Electrical Stimulation and Vaginal Palpation in Pelvic Floor Muscles Awareness

NCT02062242 | Unknown

• 1 other identifier: CEP 211.405
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, two months

Secondary Outcomes (1)

• Change from baseline in the sexual function

  Baseline, two months

Study Arms (4)

Transvaginal electrical stimulation

EXPERIMENTAL

Patients treated with transvaginal electrical stimulation.

Other: Transvaginal electrical stimulation

Palpation

EXPERIMENTAL

Patients treated with vaginal palpation.

Other: Palpation

Palpation with posterior pelvic tilt

EXPERIMENTAL

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

Other: Palpation with posterior pelvic tilt

Control group

EXPERIMENTAL

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

Other: Control

Interventions

Transvaginal electrical stimulation 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.

Transvaginal electrical stimulation

Palpation 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

Palpation with posterior pelvic tilt 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.

Palpation with posterior pelvic tilt

Control OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Clinical Hospital of Faculty of Medicine of Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

Related Publications (3)

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

  PMID: 7732416 RESULT

• 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.

  PMID: 14595609 RESULT

• 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.

  PMID: 29429823 DERIVED

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Elaine Vasconcelos, PhD student

  USP Ribeirão Preto

  PRINCIPAL INVESTIGATOR

• Cristine Ferreira, Mastermind

  USP Ribeirão Preto

  STUDY DIRECTOR

Central Study Contacts

Elaine Vasconcelos, PhD student

CONTACT

+5516991533514; elainelemes@hcrp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: February 1, 2014
• First Posted: February 13, 2014
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

BR (1)