Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse

Not Applicable

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: Exercises

• Registration Number: NCT01196598
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

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

Study Timeline

• Study Start: 2008-01
• Status Verified: 2010-08
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-07
• Last Update Submitted: 2010-09-07
• Study First Posted: 2010-09-08
• Last Update Posted: 2010-09-08
• Primary Completion: 2010-10
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Exercises	Women who undergo to a session for lifestyle advice.
PFMT group	Exercises	Women who undergo to three months of a pelvic floor muscle training program.
HE + PFM group	Exercises	Women who undergo to three months of a hypopressive exercises plus pelvic floor muscle contraction program.
HE group	Exercises	Women who undergo to three months of a hypopressive exercises program.

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle changes	3 months after the begining of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse changes	3 months after the begining of treatment	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.

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil