Electrostimulation PROTOCOL Incontinence

Sponsor

Hospital Universitário Professor Edgard Santos (Other)

Overall Status

Completed

CT.gov ID

NCT03682926

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Female Stress Incontinence	Other: Electro-stimulation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

contractile function of the perineal musculature [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)

Secondary Outcome Measures

King's Health Questionnaire [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital Universitário Professor Edgard Santos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ROSANA CRISTINA PEREIRA DE ANDRADE, Dra, Hospital Universitário Professor Edgard Santos

ClinicalTrials.gov Identifier:

NCT03682926

Other Study ID Numbers:

ROAND2015

First Posted:

Sep 25, 2018

Last Update Posted:

Oct 3, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Urinary Incontinence, Stress

Study Results

No Results Posted as of Oct 3, 2018