Electrostimulation PROTOCOL Incontinence

October 1, 2018 updated by: ROSANA CRISTINA PEREIRA DE ANDRADE, Hospital Universitário Professor Edgard Santos

EFFECT OF A PROTOCOL Electrostimulation for Urinary Incontinence and Its Influence on WOMEN 'S QUALITY OF LIFE

To verify the effect of an adapted electrostimulation (EE) protocol for stress and mixed urinary incontinence (SUI / M) and its impact on quality of life (QoL)

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

Controlled and randomized clinical trial performed at the Physiotherapy Outpatient Clinic at the Magalhães Neto Pavilion of ComHUPES / UFBA. Women aged between 30 and 65 years and diagnosis of SUI / IUM. The patients were allocated to two groups (GA) submitted to selective electrostimulation for tonic fiber, phasic fibers IIa / IIb and different times of electrical stimulation; (GB) used 50hz for all fibers by 20mm, both answered the questionnaire King's Health Questionnaire (KHQ).

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.
20

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

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

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women between the ages of 30 and 65
  • With diagnosis of stress urinary incontinence and / or mixed
  • Perineal muscle weakness
  • Accepted to sign the TCLE

Exclusion Criteria:

  • Women with neurological changes
  • Pregnant women
  • IUD use
  • Pacemaker
  • Genitourinary tract infection
  • Cancer
  • Refuse to sign the TCLE

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.
Experimental: electrostimulation individualized
Selective electrostimulation for tonic fiber, phasic fiber FIa and FIIb and different stimulus times. Muscle fibers (Tonic) with a frequency of 20Hz, pulse width (t) of 700μs to 1ms, time of rise and fall of the wave of 1.0 seconds, duration of contraction and repetition was based on the perineal evaluation But the resting time was twice as long as sustained. For the IIa (phasic) fibers the frequency was 50 Hz with a pulse width of 400μs to 500μs, for 3 seconds of sustentation and 6 seconds of relaxation, time of rise of 0,5 seconds and 0,5 seconds of descent. E for type IIb (phasic) fibers, 80 Hz frequency, pulse width 250μs to 400μs, 1 second contraction for 3 seconds rest and 0.2 seconds rise and fall time.
Other: Electro-stimulation
Intracavitary electrostimulation with Quark medical vaginal electrode for perineal muscle strengthening protocol.
Other Names:
  • electro physical therapy
  • dualpex 961 quark
Active Comparator: electrostimulation with fixed protocol
Intervention -Electro-stimulate all fibers with a single electrical parameter. Pulse width 700μs, rise and fall time of 2 seconds each, sustain time of 4 seconds and rest 8 seconds for 20 minutes, the intensity will be modulated, as in the previous group by patient tolerance in milliamperes.
Other: Electro-stimulation
Intracavitary electrostimulation with Quark medical vaginal electrode for perineal muscle strengthening protocol.
Other Names:
  • electro physical therapy
  • dualpex 961 quark

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
contractile function of the perineal musculature
Time Frame: 3 months
Perineal muscle function evaluated subjectively by vaginal touch using the PERFECT system to measure strength (graded from 0 to 5), strength (holding capacity of contraction recorded in seconds) and number of contractions of tonic and phasic fibers (ability to repeat muscle contractions perineal). Objectively, the vaginal cones were used to determine which load the patient was able to support (kit with 5 cones with weights ranging from 20 to 70g)
3 months

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
King's Health Questionnaire
Time Frame: 3 months
It allows qualitative evaluation of the impact of urinary incontinence on the quality of life of women, it is responsible for 20 questions, divided into 8 domains, in addition to these domains, there are two other independent scales: the first evaluates the severity of UI (severity measures) and the second, the presence and intensity of urinary symptoms through the scale of urinary symptoms (VAS) where there is a graduation from 0 to 10, where the higher the score, the higher the severity
3 months

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.
Hospital Universitário Professor Edgard Santos

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

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.
October 1, 2014

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.
November 1, 2014

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.
December 1, 2015

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).
March 11, 2015

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.
September 20, 2018

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.
September 25, 2018

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.
October 3, 2018

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.
October 1, 2018

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.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • ROAND2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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