Trial record 2 of 59 for:    Open Studies | "Pelvic Floor"

Electrical Stimulation and Vaginal Palpation in Pelvic Floor Muscles Awareness

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Elaine Cristine Lemes Mateus de Vasconcelos, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02062242
First received: February 1, 2014
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Pelvic Floor Disorders
Other: Transvaginal electrical stimulation
Other: Palpation
Other: Palpation with posterior pelvic tilt
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Electrical Stimulation and Vaginal Palpation in the Pelvic Floor Muscles Awareness: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Change from baseline in the PFM awareness [ Time Frame: Baseline, two months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline, two months ] [ Designated as safety issue: Yes ]
    The improvement of PFM awareness will increase the sexual function of the women studied measured by the increase the score index of FSFI.


Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transvaginal electrical stimulation
Patients treated with transvaginal electrical stimulation.
Other: 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.
Experimental: Palpation
Patients treated with vaginal palpation.
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.
Experimental: Palpation with posterior pelvic tilt
Patients treated with vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles.
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.
Experimental: Control group
Patients receive verbal instructions related to the pelvic floor and its contraction.
Other: Control
The patient receive verbal instructions related to the pelvic floor and its contraction.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062242

Contacts
Contact: Elaine Vasconcelos, PhD student +5516991533514 elainelemes@hcrp.usp.br

Locations
Brazil
Clinical Hospital of Faculty of Medicine of Ribeirão Preto Recruiting
Ribeirão Preto, São Paulo, Brazil, 14048-900
Contact: Elaine Vasconcelos, PhD student    +5516991533514    elainelemes@hcrp.usp.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Elaine Vasconcelos, PhD student USP Ribeirão Preto
Study Director: Cristine Ferreira, Mastermind USP Ribeirão Preto
  More Information

Publications:
Responsible Party: Elaine Cristine Lemes Mateus de Vasconcelos, PhD student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02062242     History of Changes
Other Study ID Numbers: CEP 211.405
Study First Received: February 1, 2014
Last Updated: February 11, 2014
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
Pelvic Floor
Physical Therapy Specialty
Awareness
Electric Stimulation
Palpation

ClinicalTrials.gov processed this record on July 20, 2014