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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS + Exercises therapies | Experimental | Real transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes, 2mA |
|
| Sham tDCS + Exercises therapies | Sham Comparator | Sham transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes (30 seconds ON), 2mA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor. The BDI is a tool of self-assessment of depression using a questionnaire with 21 items whose in- tensity varies from 0 to 3 (higher scores indicating more depressive symptoms). | 4 weeks, 3 and 6 months after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Therapy. Federal University of Piaui | Parnaíba | Piauí | 64202-020 | Brazil | ||
| Antonia Mykaele Cordeiro Brandao |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence | 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. |
|
| 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 |
| Anxiety |
Visual analogue scale (VAS) for anxiety assesses anxiety symptoms that we tracked as possible confounding factor. The visual analogue scale for general anxiety is assessed by a horizontal 100-mm-long line. The score are from 0 (worst) to 100 (best). |
| 4 weeks, 3 and 6 months after randomization |
| Satisfaction with care: Medrisk Instrument | Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care. | 4 weeks after randomization |
| Parnaíba |
| Piauí |
| 642020020 |
| Brazil |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |