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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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 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.
Department of Physical Therapy. Federal University of Piaui
Parnaíba, Piauí, Brazil
Antonia Mykaele Cordeiro Brandao
Parnaíba, Piauí, Brazil
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.
Time frame: 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
Time frame: 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.
Time frame: 4 weeks after randomization
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 4 weeks, 3 and 6 months after randomization
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