tDCS and Female Urinary Incontinence

Study Overview
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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.

Official Title
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Efficacy of Transcranial Direct Current Stimulation Combined With Exercise Therapies in Female Urinary Incontinence: a Randomized Clinical Trial

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Procedure: Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence
* Procedure: Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anodal tDCS + Exercises therapies<br>Real transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes, 2mA | Procedure: Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence<br>* 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.<br>|
| Sham Comparator: Sham tDCS + Exercises therapies<br>Sham transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes (30 seconds ON), 2mA | Procedure: Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary leakage | Urinary leakage will be measured by the pad test. Pad testing yields an objective measurement of fluid loss over a certain period. The outcome of the 1-h pad test will be recorded as the weight gain as measured by a verified spring balance. Pad test assessment: Change in 1-hour exercise (stress), classified as mild, moderate or severe urinary leaking. | 4 weeks after randomization | 
| Incontinence severity | Incontinence severity will be assessed by the Brazilian version of Incontinence severity index (ISI) that quantifies the frequency and number of urinary leaking. The ISI comprehend two questions about quantity and frequency of urinary losses. The score are from 0 to 12: 0 continent 1 or 2 mild incontinence 3 or 6 moderate incontinence 8 or 9 severe incontinence 12 very severe incontinence | 4 weeks after randomization | 
| Quality of life impact | Quality of life impact of urinary incontinence will be assessed by the Brazilian Version of International consultation on incontinence questionnaire urinary incontinence (ICIQ_UI short form). The ICIQ-UI Short form provides a score ranging from 0-21. With a higher score indicating greater severity of symptoms. | 4 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary leakage | Urinary leakage will be measured by the pad test. Pad testing yields an objective measurement of fluid loss over a certain period. The outcome of the 1-h pad test will be recorded as the weight gain as measured by a verified spring balance. Pad test assessment: Change in 1-hour exercise (stress), classified as mild, moderate or severe urinary leaking. | 3 and 6 months after randomization | 
| Incontinence severity | Incontinence severity will be assessed by the Brazilian version of Incontinence severity index (ISI) that quantifies the frequency and number of urinary leaking. The ISI comprehend two questions about quantity and frequency of urinary losses. The score are from 0 to 12: 0 continent 1 or 2 mild incontinence 3 or 6 moderate incontinence 8 or 9 severe incontinence 12 very severe incontinence | 3 and 6 months after randomization ] | 
| Quality of life impact | Quality of life impact of urinary incontinence will be assessed by the Brazilian Version of International consultation on incontinence questionnaire urinary incontinence (ICIQ_UI short form). The ICIQ-UI Short form provides a score ranging from 0-21. With a higher score indicating greater severity of symptoms. | 3 and 6 months after randomization ] | 
| Quality of life in women with UI (severity symptoms) | Quality of life will be analyzed by the Brazilian version of King's Health Questionnaire. KHQ is a patient self-administered self-report and has 3 parts consisting of 21 items. The score from eight subscales domains are from 0 (best) to 100 (worst). Decreases in KHQ domain scores indicate an improvement in quality of life. | 4 weeks, 3 and 6 months after randomization | 
| Emotional impact | The emotional impact of urinary incontinence on quality of life will be analyzed by the Brazilian version of Incontinence Quality of Life Questionnaire (IQOL) that evaluates the social, physical and mental aspects of the woman with urinary incontinence. The IQOL is a self-report questionnaire with 22 questions and three subscales (domains). The score are from 0 (worst) to 100 (best). | 4 weeks, 3 and 6 months after randomization | 
| Pelvic floor muscle strength - Subjective test | Pelvic floor strength will be analyzed by Bidigital vaginal palpation of the vaginal introitus. | 4 weeks, 3 and 6 months after randomization | 
| Pelvic floor muscle strength - Quantitative test | Pelvic floor strength will be analyzed by a clinical perineometer in cm H2O. | 4 weeks, 3 and 6 months after randomization | 
| Urinary leaking | Diary delivered to the participant to note for 24h the urinary frequency daytime, night, amount of loss and exchange of absorbents if you use. | 4 weeks, 3 and 6 months after randomization | 
| Global perceived effect (GPE) | Global perceived effect is an 11 point scale that ranges from 5 (vastly worse) through 0 (no change) to 5 (completely recovered). | 4 weeks, 3 and 6 months after randomization |