Intravaginal Electrical Nerve Stimulation in Women With Non-contracting Pelvic Floor

June 16, 2020 updated by: Flávia Ignácio Antônio Vassimon, University of Sao Paulo

Intravaginal Electrical Nerve Stimulation to Achieve a Voluntary Contraction in Women With Non-contracting Pelvic Floor: a Randomized Controlled Trial

It is estimated that about 30% of women cannot voluntarily contract the pelvic floor muscles (PFM). PFM training (PFMT) represents the first therapeutic option for the treatment of female urinary incontinence (UI), however the inability to contract this muscle makes PFMT unfeasible. The primary objective of this project is to evaluate clinically the efficacy of intravaginal electrical stimulation associated with verbal instructions to provide the ability of women to contract voluntary their PFM. The secondary objective is to evaluate the UI prevalence and impact on quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized controlled trial. A simple randomization procedure will be conducted using computer generated list. This list will be kept with a secretary not involved with the research. A concealed allocation will be performed. All participants will be recruited at Rehabilitation Center of the Clinical Hospital of Ribeirão Preto Medical School, University of São Paulo. The primary outcome of the study will be vaginal palpation, to differentiate women capable or not capable to perform a PFM contraction. The secondary outcome will be measured using the ICIQ- UI SF questionnaire.

To analyze the proportions of improvement after the intervention in relation to primary outcome we will consider the proportion of women with values equal or above 2 and 3 as specified in the outcome measure section, using the modified oxford grading scale. The sample size calculation will be done based in a pilot study after the study initiate (after registration) considering we found no data from a RCT investigating exactly the same intervention. The study of Vasconcelos et al. (2017) that investigated a similar intervention in the same population performed a sample size calculation using a test of differences between proportions and Fisher's exact test based in the proportion of change in the group receiving electrical stimulation ( 0.35 point) and in the control group (CG) (0.13 point). Considering a significance level of 5% and 80% test power, in the comparison between the intervention group (IG) and control group (CG), the minimum number indicated was 61 participants per group; however as the intervention was not exactly the same and the control group received instructions to perform home training we intend to do this calculation again based in a pilot sample after the study initiate (after registration).

As stated before in the initial registration, the sample size calculation was conducted based on a pilot test carried out by the researcher. The sample calculation was used for qualitative data (primary outcome measure) and non-paired sample based on the proportion of improvement after the intervention. The sample calculation compared n=14 in the control group and n= 9 in the intervention group. Considering the proportion of improvement, after intervention, in women with values equal or above 2 is suggested that a sample size of 14 participants per group would be adequate to see between group differences at power=0.90 and α=0.05. In a second situation, the proportion of improvement will be considered as a value equal or above 3, in this case a sample size of 28 participants per group would be adequate to see between group differences at power=0.80 and α=0.05, and 37 participants per group would be adequate to see between group differences at power=0.90 and α=0.05.

Data analysis The data will be analyzed initially through descriptive statistics, which will enable the characterization of the sample regarding the variables collected. This methodology has as basic objective to synthesize a series of values of the same nature, allowing a global view of the variation of these values, organizing and describing the data through tables of frequencies and descriptive measures.

To verify the association between the categorical variables, the data will be submitted to Fisher's exact test. The association quantification will be measured through logistic regression models, where the crude odds ratio with its respective 95% confidence intervals will be calculated.

The analysis of variance (ANOVA) will be used to verify the homogeneity between the groups of quantitative variables. The Student's t-test will be used to compare two means from unpaired samples. To test whether the variances of the two groups are statistically equal, and if the data follows the normal distribution, the PROC TEST procedure of the SAS software will be used. The mixed effects linear models (random and fixed effects) will be used for the analysis of the ICIQ-S questionnaire. This method is used in the analysis of data where the responses of the same individual are grouped and the assumption of independence between observations in the same group is not adequate (Schall, 1991). In the mixed-effects model used, individuals will be considered as random effects and, as fixed effects, the groups, the times and the interaction between them. The adjustment of the model will be done through the PROC MIXED procedure of the statistical software SAS.

