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

September 1, 2010
September 7, 2010
January 2008
October 2010   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01196598 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse
Impact of Pelvic Floor Muscle Training and Hypopressive Exercises in Women With Pelvic Organ Prolapse: Randomized Controlled Trial

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pelvic Organ Prolapse
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: PFMT group
    Women who undergo to three months of a pelvic floor muscle training program.
    Intervention: Other: Exercises
  • Active Comparator: HE + PFM group
    Women who undergo to three months of a hypopressive exercises plus pelvic floor muscle contraction program.
    Intervention: Other: Exercises
  • Active Comparator: HE group
    Women who undergo to three months of a hypopressive exercises program.
    Intervention: Other: Exercises
  • Active Comparator: Control
    Women who undergo to a session for lifestyle advice.
    Intervention: Other: Exercises
Bernardes BT, Resende AP, Stüpp L, Oliveira E, Castro RA, Bella ZI, Girão MJ, Sartori MG. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial. Sao Paulo Med J. 2012;130(1):5-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
84
January 2011
October 2010   (final data collection date for primary outcome measure)

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
Female
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01196598
1978/07
No
Ana Paula Magalhães Resende, Federal University of São Paulo
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Ana Paula M. Resende Post graduate student
Federal University of São Paulo
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP