Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse

Study Overview
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Brief Summary
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To verify if pelvic floor muscle training program and/or a hypopressive exercise program could improve women with stage II of pelvic organ prolapse, their symptoms or pelvic floor muscle strength.

Detailed Description
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To verify if three months of an exercise program could improve stage II of pelvic organ prolapse, as a conservative treatment.

Official Title
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Impact of Pelvic Floor Muscle Training and Hypopressive Exercises in Women With Pelvic Organ Prolapse: Randomized Controlled Trial

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Other: Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with stage II of pelvic organ prolapse, preferably symptomatic and not to be submitted to surgery to correct pelvic organ prolapse during the study Exclusion Criteria: Neuromuscular diseases and use of hormonal therapy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PFMT group<br>Women who undergo to three months of a pelvic floor muscle training program. | Other: Exercises<br>* Three individual initial sessions for learn about pelvic floor muscle localization and function; receive lifestyle advice and practice the exercises correctly. The control group receive only lifestyle advice. Followed by three months of home training with appointments each two weeks with physiotherapist.<br>|
| Active Comparator: HE + PFM group<br>Women who undergo to three months of a hypopressive exercises plus pelvic floor muscle contraction program. | Other: Exercises<br>* Three individual initial sessions for learn about pelvic floor muscle localization and function; receive lifestyle advice and practice the exercises correctly. The control group receive only lifestyle advice. Followed by three months of home training with appointments each two weeks with physiotherapist.<br>|
| Active Comparator: HE group<br>Women who undergo to three months of a hypopressive exercises program. | Other: Exercises<br>* Three individual initial sessions for learn about pelvic floor muscle localization and function; receive lifestyle advice and practice the exercises correctly. The control group receive only lifestyle advice. Followed by three months of home training with appointments each two weeks with physiotherapist.<br>|
| Active Comparator: Control<br>Women who undergo to a session for lifestyle advice. | Other: Exercises<br>* Three individual initial sessions for learn about pelvic floor muscle localization and function; receive lifestyle advice and practice the exercises correctly. The control group receive only lifestyle advice. Followed by three months of home training with appointments each two weeks with physiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle changes | Digital palpation - Evaluates the pelvic floor muscle contraction and assign values according to scales: Oxford (previously validated) and muscular endurance (measured in seconds) Surface electromyography - evaluates the electrical activity generated by activation of motor units of pelvic floor muscles - during the rest and during the maximum voluntary contraction 2D perineal ultrasound - evaluates the cross sectional area of levator ani muscle. | 3 months after the begining of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Organ Prolapse changes | Quantification of stage of pelvic organ prolapse. Measured during gynecology exam by pelvic organ prolapse quantification (POP-Q)exam. Measure of changes in symptoms of pelvic organ prolapse using a questionnaire. | 3 months after the begining of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic floor, pelvic organ prolapse