The results will be reported as estimates of effect size. In relation to the primary outcome we will present the proportion of improvement, crude odds ratio with respective confidence intervals of 95%. For the secondary outcome measure we will present mean difference and 95% CI).

Data will be analyzed Independent of compliance to intervention (intention to treat analysis). A secondary per-protocol analysis will be done to verify the effect of trial adherence on the primary outcome. This analysis will include only women who received at least 80% of the physiotherapy sessions.

A sensitivity analysis will be performed if necessary to adjust for possible baseline imbalances.

All statistical analyzes will be performed using the SAS® 9 statistical software. The level of significance adopted for all tests will be 5%.

Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.

Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (for example, medical records, paper or electronic case report forms, or interactive voice response systems).

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used (for example, World Health Organization Drug Dictionary, MedDRA), and normal ranges if relevant.

Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.

.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14620000
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who are routinely referred to the Lucy Montoro Rehabilitation Center of the Hospital das Clínicas of the University of São Paulo at Ribeirão Preto Medical School - HCFMRP-USP for the physiotherapeutic treatment of pelvic floor dysfunctions;
  • Pelvic floor muscle function grade 0 (zero) or 1 evaluated by bidigital palpation (Modified Oxford Scale);
  • Consent to participate in the study and signing of the free and informed consent form.

Exclusion Criteria:

  • Women with associated neurological pathologies;
  • Symptoms of vaginal or urinary tract infection;
  • Prolapses classified above grade 2;
  • Suspected or confirmed pregnancy and cognitive deficit that compromises the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Control group: participants will receive only verbal instructions on PFM anatomy and function during the first assessment when women will be required to contract their pelvic floor muscle. The participants will have no contact with the service until the second assessment
Active Comparator: Intervention
Intravaginal Electrical Nerve Stimulation: participants will be submitted to Intravaginal Electrical Nerve Stimulation
Device: Intravaginal Electrical Nerve Stimulation
The Intervention group will receive Intravaginal Electrical Nerve Stimulation using Quark® Dualpex equipment, once per week during 8 weeks. The selected current will be biphasic, and the stimulation parameters will be: 50 Hz frequency, pulse width of 200 microseconds, contraction time (Ton) of 5 seconds, relaxation time (Toff) of 10 seconds, intensity of current defined according to the sensitivity (tolerance) of the patient, and total stimulation time of 20 minutes once a week delivered by an experienced Physiotherapist. In the last 10 minutes of each electrical nerve stimulation session women will be requested to perform voluntary PFM contractions along with the contractions induced by the electrical stimulation. Women will not be instructed to perform any aditional exercise or therapy at home.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bidigital Vaginal Palpation
Time Frame: 30 minutes

The primary outcome will be assessed by bidigital vaginal palpation using the modified Oxford scale at baseline and after 10 weeks. The correct contraction of the PFM will be considered as the action of occlusion and elevation of the PFM around the examiner's fingers in the ventral and cranial directions. Therefore, it will be considered a clinically relevant improvement to obtain a score above 3 on the modified Oxford scale.

The examination will be performed following the following steps:

  • The participant will receive information about the procedure, and basic anatomy of the PFM.
  • She will be placed in dorsal decubitus, with hips and knees flexed, feet supported and legs apart;
  • The examiner using a procedure glove will carefully insert the index and middle fingers into the vaginal canal;
  • The participant will be instructed to contract the PFM in order to raise and compress the examiner's fingers.
  • To conclude, the participant will be directed to completely relax the PFM.
30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Time Frame: 20 minutes
Reports of urinary incontinence (UI) will be evaluated through the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)at baseline and after 10 weeks. This questionnaire was translated and validated into the Portuguese language by Tamanini et al. (2004), and evaluates the symptoms, severity of UI, and the impact that UI has on women's quality of life (QoL). It is a brief questionnaire and the purpose of its use is to facilitate the comparison of data from different studies and to enable a more consistent and unified assessment of UI symptoms and its repercussion in QoL.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cristine HJ Ferreira, PhD, Ribeirão Preto Medical School, University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 73055317.8.0000.5440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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