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tDCS and Female Urinary Incontinence

NCT ID: NCT04084340

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-14

Study Completion Date

2023-11-27

Brief Summary

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Urinary incontinence (UI) is defined as any involuntary loss of urine and can be divided into three types: urgency, stress and mixed. Pelvic floor exercises are considered the main non pharmacological choice for UI treatment. Its mechanisms are not fully understood, however there are some evidence that central mechanisms play an important role in the continence control. In this context, neuromodulatory techniques, such as transcranial direct current stimulation (tDCS), that address cortical targets has been demonstrated promising results in different health conditions. However, few studies have investigated the efficacy of adding tDCS to exercise therapies for women with UI.

Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Anodal tDCS + Exercises therapies

Real transcranial direct current stimulation associated with therapeutic exercises

tDCS: 20 minutes, 2mA

Group Type EXPERIMENTAL

Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence

Intervention Type PROCEDURE

Real transcranial direct current stimulation associated with therapeutic exercises for urinary incontinence

tDCS: 20 minutes, 2mA, motor supplementary area anode and supraorbital cathode (ipsilateral to the dominant lower limb).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively.

Sham tDCS + Exercises therapies

Sham transcranial direct current stimulation associated with therapeutic exercises

tDCS: 20 minutes (30 seconds ON), 2mA

Group Type SHAM_COMPARATOR

Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence

Intervention Type PROCEDURE

Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence

tDCS: 20 minutes (30 seconds ON), 2mA, motor supplementary area anode and supraorbital cathode (ipsilateral to the dominant lower limb).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively.

Interventions

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Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence

Real transcranial direct current stimulation associated with therapeutic exercises for urinary incontinence

tDCS: 20 minutes, 2mA, motor supplementary area anode and supraorbital cathode (ipsilateral to the dominant lower limb).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively.

Intervention Type PROCEDURE

Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence

Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence

tDCS: 20 minutes (30 seconds ON), 2mA, motor supplementary area anode and supraorbital cathode (ipsilateral to the dominant lower limb).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Complaining of urinary loss
* Seeking care for urinary incontinence

Exclusion Criteria

* Grade III vaginal dystopias
* Intrapelvic tumors
* Cardiac pacemaker or other implanted devices
* Current pregnancy
* Urinary tract infections
* Previous treatment with tDCS
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Piauí

OTHER

Sponsor Role lead

Responsible Party

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Fuad Ahmad Hazime

Clinical Professor - Physical Therapy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, Brazil

Site Status

Antonia Mykaele Cordeiro Brandao

Parnaíba, Piauí, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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tDCS and Urinary Incontinence

Identifier Type: -

Identifier Source: org_study_id