Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse

NCT ID: NCT01196598

Last Updated: 2010-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-01-31

Brief Summary

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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

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

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PFMT group

Women who undergo to three months of a pelvic floor muscle training program.

Group Type ACTIVE_COMPARATOR

Exercises

Intervention Type OTHER

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.

HE + PFM group

Women who undergo to three months of a hypopressive exercises plus pelvic floor muscle contraction program.

Group Type ACTIVE_COMPARATOR

Exercises

Intervention Type OTHER

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.

HE group

Women who undergo to three months of a hypopressive exercises program.

Group Type ACTIVE_COMPARATOR

Exercises

Intervention Type OTHER

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.

Control

Women who undergo to a session for lifestyle advice.

Group Type ACTIVE_COMPARATOR

Exercises

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Federal University of São Paulo

Principal Investigators

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Ana Paula M. Resende

Role: PRINCIPAL_INVESTIGATOR

Post graduate student

Locations

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Federal University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Resende APM, Bernardes BT, Stupp L, Oliveira E, Castro RA, Girao MJBC, Sartori MGF. Pelvic floor muscle training is better than hypopressive exercises in pelvic organ prolapse treatment: An assessor-blinded randomized controlled trial. Neurourol Urodyn. 2019 Jan;38(1):171-179. doi: 10.1002/nau.23819. Epub 2018 Oct 12.

Reference Type DERIVED
PMID: 30311680 (View on PubMed)

Bernardes BT, Resende AP, Stupp L, Oliveira E, Castro RA, Bella ZI, Girao 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. doi: 10.1590/s1516-31802012000100002.

Reference Type DERIVED
PMID: 22344353 (View on PubMed)

Other Identifiers

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1978/07

Identifier Type: -

Identifier Source: org_study_id