Pelvic Floor DisordersNCT02062242
Electrical Stimulation and Vaginal Palpation in Pelvic Floor Muscles Awareness
A study testing Transvaginal electrical stimulation, Palpation and Palpation with posterior pelvic tilt in people with Pelvic Floor Disorders, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Transvaginal electrical stimulation, Palpation and Palpation with posterior pelvic tilt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinical Hospital of Faculty of Medicine of Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900
Elaine Vasconcelos, PhD student, +5516991533514, elainelemes@hcrp.usp.br
About this study
Official title: Electrical Stimulation and Vaginal Palpation in the Pelvic Floor Muscles Awareness: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Transvaginal electrical stimulation, Palpation, Palpation with posterior pelvic tilt, Control
- Keywords
- Pelvic Floor, Physical Therapy Specialty, Awareness, Electric Stimulation, Palpation
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal electrical stimulationOther
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.
PalpationOther
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 tiltOther
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.
ControlOther
The patient receive verbal instructions related to the pelvic floor and its contraction.
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal electrical stimulation | Experimental | Patients treated with transvaginal electrical stimulation. Receives: Other: Transvaginal electrical stimulation |
| Palpation | Experimental | Patients treated with vaginal palpation. Receives: Other: Palpation |
| Palpation with posterior pelvic tilt | Experimental | Patients treated with vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles. Receives: Other: Palpation with posterior pelvic tilt |
| Control group | Experimental | Patients receive verbal instructions related to the pelvic floor and its contraction. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, two months
Secondary outcomes (1)
Change from baseline in the sexual function
The improvement of PFM awareness will increase the sexual function of the women studied measured by the increase the score index of FSFI.
Measured: Baseline, two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Cristine Lemes Mateus de Vasconcelos, University of Sao Paulo
- Investigators
- Elaine Vasconcelos, PhD student, Principal investigator, USP Ribeirão PretoCristine Ferreira, Mastermind, Study director, USP Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062242
- Sponsor's protocol ID
- CEP 211.405
- Status last verified
- Feb 2014
- First submitted
- 1 Feb 2014
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Laycock J. Pelvic muscle exercises: physiotherapy for the pelvic floor. Urol Nurs. 1994 Sep;14(3):136-40. No abstract available.
PubMed 7732416Bo 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.
PubMed 14595609Mateus-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.
PubMed 29429823
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation and Vaginal Palpation in the Pelvic Floor Muscles Awareness: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02062242
- Acronym / sponsor ID
- CEP 211.405
- Conditions
- Pelvic Floor Disorders
- Keywords
- Pelvic Floor, Physical Therapy Specialty, Awareness, Electric Stimulation, Palpation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transvaginal electrical stimulation | Experimental | Other: Transvaginal electrical stimulationPatients treated with transvaginal electrical stimulation. |
| Palpation | Experimental | Other: PalpationPatients treated with vaginal palpation. |
| Palpation with posterior pelvic tilt | Experimental | Other: Palpation with posterior pelvic tiltPatients treated with vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles. |
| Control group | Experimental | Other: ControlPatients receive verbal instructions related to the pelvic floor and its contraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal electrical stimulationThe 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. | Other | Transvaginal electrical stimulation |
| PalpationThe 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. | Other | Palpation |
| Palpation with posterior pelvic tiltThe 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. | Other | Palpation with posterior pelvic tilt |
| ControlThe patient receive verbal instructions related to the pelvic floor and its contraction. | Other | Control group |
Primary outcome
Change from baseline in the PFM awareness
Time frame: 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.
1 secondary outcome
Change from baseline in the sexual function
Time frame: Baseline, two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- Results publication: PubMed 7732416Laycock J. Pelvic muscle exercises: physiotherapy for the pelvic floor. Urol Nurs. 1994 Sep;14(3):136-40. No abstract available.
- Results publication: PubMed 14595609Bo 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.
- Derived from this study: PubMed 29429823Mateus-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Vasconcelos, PhD student principal investigator
USP Ribeirão Preto
Cristine Ferreira, Mastermind study director
USP Ribeirão Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal electrical stimulation, Palpation and Palpation with posterior pelvic tilt in people with Pelvic Floor Disorders, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elaine Vasconcelos, PhD student (+5516991533514, elainelemes@hcrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the PFM awareness (time frame: Baseline, two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062242, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014.