomized Controlled Trial

Conditions
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Stress Urinary Incontinence, Sexual Satisfaction, Quality of Life

Intervention / Treatment
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* Behavioral: Paula Method
* Behavioral: Pelvic Floor Muscle Training (PFMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women after menopause (12 months with no period) aged 40 or more have a positive pad test leakage of 1-50 grams no systemic or local hormonal therapy literate in Hebrew and/or English Exclusion Criteria: women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders) pelvic surgery within the last 6 months post hysterectomy or oophorectomy genital prolapse grade 3 or higher

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic Floor Muscle Training (PFMT)<br> | Behavioral: Pelvic Floor Muscle Training (PFMT)<br>* All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list .<br>|
| Active Comparator: Paula Method<br> | Behavioral: Paula Method<br>* All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the quantity of urinary leakage, measured by the one hour pad test | To examine whether the Paula method intervention is more effective than PFMT in reducing urinary leakage in menopausal women with SUI | 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID |  | 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention | 
| improvement of sexual function | To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI | 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention | 
| improvement of quality of life | To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI | 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention |