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Electrostimulation PROTOCOL Incontinence

Primary Purpose

Female Stress Incontinence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electro-stimulation
Sponsored by
Hospital Universitário Professor Edgard Santos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Stress Incontinence

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    electrostimulation individualized

    electrostimulation with fixed protocol

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    contractile function of the perineal musculature
    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)

    Secondary Outcome Measures

    King's Health Questionnaire
    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

    Full Information

    First Posted
    March 11, 2015
    Last Updated
    October 1, 2018
    Sponsor
    Hospital Universitário Professor Edgard Santos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03682926
    Brief Title
    Electrostimulation PROTOCOL Incontinence
    Official Title
    EFFECT OF A PROTOCOL Electrostimulation for Urinary Incontinence and Its Influence on WOMEN 'S QUALITY OF LIFE
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitário Professor Edgard Santos

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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)
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Female Stress Incontinence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    electrostimulation individualized
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    electrostimulation with fixed protocol
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Electro-stimulation
    Other Intervention Name(s)
    electro physical therapy, dualpex 961 quark
    Intervention Description
    Intracavitary electrostimulation with Quark medical vaginal electrode for perineal muscle strengthening protocol.
    Primary Outcome Measure Information:
    Title
    contractile function of the perineal musculature
    Description
    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)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    King's Health Questionnaire
    Description
    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
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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