tDCS and Female Urinary Incontinence

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2020

Interventions

  • Procedure: Real 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.
  • Procedure: Sham 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.

Arms, Groups and Cohorts

  • Experimental: Anodal tDCS + Exercises therapies
    • Real transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes, 2mA
  • Sham Comparator: Sham tDCS + Exercises therapies
    • Sham transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes (30 seconds ON), 2mA

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Urinary leakage
    • Time Frame: 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
    • Time Frame: 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
  • Quality of life impact
    • Time Frame: 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.
  • Quality of life in women with UI (severity symptoms)
    • Time Frame: 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.
  • Emotional impact
    • Time Frame: 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 – Subjective test
    • Time Frame: 4 weeks, 3 and 6 months after randomization
    • Pelvic floor strength will be analyzed by Bidigital vaginal palpation of the vaginal introitus.
  • Pelvic floor muscle strength – Quantitative test
    • Time Frame: 4 weeks, 3 and 6 months after randomization
    • Pelvic floor strength will be analyzed by a clinical perineometer in cm H2O.
  • Urinary leaking
    • Time Frame: 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)
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidade Federal do Piauí
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fuad Ahmad Hazime, Clinical Professor – Physical Therapy Department – Universidade Federal do Piauí

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