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tDCS and Female Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence
Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence
Sponsored by
Universidade Federal do Piauí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Therapy. Federal University of PiauiRecruiting
  • Antonia Mykaele Cordeiro Brandao

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Anodal tDCS + Exercises therapies

Sham tDCS + Exercises therapies

Arm Description

Real transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes, 2mA

Sham transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes (30 seconds ON), 2mA

Outcomes

Primary Outcome Measures

Urinary leakage
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
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
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

Urinary leakage
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
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
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)
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
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
Pelvic floor strength will be analyzed by Bidigital vaginal palpation of the vaginal introitus.
Pelvic floor muscle strength - Quantitative test
Pelvic floor strength will be analyzed by a clinical perineometer in cm H2O.
Urinary leaking
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)
Global perceived effect is an 11 point scale that ranges from 5 (vastly worse) through 0 (no change) to 5 (completely recovered).

Full Information

First Posted
September 2, 2019
Last Updated
January 15, 2021
Sponsor
Universidade Federal do Piauí
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1. Study Identification

Unique Protocol Identification Number
NCT04084340
Brief Title
tDCS and Female Urinary Incontinence
Official Title
Efficacy of Transcranial Direct Current Stimulation Combined With Exercise Therapies in Female Urinary Incontinence: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Piauí

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS + Exercises therapies
Arm Type
Experimental
Arm Description
Real transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes, 2mA
Arm Title
Sham tDCS + Exercises therapies
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes (30 seconds ON), 2mA
Intervention Type
Procedure
Intervention Name(s)
Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence
Intervention Description
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 Measure Information:
Title
Urinary leakage
Description
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.
Time Frame
4 weeks after randomization
Title
Incontinence severity
Description
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
Time Frame
4 weeks after randomization
Title
Quality of life impact
Description
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.
Time Frame
4 weeks after randomization
Secondary Outcome Measure Information:
Title
Urinary leakage
Description
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.
Time Frame
3 and 6 months after randomization
Title
Incontinence severity
Description
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
Time Frame
3 and 6 months after randomization ]
Title
Quality of life impact
Description
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.
Time Frame
3 and 6 months after randomization ]
Title
Quality of life in women with UI (severity symptoms)
Description
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.
Time Frame
4 weeks, 3 and 6 months after randomization
Title
Emotional impact
Description
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).
Time Frame
4 weeks, 3 and 6 months after randomization
Title
Pelvic floor muscle strength - Subjective test
Description
Pelvic floor strength will be analyzed by Bidigital vaginal palpation of the vaginal introitus.
Time Frame
4 weeks, 3 and 6 months after randomization
Title
Pelvic floor muscle strength - Quantitative test
Description
Pelvic floor strength will be analyzed by a clinical perineometer in cm H2O.
Time Frame
4 weeks, 3 and 6 months after randomization
Title
Urinary leaking
Description
Diary delivered to the participant to note for 24h the urinary frequency daytime, night, amount of loss and exchange of absorbents if you use.
Time Frame
4 weeks, 3 and 6 months after randomization
Title
Global perceived effect (GPE)
Description
Global perceived effect is an 11 point scale that ranges from 5 (vastly worse) through 0 (no change) to 5 (completely recovered).
Time Frame
4 weeks, 3 and 6 months after randomization
Other Pre-specified Outcome Measures:
Title
Depression
Description
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).
Time Frame
4 weeks, 3 and 6 months after randomization
Title
Anxiety
Description
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).
Time Frame
4 weeks, 3 and 6 months after randomization
Title
Satisfaction with care: Medrisk Instrument
Description
Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care.
Time Frame
4 weeks after randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonia Mykaele C Brandao, PT
Phone
+55 86 3323-5209
Email
mykaelecordeiro@ufpi.edu.br
Facility Information:
Facility Name
Department of Physical Therapy. Federal University of Piaui
City
Parnaiba
State/Province
PIaui
ZIP/Postal Code
64202-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Antonia Mykaele Cordeiro Brandao
City
Parnaiba
State/Province
Piaui
ZIP/Postal Code
642020020
Country
Brazil
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

Plan to Share IPD
No

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tDCS and Female Urinary Incontinence

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