Urinary IncontinencePhase 2/3NCT04084340
tDCS and Female Urinary Incontinence
A Phase 2/3 study testing Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence in people with Urinary Incontinence, run by Universidade Federal do Piauí at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- 14 Nov 2019to 27 Nov 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complaining of urinary loss
- Seeking care for urinary incontinence
Who cannot join
- Grade III vaginal dystopias
- Intrapelvic tumors
- Cardiac pacemaker or other implanted devices
- Current pregnancy
- Urinary tract infections
- Previous treatment with tDCS
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Department of Physical Therapy. Federal University of Piaui
Parnaíba, Piauí, 64202-020
Antonia Mykaele Cordeiro Brandao
Parnaíba, Piauí, 642020020
About this study
Official title: 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.
- Conditions
- Urinary Incontinence
- Being tested
- Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence, Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real transcranial direct current stimulation + therapeutic exercises for urinary incontinenceProcedure or surgery
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 incontinenceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS + Exercises therapies | Experimental | Real transcranial direct current stimulation associated with therapeutic exercises
tDCS: 20 minutes, 2mA Receives: 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 Receives: Procedure: Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 4 weeks after randomization
Secondary outcomes (9)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 4 weeks, 3 and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start14 Nov 2019
- Primary completion15 Jan 2021
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Piauí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuad Ahmad Hazime, Universidade Federal do Piauí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084340
- Sponsor's protocol ID
- tDCS and Urinary Incontinence
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2019
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcranial Direct Current Stimulation Combined With Exercise Therapies in Female Urinary Incontinence: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04084340
- Acronym / sponsor ID
- tDCS and Urinary Incontinence
- Conditions
- Urinary Incontinence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS + Exercises therapies | Experimental | Procedure: Real transcranial direct current stimulation + therapeutic exercises for urinary incontinenceReal transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes, 2mA |
| Sham tDCS + Exercises therapies | Sham comparator | Procedure: Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinenceSham transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes (30 seconds ON), 2mA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complaining of urinary loss
- Seeking care for urinary incontinence
Key exclusion criteria (6 listed)
- Grade III vaginal dystopias
- Intrapelvic tumors
- Cardiac pacemaker or other implanted devices
- Current pregnancy
- Urinary tract infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real transcranial direct current stimulation + therapeutic exercises for urinary incontinenceReal 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. | Procedure or surgery | Anodal tDCS + Exercises therapies |
| Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinenceSham 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. | Procedure or surgery | Sham tDCS + Exercises therapies |
Primary outcome
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.
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
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.
9 secondary outcomes
Urinary leakage
Time frame: 3 and 6 months after randomization
Incontinence severity
Time frame: 3 and 6 months after randomization ]
Quality of life impact
Time frame: 3 and 6 months after randomization ]
Quality of life in women with UI (severity symptoms)
Time frame: 4 weeks, 3 and 6 months after randomization
Emotional impact
Time frame: 4 weeks, 3 and 6 months after randomization
Pelvic floor muscle strength - Subjective test
Time frame: 4 weeks, 3 and 6 months after randomization
Pelvic floor muscle strength - Quantitative test
Time frame: 4 weeks, 3 and 6 months after randomization
Urinary leaking
Time frame: 4 weeks, 3 and 6 months after randomization
Global perceived effect (GPE)
Time frame: 4 weeks, 3 and 6 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
Urinary Tract Infections, Stress Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence in people with Urinary Incontinence, run by Universidade Federal do Piauí at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary leakage (time frame: 4 weeks after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.