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tDCS and Female Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084340
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Fuad Ahmad Hazime, Universidade Federal do Piauí

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Procedure: Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence Procedure: Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Transcranial Direct Current Stimulation Combined With Exercise Therapies in Female Urinary Incontinence: a Randomized Clinical Trial
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anodal tDCS + Exercises therapies

Real transcranial direct current stimulation associated with therapeutic exercises

tDCS: 20 minutes, 2mA

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.


Sham Comparator: Sham tDCS + Exercises therapies

Sham transcranial direct current stimulation associated with therapeutic exercises

tDCS: 20 minutes (30 seconds ON), 2mA

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.





Primary Outcome Measures :
  1. 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.


  2. 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


  3. 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 Outcome Measures :
  1. 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.


  2. 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


  3. 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.


  4. 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.


  5. 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).


  6. 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.

  7. 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.

  8. 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.

  9. 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).


Other Outcome Measures:
  1. Depression [ Time Frame: 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).


  2. Anxiety [ Time Frame: 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).


  3. Satisfaction with care: Medrisk Instrument [ Time Frame: 4 weeks after randomization ]
    Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084340


Contacts
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Contact: Antonia Mykaele C Brandao, PT +55 86 3323-5209 mykaelecordeiro@ufpi.edu.br

Locations
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Brazil
Department of Physical Therapy. Federal University of Piaui Recruiting
Parnaiba, PIaui, Brazil, 64202-020
Antonia Mykaele Cordeiro Brandao Enrolling by invitation
Parnaiba, Piaui, Brazil, 642020020
Sponsors and Collaborators
Universidade Federal do Piauí
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Responsible Party: Fuad Ahmad Hazime, Clinical Professor - Physical Therapy Department, Universidade Federal do Piauí
ClinicalTrials.gov Identifier: NCT04084340    
Other Study ID Numbers: tDCS and Urinary Incontinence
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders