tDCS and Female Urinary Incontinence

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

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 Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Procedure: Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence; Procedure: Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • PIaui
    • Parnaiba, PIaui, Brazil, 64202-020
      • Department of Physical Therapy. Federal University of Piaui
  • Piaui
    • Parnaiba, Piaui, Brazil, 642020020
      • Antonia Mykaele Cordeiro Brandao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks after randomization
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	4 weeks after randomization
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.	4 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 and 6 months after randomization
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	3 and 6 months after randomization ]
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.	3 and 6 months after randomization ]
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.	4 weeks, 3 and 6 months after randomization
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).	4 weeks, 3 and 6 months after randomization
Pelvic floor muscle strength - Subjective test	Pelvic floor strength will be analyzed by Bidigital vaginal palpation of the vaginal introitus.	4 weeks, 3 and 6 months after randomization
Pelvic floor muscle strength - Quantitative test	Pelvic floor strength will be analyzed by a clinical perineometer in cm H2O.	4 weeks, 3 and 6 months after randomization
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.	4 weeks, 3 and 6 months after randomization
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).	4 weeks, 3 and 6 months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	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).	4 weeks, 3 and 6 months after randomization
Anxiety	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).	4 weeks, 3 and 6 months after randomization
Satisfaction with care: Medrisk Instrument	Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care.	4 weeks after randomization

Collaborators and Investigators

• Sponsor: Universidade Federal do Piauí

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis
• Other Study ID Numbers: tDCS and Urinary Incontinence

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No