tDCS and Female Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084340
• Other study ID #: tDCS and Urinary Incontinence
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 14, 2019
• Est. completion date: November 27, 2023

Study information

• Verified date: November 2023
• Source: Universidade Federal do Piauí
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 27, 2023
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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 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.

Locations

Country	Name	City	State
Brazil	Antonia Mykaele Cordeiro Brandao	Parnaiba	Piaui
Brazil	Department of Physical Therapy. Federal University of Piaui	Parnaiba	PIaui

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Piauí

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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 ]
Secondary	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 ]
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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