Efficacy of Transcranial Direct Current Stimulation Combined With Exercise Therapies in Female Urinary Incontinence: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Urinary leakage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Anodal tDCS + Exercises therapies
Real transcranial direct current stimulation associated with therapeutic exercises
tDCS: 20 minutes, 2mA
Intervention: Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence (Procedure)
Sham tDCS + Exercises therapies
Sham transcranial direct current stimulation associated with therapeutic exercises
tDCS: 20 minutes (30 seconds ON), 2mA
Intervention: Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence (Procedure)
Outcomes
Primary Outcomes
Urinary leakage
Time Frame: 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.
Incontinence severity
Time Frame: 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
Quality of life impact
Time Frame: 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 Outcomes
- Pelvic floor muscle strength - Subjective test(4 weeks, 3 and 6 months after randomization)
- Quality of life in women with UI (severity symptoms)(4 weeks, 3 and 6 months after randomization)
- Incontinence severity(3 and 6 months after randomization ])
- Global perceived effect (GPE)(4 weeks, 3 and 6 months after randomization)
- Quality of life impact(3 and 6 months after randomization ])
- Urinary leaking(4 weeks, 3 and 6 months after randomization)
- Pelvic floor muscle strength - Quantitative test(4 weeks, 3 and 6 months after randomization)
- Urinary leakage(3 and 6 months after randomization)
- Emotional impact(4 weeks, 3 and 6 months after randomization)
Investigators
Fuad Ahmad Hazime
Clinical Professor - Physical Therapy Department
Universidade Federal do Piauí