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NCT Number: NCT04084340

tDCS and Female Urinary Incontinence

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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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Antonia Mykaele Cordeiro Brandao, Parnaíba, Piauí, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Piauí

Other

Registry information

Official study title

Efficacy of Transcranial Direct Current Stimulation Combined With Exercise Therapies in Female Urinary Incontinence: a Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Sep 10, 2019
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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