The Effectiveness of Parassacral Transcutaneous Stimulation Compared to Tibial Transcutaneous Stimulation, Home Protocol and Behavioral Therapy in the Treatment of Female Hyperative Bladder: Randomized Clinical Trial

Study Overview
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Brief Summary
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Introduction: The overactive bladder is a highly prevalent condition, which negatively impacts the quality of life and daily activities of women. Transcutaneous electrostimulation is currently a therapeutic alternative for urinary urgency symptoms. Although it can be applied to the sacral plexus or tibial nerve, the literature shows the effectiveness of these two modalities, in isolation, but there are few scientific studies that compare them as two therapeutic alternatives. Primary objective: to evaluate the efficacy between parascutaneous electrostimulation, tibial transcutaneous stimulation, and home protocol in the treatment of female overactive bladder. Methodology: This is a clinical trial, which will include women with a clinical complaint of overactive bladder, with or without urgency-incontinence, who will be randomized into 3 groups: transcutaneous parasacral electrostimulation (EETP), transcutaneous tibial electrostimulation (EETT) and a third group, home transcutaneous parasacral electrostimulation (EETPD), will consist of women who have financial difficulties or locomotion to attend the clinic.All groups, in the first session, will be guided to conduct behavioral therapy and will receive an educational booklet with guidelines. The equipment to be used will have a wave frequency of 10 Hz, a pulse width of 700 µs and a 20-minute session, with intensities according to the participant's tolerance. The intervention protocol of the EETP group is 30 sessions, three times a week, with an active electrode in the parasacral region. For EETT, 30 sessions will also be held, three times a week, with the electrode active in the tibial region. Participants will be captured at educational events held by the Pelvic Floor Service Center in Salvador and the metropolitan region. Participants will answer the basic anamnesis questionnaires, ICIQ-OAB, ROMA III criteria, Bristol scale, Hospital Anxiety and Depression Scale, Oswestry scale, Pittsburgh sleep quality index and Female Sexual Function Index. Then, the assessment of the bladder neck and the thickness of the bladder wall will be performed by 2D ultrasonography via suprapubic and intravaginal, following the assessment protocol described for the intervention groups. Primary outcomes: clinical improvement of symptoms, urinary frequency, episodes of urgent urinary incontinence, presence of adverse effects and constipation. Secondary outcomes: quality of life, sexual function, quality of sleep, anxiety and depression, muscle function (PERFECT and electromyography), lumbar-pelvic pain (pain intensity) and ultrasound. Participants will be followed for a minimum of 12 months to verify the long-term response, returning every 3 months. Expected results: The outpatient transcutaneous parasacral electrostimulation is expected to be superior when compared to the tibial transcutaneous electrostimulation in the resolution of the symptoms of the overactive female bladder.

Official Title
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The Effectiveness of Parassacral Transcutaneous Stimulation Compared to Tibial Transcutaneous Stimulation, Home Protocol and Behavioral Therapy in the Treatment of Female Hyperative Bladder: Randomized Clinical Trial

Conditions
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Women, Transcutaneous Electrical Nerve Stimulation, Urgent Urinary Incontinence, Bladder Hyperactive

Intervention / Treatment
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* Device: parassacral transcutaneous electrostimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with symptoms of overactive bladder, aged 18 to 65 years. Exclusion Criteria: Participants who have difficulty understanding the stages of the research, report cognitive deficit or psychiatric illness, patients with congenital orthopedic / neurological diseases, overactive bladder due to neurological impairment, presence of lower urinary tract infection, sensory deficit in the sacral or tibial region, diagnosis of chronic renal failure, patients with pacemakers and implantable cardioverter defibrillators and pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parasacral transcutaneous electrostimulation outpatient<br>electrostimulation device | Device: parassacral transcutaneous electrostimulation<br>* Use of parassacral transcutaneous electrostimulation<br>|
| Experimental: transcutaneous tibial electrostimulation outpatient<br>electrostimulation device | Device: parassacral transcutaneous electrostimulation<br>* Use of parassacral transcutaneous electrostimulation<br>|
| Experimental: home parasacral electrostimulation<br>electrostimulation device | Device: parassacral transcutaneous electrostimulation<br>* Use of parassacral transcutaneous electrostimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of urinary leakage episodes | Clinical improvement of symptoms of urinary leakage episodes analyzed by voiding diary, urofluxometry and International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) | 90 days | 
| Reduction in urinary frequency | Reduction in the number of daily urination analyzed by voiding diary , urofluxometry, 2 D ultrasonography and International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) | 90 days | 
| Clinical improvement of constipation | Effort in bowel movements, stool shape, number of weekly bowel movements analyzed by Rome, Bristol criterion and 2 D ultrasonography | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring quality of life by questionnaire | Will be used the King´s Health Questionnaire (KHQ) | 90 days | 
| Sexual function | Will be used the questionnaire of Female Sexual Function (FSFI) | 90 days | 
| Quality of sleep | Will be used the Pittsburgh sleep quality index (PSQI) | 90 days | 
| Anxiety and depression | Scale of the Hospital Anxiety and Depression Scale (HADS) | 90 days | 
| Muscle function | Analyze through the PERFECT test and by electromyography | 90 days |