Electrical Stimulation and Vaginal Palpation in Pelvic Floor Muscles Awareness

Not Applicable

• Conditions: Pelvic Floor Disorders
• Interventions: Other: Control; Other: Palpation with posterior pelvic tilt; Other: Transvaginal electrical stimulation; Other: Palpation

• Registration Number: NCT02062242
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-03
• Status Verified: 2014-02
• Study First Submitted: 2014-02-01
• Study First Submitted QC: 2014-02-11
• Last Update Submitted: 2014-02-11
• Study First Posted: 2014-02-13
• Last Update Posted: 2014-02-13
• Primary Completion: 2014-06
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control	Patients receive verbal instructions related to the pelvic floor and its contraction.
Palpation with posterior pelvic tilt	Palpation with posterior pelvic tilt	Patients treated with vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles.
Transvaginal electrical stimulation	Transvaginal electrical stimulation	Patients treated with transvaginal electrical stimulation.
Palpation	Palpation	Patients treated with vaginal palpation.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the PFM awareness	Baseline, two months	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

Name	Time	Method
Change from baseline in the sexual function	Baseline, two months	The improvement of PFM awareness will increase the sexual function of the women studied measured by the increase the score index of FSFI.

Trial Locations

Locations (1)

Clinical Hospital of Faculty of Medicine of Ribeirão Preto; 🇧🇷 Ribeirão Preto, São Paulo, Brazil