tDCS and Female Urinary Incontinence

NCT04084340 | Completed Phase 2 DMC

• 1 other identifier: tDCS and Urinary Incontinence
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Urinary leakage

  3 and 6 months after randomization

• Incontinence severity

  3 and 6 months after randomization ]

• Quality of life impact

  3 and 6 months after randomization ]

• Quality of life in women with UI (severity symptoms)

  4 weeks, 3 and 6 months after randomization

• Emotional impact

  4 weeks, 3 and 6 months after randomization

Other Outcomes (3)

• Depression

  4 weeks, 3 and 6 months after randomization

• Anxiety

  4 weeks, 3 and 6 months after randomization

• Satisfaction with care: Medrisk Instrument

  4 weeks after randomization

Study Arms (2)

Anodal tDCS + Exercises therapies

EXPERIMENTAL

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

Procedure: Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence

Sham tDCS + Exercises therapies

SHAM COMPARATOR

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

Interventions

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.

Anodal tDCS + Exercises therapies

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.

Sham tDCS + Exercises therapies

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complaining of urinary loss
• Seeking care for urinary incontinence

You may not qualify if:

• Grade III vaginal dystopias
• Intrapelvic tumors
• Cardiac pacemaker or other implanted devices
• Current pregnancy
• Urinary tract infections
• Previous treatment with tDCS

Sponsors & Collaborators

• Universidade Federal do Piauí: lead

Study Sites (2)

Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, 64202-020, Brazil

Location

Antonia Mykaele Cordeiro Brandao

Parnaíba, Piauí, 642020020, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor - Physical Therapy Department

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 10, 2019
• Study Start: November 14, 2019
• Primary Completion: January 15, 2021
• Study Completion: November 27, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)