Clinical trial NCT04084340: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urinary Incontinence
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Urinary leakage
timeFrame: 4 weeks after randomization
measure: Incontinence severity
timeFrame: 4 weeks after randomization
measure: Quality of life impact
timeFrame: 4 weeks after randomization
Secondary outcomes:
measure: Urinary leakage
timeFrame: 3 and 6 months after randomization
measure: Incontinence severity
timeFrame: 3 and 6 months after randomization ]
measure: Quality of life impact
timeFrame: 3 and 6 months after randomization ]
measure: Quality of life in women with UI (severity symptoms)
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Emotional impact
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Pelvic floor muscle strength - Subjective test
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Pelvic floor muscle strength - Quantitative test
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Urinary leaking
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Global perceived effect (GPE)
timeFrame: 4 weeks, 3 and 6 months after randomization
Other outcomes:
measure: Depression
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Anxiety
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Satisfaction with care: Medrisk Instrument
timeFrame: 4 weeks after randomization
Locations:
city: Parnaiba
country: Brazil
facility: Department of Physical Therapy. Federal University of Piaui
state: PIaui
city: Parnaiba
country: Brazil
facility: Antonia Mykaele Cordeiro Brandao
state: Piaui
Study officials:
References: