Urinary Incontinence
Conditions
Brief summary
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.
Interventions
PROCEDUREReal 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.
PROCEDURESham 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.
Sponsors
Universidade Federal do Piauí
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence severity | 4 weeks after randomization | 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 |
| Urinary leakage | 4 weeks after randomization | 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. |
| Quality of life impact | 4 weeks after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor muscle strength - Subjective test | 4 weeks, 3 and 6 months after randomization | Pelvic floor strength will be analyzed by Bidigital vaginal palpation of the vaginal introitus. |
| Quality of life impact | 3 and 6 months after randomization ] | 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. |
| Emotional impact | 4 weeks, 3 and 6 months after randomization | 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). |
| Pelvic floor muscle strength - Quantitative test | 4 weeks, 3 and 6 months after randomization | Pelvic floor strength will be analyzed by a clinical perineometer in cm H2O. |
| Urinary leaking | 4 weeks, 3 and 6 months after randomization | Diary delivered to the participant to note for 24h the urinary frequency daytime, night, amount of loss and exchange of absorbents if you use. |
| Global perceived effect (GPE) | 4 weeks, 3 and 6 months after randomization | Global perceived effect is an 11 point scale that ranges from 5 (vastly worse) through 0 (no change) to 5 (completely recovered). |
| Quality of life in women with UI (severity symptoms) | 4 weeks, 3 and 6 months after randomization | 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. |
| Urinary leakage | 3 and 6 months after randomization | 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. |
| Incontinence severity | 3 and 6 months after randomization ] | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depression | 4 weeks, 3 and 6 months after randomization | 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). |
| Satisfaction with care: Medrisk Instrument | 4 weeks after randomization | Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care. |
| Anxiety | 4 weeks, 3 and 6 months after randomization | 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). |
Countries
Brazil
Outcome results
None listed