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Electrical Stimulation and Vaginal Palpation in Pelvic Floor Muscles Awareness

Primary Purpose

Pelvic Floor Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transvaginal electrical stimulation
Palpation
Palpation with posterior pelvic tilt
Control
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring Pelvic Floor, Physical Therapy Specialty, Awareness, Electric Stimulation, Palpation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women with age greater than or equal 18 years; Women with pelvic floor muscle function graded 0 and 1 measured by Oxford Modified Scale; Women who voluntarily consente to participate in research.

Exclusion Criteria:

Women with associated neurological pathologies; Women with symptoms of vaginal or urinary tract infection; Women with pelvic organs prolapse graded greater than 2; Pregnancy suspected or confirmed; Cognitive deficit that impedes or impair the procedure.

Sites / Locations

  • Clinical Hospital of Faculty of Medicine of Ribeirão PretoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Transvaginal electrical stimulation

Palpation

Palpation with posterior pelvic tilt

Control group

Arm Description

Patients treated with transvaginal electrical stimulation.

Patients treated with vaginal palpation.

Patients treated with vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles.

Patients receive verbal instructions related to the pelvic floor and its contraction.

Outcomes

Primary Outcome Measures

Change from baseline in the PFM awareness
The transvaginal electrical stimulation, vaginal palpation, and vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles improve the results in the acquisition of contraction capacity of PFM when compared to controls that receive verbal instructions related to the PFM. The improvement will be assessed through the increase of the grade of vaginal palpation measured by Oxford Modified Scale and through the increase of values of the perineometry and surface eletromyography.

Secondary Outcome Measures

Change from baseline in the sexual function
The improvement of PFM awareness will increase the sexual function of the women studied measured by the increase the score index of FSFI.

Full Information

First Posted
February 1, 2014
Last Updated
February 11, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02062242
Brief Title
Electrical Stimulation and Vaginal Palpation in Pelvic Floor Muscles Awareness
Official Title
Electrical Stimulation and Vaginal Palpation in the Pelvic Floor Muscles Awareness: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of transvaginal electrical stimulation, vaginal palpation, and vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles in the acquisition of ability to contract the pelvic floor muscles (PFM), as well as to evaluate the sexual function of women studied.
Detailed Description
Many women does not know to contract the PFM voluntarily favoring the development of disorders such as urinary and fecal incontinence, pelvic organ prolapse and sexual disorders. However there are no studies in the literature that address the application of therapeutic resources available to improve the PFM awareness. The objective of this study is to evaluate the effectiveness of transvaginal electrical stimulation, vaginal palpation, vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles in the acquisition of ability to contract the PFM, as well as to evaluate the sexual function of women studied. One hundred twenty women with PFM function graded 0 and 1 measured by Oxford Modified Scale will be submitted at random to physical therapy with transvaginal electrical stimulation, vaginal palpation, vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles (glutes and hip adductors) and the control group who receive verbal instructions related to the pelvic floor and its contraction. For the evaluation of the sexual function will be applied the Female Sexual Function Index (FSFI). The patients will be assessed by vaginal palpation, perineometry and surface electromyography before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
Pelvic Floor, Physical Therapy Specialty, Awareness, Electric Stimulation, Palpation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transvaginal electrical stimulation
Arm Type
Experimental
Arm Description
Patients treated with transvaginal electrical stimulation.
Arm Title
Palpation
Arm Type
Experimental
Arm Description
Patients treated with vaginal palpation.
Arm Title
Palpation with posterior pelvic tilt
Arm Type
Experimental
Arm Description
Patients treated with vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Patients receive verbal instructions related to the pelvic floor and its contraction.
Intervention Type
Other
Intervention Name(s)
Transvaginal electrical stimulation
Intervention Description
The current employed is biphasic and the stimulation parameters are: frequency of 50 Hz, pulse width of 200 microseconds, contraction time (Ton) of 5 seconds and relaxation time (Toff) of 10 seconds. The current intensity is defined according to the tolerance of patient and the total stimulation time is 20 minutes.
Intervention Type
Other
Intervention Name(s)
Palpation
Intervention Description
The patient is positioned supine with the lower limbs bent and feet flat on the stretcher. The examiner will hold vaginal palpation and to request her the contraction of PFM. It will be requested 3 sets of 10 contractions with a rest period between contractions. There are two minutes a rest period between sets.
Intervention Type
Other
Intervention Name(s)
Palpation with posterior pelvic tilt
Intervention Description
The patient is positioned supine with the lower limbs bent and feet flat on the stretcher. The examiner will hold vaginal palpation and to request her the contraction of PFM associated with posterior pelvic tilt and contraction of accessory muscles. It will be requested 3 sets of 10 contractions with a rest period between contractions. There are two minutes a rest period between sets.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The patient receive verbal instructions related to the pelvic floor and its contraction.
Primary Outcome Measure Information:
Title
Change from baseline in the PFM awareness
Description
The transvaginal electrical stimulation, vaginal palpation, and vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles improve the results in the acquisition of contraction capacity of PFM when compared to controls that receive verbal instructions related to the PFM. The improvement will be assessed through the increase of the grade of vaginal palpation measured by Oxford Modified Scale and through the increase of values of the perineometry and surface eletromyography.
Time Frame
Baseline, two months
Secondary Outcome Measure Information:
Title
Change from baseline in the sexual function
Description
The improvement of PFM awareness will increase the sexual function of the women studied measured by the increase the score index of FSFI.
Time Frame
Baseline, two months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with age greater than or equal 18 years; Women with pelvic floor muscle function graded 0 and 1 measured by Oxford Modified Scale; Women who voluntarily consente to participate in research. Exclusion Criteria: Women with associated neurological pathologies; Women with symptoms of vaginal or urinary tract infection; Women with pelvic organs prolapse graded greater than 2; Pregnancy suspected or confirmed; Cognitive deficit that impedes or impair the procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Vasconcelos, PhD student
Phone
+5516991533514
Email
elainelemes@hcrp.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Vasconcelos, PhD student
Organizational Affiliation
USP Ribeirão Preto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristine Ferreira, Mastermind
Organizational Affiliation
USP Ribeirão Preto
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Hospital of Faculty of Medicine of Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14048-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Vasconcelos, PhD student
Phone
+5516991533514
Email
elainelemes@hcrp.usp.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
7732416
Citation
Laycock J. Pelvic muscle exercises: physiotherapy for the pelvic floor. Urol Nurs. 1994 Sep;14(3):136-40. No abstract available.
Results Reference
result
PubMed Identifier
14595609
Citation
Bo K. Pelvic floor muscle strength and response to pelvic floor muscle training for stress urinary incontinence. Neurourol Urodyn. 2003;22(7):654-8. doi: 10.1002/nau.10153.
Results Reference
result
PubMed Identifier
29429823
Citation
Mateus-Vasconcelos ECL, Brito LGO, Driusso P, Silva TD, Antonio FI, Ferreira CHJ. Effects of three interventions in facilitating voluntary pelvic floor muscle contraction in women: a randomized controlled trial. Braz J Phys Ther. 2018 Sep-Oct;22(5):391-399. doi: 10.1016/j.bjpt.2017.12.006. Epub 2018 Feb 3.
Results Reference
derived

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Electrical Stimulation and Vaginal Palpation in Pelvic Floor Muscles Awareness

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