Electrical Stimulation and Vaginal Palpation in Pelvic Floor Muscles Awareness

NCT ID: NCT02062242

Last Updated: 2014-02-13

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Pelvic Floor Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Transvaginal electrical stimulation

Patients treated with transvaginal electrical stimulation.

Group Type EXPERIMENTAL

Transvaginal electrical stimulation

Intervention Type OTHER

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.

Palpation

Patients treated with vaginal palpation.

Group Type EXPERIMENTAL

Palpation

Intervention Type OTHER

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.

Palpation with posterior pelvic tilt

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

Group Type EXPERIMENTAL

Palpation with posterior pelvic tilt

Intervention Type OTHER

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.

Control group

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

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

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

Interventions

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Transvaginal electrical stimulation

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

Palpation

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

Palpation with posterior pelvic tilt

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

Control

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Elaine Cristine Lemes Mateus de Vasconcelos

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elaine Vasconcelos, PhD student

Role: PRINCIPAL_INVESTIGATOR

USP Ribeirão Preto

Cristine Ferreira, Mastermind

Role: STUDY_DIRECTOR

USP Ribeirão Preto

Locations

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Clinical Hospital of Faculty of Medicine of Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Elaine Vasconcelos, PhD student

Role: CONTACT

+5516991533514

Facility Contacts

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Elaine Vasconcelos, PhD student

Role: primary

+5516991533514

References

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Laycock J. Pelvic muscle exercises: physiotherapy for the pelvic floor. Urol Nurs. 1994 Sep;14(3):136-40. No abstract available.

Reference Type RESULT
PMID: 7732416 (View on PubMed)

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.

Reference Type RESULT
PMID: 14595609 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29429823 (View on PubMed)

Other Identifiers

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CEP 211.405

Identifier Type: -

Identifier Source: org_study_id

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