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Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercises
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic floor, pelvic organ prolapse

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

PFMT group

HE + PFM group

HE group

Control

Arm Description

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

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

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

Women who undergo to a session for lifestyle advice.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 1, 2010
Last Updated
September 7, 2010
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01196598
Brief Title
Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse
Official Title
Impact of Pelvic Floor Muscle Training and Hypopressive Exercises in Women With Pelvic Organ Prolapse: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pelvic floor, pelvic organ prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PFMT group
Arm Type
Active Comparator
Arm Description
Women who undergo to three months of a pelvic floor muscle training program.
Arm Title
HE + PFM group
Arm Type
Active Comparator
Arm Description
Women who undergo to three months of a hypopressive exercises plus pelvic floor muscle contraction program.
Arm Title
HE group
Arm Type
Active Comparator
Arm Description
Women who undergo to three months of a hypopressive exercises program.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Women who undergo to a session for lifestyle advice.
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
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 Outcome Measure Information:
Title
Pelvic floor muscle changes
Description
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.
Time Frame
3 months after the begining of treatment
Secondary Outcome Measure Information:
Title
Pelvic Organ Prolapse changes
Description
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.
Time Frame
3 months after the begining of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Paula M. Resende
Organizational Affiliation
Post graduate student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
30311680
Citation
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.
Results Reference
derived
PubMed Identifier
22344353
Citation
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.
Results Reference
derived

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Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse

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