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Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01196598
First received: September 1, 2010
Last updated: September 7, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
 Other: Exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Pelvic Floor Muscle Training and Hypopressive Exercises in Women With Pelvic Organ Prolapse: Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pelvic floor muscle changes [ Time Frame: 3 months after the begining of treatment ] [ Designated as safety issue: No ]

    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:
  • Pelvic Organ Prolapse changes [ Time Frame: 3 months after the begining of treatment ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 84
Study Start Date: January 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PFMT group
Women who undergo to three months of a pelvic floor muscle training program.
 Other: Exercises

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.
Active Comparator: HE + PFM group
Women who undergo to three months of a hypopressive exercises plus pelvic floor muscle contraction program.
 Other: Exercises

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.
Active Comparator: HE group
Women who undergo to three months of a hypopressive exercises program.
 Other: Exercises

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.
Active Comparator: Control
Women who undergo to a session for lifestyle advice.
 Other: Exercises

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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196598

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Ana Paula M. Resende Post graduate student
  More Information

No publications provided by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ana Paula Magalhães Resende, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01196598     History of Changes
Other Study ID Numbers: 1978/07
Study First Received: September 1, 2010
Last Updated: September 7, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
pelvic floor
pelvic organ prolapse

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013