Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01196598
• Other study ID #: 1978/07
• Status: Active, not recruiting
• Phase: N/A
• First received: September 1, 2010
• Last updated: September 7, 2010
• Start date: January 2008
• Est. completion date: January 2011

Study information

• Verified date: August 2010
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No