Overview

This trial is active, not recruiting.

Condition pelvic organ prolapse
Treatment exercises
Sponsor Federal University of São Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date January 2008
End date October 2010
Trial size 84 participants
Trial identifier NCT01196598, 1978/07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Women who undergo to three months of a pelvic floor muscle training program.
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)
Women who undergo to three months of a hypopressive exercises plus pelvic floor muscle contraction program.
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)
Women who undergo to three months of a hypopressive exercises program.
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)
Women who undergo to a session for lifestyle advice.
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.

Primary Outcomes

Measure
Pelvic floor muscle changes
time frame: 3 months after the begining of treatment

Secondary Outcomes

Measure
Pelvic Organ Prolapse changes
time frame: 3 months after the begining of treatment

Eligibility Criteria

Female participants from 40 years up to 70 years old.

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

Additional Information

Official title Impact of Pelvic Floor Muscle Training and Hypopressive Exercises in Women With Pelvic Organ Prolapse: Randomized Controlled Trial
Principal investigator Ana Paula M. Resende
Description To verify if three months of an exercise program could improve stage II of pelvic organ prolapse, as a conservative treatment.
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.