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Electrical Stimulation and Vaginal Palpation in Pelvic Floor Muscles Awareness

Electrical Stimulation and Vaginal Palpation in the Pelvic Floor Muscles Awareness: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02062242
Enrollment
120
Registered
2014-02-13
Start date
2013-03-31
Completion date
2014-12-31
Last updated
2014-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Disorders

Keywords

Pelvic Floor, Physical Therapy Specialty, Awareness, Electric Stimulation, Palpation

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.

Interventions

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.

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.

OTHERPalpation 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.

OTHERControl

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in the PFM awarenessBaseline, two monthsThe 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

MeasureTime frameDescription
Change from baseline in the sexual functionBaseline, two monthsThe improvement of PFM awareness will increase the sexual function of the women studied measured by the increase the score index of FSFI.

Countries

Brazil

Contacts

Primary ContactElaine Vasconcelos, PhD student
elainelemes@hcrp.usp.br+5516991533514

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026